PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley
Personnel Information 1
Vulnerable Subject Checklist 4
Study Sites 5
General Checklist 6
Funding 7
Expedited Paragraphs 10
Purpose, Background, Collaborative Research 13
Subject Population 16
Study Procedures, Alternatives to Participation 19
Radiation 22
Medical Equipment, Investigational Devices 23
Drugs, Reagents, or Chemicals 24
Risks and Discomforts 25
Benefits, Confidentiality 27
Potential Financial Conflict of Interest 30
Informed Consent 31
Child Assent & Parent Permission 33
HIPAA 35
Attachments 37
Assurance 40 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley
Event History 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------1
* * * Personnel Information * * * Enter all UC Berkeley study personnel (if not previously entered) and relevant training information. Please read Personnel Titles and Responsibilities: Roles in eProtocol before completing this section.
Note: The Principal Investigator or Faculty Sponsor, Co-Principal Investigator, Student or Postdoctoral Investigator, Administrative Contact, and Other Contact can EDIT and SUBMIT. Other Personnel can only VIEW the protocol.
Principal Investigator or Faculty Sponsor
Name of Principal Investigator Degree (e.g., MS/PhD) Title Adam Arkin PhD Professor Email Phone Fax [email protected] +1 510 643-5692 +1 510 642-9725 Department Name Mailing Address Bioengineering 94704-5230 UCB status (select all that apply): X Faculty Postdoc Grad Undergrad Other Faculty (with some exceptions), staff, and students engaged in human subjects research must complete either the biomedical or social-behavioral human research course through the online Collaborative Institutional Training Initiative (CITI), depending upon which is most germane to the research. ALL PIs on an NIH award are required to complete either CITI or NIH Training. See Training and Education for more information.
If applicable, please insert date (mm/dd/yy) of completion in appropriate box(es) below: CITI NIH Other Training (title & date completed) 05/08/16
Student or Postdoctoral Investigator
Note: All Student/Postdoc Investigators must have a Faculty Sponsor who will serve as the "responsible researcher." If NOT a student or postdoc project, enter the student(s) and/postdoc(s) under Other Personnel below. Name of Student/Postdoc Investigator Degree Title Ryan H HSU Undergraduate Researcher Email Phone Fax
Page 1 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------2 [email protected] 5305748265 Department Name Mailing Address Plant & Microbial Biology UCB status (select all that apply): Faculty Postdoc Grad X Undergrad Other Faculty (with some exceptions), staff, and students engaged in human subjects research must complete either the biomedical or social-behavioral human research course through the online Collaborative Institutional Training Initiative (CITI), depending upon which is most germane to the research. ALL PIs on an NIH award are required to complete either CITI or NIH Training. See Training and Education for more information.
If applicable, please insert date (mm/dd/yy) of completion in appropriate box(es) below: CITI NIH Other Training (title & date completed) 01/28/2016
Administrative Contact
Name of Administrative Contact Degree Title Gwyneth TERRY Administrator Email Phone Fax [email protected] +1 510 643-5692 +1 510 486-6219 Department Name Mailing Address 94704-5230 UCB status (select all that apply): X Faculty Postdoc Grad Undergrad Other
Other Personnel
Page 2 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------3
Name Degree Title Department Name Katherine Louise Undergraduate Integ Biol SCHREINER Researcher MITCHELL LEE Undergraduate Integ Biol JOAQUIN JR SEITZ Researcher DYLAN MICHAEL Undergraduate Molecular & Cell Biology MCCORMICK Researcher
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Page 3 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------4
* * * Vulnerable Subject Checklist * * *
Vulnerable Subject Checklist Yes No N Children/Minors N Prisoners N Pregnant Women N Fetuses N Neonates N Educationally Disadvantaged N Economically Disadvantaged N Cognitively Impaired N Other (i.e., any vulnerable subject population(s) not specified above)
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Page 4 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------5
* * * Study Sites * * *
Study Sites Select All That Apply : International International Site(s) (specify country, region, and township or village)
Local X UC Berkeley UC Davis UC Irvine UC Los Angeles UC Merced UC Riverside UC San Diego UC San Francisco UC Santa Barbara UC Santa Cruz Lawrence Berkeley National Laboratory Alameda Unified School District (specify schools below)
Berkeley Unified School District (specify schools below)
Oakland Unified School District (specify schools below)
X Other (Specify other Study Sites) uBiome Inc. ------
Page 5 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------6
* * * General Checklist * * * General Checklist Yes No N Is the research receiving any federal funding (e.g., NIH, NSF, DOD, etc.)? N Is another campus relying on UC Berkeley for IRB review by means of the UC System Memorandum of Understanding (MOU)? N Is another institution relying on UC Berkeley for IRB review by means of an Inter-institutional IRB Authorization Agreement? N Will subjects be paid for participation? N Is this protocol administratively supported by Campus Shared Services Team 9? N Does this research fall under FDA regulations? Y Any use of human blood, body fluids, tissues, or cells (including cell lines)* by drawing samples, accepting samples already drawn, receiving samples from any source, or in any other way? If yes, Lab Location: uBiome, Inc. And Biological Use Authorization (BUA) #(s): N/A N Will biological specimens be stored for future research projects? Y Will specimens be sent out of UCB as part of a research agreement? N Will proprietary drug or device testing be done? N Any use of embryonic stem cells? *NOTE: If research involves embryonic stem cells, see UCB Stem Cell Policy and Committee. N Any use of medical devices or equipment cleared/approved for marketing? N Any use of any experimental or investigational devices or equipment (i.e., not cleared/approved for marketing?) N Any use of commercially available drugs, reagents, or other chemicals administered to subjects (even if drugs themselves are not being studied)? N Any use of investigational drugs, reagents, or chemicals (i.e., not cleared/approved for marketing)? ------
Page 6 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------7
* * * Funding * * *
Funding Checklist
If the research is not funded, check the "Not Funded" box below. If the research is funded, add the funding source to the appropriate table below.
NOTE: Only the Principal Investigator (PI) of the grant or subcontract can add his or her own SPO Funding information in this section. The PI of the grant must also be listed in the Personnel Information section of the protocol in one of the following roles: Principal Investigator or Faculty Sponsor, Student or Postdoctoral Investigator, Co-Principal Investigator, Administrative Contact, or Other Contact. Training Grants can be added by anyone in one of the aforementioned roles. For step-by-step instructions, see Add SPO Funding Quick Guide Not Funded
SPO - Funding
Funding - Other
Page 7 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------8
Funding Sponsor/Provi # Title Amount Begin End Narrative Lead PI Type der Descripti (If on different from Protocol PI) Crowdso 6405 Funding urced for the Fundraisi project ng was (Crowdfu privately nding) sourced through crowdfun ding at experime nt.com (https://e xperimen t.com/pro jects/imp act-of- soylent- consumpt ion-on- human- microbio me- compositi on). $6405 has been raised to conduct the study.
Funding - Other
Funding Type Other Crowdsourced Fundraising (Crowdfunding) Sponsor/Provider # Title Amount 6405
Page 8 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------9
Begin End Narrative Description Funding for the project was privately sourced through crowdfunding at experiment.com (https://experiment.com/projects/impact-of-soylent- consumption-on-human-microbiome-composition). $6405 has been raised to conduct the study. Lead PI (If different from Protocol PI)
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Page 9 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------10
* * * Expedited Paragraphs * * *
Request for Expedited Review
An expedited review procedure consists of a review of research involving human subjects by the IRB Chair, or by one or more experienced reviewers designated by the Chairperson from among the members of the committees.
In order to be eligible for expedited review, ALL aspects of the research must include activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures included in one or more of the specific categories listed below.
If requesting Expedited Review, select one or more of the applicable paragraph(s) below. (DO NOT select any paragraph(s) if your protocol does not qualify for expedited review. Protocols that do not qualify for expedited review will be reviewed by the full (convened) Committee.)
1. Clinical studies of drugs and medical devices only when conditions (a) and (b) are met.
a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
b) Research on medical devices for which
i) an investigational device exemption application (21 CFR Part 812) is not required; or ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
a) From healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
b) From other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
Page 10 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------11
3. Prospective collection of biological specimen for research purposes by non-invasive means. Examples: a) hair and nail clippings in a non-disfiguring manner; b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; c) permanent teeth if routine patient care indicates a need for extraction; d) excreta and external secretions (including sweat); e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; f) placenta removed at delivery; g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; j) sputum collected after saline mist nebulization.
4. Collection of data through non-invasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
Examples: a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; b) weighing or testing sensory acuity; c) magnetic resonance imaging; d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
5. Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (NOTE: Some research in this paragraph may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
Page 11 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------12
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
8. Continuing review of research previously approved by the convened IRB as follows:
a) Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or b) Where no subjects have been enrolled and no additional risks have been identified; or c) Where the remaining research activities are limited to data analysis.
9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. ------
Page 12 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------13
* * * Purpose, Background, Collaborative Research * * *
Old CPHS # (for Protocols approved before eProtocol)
Study Title Impact of Soylent Consumption on Human Microbiome Composition
Complete each section. When a question is not applicable, enter "N/A". Do not leave any sections blank. 1. Purpose Provide a brief explanation of the proposed research, including specific study hypothesis, objectives, and rationale. Soylent 2.0 is a popular meal replacement drink that is used to supplement or replace one’s regular diet. Soylent is designed to fully fulfill one's nutritional needs, but its impact on the human microbiome remains unknown. This study aims to track the composition of participants’ gut microbiomes before, during, and after Soylent consumption to more holistically understand its impact on microbiome health. We predict that a short term Soylent-based diet will induce observable and reversible changes to participants’ gut microbiomes.
2. Background
Give relevant background (e.g., summarize previous/current related studies) on condition, procedure, product, etc. under investigation, including citations if applicable (attach bibliography in Attachments section). The important role of the human gut microbiome in overall health is becoming increasingly understood. While most medical studies have focused on disease, such as Clostridium difficile infection or Irritable Bowel Syndrome, human microbiome composition has much further reaching implications than just to patients (1, 3). Diet has been shown to rapidly and reproducibly alter the human gut microbiome, with distinct diets showing distinct microbiome communities (2). This study aims to observe and characterize the effects of Soylent, a popular meal replacement, on human microbiome compositions. Soylent is a popular meal replacement and is classified by the FDA as food (5). Consumption of five servings of Soylent a day fully provides 2000 calories and satisfies all major recommended daily values, including a majority of vitamins and minerals (4). Diversity of microbial species is also introduced through food, and individual species of bacteria found on food prior to consumption have been shown to later reside in the human gut (2). Soylent is sterile, and therefore may reduce the amount of microbial diversity introduced through one's diet. Human gut microbiome compositions will be measured using the commercially available uBiome Gut Kit. Sampling is done by swabbing used toilet paper with the sterile kit and sending the sample to uBiome (6).
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uBiome then sequences bacterial 16s rRNA genes in the sample to resolve composition data (6). uBiome is fully complaint with HIPAA regulations and has an IRB for their testing (6). No human DNA is sequenced as part of this study.
