Irb

Human Research Protection Program
Institutional Review Boards
FWA00002571
25 Science Park – 3rd Fl., 150 Munson St.
New Haven CT 06520-8327

Telephone: 203-785-4688
http://www.yale.edu/hrpp

February 28, 2023

EXEMPTION DETERMINATION
Determination Date: 2/2/2023

Investigator:
Type of Review:
Title of Study:

Jennifer Miller
Initial Study
EXEMPT: A positive deviance approach for representing
women, older adults and patients identifying as racial and ethnic
minorities in oncology research

IRB Protocol ID:
Submission ID:
Documents:

2000033803
2000033803
• COVID Supplement, Category: Other;
• Demographic Survey, Category: Study questionnaires,
measures, focus groups/interview questions;
• Exemption Form , Category: IRB Protocol;
• Interview Guide, Category: Study questionnaires, measures,
focus groups/interview questions;
• Recruitment Email , Category: Recruitment Materials;
• Updated Consent Forms Clean, Category: Consent Form;




This research was deemed exempt under Exempt Category 45 CFR
46.104(d)(2)(ii).
The protocol does not require annual IRB review.

See the next page for important reminders.

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Human Research Protection Program
Institutional Review Boards
FWA00002571
25 Science Park – 3rd Fl., 150 Munson St.
New Haven CT 06520-8327

Telephone: 203-785-4688
http://www.yale.edu/hrpp

IMPORTANT REMINDERS:


Exempt research does not require additional IRB oversight except in cases where
the study is to be modified in a way that would change the applicability of the exempt
status.



Should you wish to modify the study in way that affects the applicability of the
exemption determination, a new protocol must be submitted for the IRB review. See
IRB Guidance document 100 GD 9: Guidance on Exemption from IRB Review for
examples.



Information that requires prompt reporting to the IRB must be done so within 5 days
of the PI becoming aware of the event (see Policy 710: Reporting Unanticipated
Problems Involving Risks to Subjects or Others, including Adverse Events). This
includes potential serious noncompliance, continuing noncompliance, and
unanticipated problems to subjects or others.



In conducting this activity, you should refer to and follow the Investigator Manual
(HRP-103) as applicable, which can be found in the IRB Library within the IRB
system.

Please keep this letter with your copy of the protocol documents.

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