Human Subjects Committee: Sample Forms

F200: Application for Human Research

PROJECT TITLE:

INVESTIGATOR INFORMATION Principal Investigator Name, Degree(s): Affiliation UA B–UMG Other: Principal Investigator UA NetID Status/Rank: Center: Department: College: Contact phone: Official Institutional Email:

ADVISOR CONTACT INFORMATION (REQUIRED FOR ALL STUDENTS AND RESIDENTS) Name, Degree(s), UA NetID: Contact phone: Official University Email:

ALTERNATE/COORDINATOR or Co-PI CONTACT INFORMATION Name, UA NetID: Contact phone: Official University Email:

of 10 HSPP Use Only: Form 200 v 2016-01 SECTION 1: REQUIRED SIGNATURES 1. PRINCIPAL INVESTIGATOR I will conduct my study according to the University of Arizona HSPP policies and procedures for research with human subjects.

Signature Date Print Name

2. ADVISOR (FOR ALL STUDENTS AND RESIDENTS ACTING AS THE PI) I will oversee the student researcher according to the University of Arizona HSPP policies and procedures for research with human subjects.

3. SCIENTIFIC/SCHOLARLY REVIEW (SEE HSPP GUIDANCE ON REQUIREMENTS FOR SCIENTIFIC/SCHOLARLY ASSESSMENT - INCLUDE DOCUMENTATION FOR OPTIONS A AND B WITH SUBMISSION MATERIALS.) a. Nationally based, federal funding organization (NIH, NSF) subject to full peer review b. Nationally based, non-federal funding organization (March of Dimes, Amer Academy of Pediatrics) subject to peer review c. Locally constituted peer review (signature required)

4. DEPARTMENT/CENTER/SECTION REVIEW I have reviewed this application and determined that all departmental requirements are met and that the investigator has adequate resources to conduct the Human Research.

Signature Date Print Name/Email

5. RESPONSIBLE PHYSICIAN (PROJECTS INVOLVING MEDICAL PROCEDURES WHICH THE PI IS NOT AUTHORIZED TO CONDUCT) I am a physician licensed by the State of Arizona (or US license for the SAVAHCS). I will be responsible for ensuring that all procedures that are part of this project and that require the attendance of a licensed physician will have a suitable physician present during the procedures. If at any time this is not possible, I will inform the IRB before any procedures are conducted.

of 10 HSPP Use Only: Form 200 v 2016-01 SECTION 2: GENERAL INFORMATION 1. How many Human Research studies does the PI have open?

2. How many research staff will be involved in the Human Research?

3. What is the expected length of this project?

4. Retention of study materials before, during, and after completion of the project: a. Where will original signed consent and PHI Authorization documents be stored (building name and room)? Location:

b. How long will consents be maintained after conclusion of the project? 6 years (UA standard) 6 years after child reaches 18 Other (explain): 5. Is or will the project be funded by an external funding source? No Yes- Complete below:

a. Funding PI: b. Proposal Title: c. Funder Name: d. Total funding amount OR per subject amount: e. UAccess- Provide one of the following below: i. Proposal Development #: ii. Institutional Proposal #: f. IRB Payment eDoc # (Required for For-profit sponsored research):

Submit complete copy, cover-to-cover, of grant or award. If you need help locating any of the UAccess numbers please call Sponsored Projects at 626-6000. 6. Conflict of Interest (COI): The Principal Investigator hereby affirms that ALL individuals who meet the definition of investigator for this project in the current Policy on Investigator Conflict of Interest in Research have completed the mandatory Conflict of Interest training and Disclosure of Significant Financial Interests.

Yes - All individuals who meet the definition of "investigator" have completed COI training and disclosure. No (explain):

7. Additional requirements: Certain types of research require additional regulatory documentation. Please identify which of the following apply to your project. Complete the appropriate Appendix and submit as part of the submission materials.