3. Collaborative Research a) If any non-UCB institutions or individuals are engaged in the research, explain their human research roles and what human subjects training they have/PI has planned to provide. We will purchase uBiome's commercially available Gut DNA Kit and use their bacterial DNA sequencing service for this study. Participants in our study will sample their microbiomes by swabbing their used toilet paper using the provided sterile swab. This swab will be secured in a buffer and sealed in a prepaid postage envelope by the participant immediately. The packages will be mailed to uBiome, where the bacterial DNA will be extracted and sequenced. The DNA sequencing files will be sent back to the researchers. No BUA is required for this study because no UC Berkeley researcher will be handling the samples in any way. All samples will be processed in a CLIA certified laboratory (written confirmation attached: CLIA.pdf). We are using uBiome solely as a service provider. uBiome is not a research collaborator for our study.
b) If any non-UCB institutions or individuals are collaborating in the research, complete the table below and attach any relevant IRB approvals in the Attachments section.
Non-UCB institutions Institution Name Individual FWA # Local IRB IRB Approval IRB Approval Contact/ Affiliate Review? (Y or Date Expiration Date of Institution N) uBiome, Inc. Orli Kadoch 00006502 N
4. Qualifications of Study Personnel a) Explain expertise of Principal Investigator, Student/Postdoc Investigator, Faculty Sponsor (if applicable), any Co-Investigators or other key personnel listed in the application, and how it relates to their specific roles in the study team. Principle Investigator: Adam Arkin is an expert in environmental genomics and the systems and synthetic biology of microbes and their communities. As such he will advise on the protocols for processing and analysis of microbiome samples as needed by the project team and ensure overall adherence to the human and safety protocols. Student Investigators: Ryan Hsu, Dylan McCormick, Kate Schreiner and Mitchell Seitz are all UC Berkeley undergraduates in their 4th year studying a variety of Biology related majors. All four undergraduates have
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had at least two years of laboratory research experience and have conducted hypothesis driven research. Ryan and Dylan have experience performing computational analysis of microbiome sequencing data and will be primarily responsible in the scientific analysis of the study. Kate and Mitchell have experience in leadership and organization of student groups and will be responsible for coordinating the research participants in the study.
b) In case of international research, describe the expertise you have, or have access to, which prepares you to conduct research in this location and/or with this subject population, including specific qualifications (e.g., relevant coursework, background, experience, training). Also, explain your knowledge of local community attitudes and cultural norms, and cultural sensitivities necessary to carry out the research. See Human Subjects Research in an International Setting and CPHS Guidelines on Research in an International Setting. N/A
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Page 15 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------16
* * * Subject Population * * *
5. Subject Population a) Describe proposed subject population, stating age range, gender, race, ethnicity, language and literacy. The subject population will consist of undergraduate UC Berkeley students with no health complications or food allergies. Eligible subjects may be of any language, gender, race or ethnicity. Age is restricted to 18- 30. Since subjects will be chosen from the UC Berkeley undergraduate student body, proficiency in the English language and literacy are expected. b) State total (maximum) number of subjects planned for the study and how many must be recruited to obtain this sample size. Explain how number of subjects needed to answer the research question was determined. The maximum number of participants in this study is 20. The main comparison of this study will be done between the microbiomes of regular diet vs soylent diet participants. c) If any proposed subjects are children/minors, prisoners, pregnant women, those with physical or cognitive impairments, or others who are considered vulnerable to coercion or undue influence, state rationale for their involvement. N/A
6. Recruitment a) Explain how, where, when, and by whom prospective subjects will be identified/selected and approached for study participation. If researcher is subject's instructor, physician, or job supervisor, or if vulnerable subject groups will be recruited, explain what precautions will be taken to minimize potential coercion or undue influence to participate. See CPHS Guidelines on Recruitment for more information. Recruitment for the study will occur at a general meeting for Mycrobes, a UC Berkeley student organization. The informed consent documents will be distributed to the members of the organization, and the researchers will verbally review the documents and aspects of the study during the meeting. To reduce likeliness of undue influence, members will take home a copy of the consent form for consideration. At the next general meeting, all members will be provided with the following on paper: 1. A new consent document 2. A screening form 3. A participant ID (on a sheet of paper) The members will then be asked to do one of the following: 1. If they consent, fill in the consent document and screening form with the provided participant ID. Return all three documents once completed. 2. If they do not consent, do not fill in the forms. They may return the unfilled forms when they choose to.
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This will reduce social pressure, since forms will be collected even from individuals who are not participating in the study. Individuals will turn in their forms one by one at a table with one of the researchers. If the individual is consenting to research, the researcher will record the individuals name, email address, and participant ID onto our single copy linking document described throughout the protocol. b) Describe any recruitment materials (e.g., letters, flyers, advertisements [note type of media/where posted], scripts for verbal recruitment, etc.) and letter of permission/cooperation from institutions, agencies or organizations where off-site subject recruitment will take place (e.g., another UC campus, clinic, school district). Attach these documents in Attachments section. Please see eProtocol Attachments Check List for Non-Exempt Applications for more information. Members of the Mycrobes student organization will be informed about the study via the informed consent document and a verbal review of the document by the researchers during a general meeting. c) Will anyone who will be recruiting or enrolling human subjects for this research receive compensation for each subject enrolled into this protocol? If yes, please identify the individual(s) and the amount of payment (per subject and total). No compensation will be given.
7. Screening a) Provide criteria for subject inclusion and exclusion. If any inclusion/exclusion criteria are based on gender, race, or ethnicity, explain rationale for restrictions. Vulnerable individuals as defined by the CPHS guidelines will be excluded, such as pregnant women.
Soylent's ingredients and nutritional facts will be passed out along with the screening document (attached: Soylent_Nutritional_Facts.pdf). Individuals who report allergies or sensitivities to any of the ingredients will be excluded. Individuals who report health issues, including those that may impact diet, will also be excluded. Individuals who regularly take substances that may complicate diet or gut bacteria, including antibiotics, probiotics, coffee, alcohol, or supplements, will also be excluded. If there is an excess of willing participants, individuals will be chosen to ensure a diverse spread of reported diets (i.e. vegetarian, vegan, meat-rich, other unique diets). b) If prospective subjects will be screened via tests, interviews, etc., prior to entry into the "main" study, explain how, where, when, and by whom screening will be done. NOTE: Consent must be obtained for screening procedures as well as "main" study procedures. As appropriate, either: 1) create a separate "Screening Consent Form;" or 2) include screening information within the consent form for the main study. Participants will be screened using our screening questions form (attached: Screening Questions.pdf)
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during a Mycrobes weekly meeting by the researchers.
8. Compensation and Costs a) Describe plan for compensation of subjects. If no compensation will be provided, this should be stated. If subjects will be compensated for their participation, explain in detail about the amount and methods/ terms of payment.
Include any provisions for partial payment if subject withdraws before study is complete.
When subjects are required to provide Social Security Number in order to be paid, this data must be collected separately from consent documentation. If applicable, describe security measures that will be used to protect subject confidentiality.
If non-monetary compensation (e.g., course credit, services) will be offered, explain how No compensation will be given. b) Discuss reasoning behind amount/method/terms of compensation, including appropriateness of compensation for the study population and avoiding undue influence to participate. N/A c) Costs to Subjects. If applicable, describe any costs/charges which subjects or their insurance carriers will be expected to pay. (If there are no costs to subjects or their insurers, this should be stated.) There will be no costs to the participants. uBiome Kits and Soylent will be provided by the researchers. ------
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* * * Study Procedures, Alternatives to Participation * * *
9. Study Procedures a) Describe in chronological order of events how the research will be conducted, providing information about all study procedures (e.g., all interventions/interactions with subjects, data collection procedures etc.), including follow-up procedures. If any interviews, questionnaires, surveys, or focus groups will be conducted for the study, explain and attach one copy each of all study instruments (standard and/or non- standard) in the Attachments section. Please see eProtocol Attachments Check List for Non-Exempt Applications for more information. If the proposed research involves use of existing data/specimens, describe how data/specimens will be acquired. Prior to the main study: Consent forms, screening documents, and participant IDs are all simultaneously given to our club members. Individuals who sign the consent form and fill out the screening document (attached: Screening Questions.pdf) will have their participant IDs recorded as described in part 6. Their name, email address, and ID number will be recorded on a participant reference sheet as entries in a physical notebook. This notebook will not be copied and will remain locked in a document cabinet or in the possession of one of the investigators during use. This will serve as the link between the participant ID and the individual. Once all of the study data is received, this document will be shredded. Conducting the study: After collecting this preliminary information, main study participants will be chosen based on our described inclusion/exclusion criteria. Ryan Hsu, Dylan McCormick, Katherine Schreiner, and Mitchell Lee Seitz will distribute eight uBiome gut kits to each participant in preparation for the study. The study duration is 10 days and consists of three phases: In Phase A, participants will adhere to their regular diet for two days. This initial condition provides a baseline of each participant’s unique microbiome, acting as an internal control. In Phase B, a subset of the participants, which will be chosen by random drawing from a box, will switch to an all-Soylent diet. During this phase, they will consume five bottles of Soylent 2.0 daily for four days (one for breakfast, two for lunch, and two for dinner), fully meeting a 2000kcal diet and all recommended nutritional daily values (attached: Soylent_Nutritional_Facts.pdf). The remaining participants will retain their regular diets for four days. These individuals act as a control for the daily variance of microbiome fluctuations. In Phase C, participants will return to their regular diets for four days, after which the study will conclude. For the duration of the study, participants will log their diets and bowel movements electronically on a daily basis. A printout of the Bristol Stool Chart (attached: Bristol_Stool_Chart.pdf) will be provided at the beginning of the study to each participant. Each entry will be logged through a Google Form and labeled with each individual's participant ID, which will link them to their responses. The link will include name, email, and phone number. The completed forms are only accessible through a single Google account, which is password protected, encrypted, and only accessible by the investigators (attached: Daily Log Form.pdf). In addition, participants will sample their microbiomes using the uBiome gut kits on the following days: 1, 2, 3, 4, 5, 6, 7, and 10. Sampling is done by swabbing used toilet paper after bowel movements. Participants will seal the samples in the kits and mail them to uBiome with the included prepaid postage. The investigators will not come into direct contact with any of the samples.
