SUNY Downstate Medical Center Institutional Review Board s1

SUNY Downstate Medical Center Institutional Review Board IRB Application for Exempt Request and Review of Human Research NOTE: Please use the latest version of forms available in IRBNet. The IRB will generally accept previous versions of forms, provided they were available in IRBNet at least 3 months prior to the submission date.

FEDERAL REGULATIONS PROHIBIT APPLYING THESE EXEMPT CATEGORIES TO RESEARCH INVOLVING PRISONERS. ALL RESEARCH INVOLVING PRISONERS MUST BE EXPEDITED OR REVIEWED BY THE FULL BOARD.

Submission Checklist Guidance (OPTIONAL): In your IRBNet submission to the IRB, please upload the following documents to the “Designer” page of your submission package: All required applicable materials and all required signatures must be submitted or the IRB application package cannot be processed. To obtain available IRB templates, click on the “Forms and Templates” button on the left menu in IRBNet. See “*Guidance- Submission Requirements for IRB Review” or call the IRB for assistance with understanding submission requirements.

REQUIRED FOR ALL NEW SUBMISSIONS: Registration Form. See instructions on page 2. Application for New Study (this form). Do not use this form for exempt review requests or for a request for an IRB determination. Scientific Review Worksheet. To be uploaded by the Department’s Scientific Review Committee. Complete Protocol. This may be a sponsor’s protocol or a protocol submitted to FDA or NIH. A “Template Research Protocol” is available in IRBNet for investigator initiated research.

REQUIRED FOR ALL FEDERALY FUNDED/SUPPORTED STUDIES: Grant Application or Grant Cover sheet. Include the NIH application section “Key Personnel” and “Human Subjects section and Research Methodology” for federally (e.g., HHS, NIH, NCI etc.) funded studies.

INFORMATION SHEETS (AS APPLICABLE): Information Sheet (if applicable). Required when requesting a waiver of documentation of informed consent, when IIHI or PHI is NOT involved. Information Sheet, including authorization to access, use, or disclose IIHI or PHI (if applicable). Required when requesting a waiver of documentation of informed consent, when IIHI or PHI is involved. Short Form. May be used for certain studies when enrolling non-English speaking participants or those with Limited English Proficiency (LEP).

WAIVERS (IF APPLICABLE): HIPAA Waiver(s). Waiver of Informed Consent. Required when waiving entire consent process (e.g., for retrospective data reviews) NOTE: If PHI is involved, the IRB may accept the HIPAA waiver form to document a request to waive informed consent. Waiver of Documentation of Informed Consent. Required when waiving documentation (e.g., signature) of informed consent.

INCLUDE ANY OF THE FOLLOWING WHEN APPLICABLE TO THE RESEARCH: HIPAA Preparatory to Research Certification Form Recruitment Materials (including, but not limited to flyers, brochures, ads, e-mails, telephone script, etc).

1 IRB Application for Exempt Request and Review of Human Research (07.28.2016) SUNY Downstate Medical Center Institutional Review Board

Subject Recruitment Authorization Form (Signed by patient). Physician’s Documentation of Patient’s Verbal Authorization. Questionnaires/Surveys. Data Collection Tools (or list of data to be collected). CV or Biosketch of PI (optional). This is generally not needed unless the PI is new; however, the IRB may request this to evaluate the PI’s qualifications, as required by the FDA and OHRP regulations. Credentials of PI or other study staff (optional). Sponsor contract (optional). Generally not needed, unless the IRB needs to review language in the informed consent regarding injuries or additional costs. Letter of support from the external site (except KCHC) when not covered by an IRB Reliance Agreement or External IRB approval.