Children (subjects under 18) - Appendix A Drugs/Devices (A clinical investigation of a drug or device) - Appendix B Multi-Site study (The UA IRB will review research activities for an investigator or research staff not

of 10 HSPP Use Only: Form 200 v 2016-01 affiliated with the UA who is ‘engaged in the research’ (e.g. consenting, collecting data, or analyzing identifiable information) - Appendix C Pregnant Women/Neonates - Appendix D Prisoners - Appendix E Waivers of consent, waiver of a signature, or waiver or alteration of PHI - Appendix F None apply to the proposed study

8. Location of Research Check all that apply

Banner – University Medicine Group: Phoenix Campus Biological specimens Clinical Data Tucson Campus Biological specimens Clinical Data South Campus Biological specimens Clinical Data

University of Arizona Cancer Center: North Campus Biological specimens Clinical Data Orange Grove Clinics Biological specimens Clinical Data Phoenix Biological specimens Clinical Data

Other:

SECTION 3. PROJECT NARRATIVE Delete the red text prior to submitting this form to the IRB. A lay summary is required for all items below. For more complete technical explanations, refer ence the title and page numbers for any items described in the sponsor's protocol or other docu ments submitted with the application. 1) Background Provide the scientific or scholarly background for the proposed Human Research. Discuss relevant prior experience or preliminary data (e.g., existing literature).

2) Purpose This section should describe the purpose, specific aims, objectives, questions to be answered, hypotheses, and/or primary and secondary study endpoints of the Human Research.

3) Lay Summary (approximately 400 words) Provide a brief description of the proposed research using terms that someone who is not familiar with the science or discipline can understand.

4) Setting of the Human Research Page 4 of 10 HSPP Use Only: Form 200 v 2016-01 This section should discuss the setting and location in which the Human Research is to be conducted. Describe site-specific regulations or customs affecting the research, local scientific and/or ethical review structures that differ, and if community advisory boards are involved. If so, describe their composition and involvement. NOTE: Authorization from sites where research will take place is required with the application. Permission to conduct research outside of the country requires review by the Office of Global Initiatives.

5) Resources available to conduct the Human Research Describe the resources (personnel, facilities, time, emergency resources, etc.) available to recruit, consent, conduct study procedures, and analyze data. This includes access and use of UA core facilities, resources from other organizations (e.g. hospital), or from other laboratories. Remember that the IRB may not be familiar with the facility in which you are conducting research. Describe your process to ensure that all persons assisting with the study (e.g., school teachers or floor nurses) will receive appropriate training for their study-related duties and functions.

6) Study Population Provide a general description of who is in the study and how many individuals are anticipated to complete the proposed study (both locally and overall if multi-site). For more information, see HSPP Guidance, Enrollment and Accrual of Study Participants. The populations described here should reflect all the populations being recruited and asked to consent. If a power analysis is applicable to your study, include the planned number of subjects to be enrolled and projected total sample size accounting for attrition due to withdrawal, screen failures, etc. Provide the primary inclusion criteria and/or exclusion criteria, as applicable. Detailed criteria may reference the study protocol. See HSPP Guidance, Vulnerable Populations, to address criteria required for inclusion in the study. Complete and attach the relevant Appendix A, D, or E if vulnerable populations (children, pregnant women, neonates or prisoners) will be enrolled to address the relevant regulatory criteria.

7) Recruitment Methods and Consenting Process a. Recruitment Process: Describe how potential subjects will be identified, where recruitment will take place, when recruitment will occur, and the methods that will be used to recruit. Provide copies of any materials used to recruit subjects directly (e.g. recruitment scripts, emails, print/audio/visual advertisements, or online notices). See HSPP Guidance, Recruitment and Advertisement, for information on acceptable practices for recruitment of subjects (e.g. no cold calling or finder’s fees).

of 10 HSPP Use Only: Form 200 v 2016-01 b. Informed Consent: Describe the consent process, setting, time to discuss and ask questions, and who will be involved. Describe how subjects will be notified of updates throughout the Human Research. Include oral and written processes for people who do not speak and/or read English. Copies of translated documents are required. Include how consent will be documented (e.g. written, oral, online, or waived). Describe procedures that minimize the potential for coercion or undue influence. When children are subjects or where subjects are unable to consent, include procedures to protect these populations (e.g. parental permission or Legally Authorized Representative). See HSPP Guidance, Requirements for obtaining informed consent, for more information on consent. Complete and attach the relevant Appendix F if the consent will be waived (e.g. online surveys), consent will be waived entirely (e.g retrospective reviews), or if a waiver or alteration to PHI is requested (e.g. prescreening of subjects from the medical record) to address the relevant regulatory criteria.