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All electronic logs and samples will be labeled with each participant's unique participant ID. The link between each participant and their sample kits will be maintained on the participant reference sheet kept by the researchers. uBiome will not have access to this link. Samples sent to uBiome will only be labeled with the kit serial number and will not include any participant- related information. If participants wish to receive a copy of their own sampling data, they can provide identifiable information to uBiome by creating an account on their website. If the participant chooses to create such an account, they will be asked to register each kit (via serial number) to their individual account to separately receive a copy of their own data. This allows uBiome to maintain a link between participant and samples separately from our link. Registering kits with uBiome is completely optional and up to each participant whether or not to do it. Once all data in the study has been received, the participant reference sheet will be shredded and all of the data will become unidentifiable. While Soylent has no documented instances of causing physical complications to consumers, if any participant feels unwell during any point in the study, they are encouraged to cease participation and contact their primary care doctor for guidance. Performing analysis: Results from the uBiome gut kits will be received in about four to six weeks. uBiome will share the data individually with each participant (if participants chose to create an account and register their kits as stated above) and in bulk with the researchers. For participants that did not register their kits with uBiome, the data generated from those participants will only be sent to the researchers. The data consists of sequencing data labeled with each kit's serial number. We will then correlate our electronic log data with the uBiome sample data for further analysis. The data generated in this study is in no way intended for medical diagnosis of any kind. uBiome's website states the following: "It’s important to be aware that uBiome is designed to be a tool for personal research, NOT a diagnostic tool. You won't find any predictions about your future health. And your results will not diagnose any medical condition." b) Explain who will conduct the procedures, where and when they will take place. Indicate frequency and duration of visits/sessions, as well as total time commitment for the study. Participants will sample their own microbiome using the uBiome Gut kits by swabbing used toilet paper. The samples will be immediately sealed by the participants and mailed to uBiome directly. The wet-lab procedures will be conducted by uBiome Inc, which involves extracting bacterial DNA and bacterial DNA sequencing. uBiome will send the processed data to the UC Berkeley investigators for analysis in a coded non-identifiable way. The participants perform the sampling on their own time during the week. The duration of this study is 10 days, during which participants' diets will be controlled and logged. No BUA is required for this study because no UC Berkeley researcher will be handling any of the stool samples. c) Identify any research procedures that are experimental/investigational. Experimental or investigational procedures are treatments or interventions that do not conform to commonly accepted clinical or research practice as may occur in medical, psychological, or educational settings. Note: if the study only involves standard research or clinical procedures, state "N/A." N/A
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d) If a placebo will be used, provide rationale and explain why active control is not appropriate. N/A e) If any type of deception or incomplete disclosure will be used, explain what it will entail, why it is justified, and what the plans are to debrief subjects. See CPHS Guidelines on Deception and Incomplete Disclosure for more information. Any debriefing materials should be included in the Attachments section. N/A f) State if audio or video recording will occur and for what purpose (e.g. transcription, coding facial expressions). N/A
10. Alternatives to Participation Describe appropriate alternative resources, procedures, courses of treatment, if any, that are available to prospective subjects. If there are no appropriate alternatives to study participation, this should be stated. If the study does not involve treatment/intervention, enter "N/A" here. N/A ------
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* * * Radiation * * *
11. Ionizing Radiation (e.g. X-ray) and Non-ionizing Radiation (e.g. MRI) a) Do you intend to use ionizing radioactive materials or ionizing N radiation-producing devices in your research (e.g., injectable, oral, x- rays, etc.)? CAUTION: The UCB Radioactive Materials License does not permit human research using radioactive materials or radiation from such materials.
If Yes, provide Radiation Use Authorization (RUA) number(s): Note: The research may not proceed without an RUA. Please visit: http://www.ehs.berkeley.edu/how-create-new-radiation-use-authorization-rua b) Do you intend to use any non-ionizing radiation sources (laser or N magnetic sources) in your research?
If Yes, provide Laser Use Registration (LUR) number(s):
And/or Magnetic Inventory number(s):
Note: The research may not proceed without an LUR or Magnetic Inventory Number. Please visit: http://ehs.berkeley.edu/laser-safety/how-do-i-register-my-new-laser
c) Describe the source of ionizing radiation or non-ionizing radiation. N/A
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* * * Medical Equipment, Investigational Devices * * *
12. Medical Equipment
If the research involves use of medical equipment, explain whether the equipment is approved for marketing and routinely employed in clinical practice. N/A
13. Investigational Devices List in the table below all Investigational Devices to be used on subjects Investigational Devices
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* * * Drugs, Reagents, or Chemicals * * *
14. Drugs, Reagents, or Chemicals a) List in the table below all investigational drugs, reagents or chemicals to be administered to subjects during this study.
b) List in the table below all commercial drugs, reagents or chemicals to be administered to subjects during this study.
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* * * Risks and Discomforts * * *
15. Risks and Discomforts
a) Describe all known risks and discomforts associated with study procedures, whether physical, psychological, economic or social (e.g., pain, stress, invasion of privacy, breach of confidentiality), noting the likelihood and degree of potential harm. Subjects may experience physical discomfort resulting from consuming Soylent, including gastrointestinal discomfort, bloating, constipation, diarrhea, and increased frequency of bowel movements. Additionally, stools may become more liquid. As such, participants are able to leave the study at any period if they feel unwell, and will be encouraged to contact their primary care provider. The amount of Soylent consumed in this study will fully meet the recommended daily values for all nutritional requirements (attached: Soylent_Nutritional_Facts.pdf). Soylent consumption has no reported or documented psychological, economic, or social risks. Furthermore, participation in this study has minimal psychological, economic, and social risks.
b) Discuss measures that will be taken to minimize risks and discomforts to subjects.
Participants will be encouraged to leave the study and contact their primary care physician in the case that they feel unwell in any way as a result from participation in the study.
c) If applicable, indicate if a particular study treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable. N/A
d) If applicable, describe the Data Safety Monitoring Plan (DSMP). NIH may require a DSMP for some projects. N/A
e) Explain how unanticipated negative outcomes/experiences or serious adverse events will be managed. (NOTE: This may apply in social-behavioral as well as biomedical research, e.g., undue stress or anxiety of subject, breach of confidentiality via loss of laptop computer with study data. Provisions should be made and described here if applicable.) Participants will be encouraged to leave the study and contact their primary care physician in the case that they feel unwell in any way as a result from participation in the study.
f) Discuss plans for reporting unanticipated problems involving risks to subjects or others, or serious adverse
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events, to CPHS. (This applies to all types of research.) See Adverse Event and Unanticipated Problem Reporting. An initial report will be made by phone and email to the Director of Research Subject Protection within 7 days of the incident. The initial report will be followed by a formal written report within no more than two weeks of the Principal Investigator learning of the incident.
g) Describe plans for provision of treatment for study-related injuries, and how costs of injury treatment will be covered. If the study involves more than minimal risk, indicate that the researchers are familiar with and will follow University of California policy in this regard, and will use recommended wording on any consent forms (see CPHS Informed Consent Guidelines). The study involves no more than minimal risk. ------
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* * * Benefits, Confidentiality * * *
16. Benefits Describe any potential benefits to the individual subject, group of subjects, and/or society. If subjects will not benefit directly from study procedures, this should be stated.
NOTE: Do not include compensation/payment of subjects in this section, as remuneration is not considered a "benefit" of participation in research. Although this study does not intend to diagnose any diseases, we hope it will provide foundational knowledge for future microbiome research linking microbiome health to dietary choices.
17. Confidentiality and Privacy
NOTE: See CPHS Data Security Policy and Guidelines before completing this section. a) If reviewing or accessing Protected Health Information (PHI) from UC Berkeley's Tang Center, Optometry Clinic, Psychology Clinic, Intercollegiate Athletics, or Human Resources for activities preparatory to research, describe the process and confirm that the health information will not be removed from the "covered entity". N/A b) What identifiable participant data will you obtain? Note: Audio, photo, and video recordings are generally considered identifiable unless distinguishing features can be successfully masked. Name, email, and phone number will be obtained for correspondence with participants during the study. c) If obtaining existing data/specimens, will you have access to identifiers? Please see The Industry Alliance Office website for requirements when receiving existing data/specimens for research. N/A d) Explain how the confidentiality of subject information will be maintained. Include:
i. Who will have access to study records/specimens? If the study is subject to FDA regulations, include a statement that the FDA might inspect the records of the study.
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Only the 5 researchers listed on this IRB will have access to the study records. Specimens are not handled by any UC Berkeley researcher. Specimens are handled by uBiome Inc. uBiome may retain the stool samples for future R&D purposes indefinitely. They will also store a copy of the sequencing data according to their policies.
ii. How the records will be secured (e.g., password-protected computer, encrypted files, locked cabinet). Response should be consistent with CPHS Data Security Policy. Records and data will be stored on personal computers encrypted by Apple FileVault encryption and under a password. The single copy physical document linking participants to their IDs will locked in a cabinet while not in use, or directly in possession by one of the investigators during use. It will be shredded after all data has been collected. Google Form information will be accessible via a single encrypted and password protected account.
iii. How long study data will be retained. Study data generated by the researchers will be retained for 3 to 10 years after the end of the study. uBiome will separately retain the sequencing data according to its policies. After screening has taken place, screening information from participants who are not selected for the main study will be immediately destroyed.
iv. When audio/video recordings will be transcribed and when they will be destroyed (if ever). N/A e) Identifiers should be removed from data/specimens as soon as possible following collection, except in cases where the identifiers are embedded (e.g., voices in audio or faces in video recordings). If data are coded in order to retain a link between the data and identifiable information, explain where the key to the code will be stored, how it will be protected, who will have access to it, and when it will be destroyed. The data will be coded via a participant ID assigned to each participant. The link between data and individual will be stored on a physical single copy document. This document will remain in a locked cabinet while not in use. While in use, it will be directly in possession of an investigator at all times. It will be destroyed once all study data has been collected. f) Describe how identifiable data will be transferred (e.g., courier, mail) or transmitted (e.g., file transfer software, file sharing, email). If transmitted via electronic networks, describe how you will secure the data while in transit (e.g., prior encryption). If not applicable, enter N/A. Identifiable data will only be stored physically on paper and be collected by investigators in person. All identifiable data will be stored in a locked cabinet while not in use. Unidentifiable bulk sequencing data will be sent from uBiome to the researchers via a secure download link. g) Will subjects be asked to give permission for release of identifiable data (e.g., for future studies, publications, presentations, etc.), now or in the future? If so, explain here and include appropriate
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statements in the consent materials. See Media Records Release Form template for guidance. No. h) Explain how subject privacy will be protected (e.g., conducting interviews in a discreet location). Prior to the main part of the study, participants will fill out the screening questions form during a Mycrobes general meeting in a classroom on campus. All parts of the main study can be done in any private location. These parts include food consumption, completing daily log forms, and microbiome sampling.
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* * * Potential Financial Conflict of Interest * * * 18. Potential Financial Conflict of Interest
Individuals who have independent roles in projects and who are responsible for the design, analysis, conduct, or reporting of the results of research performed (or to be performed) under a human subjects protocol must disclose whether or not they have a financial interest in or association with the sponsor or the company supplying materials, drugs, or devices for the project. This checklist pertains to the entire project team working under the protocol. Any individual who has a conflict must comply with University regulations and procedures for disclosure of financial conflict of interest.
See Conflict of Interest Committee Website for more information.
Please answer the following questions:
Does any member of the project team (defined as UCB or non-UCB personnel working under the protocol) with substantive responsibility for the design, conduct, or reporting of activities under the protocol, or any member of their immediate family (defined as spouse, dependent child or registered domestic partner) have any of the following relationships with the non-UC entity financing the research to be done under the protocol or the non-UC entity supplying materials, drugs or devices being tested under the protocol:
1. N Positions of management (e.g., board member, scientific advisor, director, officer, partner, trustee, employee, consultant). 2. N Equity interest (e.g., stock, stock options, investment, or other ownership). 3. N Rights to a pending patent application or issued patent to any invention(s), or license rights or copyright for software that has a direct relationship to the project proposed.