IMPORTANT CONSIDERATIONS:

1. If you are requesting this study be reviewed by an External IRB (e.g., Central IRB, Commercial IRB, Main Study Site IRB, or Single IRB) for a Multi- site study, please do not use this form. Please use the “Application to Request Use of External IRB.” 2. Before using this form, please check the version date at the bottom of this form and make sure you have the most recent available form downloaded from IRBNet. In general, the IRB will accept the most recent version or any version that is not greater than 6 months old. 3. When preparing your IRB Application in IRBNet, click on Forms and Templates and Follow the guidance documents in IRBNet. For additional help, please call the IRB at 718-270-8480. For guidance on how to use IRBNet™, please see “IRBNET™: IRB Application and Reporting System.” 4. The Department Chair must approve the use of internal funds used for research purposes. 5. The IRB will approve the inclusion of co-investigators from other sites; however, these investigators must comply with both SUNY DMC requirements and their own institutional requirements, including when necessary, separate IRB approval if required from their institution. 6. A letter of support must be provided from the faculty or director of an external site, when recruiting research participants from an external site or when using identifiable data from an external site, when the external site is not covered by an IRB Authorization Agreement with the SUNY DMC IRB. 7. All IRB Submissions are done electronically through IRBNet. 8. In order for all Scientific Reviewers and Department Chairs to have IRBNet access to review and sign off on a new study, they will have to register for an IRBNet account. The Principal Investigator or coordinator must share the IRBNet submission with the appropriate Department Chair and Scientific Review Committee, Reviewer so they can access, review and approve the study package before submission. 9. For research that takes place at KCHC, contact the KCHC Research Facility Coordinator, Bryce Petty at (718) 245-2973 or [email protected] for additional requirements. Approval in STAR system at NYCHHC is also required. Instructions are available in IRBNet forms and template library.

IRB Application for Exempt Request and Review of Human Research (12.16.2016) 2

SUNY Downstate Medical Center Institutional Review Board

1) GENERAL INFORMATION

a) Protocol Title:

OPTIONAL: Please list the IRB# of any similar or associated research projects that have been approved by the SUNY Downstate IRB. Listing such projects will inform IRB Members of past research and may help the review process.

b) Abstract (Lay Summary): Please use non-scientific lay language and eliminate or explain any scientific terms.

Guidance: What the lay summary should include: 1. A statement of the problem of interest (background information). 2. General statement of how the problem will be studied . 3. Objective(s) and Hypothesis(es): State each of the main objectives and/or hypotheses in a single sentence (one sentence per objective/hypothesis). 4. Standard of Care (studies of treatment effects): What is the current standard of care, if any. 5. Potential Impact: how the research will advance scientific knowledge and/or human health.

Additional suggestions: • Technical terms need to be defined in simple language. • Abbreviations should be spelled out the first time used and defined in easily understood terms, if necessary. • It is not necessary to include a complete description of the study design in the lay summary-- a general idea of the strategy and/or techniques involved is sufficient • It is not necessary to include a complete description of the study design in this portion of the submission; rather, give a general sense of the strategy and/or techniques involved. • The summary should not exceed 2 pages

c) Principal Investigator (PI): Dept:

Indicate PI Status below (check all that apply): Downstate Faculty Member KCHC Employee with Clinical Privileges Other. Specify:

Contact Information: Phone # (required): Email (required): Alternate E-mail (optional):

d) Will there be multiple Principal Investigators responsible for the scientific and technical direction for this study? Yes No If yes, provide rationale for choosing a multiple PI approach: If yes, complete the table below: Additional PI PI Status? Contact Description of the roles, responsibilities and the working relationship to the Name Information primary PI. Downstate Faculty Phone # Member Email : KCHC Employee with Clinical Privileges Other. Specify:

Downstate Faculty Phone # Member Email : KCHC Employee with Clinical Privileges Other. Specify:

Note: Attach additional sheets if needed. The first PI listed in the IRB application must be affiliated with the Downstate or KCHC and will serve as the contact IRB Application for Exempt Request and Review of Human Research (12.16.2016) 4

PI. Each PI must electronically sign the initial submission

e) Is this a sponsored study? Yes No

If Yes, answer the following:

e1) Will a SUNY HSCB/DMC Department receive sponsored funding for this study? Yes No If Yes, which Department?

e2) Provide the Sponsor Award #: or the Federal Award #:

f) If someone, other than the PI, will be the main contact for this study, please provide his/her contact information below: Name (if not PI): Phone: Email: Role on Study:

2) INSTRUCTIONS FOR COMPLETING THE TABLE OF STUDY STAFF:

a) Name & degree: Please provide first and last name of each individual and their highest degree, if applicable.

b) Role(s) on Project: Please describe the role(s) of each individual. Examples: Principal Investigator, Co-Investigator, Coordinator, Consultant, Fellow, Resident, Student, Research Staff, Healthcare Operations only, Access to de-identified data only, Specimen shipment, etc.