8) Research procedures involved in the Human Research This section should explain the research in lay language. Include how long subject participation is expected to last. Discuss all research procedures involved in the Human Research for each subject population participating in the study. Research procedures may be direct interactions or interventions, like surveys, questionnaires, recordings, photographs, blood draws, or medical exams. Procedures may also include indirect interactions, such as records review and data analysis. NOTE: Procedures the subject would complete regardless of the research should not be included. For projects investigating drugs/devices/ or treatment plans describe the tests and procedures that will be done to accomplish this. If applicable discuss the randomization ratio, the dosages of drugs being used, and the investigational treatment plan. Also, if any specimens (blood, urine, tissue, etc.) are being collected for research be sure to state the how much will be obtained and what the specimen will be used for. Finally be sure to explicitly list which procedures are standard of care and which are being done specific for research. Describe what information will be collected, including screening and long-term follow-up. Include a description of information collected by study staff and attach documentation as appropriate (see the Submission list for F200). If records will be accessed to collect information about subjects, discuss to whom the records belong and how the records will be made accessible to the researcher. Complete and attach the relevant Appendix B if drugs or devices will be studied to address the relevant regulatory criteria. Note: Drugs and devices may be used in research but may not be the purpose of the investigation (e.g. As an adjunct to a standard procedure or test for screening). Information about these drugs or devices must be included in the ‘Procedures’ section so an assessment of risk and safety to subjects can be made.

9) Cost to subjects

of 10 HSPP Use Only: Form 200 v 2016-01 Describe any costs, monetary and non-monetary, that subjects may incur. Include how much time it takes participants to complete research activities. The information in this section should match what appears in the consent documents.

10) Risks to subjects Risks may be physical, psychological, social, legal, and or economic. Risks should be 'reasonably foreseeable risks of the research.' If known, discuss their probability, magnitude and expected duration. If applicable, discuss what steps have been taken to minimize risk to subjects. Medical research: When evaluating two or more standards of care the risks of each standard of care may be different, and therefore the risks of the standard of care are the risks of the research and must be addressed. If studies have procedures that may present risk to an embryo or fetus and involve a population that are or could become pregnant, these risks should be included. NOTE: Risks the subject may experience regardless of the research should not be included.

11) Potential benefits to subjects and/or society Benefits may be educational, psychological, physical, and/or medical. If applicable, indicate the probability, magnitude, and duration of the benefit, including benefit to society at large. There may be no benefit to subjects. NOTE: Compensation to subjects is not a benefit and may not be listed in this section.

12) Provisions to protect the privacy of subjects and the confidentiality of data a. Protection of subject privacy: Describe steps, if any, to protect the privacy of the subject s throughout their participation in the Human Research (e.g. during the recruitment process, consent process, and/or research procedures). b. Protection of data confidentiality: Describe steps, if any, to protect information obtained from subjects. Discuss the process for storing, securing access (including who may have access to the information), what security measures are in place (such as file encryption), and how long the information will be stored. Describe if the data will be coded, who maintains the code, and if the code will be destroyed. See HSPP Guidance, Data Storage and Retention. If using video or audio recording, discuss when the recording will be transcribed and if the originals will be destroyed, shared, or kept for future research.

Delete any of the following sections if not applicable to the Human Research

13) Access to Private Information See HSPP Guidance, Access to records a. Access to medical records (HIPAA): Describe what information will be accessed, who will access the information, and how the information will be recorded and

of 10 HSPP Use Only: Form 200 v 2016-01 stored. Written authorization is required unless waived. Provide a description of the data elements that will be reviewed or abstracted from the medical record. b. Access to educational records (FERPA): Describe what records will be accessed, who will access the information, and how the information will be recorded and stored. Written authorization is required in most instances. c. Access to employee records: Access to information from an employee record requires the written permission of the employee and is protected under Arizona Board of Regents policy (e.g. medical residents, staff or faculty).

14) Subject compensation Discuss the amount and timing of any compensation (monetary and/or non-monetary). Describe if compensation will be prorated. See HSPP Guidance, Compensation of Subjects. NOTE: If raffles will be used, please refer to State of Arizona specific laws governing raffles. See HSPP Guidance, Raffles.

15) Medical care and compensation for injury If the research involves more than minimal risk to subjects, describe the provisions for medical care and available compensation in the event of research related injury. If the Human Research has a clinical trial agreement, this language should reflect what is stated in the agreement. The information in this section should be reflected in the consenting instruments. However, due to the technical nature of the agreement, the actual wording in the consent form may be different.

16) Monitoring for subject safety If the Human Research involves more than minimal risk to subjects, provide a brief lay discussion of the plan to monitor for subject safety. Describe how the data will be evaluated, include a timeline of when the review(s) will occur, who will review the information, and what information will be reviewed.

17) Withdrawal of subjects Discuss how, when and why subjects may be removed from the study. If abrupt withdrawal is necessary, discuss how subjects will be withdrawn so that they are not put at increased risk. Discuss what happens if a subject is withdrawn from one part of the study but asked to continue with other parts, such as ongoing follow-up.