If the answer to any of the above is Yes, then each individual with any "Yes" response (s) must submit a Human Subjects Financial Conflict of Interest Form DIRECTLY to the Conflict of Interest (COI) Committee for a separate review.
NOTE: When review by the COI Committee is required, CPHS approval or exemption of protocols will be contingent upon the disclosure and resolution of all financial conflicts of interest, as determined by the COI Committee. ------
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* * * Informed Consent * * *
19. Informed Consent
Add the consent documents and/or waivers needed for this research using the table at the bottom of the page, including any translated versions. For any translated consent, include an affirmation of the translation's accuracy, indicating who is affirming the accuracy (PI, Co-PI, or Student Investigator), in the Consent/Waiver Description or in the Attachment section. Describe the consent process and provide justification for any waivers for each consent document, translation, and/or waiver. The various consent/waiver options are described below. Note: DO NOT include child assent documents, parent permission documents or waivers here (these are addressed in the next section).
Altered and Unsigned Consent - A consent document that has omitted required information and does not include a place for a participant's signature. This means that CPHS is being asked to waive one or more elements of consent in addition to the requirement for documented consent.
Altered Consent Form - A consent form that has omitted required information. This means that the CPHS is asked to waive one or more required elements of informed consent. For example, if the purpose of the study will not be disclosed to participants in order to avoid bias, this option should be selected because disclosure of the "purpose" is a required element of informed consent. The form must include a signature line and date line for the individual to sign if he or she agrees to participate.
Consent Form - A standard consent document that embodies all of the required information (elements of informed consent) designed to help an individual make an informed decision about whether or not to participate in the research. The form must include a signature line and date line for the individual to sign if he or she agrees to participate. The Consent Form can also be presented as a "short form" document stating that the required elements of informed consent have been presented orally to the participant. When the short form method is used, a "summary" of the information that is presented to the participant must also be provided for CPHS approval and there must be an impartial witness to the oral presentation. The witness must sign the summary as well as the short form and the participant must sign the summary. The "short form" method may be used in circumstances where oral presentation of consent is preferable or necessary, e.g., subjects are illiterate in English or their native language.
Consent Waiver - No consent will be sought at all. This means that the CPHS is asked to waive the requirement for informed consent. This option is often appropriate for research that involves use of existing data or samples
Unsigned Consent - A document that embodies all of the required information (elements of informed consent), but does not include a place for a participant to indicate with a signature that he or she agrees to
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take part in the research. This means that the CPHS is asked to waive the requirement for documented (signed) consent. For example, if consent will be obtained verbally or using a button on the web, this option should be selected.
•Informed Consent Guidelines, Templates and Sample Forms •Informed Consent Policies and Procedures •Consent Builder: Online Tool for Creating Consent Forms Informed Consent
Consent/Waiver Description Consent Type Consent Document
Informed Consent
Consent/Waiver Description (e.g. Consent for Group All Groups A, Waiver for Group B, Surrogate Consent for Group C) Consent Type Consent Form Attach Consent Document (in PDF format) X Consent Informed Consent Document Explain how, where, when, and by whom informed consent will be obtained. If any vulnerable subject groups are involved, discuss relevant considerations. Note: If attaching multiple consent forms and consent process has already been described for another consent form, simply refer to the other form (e.g., consent process is the same as for Group A). Informed consent will be obtained during a general meeting of the Mycrobes UC Berkeley student organization. The student organization meets weekly in a UC Berkeley classroom and informed consent forms will be provided to participants by the researchers. Consent for all groups will be obtained through the same form.
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* * * Child Assent & Parent Permission * * *
20. Child Assent and Parent/Guardian Permission
Add each child assent document, parent/guardian permission document, and/or waiver needed for this research using the table at the bottom of the page, including any translated versions. For any translated consent, include an affirmation of the translation's accuracy, indicating who is affirming the accuracy (PI, Co-PI, or Student Investigator), in the Consent/Waiver Description or in the Attachment section. Describe the consent process and provide justification for any waivers for each consent document, translation, and/or waiver. The various consent/waiver options are described below.
Altered and Unsigned Parent/Guardian Permission Form - A parent permission document that has omitted required information (elements) and does not include a place for a parent to indicate with a signature that he or she agrees to permit the child's participation. This means that CPHS is being asked to waive one or more elements of consent in addition to the requirement for documented consent.
Altered Parent/Guardian Permission Form - A permission form that has omitted required information (elements). This means that the CPHS is asked to waive one or more required elements of informed consent. However, the form must include signature and date lines for the parent(s)/guardian(s) to sign if the child is permitted to take part in the research.
Assent Document - A form or script of the information that will be conveyed to the child about the study. In general, researchers must obtain the affirmative agreement of children ages seven years and older for their participation. Assent forms should be written at a level understandable to the child. If the study includes a broad age range of children, more than one assent form may be needed (i.e., an assent form suitable for a 15 year old is not usually suitable for a 7 year old child).
Assent Waiver - No child assent will be sought at all. This means that CPHS is asked to waive the requirement for child assent. Among other circumstances, this option is appropriate when the capability of the child to understand the research is too limited or when the research holds out a prospect of direct benefit that is important to the health or well being of the child.
Parent/Guardian Permission Form - A document that embodies all of the required information (elements of informed consent) designed to help the parent/guardian of a child make an informed decision about whether or not to permit the child's participation in the research. The form must include signature and date lines for the parent(s)/guardian(s) to sign if the child is permitted to take part in the research.
Permission Waiver - No parent/guardian permission will be sought at all. This means that the CPHS is asked to waive the requirement for parent/guardian permission. This option, for example, is often appropriate for research designed to study conditions in children or a study population for which parental permission is not a reasonable requirement to protect the children (e.g., neglected or abused children).
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Unsigned Parent/Guardian Permission - A parent permission document that embodies all of the required information (elements of informed consent), but does not include a place for a parent to indicate with a signature that he or she agrees to permit the child's participation. This means that the CPHS is asked to waive the requirement for documented (signed) consent.
• Child Assent and Parent Permission Guidelines, Templates, and Sample Forms •Policies and Procedures on Child Assent and Parent Permission
Documents and Waivers
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* * * HIPAA * * *
21. Health Insurance Portability and Accountability Act (HIPAA)
The HIPAA Privacy Rule establishes the right of an individual to authorize a covered entity, such as a health plan, health care clearinghouse or health care provider, to use and disclose his/her Protected Health Information (PHI) for research purposes. UC Berkeley's covered entities are the Tang Health Center, the Human Resources Health Plan, Athletics and Recreational Sports, and Optometry Clinic The Privacy Rule defines the elements of individual information that comprise PHI and establishes the conditions under which PHI may be used or disclosed by covered entities for research purposes. It also includes provisions to allow an individual's PHI to be disclosed or used in research without their authorization (i.e., IRB waiver of authorization). For more information, see CPHS Guidelines HIPAA and Human Subjects Research.
a. Does the study involve use of Protected Health Information (PHI) from a "covered entity" outside of UC Berkeley (i.e. another organization or institution)? For more information, see HIPAA and Human Subjects Research.
N If Yes, explain what arrangements have been made to comply with the HIPAA requirements of the entity from which the PHI will be obtained:
b. Does the study involve use of a "Limited Data Set" from a covered entity? For more information, see HIPAA and Human Subjects Research Please see The Industry Alliance Office website for limited data set requirements.
N
If Yes, patient authorization for use of the data set is not required; however, you must have a data use agreement in place with the data holder from which the data will be obtained as required by HIPAA. Contact the Industry Alliance Office for further information at (510) 642-5766.
c. Does the study involve use of Protected Health Information (PHI) from UC Berkeley's Tang Health Center, the Human Resources Health Plan, Athletics and Recreational Sports, and/or the Optometry Clinic?
N
If Yes (and a limited data set will not be used), EITHER request/add a Waiver/Alteration of HIPAA Authorization below OR provide a HIPAA Authorization Form in the Attachments section of the protocol.
Page 35 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------36
HIPAA WAIVER/ALTERATION: For each waiver or alteration of the requirement for authorization from the patient for use of his or her PHI, provide justification in the table below.
Note: Use table below ONLY when requesting waiver/alteration of HIPAA authorization for use of PHI from UC Berkeley's Tang Health Center, the Human Resources Health Plan, Athletics and Recreational Sports, and/or the Optometry Clinic. For more information, see HIPAA and Human Subjects Research.
------
Page 36 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------37
* * * Attachments * * *
22. Attachments
Add appropriate attachments (e.g., advertisements, data collection instruments, IRB approvals from collaborating institutions, etc.) in this section. Attachments MUST be in PDF format. Please see eProtocol Attachments Check List for Non-Exempt Applications for more information. Document Type Document Name Attached Date Submitted Date CITI Certificate(s) CITI Completion 06/06/2016 06/27/2016 Report_RH CITI Certificate(s) CitiCompletionReport_DM 06/06/2016 06/27/2016 CITI Certificate(s) CITI Completion 06/06/2016 06/27/2016 Report_KS CITI Certificate(s) Citi Completion 06/06/2016 06/27/2016 Report_MS Medical Research bill_of_rights 06/07/2016 06/27/2016 Subject's Bill of Rights References Citations 06/07/2016 06/27/2016 CITI Certificate(s) CITI Completion 06/13/2016 06/27/2016 Report_AA References Soylent_Nutritional_Facts 06/13/2016 06/27/2016 Other CLIA 08/19/2016 08/19/2016 Data Collection Forms Daily Log Form 08/24/2016 08/25/2016 Other Bristol_Stool_Chart.pdf 09/22/2016 09/26/2016 Survey Instruments Screening Questions.pdf 09/26/2016 09/26/2016
Document Type CITI Certificate(s) Document Name CITI Completion Report_RH
Document Type CITI Certificate(s) Document Name CitiCompletionReport_DM
Document Type CITI Certificate(s) Document Name CITI Completion Report_KS
Page 37 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------38
Document Type CITI Certificate(s) Document Name Citi Completion Report_MS
Document Type Medical Research Subject's Bill of Rights Document Name bill_of_rights
Document Type References Document Name Citations
Document Type CITI Certificate(s) Document Name CITI Completion Report_AA
Document Type References Document Name Soylent_Nutritional_Facts
Document Type Other Document Name CLIA
Document Type Data Collection Forms Document Name Daily Log Form
Document Type Other Document Name Bristol_Stool_Chart.pdf
Document Type Survey Instruments Document Name Screening Questions.pdf
Page 38 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------39
------
Page 39 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------40
* * * Assurance * * *
Assurance
As Faculty Sponsor, I understand that I am responsible for overseeing the protection of the rights and welfare of the human subjects, and adherence to CPHS requirements, federal regulations, and state statutes for human subjects research.
I hereby assure the following:
1. I have read the protocol.
2. I have discussed with the Student/Postdoc Investigator how to comply with his or her assurances.
3. I will be available throughout the course of the study to provide guidance and consultation.
X I have read and agree to the above assurances.