c) Indicate place of employment.

d) Will this person be obtaining Informed Consent/Authorization: Check “Yes,” if the person will be obtaining written and/or verbal informed consent and/or HIPAA Authorization. The IRB must approve the IRB application listing those who will be obtaining informed consent/HIPAA Authorization before those individuals can obtain informed consent.

e) Is this an “Investigator for the Purposes of COI”? For more information, please see the IRB “Guidance- Training and COI Requirements” in the IRBNet Forms and Templates. NOTE: For exempt research, the COI policy only applies to federally funded research.

f) Will this person aid the shipment of hazardous materials (e.g., dangerous goods, specimens) to be transported by a public carrier? If yes, a Dangerous Goods Shipping Certification must be provided for each individual responsible for shipment. For more information, please see the IRB “Guidance- Training and COI Requirements” in the IRBNet Forms and Templates.

TRAINING REQUIREMENTS: For more information, please see the IRB “Guidance- Training and COI Requirements” in the IRBNet Forms and Templates.

CONFLICT OF INTEREST (COI) DISCLOSURES: For more information, please see the IRB “Guidance- Training and COI Requirements” in the IRBNet Forms and Templates.

3) TABLE OF STUDY STAFF: See section 1 of this application for instructions. If additional space is needed, please continue on a separate page using the same format. a. b. c. d. e. f. Name & degree Role(s) on Project. Examples: Place of employment Will this person be Is this person an Will this person aid Principal Investigator, Co- obtaining verbal “Investigator for the shipment of haz Investigator, Coordinator, Consultant, or written the purposes of ardous materials Fellow, Resident, Student, Research Informed COI reporting”? (e.g., dangerous goo Staff, Healthcare Operations only, Consent/Authoriza ds, specimens) to be Access to de-identified data only, tion FEDERALLY transported by a pu Specimen shipment, etc. FUNDED blic carrier? STUDIES ONLY

SUNY Downstate Yes No Yes No Yes No KCHC Other: SUNY Downstate Yes No Yes No Yes No KCHC Other: SUNY Downstate Yes No Yes No Yes No KCHC Other: SUNY Downstate Yes No Yes No Yes No KCHC Other: SUNY Downstate Yes No Yes No Yes No KCHC Other: SUNY Downstate Yes No Yes No Yes No KCHC Other: SUNY Downstate Yes No Yes No Yes No KCHC Other: Attach additional pages if needed.

4) PROPOSED EXEMPTION RESEARCH CLASSIFICATION(S)

Please check the proposed exemption research category (or categories) for this project. Unless otherwise required by SUNY DMC IRB policy or federal regulations, research activities in which the only involvement of humans will be in one or more of the following exemption categories. Answer the questions below the box to confirm and justify the exemption category.

Do ALL of the activities for this research meet the specific criteria of one or more categories outlined within the exemption research categories outlined below? Yes No If no is checked, do not use this form, as the research will not qualify as “exempt” research.

1) Does the research meet the criteria indicated below for EXEMPTION CATEGORY #1? Yes No

EXEMPTION CATEGORY #1: Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as a) research on regular and special education instructional strategies, or b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

If, category #1 is checked please explain how the research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, OR (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods:

Please provide any additional information for the IRB to consider:

NOTE: EXEMPTION CATEGORY 2 CANNOT BE APPLIED TO RESEARCH INVOLVING CHILDREN, EXCEPT FOR RESEARCH INVOLVING OBSERVATION OF PUBLIC BEHAVIOR WHEN THE INVESTIGATORS DO NOT PARTICIPATE IN THE ACTIVITIES BEING OBSERVED.

EXEMPTION CATEGORY #2: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: a) information obtained is recorded in such a manner that research participants can be identified, directly or through identifiers linked to the them; and b) any disclosure of the research participants’ responses outside the research could reasonably place them at risk of criminal or civil

liability or be damaging to the subjects' financial standing, employability, or reputation.

