-ADMINISTRATIVE PRE-REVIEW CHECKLIST

New Exempt Application

IRB-HSR Submission #: ______IRB-HSR # ______

PI Name:______

Outside Sponsor NA Yes If yes: Sponsor ______

Funded by Grant? No Yes GIRB # List as Sponsor in database**IF THE ONLY PROTOCOLS FUNDED BY A GRANT MEETS EXEMPT CRITERA, THE IRB IS NOT REQUIRED TO REVIEW THE GRANT APPLICATION FUNDING THE PROTOCOLS.

Coversheet Review NA No issues with coversheet responses

Q # / Issue / Resolved?
Item / Review instruction : All must be YES or NA / YES / NO
At least one (1) item in #1 is checked
Under #1, either b or c are checked AND #3 If you are receiving or sending data…= YES
#2a is checked, consent(s) are provided AND the consent form(s) are free from language prohibiting the sharing of data or specimens outside of the original study team or with other institutions or the data from research are deidentified in a multi-site database protocol where it is not possible to determine which consent was signed. .
#4 . If NO, participants will sign the Health System HIPAA Authorization form, which was submitted, or tracking must be disclosed in EPIC.
#5 The purpose of THIS project is clearly stated.
#6 Sources of data or health information are consistent with information in #1 and Data Security Plan
#7The data/information/specimens to be obtained and is consistent with #5 and with the Data Security Plan
(TIP: NO health information/specimens are being collected. Study may qualify for SBS review.)
#8 (IDENTIFIERS) = NO AND #7 indicates health information is being collected or is YES (Tip: It is OK for investigators to view identifiers during data collection but they cannot document identifiers and still meet exempt criteria. IF more than 2 data/specimen/information sources are noted OR if information will be collected at various prospective time points, verify how the will be linked. It may be that identifiers will be needed and if so, the study will not qualify for exempt criteria.)
#9 is answered YES
Verify research described complies with the Common Rule Criteria (45CFR46 and FERPA (34CFR Part 99) - Exempt Criteria All must be YES to meet exempt criteria / YES / NO
9A - all = NO
9B - 1 AND 2 = YES OR 3 alone = YES, OR 4 alone = YES. IF 4 = YES refer to Exempt Criteria
9b1 = Yes if there is an interaction with a subject. Otherwise = NO
9b1 = YES, and the appropriate recruitment materials were submitted
9C Both questions =NO
9D both questions in the table = NO
10 = YES and 10A1 is completed
10 = NO then NO health information is being collected per #7 and no additional info is present on this form
10A1 = NO or NA, and 10A1 table is blank and 10A2 is completed
10A1 = YES, the HIPAA table (what the monitor sees) is completed and 10A2 is completed
10A2 All items except 1 or 2 are NO
10B = NO (IF any item in 10A2 table is YES, then 1o B must = YES and study will not qualify for exempt)
10B1= YES, and 10B2 is complete
10B2 = NO, data are deidentified under HIPAA and remainder of the form is blank
10B2 = YES and 10C and 10D are completed
10 C and D- All items = NO and 10 D = Limited Dataset under HIPAA. Update the determination language in Appendix C to= Limited Dataset (IF there is no contract/MTA, instruct PI to sign the Data Use Agreement which is part of the Exempt Application. If there is a contract/MTA then select the language from the determination language that requires DUA language be present in the contract. )
Verbal consent NA / YES / NO
Is there an interaction with a subject (survey interview, observation?)
(remember no survey or interview with minors allowed under exempt determination)
If YES, team must provide a completed script for obtaining “verbal” consent as follows:
·  Email For Survey Studies conducted solely by email
·  Letter Recruitment - For studies performed entirely by mail
·  Verbal Consent Script Template - In Person
·  Information sheet (optional)
Research Meets Ethical Standards (all must be YES for the study to meet exempt criteria / YES / NO
Research described presents no more than minimal risk to participants
If participants will be enrolled, subject selection is equitable. Participants who are appropriate to answer the scientific question are being recruited. Any benefits and burdens or risks are distributed fairly. NA

Training is current for all project personnel. IF no, list: _

No signed Investigator Agreement is required

Regulatory Page Information:

Check the appropriate exempt category Paragraph 2 Paragraph 4 Other:

Waiver of Documentation of Consent NA

Does this study meet the criteria listed below for Waiver of Documentation of Consent? Yes No

1.  That the only record linking the subjects and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality

OR

2.  That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

IF YES, add the following items to the comment field of the assurance form:

Waiver of Documentation of Consent granted under 45CFR46.117(c )

Funded by DoD? Yes No If yes, add: and 32CFR219.117(c)

questionnaires -Waiver of Documentation of Consent/HIPAA Authorization- Questionnaires

the main study- Waiver of Documentation of Consent/HIPAA Authorization-Main Study

Other: ______

HEALTH INFORMATION Check all applicable items below (De-identified, Limited Data Set, or Identifiable Data)

HIPAA Information

Does the study include Health Information? Yes No

IF YES, is the health information de-identified? Yes No (answer YES if anonymous or coded but researcher has no access to key to the code)

IF YES, check de-identified below

IF NO, will health information be collected that meets the criteria of a Limited Data Set?

Yes No

IF YES, instruct the PI to complete the Data Use Agreement included in the Exempt Application. Approval comment should indicate that PI was instructed to sign the Data Use Agreement provided as part of the Exempt application.

IF NO, is the health information identifiable -research has a key to a code? Yes No

IF YES, PROTOCOL DOES NOT QUALIFY FOR EXEMPT APPROVAL. ADVISE PI TO RESUBMIT A PROTOCOL FOR EXPEDITED OR FULL BOARD REVIEW.

Check one of the following:

De-identified- No additional documentation is required. No category is required in IRB Online under Waiver of consent or Waiver of Documentation of Consent fields. (Exempt under DHHS regs/ HIPAA does not apply)

Limited Data Set- (Exempt under DHHS regs - No waiver is required for LDS under HIPAA regulations. )

Internal/ External - send PI Data Use Agreement (DUA)

External- Grants and Contracts office will also put DUA into contract

Identifiable- Use of Identifiable Health Information not considered exempt.

RECRUITMENT NA No recruitment

If you need additional assistance reviewing the recruitment material use the Advertising Approval Checklist

Stamp recruitment material with approval/expiration date stamp. Compete the expiration date as NA because ad approvals do not expire. Enter type of recruitment in IRB Online under Adverts

Add the following comment to comment field in IRB Online and in the determination comment in Appendix C.
Approved with this protocol is/are the following recruitment material(s): . Insert item as checked below
Direct Contact by a UVa researcher
Recruitment letters/emails
Telephone Contact Script
Other direct contact (describe): Information sheet, In Person Verbal Consent Script______

Data Security Plan is submitted and accurate.

Refer to AG 3-1 regarding how to update the database and manage the electronic files.

Reviewed by:

Date:

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Version date: March 20, 2018