As Student/Postdoctoral Investigator, I am responsible for the performance of this study, the protection of the rights and welfare of the human subjects, and strict adherence by all co-investigators and research personnel to CPHS requirements, federal regulations, and state statutes for human subjects research.
I hereby assure the following:
1. The information provided in this application is accurate to the best of my knowledge.
2. All experiments and procedures involving human subjects will be performed under my supervision or that of another qualified professional listed on this protocol.
3. This protocol covers the human subjects research activities described in the grant proposal(s) supporting this research and any such activities that are not covered have been/will be covered by a CPHS approved protocol.
4. The legally effective informed consent of all human subjects or their legally authorized representative
Page 40 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------41
will be obtained (unless waived) using only the current, approved consent form(s).
5. If any study subject experiences an unanticipated problem involving risks to subjects or others, and/or a serious adverse event, the CPHS will be informed promptly within no more than one week (7 calendar days), and receive a written report within no more than two weeks (14 calendar days), of recognition/ notification of the event.
6. No change in the design, conduct, or key personnel of this research will be implemented without prior CPHS review and approval, unless the changes are necessary to eliminate an apparent immediate hazard to subjects. Changes made to eliminate hazards to subjects will be reported to OPHS/CPHS via the AE/UP reporting process.
7. Applications for continuation review will be submitted in a timely manner prior to the expiration date to allow sufficient time for the renewal process. I understand that if approval expires, all research activity (including data analysis) must cease until I receive notice of re-approval by the CPHS.
8. Participants' complaints or requests for information about the study will be addressed appropriately.
9. I will promptly and completely comply with a CPHS decision to suspend or withdraw its approval for the project.
10. I will submit a study closure form at the conclusion of this project.
X I have read and agree to the above assurances. ------
Page 41 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------42
* * * Event History * * *
Event History Date Status View Attachments Letters 09/06/2017 CLOSED 09/06/2017 Close Requested
Page 42 of 42 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------1
Disclaimer: The generated PDF may not duplicate the original format completely. We do not warrant the accuracy of the changed format.
* * * Attached Document * * * Document Name Created Date CITI Completion Report_RH.pdf 06/06/2016
Page 1 of 1 COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM) COURSEWORK REQUIREMENTS REPORT*
* NOTE: Scores on this Requirements Report reflect quiz completions at the time all requirements for the course were met. See list below for details. See separate Transcript Report for more recent quiz scores, including those on optional (supplemental) course elements.
• Name: Ryan Hsu (ID: 5343343) • Email: [email protected] • Institution Affiliation: University of California, Berkeley (ID: 673) • Institution Unit: Plant and Microbial Biology • Phone: 510-643-5692
• Curriculum Group: Human Research • Course Learner Group: Group 1 Biomedical Research Investigators • Stage: Stage 1 - Basic Course
• Report ID: 18526691 • Completion Date: 01/28/2016 • Expiration Date: 01/26/2021 • Minimum Passing: 80 • Reported Score*: 87
REQUIRED AND ELECTIVE MODULES ONLY DATE SCORE COMPLETED Belmont Report and CITI Course Introduction (ID: 1127) 01/28/16 3/3 (100%) History and Ethics of Human Subjects Research (ID: 498) 01/28/16 7/7 (100%) Basic Institutional Review Board (IRB) Regulations and Review Process (ID: 2) 01/28/16 4/5 (80%) Informed Consent (ID: 3) 01/28/16 5/5 (100%) Social and Behavioral Research (SBR) for Biomedical Researchers (ID: 4) 01/28/16 4/4 (100%) Records-Based Research (ID: 5) 01/28/16 3/3 (100%) Genetic Research in Human Populations (ID: 6) 01/28/16 5/5 (100%) Populations in Research Requiring Additional Considerations and/or Protections (ID: 16680) 01/28/16 4/5 (80%) Vulnerable Subjects - Research Involving Prisoners (ID: 8) 01/28/16 4/4 (100%) Vulnerable Subjects - Research Involving Children (ID: 9) 01/28/16 3/3 (100%) Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates (ID: 10) 01/28/16 3/3 (100%) FDA-Regulated Research (ID: 12) 01/28/16 5/5 (100%) Research and HIPAA Privacy Protections (ID: 14) 01/28/16 4/5 (80%) Conflicts of Interest in Research Involving Human Subjects (ID: 488) 01/28/16 4/5 (80%) Avoiding Group Harms - U.S. Research Perspectives (ID: 14080) 01/28/16 1/3 (33%) Avoiding Group Harms - International Research Perspectives (ID: 14081) 01/28/16 2/3 (67%) Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research 01/28/16 2/5 (40%) (ID: 14777) Cultural Competence in Research (ID: 15166) 01/28/16 5/5 (100%) University of California, Berkeley (ID: 1014) 01/28/16 No Quiz
For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institution identified above or have been a paid Independent Learner.
CITI Program Email: [email protected] Phone: 305-243-7970 Web: https://www.citiprogram.org COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM) COURSEWORK TRANSCRIPT REPORT**
** NOTE: Scores on this Transcript Report reflect the most current quiz completions, including quizzes on optional (supplemental) elements of the course. See list below for details. See separate Requirements Report for the reported scores at the time all requirements for the course were met.
• Name: Ryan Hsu (ID: 5343343) • Email: [email protected] • Institution Affiliation: University of California, Berkeley (ID: 673) • Institution Unit: Plant and Microbial Biology • Phone: 510-643-5692
• Curriculum Group: Human Research • Course Learner Group: Group 1 Biomedical Research Investigators • Stage: Stage 1 - Basic Course
• Report ID: 18526691 • Report Date: 01/28/2016 • Current Score**: 87
REQUIRED, ELECTIVE, AND SUPPLEMENTAL MODULES MOST SCORE RECENT History and Ethics of Human Subjects Research (ID: 498) 01/28/16 7/7 (100%) Informed Consent (ID: 3) 01/28/16 5/5 (100%) Social and Behavioral Research (SBR) for Biomedical Researchers (ID: 4) 01/28/16 4/4 (100%) Belmont Report and CITI Course Introduction (ID: 1127) 01/28/16 3/3 (100%) Records-Based Research (ID: 5) 01/28/16 3/3 (100%) Genetic Research in Human Populations (ID: 6) 01/28/16 5/5 (100%) Vulnerable Subjects - Research Involving Prisoners (ID: 8) 01/28/16 4/4 (100%) Vulnerable Subjects - Research Involving Children (ID: 9) 01/28/16 3/3 (100%) Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates (ID: 10) 01/28/16 3/3 (100%) FDA-Regulated Research (ID: 12) 01/28/16 5/5 (100%) Research and HIPAA Privacy Protections (ID: 14) 01/28/16 4/5 (80%) Conflicts of Interest in Research Involving Human Subjects (ID: 488) 01/28/16 4/5 (80%) Avoiding Group Harms - U.S. Research Perspectives (ID: 14080) 01/28/16 1/3 (33%) Cultural Competence in Research (ID: 15166) 01/28/16 5/5 (100%) Avoiding Group Harms - International Research Perspectives (ID: 14081) 01/28/16 2/3 (67%) Basic Institutional Review Board (IRB) Regulations and Review Process (ID: 2) 01/28/16 4/5 (80%) Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research (ID: 01/28/16 2/5 (40%) 14777) Populations in Research Requiring Additional Considerations and/or Protections (ID: 16680) 01/28/16 4/5 (80%) University of California, Berkeley (ID: 1014) 01/28/16 No Quiz
For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institution identified above or have been a paid Independent Learner.
CITI Program Email: [email protected] Phone: 305-243-7970 Web: https://www.citiprogram.org PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------1
* * * Attached Document * * * Document Name Created Date CitiCompletionReport_DM.pdf 06/06/2016
Page 1 of 1 COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM) COURSEWORK REQUIREMENTS REPORT*
* NOTE: Scores on this Requirements Report reflect quiz completions at the time all requirements for the course were met. See list below for details. See separate Transcript Report for more recent quiz scores, including those on optional (supplemental) course elements.
• Name: Dylan McCormick (ID: 4945817) • Email: [email protected] • Institution Affiliation: University of California, Berkeley (ID: 673) • Phone: 510-643-5692
• Curriculum Group: Human Research • Course Learner Group: Group 1 Biomedical Research Investigators • Stage: Stage 1 - Basic Course
• Report ID: 18538233 • Completion Date: 01/29/2016 • Expiration Date: 01/27/2021 • Minimum Passing: 80 • Reported Score*: 96
REQUIRED AND ELECTIVE MODULES ONLY DATE SCORE COMPLETED Belmont Report and CITI Course Introduction (ID: 1127) 01/28/16 3/3 (100%) History and Ethics of Human Subjects Research (ID: 498) 01/28/16 6/7 (86%) Basic Institutional Review Board (IRB) Regulations and Review Process (ID: 2) 01/28/16 5/5 (100%) Informed Consent (ID: 3) 01/28/16 5/5 (100%) Social and Behavioral Research (SBR) for Biomedical Researchers (ID: 4) 01/28/16 4/4 (100%) Records-Based Research (ID: 5) 01/28/16 3/3 (100%) Genetic Research in Human Populations (ID: 6) 01/28/16 4/5 (80%) Populations in Research Requiring Additional Considerations and/or Protections (ID: 16680) 01/28/16 5/5 (100%) Vulnerable Subjects - Research Involving Prisoners (ID: 8) 01/29/16 4/4 (100%) Vulnerable Subjects - Research Involving Children (ID: 9) 01/29/16 3/3 (100%) Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates (ID: 10) 01/29/16 3/3 (100%) FDA-Regulated Research (ID: 12) 01/29/16 5/5 (100%) Research and HIPAA Privacy Protections (ID: 14) 01/29/16 5/5 (100%) Conflicts of Interest in Research Involving Human Subjects (ID: 488) 01/29/16 5/5 (100%) Avoiding Group Harms - U.S. Research Perspectives (ID: 14080) 01/29/16 3/3 (100%) Avoiding Group Harms - International Research Perspectives (ID: 14081) 01/29/16 3/3 (100%) Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research 01/29/16 4/5 (80%) (ID: 14777) Cultural Competence in Research (ID: 15166) 01/29/16 5/5 (100%) University of California, Berkeley (ID: 1014) 01/29/16 No Quiz
For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institution identified above or have been a paid Independent Learner. CITI Program Email: [email protected] Phone: 305-243-7970 Web: https://www.citiprogram.org COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM) COURSEWORK TRANSCRIPT REPORT**
** NOTE: Scores on this Transcript Report reflect the most current quiz completions, including quizzes on optional (supplemental) elements of the course. See list below for details. See separate Requirements Report for the reported scores at the time all requirements for the course were met.