If category #2 is checked, please answer the following:

1. Check if any of the following are involved in the research: Observation of public behavior of adults Observation of public behavior of children when the investigators do not participate in the activities being observed Educational tests (cognitive, diagnostic, aptitude, achievement) with adults Survey procedures with adults Interview procedures with adults

2. Will information obtained is recorded in such a manner that research participants can be identified, directly or through identifiers linked to the research participants? Yes No

3. Will any disclosure of the research participants’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation? Yes No

4. Please provide any additional information for the IRB to consider:

EXEMPTION CATEGORY #3: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) above, if: a. the research participants are elected or appointed public officials or candidates for public office; or b. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

If category #3 is checked, please answer the following: 1. Will the research participants be elected or appointed public officials or candidates for public office? Yes No

2. Are there Federal statute(s) that require without exception that the confidentiality of the personally identifiable

information be maintained throughout the research and thereafter? Yes No

EXEMPTION CATEGORY #4: Research involving the collection or study of *existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available OR if the information is recorded by the investigator in such a manner that research participants cannot be identified, directly or through identifiers linked to the research participants.

NOTE: *existing means before the research is approved by the IRB (e.g., already on the shelf). This does not apply to prospective research activities after IRB approval.

If category #4 is checked, please indicate which materials will be used in the research:

EXISTING data EXISTING documents EXISTING records, EXISTING pathological specimens EXISTING diagnostic specimens

If category #4 is checked, please answer the following:

1. Are these sources publicly available? Yes No;

2. If Yes, provide website or location of information:

3. Is the information recorded by the investigator in such a manner that research participants cannot be identified, directly or the exemption through identifiers linked to any individuals? Yes No

EXEMPTION CATEGORY #5: Research and demonstration projects which are conducted by or subject to the approval of federal department or federal agency heads, and which are designed to study, evaluate, or otherwise examine: a) Public benefit or service programs; b) Procedures for obtaining benefits or services under those programs; c) Possible changes in or alternatives to those programs or procedures; or d) Possible changes in methods or levels of payment for benefits or services under those programs.

If category #5 is checked, will the activity involve research and demonstration projects which is approved by a Federal Department or Agency Head (e.g., Secretary or Health and Human Services)? Yes No

If yes, which of the following is the research activity designed to study, evaluate, or otherwise examine? Public benefit or service programs? Procedures for obtaining benefits or services under those programs Possible changes in or alternatives to those programs or procedures Possible changes in methods or levels of payment for benefits or services under those programs

EXEMPTION CATEGORY #6: Taste and food quality evaluation and consumer acceptance studies, a) if wholesome foods without additives are consumed or b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

If category #5 is checked, will the activity involve taste and food quality evaluation or consumer acceptance studies? Yes No

If Yes, which of the following apply to the research? Wholesome foods without additives are consumed Food is consumed that contains a food ingredient, agricultural chemical, or environmental contaminant at or below the level found to be safe by the Food and Drug Administration (FDA), or approved by the Environmental Protection Agency (EPA) or the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA)

5) RESEARCH PARTICIPANTS (Human subjects):

a) What is the age range of the study population?

b) Please indicate whether you are including any of the following individuals: Males Females Patients

c) Please indicate if any of the following “Categorically Vulnerable” populations will be involved (enrollment or data): Note: Additional Federal regulations and IRB policies apply to the research if any of the following are checked.

Prisoners (Requires review by Full IRB). Includes individuals involuntarily confined in a penal institution, including persons (1)sentenced under a criminal or civil statue, (2) detained pending arraignment, trial, or sentencing, and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution.

If Prisoners are to be enrolled, this study does not qualify for Exemption.

Children (0-17 years old) or neonates.

Children who are Wards(0-17 years old).

Neonates of uncertain viability and non- viable neonates.

Pregnant women or fetuses.

NOTE: EXEMPTION CATEGORY 2 CANNOT BE APPLIED TO RESEARCH INVOLVING CHILDREN, EXCEPT FOR RESEARCH INVOLVING OBSERVATION OF PUBLIC BEHAVIOR WHEN THE INVESTIGATORS DO NOT PARTICIPATE IN THE ACTIVITIES BEING OBSERVED.

d) Please indicate if you are enrolling, interacting, or intervening with any of the following “Possibly Vulnerable” populations for the purpose of the research:

Patients recruited by their providers

Emancipated minors. If checked, describe:

Mature minors. If checked, describe:

Persons who are institutionalized

Research participants with Limited English Proficiency (LEP) or Non-English Speakers: If checked, indicate anticipated language(s): Recruitment of research participants with Limited English Proficiency (LEP) or Non-English Speakers is generally required, if the study holds the prospect of a direct therapeutic benefit to the research participant, and the informed consent must be obtained in the research participant’s preferred language. If checked, a Short Form must be used, when appropriate, or an amendment shall be submitted to the IRB after the English version of the materials are approved. A certificate of translation must be included with the amendment. See also related question 9b-c, below. .