18) Sharing of results with subjects If appropriate, discuss how immediate and/or long term study results will be shared with subjects, families, and/or the institution. If subjects or their insurance company will be billed for research procedures, discuss when and how procedure and billing information will be made available to the subject.

of 10 HSPP Use Only: Form 200 v 2016-01 19) Future use and long-term storage of data or specimens Describe if data or specimens will be kept for future research, including unspecified future research and genetics. Indicate who holds the repository and what information will be sent to the repository. Explain if the data/specimens will be shared with collaborating entities or sold/shared with pharmaceutical companies. NOTE: Include a separate section in the informed consent that reflects the future use and storage. See HSPP Guidance, Storing research data and/or specimens for future use.

20) Information management Please discuss the information management plan if your funding agency requires such a plan to manage data.

21) Clinical Trials.gov Information Identify if the study is or will require registration on clinicaltrials.gov and who is responsible for registering (e.g. sponsor, contractor, grantee, or awardee). See HSPP Guidance, Registration of studies on Clinicaltrials.gov.

ClinicalTrials.gov "NCT" number for this trial (provide): Registration pending Clinical trial does not require registration (explain):

22) Gases If the Human Research involves the use of gases, provide the name and approval status of the gas. Describe who will administer the gas, where the gas will be obtained, and plans to control the gas so it will be used only on subjects.

SECTION 4: LIST OF ATTACHMENTS FOR THIS SUBMISSION (REQUIRED) (Items listed here are expected to be attached as separate documents. These documents will appear in the UA HSPP IRB approval letter as 'documents submitted concurrently' with the review.) Document Name Version Date 1. 1.

See HSPP website for submission requirements. Items needed for approval:  F107: Verification of Training Form  Current PI/Co-PI CVs or biosketch, if not included with copy of grant application  Informed Consent/Permission/Assent Form(s) – including study specific release of information documents, DHHS approved sample consent forms. If consent will not be documented in writing, a script of information to be provided orally to subjects

Other Items as applicable:  Appendix A - Children Page 9 of 10 HSPP Use Only: Form 200 v 2016-01  Appendix B - Drug/Device  Appendix C- Multi Site Research  Appendix D- Pregnant Women and Neonates  Appendix E- Prisoners  Appendix F- Waiver of Consent/ PHI  Biosafety Review letter (for UA - Institutional Biosafety Committee)  Certificate of Confidentiality  Compressed Gases Review letter (for UA – Research Instrumentation)  Contract – complete or draft copy of contract including budget  Data Collection Tools – surveys, questionnaires, diaries not included in the protocol, data abstraction form for records review  Data Monitoring Charter and Plan  Drug/Device information – Investigator's Brochure, drug product sheet, device manual, user's manual, instructions for use, package insert, IND/IDE documentation, FDA 1572 form, 510k indication, FDA exemption, sponsor determination of device risk, etc.  Export Control Review  Grant Application(s) – cover-to-cover copy of grant, regardless of home institution or funding agency, and a copy of the Notice of Grant Award.  Other Approval letters (e.g., school districts, Tribal, other IRB approvals)  Participant Materials – written materials to be provided to or meant to be seen or heard by subjects (e.g. study newsletter, physician to participant letter, wallet cards, incentive items, holiday/birthday cards, certificates, instructional videos/written guides, calendars, certification of achievement, etc.)  Payer coverage analysis  PHI Authorization Form(s)  Protocol – including all amendments/revisions, sub- or extension-studies  Radiation Safety Review letter- needed regardless if the radiation device is approved and used standard of care  Recruitment Materials – telephone scripts, flyers, brochures, websites, email texts, radio/television spots, newspaper advertisements, press releases, etc.  Scientific Review Committee letter (for cancer related projects – AZCC SRC; other units as applicable if the unit has a scientific review committee)  Site Authorizations for research purposes and/or access to administrative records/samples o External sites (such as schools, other hospitals or campuses, etc.) o AHSC Research Portal Screen Shot  Supplemental site information (for sites engaged in research where the UA is the IRB of record) o Copy of any approvals granted from that site (including determinations if this site has an IRB of its own) o Site-specific F107 o Copy of the site's human subjects training policy o CV and medical license (if applicable) of site PI  Travel Authorization documentation (for UA – Office of Global Initiatives)  Use of retrospective research samples and/or data – IRB approval letter, original consent under which samples/data were collected, letter allowing access to samples

of 1 HSPP Use Only: 0 Form 200 v 2016-01