• Name: Dylan McCormick (ID: 4945817) • Email: [email protected] • Institution Affiliation: University of California, Berkeley (ID: 673) • Phone: 510-643-5692
• Curriculum Group: Human Research • Course Learner Group: Group 1 Biomedical Research Investigators • Stage: Stage 1 - Basic Course
• Report ID: 18538233 • Report Date: 01/29/2016 • Current Score**: 96
REQUIRED, ELECTIVE, AND SUPPLEMENTAL MODULES MOST SCORE RECENT History and Ethics of Human Subjects Research (ID: 498) 01/28/16 6/7 (86%) Informed Consent (ID: 3) 01/28/16 5/5 (100%) Social and Behavioral Research (SBR) for Biomedical Researchers (ID: 4) 01/28/16 4/4 (100%) Belmont Report and CITI Course Introduction (ID: 1127) 01/28/16 3/3 (100%) Records-Based Research (ID: 5) 01/28/16 3/3 (100%) Genetic Research in Human Populations (ID: 6) 01/28/16 4/5 (80%) Vulnerable Subjects - Research Involving Prisoners (ID: 8) 01/29/16 4/4 (100%) Vulnerable Subjects - Research Involving Children (ID: 9) 01/29/16 3/3 (100%) Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates (ID: 10) 01/29/16 3/3 (100%) FDA-Regulated Research (ID: 12) 01/29/16 5/5 (100%) Research and HIPAA Privacy Protections (ID: 14) 01/29/16 5/5 (100%) Conflicts of Interest in Research Involving Human Subjects (ID: 488) 01/29/16 5/5 (100%) Avoiding Group Harms - U.S. Research Perspectives (ID: 14080) 01/29/16 3/3 (100%) Cultural Competence in Research (ID: 15166) 01/29/16 5/5 (100%) Avoiding Group Harms - International Research Perspectives (ID: 14081) 01/29/16 3/3 (100%) Basic Institutional Review Board (IRB) Regulations and Review Process (ID: 2) 01/28/16 5/5 (100%) Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research (ID: 01/29/16 4/5 (80%) 14777) Populations in Research Requiring Additional Considerations and/or Protections (ID: 16680) 01/28/16 5/5 (100%) University of California, Berkeley (ID: 1014) 01/29/16 No Quiz
For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institution identified above or have been a paid Independent Learner.
CITI Program Email: [email protected] Phone: 305-243-7970 Web: https://www.citiprogram.org PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------1
* * * Attached Document * * * Document Name Created Date CITI Completion Report_KS.pdf 06/06/2016
Page 1 of 1 COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM) COURSEWORK REQUIREMENTS REPORT*
* NOTE: Scores on this Requirements Report reflect quiz completions at the time all requirements for the course were met. See list below for details. See separate Transcript Report for more recent quiz scores, including those on optional (supplemental) course elements.
• Name: Katherine Schreiner (ID: 5345173) • Email: [email protected] • Institution Affiliation: University of California, Berkeley (ID: 673) • Institution Unit: Integrative Biology • Phone: 5106435692
• Curriculum Group: Human Research • Course Learner Group: Group 1 Biomedical Research Investigators • Stage: Stage 1 - Basic Course
• Report ID: 18531889 • Completion Date: 01/28/2016 • Expiration Date: 01/26/2021 • Minimum Passing: 80 • Reported Score*: 92
REQUIRED AND ELECTIVE MODULES ONLY DATE SCORE COMPLETED Belmont Report and CITI Course Introduction (ID: 1127) 01/28/16 3/3 (100%) History and Ethics of Human Subjects Research (ID: 498) 01/28/16 7/7 (100%) Basic Institutional Review Board (IRB) Regulations and Review Process (ID: 2) 01/28/16 5/5 (100%) Informed Consent (ID: 3) 01/28/16 5/5 (100%) Social and Behavioral Research (SBR) for Biomedical Researchers (ID: 4) 01/28/16 4/4 (100%) Records-Based Research (ID: 5) 01/28/16 3/3 (100%) Genetic Research in Human Populations (ID: 6) 01/28/16 5/5 (100%) Populations in Research Requiring Additional Considerations and/or Protections (ID: 16680) 01/28/16 4/5 (80%) Vulnerable Subjects - Research Involving Prisoners (ID: 8) 01/28/16 4/4 (100%) Vulnerable Subjects - Research Involving Children (ID: 9) 01/28/16 3/3 (100%) Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates (ID: 10) 01/28/16 3/3 (100%) FDA-Regulated Research (ID: 12) 01/28/16 4/5 (80%) Research and HIPAA Privacy Protections (ID: 14) 01/28/16 5/5 (100%) Conflicts of Interest in Research Involving Human Subjects (ID: 488) 01/28/16 5/5 (100%) Avoiding Group Harms - U.S. Research Perspectives (ID: 14080) 01/28/16 3/3 (100%) Avoiding Group Harms - International Research Perspectives (ID: 14081) 01/28/16 3/3 (100%) Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research 01/28/16 2/5 (40%) (ID: 14777) Cultural Competence in Research (ID: 15166) 01/28/16 4/5 (80%) University of California, Berkeley (ID: 1014) 01/28/16 No Quiz
For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institution identified above or have been a paid Independent Learner. CITI Program Email: [email protected] Phone: 305-243-7970 Web: https://www.citiprogram.org COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM) COURSEWORK TRANSCRIPT REPORT**
** NOTE: Scores on this Transcript Report reflect the most current quiz completions, including quizzes on optional (supplemental) elements of the course. See list below for details. See separate Requirements Report for the reported scores at the time all requirements for the course were met.
• Name: Katherine Schreiner (ID: 5345173) • Email: [email protected] • Institution Affiliation: University of California, Berkeley (ID: 673) • Institution Unit: Integrative Biology • Phone: 5106435692
• Curriculum Group: Human Research • Course Learner Group: Group 1 Biomedical Research Investigators • Stage: Stage 1 - Basic Course
• Report ID: 18531889 • Report Date: 01/28/2016 • Current Score**: 92
REQUIRED, ELECTIVE, AND SUPPLEMENTAL MODULES MOST SCORE RECENT History and Ethics of Human Subjects Research (ID: 498) 01/28/16 7/7 (100%) Informed Consent (ID: 3) 01/28/16 5/5 (100%) Social and Behavioral Research (SBR) for Biomedical Researchers (ID: 4) 01/28/16 4/4 (100%) Belmont Report and CITI Course Introduction (ID: 1127) 01/28/16 3/3 (100%) Records-Based Research (ID: 5) 01/28/16 3/3 (100%) Genetic Research in Human Populations (ID: 6) 01/28/16 5/5 (100%) Vulnerable Subjects - Research Involving Prisoners (ID: 8) 01/28/16 4/4 (100%) Vulnerable Subjects - Research Involving Children (ID: 9) 01/28/16 3/3 (100%) Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates (ID: 10) 01/28/16 3/3 (100%) FDA-Regulated Research (ID: 12) 01/28/16 4/5 (80%) Research and HIPAA Privacy Protections (ID: 14) 01/28/16 5/5 (100%) Conflicts of Interest in Research Involving Human Subjects (ID: 488) 01/28/16 5/5 (100%) Avoiding Group Harms - U.S. Research Perspectives (ID: 14080) 01/28/16 3/3 (100%) Cultural Competence in Research (ID: 15166) 01/28/16 4/5 (80%) Avoiding Group Harms - International Research Perspectives (ID: 14081) 01/28/16 3/3 (100%) Basic Institutional Review Board (IRB) Regulations and Review Process (ID: 2) 01/28/16 5/5 (100%) Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research (ID: 01/28/16 2/5 (40%) 14777) Populations in Research Requiring Additional Considerations and/or Protections (ID: 16680) 01/28/16 4/5 (80%) University of California, Berkeley (ID: 1014) 01/28/16 No Quiz
For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institution identified above or have been a paid Independent Learner.
CITI Program Email: [email protected] Phone: 305-243-7970 Web: https://www.citiprogram.org PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------1
* * * Attached Document * * * Document Name Created Date Citi Completion Report_MS.pdf 06/06/2016
Page 1 of 1 COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM) COURSEWORK REQUIREMENTS REPORT*
* NOTE: Scores on this Requirements Report reflect quiz completions at the time all requirements for the course were met. See list below for details. See separate Transcript Report for more recent quiz scores, including those on optional (supplemental) course elements.
• Name: Mitchell Lee Seitz jr. (ID: 5347326) • Email: [email protected] • Institution Affiliation: University of California, Berkeley (ID: 673) • Phone: 2093217283
• Curriculum Group: Human Research • Course Learner Group: Group 1 Biomedical Research Investigators • Stage: Stage 1 - Basic Course
• Report ID: 18538234 • Completion Date: 01/29/2016 • Expiration Date: 01/27/2021 • Minimum Passing: 80 • Reported Score*: 96
REQUIRED AND ELECTIVE MODULES ONLY DATE SCORE COMPLETED Belmont Report and CITI Course Introduction (ID: 1127) 01/28/16 3/3 (100%) History and Ethics of Human Subjects Research (ID: 498) 01/28/16 7/7 (100%) Basic Institutional Review Board (IRB) Regulations and Review Process (ID: 2) 01/28/16 5/5 (100%) Informed Consent (ID: 3) 01/28/16 5/5 (100%) Social and Behavioral Research (SBR) for Biomedical Researchers (ID: 4) 01/28/16 4/4 (100%) Records-Based Research (ID: 5) 01/28/16 3/3 (100%) Genetic Research in Human Populations (ID: 6) 01/28/16 4/5 (80%) Populations in Research Requiring Additional Considerations and/or Protections (ID: 16680) 01/29/16 5/5 (100%) Vulnerable Subjects - Research Involving Prisoners (ID: 8) 01/29/16 4/4 (100%) Vulnerable Subjects - Research Involving Children (ID: 9) 01/29/16 3/3 (100%) Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates (ID: 10) 01/29/16 3/3 (100%) FDA-Regulated Research (ID: 12) 01/29/16 5/5 (100%) Research and HIPAA Privacy Protections (ID: 14) 01/29/16 4/5 (80%) Conflicts of Interest in Research Involving Human Subjects (ID: 488) 01/29/16 5/5 (100%) Avoiding Group Harms - U.S. Research Perspectives (ID: 14080) 01/29/16 3/3 (100%) Avoiding Group Harms - International Research Perspectives (ID: 14081) 01/29/16 3/3 (100%) Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research 01/29/16 5/5 (ID: 14777) (100%) Cultural Competence in Research (ID: 15166) 01/29/16 4/5 (80%) University of California, Berkeley (ID: 1014) 01/29/16 No Quiz
For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institution identified above or have been a paid Independent Learner.
CITI Program Email: [email protected] Phone: 305-243-7970 Web: https://www.citiprogram.org
COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM) COURSEWORK TRANSCRIPT REPORT**
** NOTE: Scores on this Transcript Report reflect the most current quiz completions, including quizzes on optional (supplemental) elements of the course. See list below for details. See separate Requirements Report for the reported scores at the time all requirements for the course were met.