Minorities [including American Indians, Alaskan Native, Asian, Native Hawaiian, Pacific Islander, Black/African American (not of H ispanic Origin) and Hispanic]

Economically or educationally disadvantaged

Study staff or investigators named on this application

Employees, Students, Residents, or Fellows subordinate to the investigative staff.

Cognitively-impaired adults (Requires review by Full IRB, if enrolling, interacting, or intervening with such individuals; however, studies, involving data only (e.g., retrospective chart review), may be expedited, if eligible.

Other (describe):

e) If any box is checked in “4c or 4d” above, please describe strategies to reduce the possibility of undue influence or coercion, when recr uiting these individuals:

Note: Patients usually have a great deal of respect for their physicians and may wish to please them or comply with their physicians wishes to recruit them or misconceive research for therapy, therefore it may be important to develop a strategy that mitigates the possibili ty of undue influence or coercion. Whenever there is a power dynamic, such as faculty recruiting their students, or supervisors recruiting their employees, additional strategies should be included to reduce the possibility of undue influence or coercion.

3) RECRUITMENT & ENROLLMENT

Check here if this study does not involve the recruitment and enrollment of individuals (e.g., review of data only) and skip to the next section.

a) From which locations will research participants be recruited and enrolled by the study team? SUNY HSCB/DMC/RF KCHC Other Site (describe): If other is checked, please provide a letter of support from the relevant faculty member or director of the external site.

b) What is the total number of research participants who will be enrolled at the above sites?

c) If this is a multisite study, what is the total number of research participants needed for all sites? (if not multi-site, type N/A)

d) How will the study team identify potential research participants? From the patient population of the study team Colleagues Chart Reviews (If chart review will be utilized, you may need to request a partial or full waiver of HIPAA Authorization. Templates are available on the Forms & Templates page in IRB Net at https://www.irbnet.org) Other/Describe:

e) What recruitment materials will be used to recruit research participants?

(Please upload any proposed advertising, e.g. flyers, radio ads to the IRB application submission package in IRBNet – these may also be submitted later as an Amendment once the study has been approved)

Flyer – Distributed where Printed Ad Internet Posting; Website:

Radio/TV Information Brochure Emails Letter to Doctors Direct Subject Contact Other/Describe: Letter to potential research participants Referral 4) HIPAA Authorization & I nformation Sheet Note: Templates are available on the Forms & Templates page in IRB Net at https://www.irbnet.org

a) Indicate whether you will obtain a HIPAA authorization, HIPAA waiver or whether the study does not involve access, review, or disclosure of Protected Health Information (PHI) also known as Individually Identifiable Health Information (IIHI). Will obtain a HIPAA Authorization (IIHI Authorization) combined with a consent document or information sheet (e.g., “What information will be kept private” section of templates) Request a HIPAA Waiver (e.g., for retrospective review of PHI/IIHI, and/or waive or alter signature or other required elements, and/or to review of PHI/IIHI for recruitment purposes and obtain a HIPAA Authorization during enrollment, if applicable) N/A - the study does not involve access, review, or disclosure of PHI/IIHI. N/A – this study involves release of a limited dataset and a Data Use Agreement (DUA)

b) Did any researcher seek access to PHI/IIHI in preparation for this IRB Application for the research project? Yes No If YES, complete and upload a “Research Certification for Reviews Preparatory to Research” to the new submission package. This form is available in the IRBNet on the Forms & Templates page.

c) Check if you are using an Authorization Form to have clinicians refer their patients to the SUNY DMC study team? Note: Template forms are available on IRB Net. Written authorization is required for release of HIV related condition or drug/alcohol abuse. Subject Recruitment Authorization Form (to be signed by patient) Physician’s Documentation of Patient’s Verbal Authorization

d) Check if you including an information sheet:

5) REVIEW OF EXISTING DATA (RETROSPECTIVE DATA REVIEW) Check here if this study does not involve the review of existing data (document, records or specimens) and skip to the next section. * Note: "Existing" means existing before the research is proposed to the institutional review board

a) From which locations will data about research participants be reviewed by the study team? SUNY Downstate Medical Center KCHC Other Site (describe): If other is checked, please provide a letter of support from the relevant faculty member or director of the external site.

b) Provide the exact date range for the data that will be reviewed or collected? Start date of data: End date of data:

c) Will the data be de- identified in accordance with DMC’s Policy # HIPAA-6, “De- Identification of Information”? Yes No

d) Will the study team have the ability to link the data reviewed or data collected back to the research participants (e.g., through identifiers or codes)? Yes No

e) What information will be collected? Note: This must also be described in the HIPAA waiver or informed consent, as applicable.

f) How will the study team obtain access to the data?

g) What is the total number of research participants whom need to have their records screened (if any) at the above sites?

h) What is the total number of research participants from the above sites whose data you will collect?

i) If this is a multisite study, what is the total number of research participants needed for all sites? (if not multi-site, type N/A)

8) BIOLOGICAL SPECIMENS

Check here if this study does not involve the biological specimens and skip to the next section.

a) Are the specimens to be obtained from an existing collection? Yes No If YES, does the original consent cover the purpose of this research? Yes No If NO, please include a waiver of informed consent and waiver of HIPAA authorization, as applicable. Please upload a copy of the original consent form to the IRB submission package in IRBNet.

If specimens are not obtained from an existing collection, this study does not qualify for Exemption category # 4.

b) Will specimens be transported by a public carrier? Yes No If YES, upload a certificate of training for Hazardous Materials training to the IRB submission package in IRBNet.

c) Will the specimens be linked to individually identifiable information (e.g. name, ID#, code, or any of the 17 HIPAA Identifiers)? Yes No

i) If YES, are the specimens linked during the storage process, after processing? Yes No ii) If YES, might the study yield clinically relevant information? Yes No iii) If YES, under what circumstances will participants be contacted?

9) BENEFITS a) Are there any prospects of direct benefits to individual research participants? (e.g., additional health benefit, etc.) Yes No If YES, please describe: Note: Financial or other forms of compensation are not considered a benefit to be derived from research participation. Although the subject may consider financial compensation desirable outcome, this fact will not be used in the risk-benefit analysis.

b) If you answered YES to question (a), is there a prospect of a therapeutic benefit? Yes No N/A

c) If you answered YES to question (b), would it be appropriate and valuable to recruit participants with limited English Proficiency? Yes No N/A

i) If YES, please describe the plans to recruit and enroll those with Limited English Proficiency or describe the risks or barriers that prohibit the study team from doing this:

Note: Please include the Short Forms in the submission package, if you are requested the use of the Short Forms for enrolling participants with Limited English Proficiency. See IRB Guidance or contact the IRB for more information.

d) What are the other potential benefits of the research (e.g., benefits to society, advanced monitoring of the participant, etc.)?

e) Does this study involve comparative effectiveness research (Comparative effectiveness research is the conduct and synthesis of systematic research comparing different interventions and strategies to prevent, diagnose, treat and monitor health conditions)? Yes No

If NO, please answer the following questions: (1) Describe any standard interventions incorporated into the study? or check N/A: N/A

(2) What would be the standard treatments/procedures were the participants not enrolled in research? or check N/A: N/A IRB Application for Exempt Request and Review of Human Research (12.16.2016) 18

(3) How do the risks and potential benefits of the research interventions differ from standard care? or check N/A: N/A

10) PRIVACY & CONFIDENTIALITY

a) What will be done to ensure the privacy or the research participant?

b) What will be done to ensure the confidentiality of the research participants’ data? (e.g. data access, data security, data disclosure, destruction of identifiers, storage, and coding)

11) COSTS AND PAYMENTS :

a) Will participants receive any reimbursement or remuneration for their participation? (Payments should not be an amount that could be considered coercive or create undue influence)

No Yes If YES, give details including, total amount and amount per visit

12) ADDITIONAL INFORMATION:

a) Please provide any additional information that you would like for the IRB to consider:

13) ANCILLARY REVIEWS: Please review the following sections to determine if any ancillary reviews are required. If so, for any ancillary reviewer other than IBC, pl ease share the IRBNet submission with the ancillary reviewer. Although the IRB may grant a “conditional approval” of the research whe n ancillary review is required, the research CANNOT begin until the IRB has granted final IRB approval.

a) Ancillary review by UHB Pathology Laboratories Services (Clinical Laboratory & Histology):

Does your study involve Clinical or Anatomic Pathology services? Yes No If Yes is checked above, please complete the following steps to determine the feasibility of using the service.