• Name: Mitchell Lee Seitz jr. (ID: 5347326) • Email: [email protected] • Institution Affiliation: University of California, Berkeley (ID: 673) • Phone: 2093217283
• Curriculum Group: Human Research • Course Learner Group: Group 1 Biomedical Research Investigators • Stage: Stage 1 - Basic Course
• Report ID: 18538234 • Report Date: 01/29/2016 • Current Score**: 96
REQUIRED, ELECTIVE, AND SUPPLEMENTAL MODULES MOST SCORE RECENT History and Ethics of Human Subjects Research (ID: 498) 01/28/16 7/7 (100%) Informed Consent (ID: 3) 01/28/16 5/5 (100%) Social and Behavioral Research (SBR) for Biomedical Researchers (ID: 4) 01/28/16 4/4 (100%) Belmont Report and CITI Course Introduction (ID: 1127) 01/28/16 3/3 (100%) Records-Based Research (ID: 5) 01/28/16 3/3 (100%) Genetic Research in Human Populations (ID: 6) 01/28/16 4/5 (80%) Vulnerable Subjects - Research Involving Prisoners (ID: 8) 01/29/16 4/4 (100%) Vulnerable Subjects - Research Involving Children (ID: 9) 01/29/16 3/3 (100%) Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates (ID: 10) 01/29/16 3/3 (100%) FDA-Regulated Research (ID: 12) 01/29/16 5/5 (100%) Research and HIPAA Privacy Protections (ID: 14) 01/29/16 4/5 (80%) Conflicts of Interest in Research Involving Human Subjects (ID: 488) 01/29/16 5/5 (100%) Avoiding Group Harms - U.S. Research Perspectives (ID: 14080) 01/29/16 3/3 (100%) Cultural Competence in Research (ID: 15166) 01/29/16 4/5 (80%) Avoiding Group Harms - International Research Perspectives (ID: 14081) 01/29/16 3/3 (100%) Basic Institutional Review Board (IRB) Regulations and Review Process (ID: 2) 01/28/16 5/5 (100%) Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research (ID: 01/29/16 5/5 (100%) 14777) Populations in Research Requiring Additional Considerations and/or Protections (ID: 16680) 01/29/16 5/5 (100%) University of California, Berkeley (ID: 1014) 01/29/16 No Quiz
For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institution identified above or have been a paid Independent Learner.
CITI Program Email: [email protected] Phone: 305-243-7970 Web: https://www.citiprogram.org PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------1
* * * Attached Document * * * Document Name Created Date bill_of_rights.pdf 06/07/2016
Page 1 of 1 Experimental Research Subject=s Bill of Rights
California law, under Health & Safety Code '24172, requires that any person asked to take part as a subject in research involving a medical experiment, or any person asked to consent to such participation on behalf of another, is entitled to receive the following list of rights written in a language in which the person is fluent. This list includes the right to:
1. Be informed of the nature and purpose of the experiment.
2. Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized.
3. Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment.
4. Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable.
5. Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits.
6. Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise.
7. Be given an opportunity to ask any questions concerning the experiment or the procedures involved.
8. Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation in the medical experiment without prejudice.
9. Be given a copy of the signed and dated written consent form.
10. Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject=s decision.
PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------1
* * * Attached Document * * * Document Name Created Date Citations.pdf 06/07/2016
Page 1 of 1 1. Dalal SR, Chang EB (2014) The microbial basis of inflammatory bowel diseases. J Clin Invest 124(10):4190–6. 2. David L a, et al. (2014) Diet rapidly and reproducibly alters the human gut microbiome. Nature 505(7484):559–63. 3. Seekatz AM, Young VB (2014) Clostridium difficile and the microbiota. J Clin Invest 124(10): 4182–9. 4. http://files.soylent.com/pdf/soylent-nutrition-facts-2-0-en.pdf 5. https://faq.soylent.com/hc/en-us/articles/200789315-Nutrition 6. http://ubiome.com PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------1
* * * Attached Document * * * Document Name Created Date CITI Completion Report_AA.pdf 06/13/2016
Page 1 of 1 COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM) COURSEWORK REQUIREMENTS REPORT*
* NOTE: Scores on this Requirements Report reflect quiz completions at the time all requirements for the course were met. See list below for details. See separate Transcript Report for more recent quiz scores, including those on optional (supplemental) course elements.
• Name: Adam Arkin (ID: 5424492) • Email: [email protected] • Institution Affiliation: University of California, Berkeley (ID: 673) • Institution Unit: Bioengineering • Phone: 510-643-5678
• Curriculum Group: Human Research • Course Learner Group: Group 1 Biomedical Research Investigators • Stage: Stage 1 - Basic Course
• Report ID: 18844289 • Completion Date: 05/08/2016 • Expiration Date: 05/07/2021 • Minimum Passing: 80 • Reported Score*: 97
REQUIRED AND ELECTIVE MODULES ONLY DATE SCORE COMPLETED Belmont Report and CITI Course Introduction (ID: 1127) 02/25/16 3/3 (100%) History and Ethics of Human Subjects Research (ID: 498) 02/25/16 6/7 (86%) Basic Institutional Review Board (IRB) Regulations and Review Process (ID: 2) 02/25/16 4/5 (80%) Informed Consent (ID: 3) 02/25/16 5/5 (100%) Social and Behavioral Research (SBR) for Biomedical Researchers (ID: 4) 02/25/16 4/4 (100%) Records-Based Research (ID: 5) 03/01/16 3/3 (100%) Genetic Research in Human Populations (ID: 6) 03/01/16 5/5 (100%) Populations in Research Requiring Additional Considerations and/or Protections (ID: 16680) 03/01/16 5/5 (100%) Vulnerable Subjects - Research Involving Prisoners (ID: 8) 03/01/16 4/4 (100%) Vulnerable Subjects - Research Involving Children (ID: 9) 03/01/16 3/3 (100%) Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates (ID: 10) 04/28/16 3/3 (100%) FDA-Regulated Research (ID: 12) 04/28/16 5/5 (100%) Research and HIPAA Privacy Protections (ID: 14) 04/28/16 5/5 (100%) Conflicts of Interest in Research Involving Human Subjects (ID: 488) 05/08/16 5/5 (100%) Avoiding Group Harms - U.S. Research Perspectives (ID: 14080) 05/08/16 3/3 (100%) Avoiding Group Harms - International Research Perspectives (ID: 14081) 05/08/16 3/3 (100%) Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research 05/08/16 5/5 (ID: 14777) (100%) Cultural Competence in Research (ID: 15166) 05/08/16 5/5 (100%) University of California, Berkeley (ID: 1014) 05/08/16 No Quiz
For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institution identified above or have been a paid Independent Learner. CITI Program Email: [email protected] Phone: 305-243-7970 Web: https://www.citiprogram.org COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM) COURSEWORK TRANSCRIPT REPORT**
** NOTE: Scores on this Transcript Report reflect the most current quiz completions, including quizzes on optional (supplemental) elements of the course. See list below for details. See separate Requirements Report for the reported scores at the time all requirements for the course were met.
• Name: Adam Arkin (ID: 5424492) • Email: [email protected] • Institution Affiliation: University of California, Berkeley (ID: 673) • Institution Unit: Bioengineering • Phone: 510-643-5678
• Curriculum Group: Human Research • Course Learner Group: Group 1 Biomedical Research Investigators • Stage: Stage 1 - Basic Course
• Report ID: 18844289 • Report Date: 06/13/2016 • Current Score**: 97
REQUIRED, ELECTIVE, AND SUPPLEMENTAL MODULES MOST SCORE RECENT History and Ethics of Human Subjects Research (ID: 498) 02/25/16 6/7 (86%) Informed Consent (ID: 3) 02/25/16 5/5 (100%) Social and Behavioral Research (SBR) for Biomedical Researchers (ID: 4) 02/25/16 4/4 (100%) Belmont Report and CITI Course Introduction (ID: 1127) 02/25/16 3/3 (100%) Records-Based Research (ID: 5) 03/01/16 3/3 (100%) Genetic Research in Human Populations (ID: 6) 03/01/16 5/5 (100%) Vulnerable Subjects - Research Involving Prisoners (ID: 8) 03/01/16 4/4 (100%) Vulnerable Subjects - Research Involving Children (ID: 9) 03/01/16 3/3 (100%) Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates (ID: 10) 04/28/16 3/3 (100%) FDA-Regulated Research (ID: 12) 04/28/16 5/5 (100%) Research and HIPAA Privacy Protections (ID: 14) 04/28/16 5/5 (100%) Conflicts of Interest in Research Involving Human Subjects (ID: 488) 05/08/16 5/5 (100%) Avoiding Group Harms - U.S. Research Perspectives (ID: 14080) 05/08/16 3/3 (100%) Cultural Competence in Research (ID: 15166) 05/08/16 5/5 (100%) Avoiding Group Harms - International Research Perspectives (ID: 14081) 05/08/16 3/3 (100%) Basic Institutional Review Board (IRB) Regulations and Review Process (ID: 2) 02/25/16 4/5 (80%) Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research (ID: 05/08/16 5/5 (100%) 14777) Populations in Research Requiring Additional Considerations and/or Protections (ID: 16680) 03/01/16 5/5 (100%) University of California, Berkeley (ID: 1014) 05/08/16 No Quiz
For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institution identified above or have been a paid Independent Learner.
CITI Program Email: [email protected] Phone: 305-243-7970 Web: https://www.citiprogram.org PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------1
* * * Attached Document * * * Document Name Created Date Soylent_Nutritional_Facts.pdf 06/13/2016
Page 1 of 1 2.0 United States/Canada
*Percent Daily Values are based on a 2,000 calorie diet. Your daily values N u triti on F acts may be higher or lower depending on your calorie needs: Serving Size 1 bottle Soylent (414 mL) Calories: 2,000 2,500 Servings Per Container 1 Total Fat Less than 65g 80g Saturated Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Amount Per Serving Sodium Less than 2,400mg 2,400mg Potassium 3,500 mg 3,500 mg Calories 400 Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories from Fat 190 Calories per gram: % Daily Value* Fat 9 • Carbohydrate 4 • Protein 4 Total Fat 21g 35% Ingredients: Water, Maltodextrin, Soy Protein Isolate, High Saturated Fat 2g 10% Oleic Algal Oil, Isomaltulose, Canola Oil, Rice Starch, Oat Polyunsaturated Fat 2.5g Fiber, Isomaltooligosaccharide, Soy Lecithin, Potassium Chloride, Calcium Phosphate, Magnesium Phosphate, Monounsaturated Fat 16g Natural & Artificial Flavors, Dipotassium Phosphate, Salt, Trans Fat 0g Choline Chloride, Gellan Gum, Sodium Ascorbate, Cholesterol 0mg 0% dl-alpha-Tocopheryl Acetate, Ferrous Gluconate, Vitamin A Sodium 300mg 13% Palmitate, Zinc Sulfate, Niacinamide, Sucralose, Calcium Potassium 700mg 20% Pantothenate, Thiamine Hydrochloride, Copper Gluconate, Manganese Sulfate, Riboflavin, Pyridoxine Hydrochloride, Total Carbohydrate 37g 12% Vitamin D, Potassium Iodide, Chromium Chloride, Biotin, Dietary Fiber 3g 12% Folic Acid, Sodium Molybdate, Phytonadione, Sodium Soluble Fiber 1g Selenite, Vitamin B12. Contains: Soy Sugars 9g Protein 20g Manufactured for Rosa Labs 207 S Broadway Suite 600 Vitamin A 20% · Vitamin C 20% Los Angeles, CA 90012 Calcium 20% · Iron 20% Vitamin D 20% · Vitamin E 20% While not intended to replace every meal, Soylent can replace any meal. Vitamin K 20% · Thiamin 20% Riboflavin 20% · Niacin 20% Children, women who are pregnant, nursing, or may become Vitamin B6 20% · Folic Acid 20% pregnant should consult their doctor before consuming Soylent. Vitamin B12 20% · Biotin 20% Please refer to soylent.com/notes for more information. Pantothenic Acid 20% · Phosphorus 20% Soylent™ is a trademark of Rosa Labs Iodine 20% · Magnesium 20% Zinc 20% · Selenium 20% Copper 20% · Manganese 20% Chromium 20% · Molybdenum 20% Chloride 15% PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------1
* * * Attached Document * * * Document Name Created Date Informed Consent.pdf 10/12/2016
Page 1 of 1 UNIVERSITY OF CALIFORNIA AT BERKELEY
BERKELEY · DAVIS · IRVINE · LOS ANGELES · MERCED · RIVERSIDE · SAN DIEGO SAN FRANCISCO · SANTA BARBARA · SANTA CRUZ
CONSENT TO PARTICIPATE IN RESEARCH
Impact of Soylent Consumption on Human
Microbiome Composition
Introduction
We are Ryan Hsu, Dylan McCormick, Kate Schreiner, and Mitchell Seitz, undergraduate students working with Professor Adam Arkin in the Department of Bioengineering at the University of California, Berkeley.