Step 1: a) Refer to the UHB Pathology Instructions, Forms, and Fees posted in IRBNet. b) Contact UHB Pathology Laboratory Administration (x1689) to be directed to the proper laboratory director/supervisor. c) Complete and submit the following form to Pathology: “Step 1 Form: Preparation for Use of UHB Laboratory/Patient specimens for Research Projects: Clinical, Histology, and Surgical Pathology Labs Feasibility Determination.”

Step 2: a) Complete and submit this IRB application after the UHB Pathology Laboratories approves the feasibility of using their services to obtain IRB approval. b) When submitting the IRB application in IRBNet, please share the IRBNet submission with the laboratory designee so that (s)he may e-sign the submission. E-signature is required before the IRB can grant final approval.

Step 3: After IRB approval is granted, complete and submit the “Step 3 Form: Protocol of UHB Laboratory Use/Patient specimens for Research Projects: Clinical, Histology, and Surgical Pathology Labs. Caution: If any changes to the IRB materials are require after final IRB approval, an amendment must be submitted to the IRB.

b) Biosafety Approval:

 All research involving the use of Recombinant or Synthetic Nucleic Acid Molecules, infectious agents, human cells or body fluids, or hazardous substances must be reviewed and approved by the Institutional Biosafety Committee (IBC) to ensure that all applicable biosafety standards are met. Early submission of the protocol to the committee is advisable to allow time for any necessary clarification, revision and reconsideration, and approval. The IBC will determine if the study requires approval from the NIH Recombinant DNA Advisory Committee. For more Information: Please contact Ms. Lydia Bailey at the IBC Office at (718) 270-3912 or [email protected].  Protocols involving work with human-derived biological materials that are collected by and handled, processed, analyzed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory are exempt from IBC review. However, any work on human-derived biological materials (including packaging and shipping) in Research laboratories at DMC is subject to IBC review.  If your study requires Institutional Biosafety Committee approval or NIH Recombinant DNA Advisory Committee approval, your study cannot be approved by the IRB until you have received the applicable approvals.

(13b1): Does your study require approval from the Institutional Biosafety Committee (IBC)?

No to (13b1), this study does NOT involve recombinant or synthetic nucleic acid molecules, infectious agents, human cells or body fluids, or hazardous substances.

No to (13b1), this study involves infectious agents, human cells or body fluids, or hazardous substances; however, all materials are human-derived and are collected by and handled, processed, analyzed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.

Yes to (13b1), this study involves the use of recombinant or synthetic nucleic acid molecules, infectious agents, human cells or body fluids, or hazardous substances and the materials are not collected nor handled by a (CLIA) certified laboratory.

If yes to (13b1), has the IBC approved the study or is the review pending?

Yes. If YES, please upload the approval letter within the new IRBNet Submission package.

PENDING IBC approval. Note: IBC review may take place in parallel; however, final IRB approval cannot be granted until IBC approval is granted.

(13b2): If Yes to (13b1), does this study involve the deliberate transfer of recombinant or synthetic nucleic acid molecules, or DNA or RNA derived from recombinant or synthetic nucleic acid molecules into one or more human research participants? Yes No If yes, approval by both the IBC and the NIH Recombinant DNA Advisory Committee (RAC) is required, prior to IRB approval.

If yes to (13b2), has the NIH RAC approved the study or is the review pending? Yes. If YES, please upload the approval letter within the new IRBNet Submission package. PENDING NIH RAC approval. Final IRB approval cannot be granted until IBC approval is granted.

c) Ancillary review by other multiple Departments:

Does this research impact or involve other Departments, other than those listed above? Yes No

If yes to 13d, describe how each specific Department is involved or impacted:

If yes to 13d, please share with Department Chair and request electronic signature in IRBNet.