We are inviting you to participate in this study because you have expressed interest in human microbiome research by attending a Mycrobes meeting. Participants must be between 18 and 30 years of age and willing to use uBiome’s microbiome sequencing services. This study will allow consumers to make more informed dietary decisions by providing insight into how Soylent affects their microbiomes.
Purpose Soylent 2.0 is a popular meal replacement drink that is used to supplement or replace one’s regular diet. Soylent is designed to fully fulfill one's nutritional needs, but its impact on the human microbiome remains unknown. This study aims to track the composition of participants’ gut microbiomes before, during, and after Soylent consumption to more holistically understand its impact on microbiome health. We predict that a short term Soylent-based diet will induce observable and reversible changes to participants’ gut microbiomes. Please note that Soylent contains GMOs (genetically modified organisms).
Procedures If you agree to be in this study, you will be asked to do the following:
CPHS #2016-04-8727 Page 1! of !6 Before you begin the main part of the study: You will need to complete a screening form to find out if you can be in the main part of the study.
The screening form asks about the following:
• Age • Sex • Ethnicity • Student Status • Food allergies and sensitivities • Health complications, including those related to diet • Previous Soylent consumption • Regular dietary supplements, medication, or drugs • Diet description • Lifestyle description • Pregnancy
A diverse study group that represents a range of dietary backgrounds will be chosen through this screening process. Pregnant women, individuals with chronic disease, reported food allergies, and individuals who are not active UC Berkeley students will be excluded.
If you are invited to participate in the main study based on your responses on the screening form, and you choose to continue, this is what will happen next:
During the main part of the study: You will be asked to fill out daily forms online to report your diet, bowel movements, and microbiome sampling information. The study consists of three distinct phases.
Phase A – Regular Diet Phase (Day 1 – 2) You will adhere to your regular diet for two days. Microbiomes will be sampled daily.
Phase B – Soylent and Regular Diets (Day 3 – 6) You will be randomly assigned into one of two groups, the Soylent diet group or the regular diet group, by drawing numbers from a box. During this phase, the Soylent diet group will consume five bottles of Soylent per day to replace their regular diets. The regular diet group will continue a regular diet. Microbiomes will be sampled daily.
CPHS #2016-04-8727 Page 2! of !6 Phase C – Return to Regular Diets (Day 7 – 10) You will return to a regular diet. Microbiomes will be sampled on Day 7 and Day 10.
uBiome Microbiome DNA Sequencing Sampling microbiomes will be done by swabbing used toilet paper using the provided uBiome Gut Kits. You will secure the swab into the kit's buffer solution and seal the kit. The kits will then be mailed directly to uBiome using the prepaid postage provided. uBiome will then perform bacterial DNA sequencing on the samples. No invasive procedures are performed and no human DNA is sequenced.
You have the option of registering your kits with uBiome in order to personally receive a copy of your own sequencing data. You will be asked to provide identifiable information to uBiome and create a uBiome account if you wish to receive your own data. These results will not be meaningful for a diagnosis of any medical condition.
uBiome will send de-identified sequencing data, labeled with your kit serial number, to the researchers.
Study time Participation in this study will involve a total of 10 days of your time.
Study location
If you agree to participate in this research, you will receive a screening questions form during a Mycrobes general meeting located on campus. After initial screening, all parts of the study, including microbiome sampling, Soylent consumption, and completing online daily log forms, can be performed from any location.
Benefits • You will not directly benefit from participating in this study. • We hope that the information gained from the study will help shed insight into how microbiomes can be affected by dietary choices, and how Soylent in particular can affect microbiomes. This will allow consumers of Soylent to make more informed dietary choices.
CPHS #2016-04-8727 Page 3! of !6 Risks/Discomforts Breach of confidentiality: As with all research, there is a chance that confidentiality could be compromised; however, we are taking precautions to minimize this risk. Some of the research questions may make you uncomfortable or upset. You are free to decline to answer any questions you don’t wish to, or to stop at any time.
Soylent has no documented instances of causing physical complications to consumers, but it is possible you may feel gastrointestinal discomfort, bloating, diarrhea, constipation, liquid stools, and increased frequency of bowel movements. If you feel unwell during any point in the study, you are encouraged to cease participation and contact your primary care doctor for guidance.
Confidentiality
Your study data will be handled as confidentially as possible. If results of this study are published or presented, individual names and other personally identifiable information will not be used.
To minimize the risks to confidentiality, we will do the following:
• The data will be collected using a randomly assigned participant ID. Data will not be stored with identifiable information, which includes name, email, and phone number. The link between participant ID, uBiome kit serial number, and your identifiable information will be maintained during the duration of the study on a single copy physical document. This physical document will be stored in a locked cabinet while not in use and will be directly in possession of an investigator otherwise. This document will be shredded once all study data has been collected. • Your research records, including DNA sequence data and daily update forms will be stored in a locked cabinet in a secured building or in an encrypted format on a password-protected computer.
Future use of study data: The research data will be maintained for possible use in future research by us or others. We will retain this data for at least 3 years and up to 10 years after the study is over. The same measures described above will be taken to protect confidentiality of this study data. uBiome will separately retain the sequencing data according to its policies.
CPHS #2016-04-8727 Page 4! of !6 Future use of study specimens: Your stool samples will be sent to uBiome for sequencing and will become the property of uBiome. The specimens and the DNA they contain may be used in this research and in other research. The specimens could lead to discoveries or inventions that may be of value to the University of California, uBiome, or to other organizations. Under state law, you do not have any right to money or other compensation stemming from products that may be developed from the specimens. uBiome may store the samples indefinitely for future R&D purposes. Although this study does not include human DNA testing, it is possible that uBiome may conduct whole DNA genome testing for future research which could result in your human DNA being sequenced.
Compensation/Payment You will not be compensated for your participation in this study.
Costs
You will be provided with 8 uBiome Gut Sequencing Kits at no cost to you. If you are in the Soylent Diet group, you will also receive 20 bottles of Soylent to consume during Phase B of the study.
Rights
Participation in research is completely voluntary. You have the right to decline to participate or to withdraw at any point in this study without penalty or loss of benefits to which you are otherwise entitled.
Treatment and compensation for injury
It is important that you promptly tell the researcher, Adam Arkin, if you believe that you have been injured because of taking part in this study. You can tell the researcher in person or call him at (510) 643-5692.
If you are injured as a result of taking part in this study, University of California will provide necessary medical treatment. The costs of the treatment may be billed to your insurer just like other medical costs, or covered by the University of California, depending upon a number of factors. The University does not normally provide any other form of compensation for injury. For more information, call OPHS at (510) 642-7461.
CPHS #2016-04-8727 Page 5! of !6 Questions If you have any questions or concerns about this study, you may contact faculty advisor Adam Arkin at [email protected] at (510) 643-5692 or Ryan Hsu at (530) 574-8265 or [email protected].
If you have any questions or concerns about your rights and treatment as a research subject, you may contact the office of UC Berkeley's Committee for the Protection of Human Subjects, at 510-642-7461 or [email protected].
Consent
You have been given a copy of this consent form and of the Medical Research Subject's Bill of Rights to keep.
If you wish to participate in this study, please sign and date below.
______
Participant's Name (please print) Date
______
Participant's Signature Date
______
Person Obtaining Consent Date
CPHS #2016-04-8727 Page 6! of !6 PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------1
* * * Attached Document * * * Document Name Created Date CLIA.pdf 08/19/2016
Page 1 of 1
PROTOCOL Protocol # 2016-04-8727 Biomedical Non- Date Printed: 10/04/2017 Exempt Berkeley Protocol Title: Impact of Soylent Consumption on Human Microbiome Composition Protocol Type: Biomedical Non-Exempt Date Submitted: 06/27/2016 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. Please check the comments section of the online protocol. Questions that appear to not have been answered may not have been required for this submission. Please see the system application for more details. ------1
* * * Attached Document * * * Document Name Created Date Daily Log Form.pdf 08/24/2016
Page 1 of 1 6/26/2016 Daily Log Form
Daily Log Form Fill out this form daily during your participation in the Soylent Microbiome Study!
* Required
1. Entry Date *
Example: December 15, 2012
2. Participant ID Number *
3. Which study group are you in? * Mark only one oval.
Regular Diet Soylent Consumption
Diet Information
4. Soylent Consumption Group How many bottles of Soylent did you consume today? Mark only one oval.
0 1 2 3 4 5 6
Regular Diet Group
Briefly describe the meals consumed today
5. Breakfast
https://docs.google.com/forms/d/1Stl_WgNBeVB6gaSNZfcEqvXscV9eQuaFseMnd1uKFME/edit 1/3 6/26/2016 Daily Log Form 6. Lunch
7. Dinner
8. Other
Microbiome Sampling
9. Did you take a sample today? * If not, please explain. Mark only one oval.
Yes
Other:
10. uBiome Sample Kit Serial Number
11. When did you take your sample?
Example: 8:30 AM
12. Bristol Stool Rating Rate your stool according to the Bristol Stool Chart Mark only one oval.
1 2 3 4 5 6 7
https://docs.google.com/forms/d/1Stl_WgNBeVB6gaSNZfcEqvXscV9eQuaFseMnd1uKFME/edit 2/3 6/26/2016 Daily Log Form Additional Information
13. Do you feel unwell from your participation in this study? Please explain.
If you feel unwell, please cease participation in this study by contacting any team member of Mycrobes and consult your primary care physician.
14. Are there any irregularities with how today's samples were collected? Please explain.
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