Risk Evaluation and Mitigation Strategy Programs to Promote Appropriate Medication Use and Knowledge: Physician Interviews on Experiences with REMS Programs (CDER)

Mass General Brigham IRB
Mass General Brigham
399 Revolution Drive, Suite 710
Somerville, MA 02145
Tel: 857-282-1900
Fax: 857-282-5693

Notification of IRB Review
Protocol #: 2021P002615
Date:

October 05, 2021 [Reissued October 19, 2021]

To:

Sarpatwari, Ameet, Ph.D, JD
BWH
Mass General Brigham > BWH > Medicine > Pharmacoepidemiology

From:

Mass General Brigham IRB
399 Revolution Drive, Suite 710
Somerville, MA 02145

Risk Evaluation and Mitigation Strategy (REMS) Programs to
Promote Appropriate Medication Use and Knowledge: Physician
Interviews on Experiences with REMS Programs
Version/Number:
Detailed Protocol-V1
09/08/2021
Version Date:
Sponsor/Funding/Support Proposal
Risk evaluation and mitigation strategy (REMS)
:
Title:
programs to promote appropriate medication use and
knowledge
Principal
Sarpatwari, Ameet
Investigator:
Immediate
Food & Drug Administration (Contracts)
Sponsor:
Award
75F40120C00044
Number:
Fund #:
123748
Title of Protocol:

IRB Review Type:
IRB Approval Date:
Next Review:
IRB Expiration Date:
IRB Review Action:

Expedited
10/05/2021
Exempt Check In
10/05/2024
Exempt

The IRB has determined that this project meets the criteria for exemption 45 CFR 46.104(d)(#).
EXEMPTION (2) Research that only includes interactions involving educational tests (cognitive,
diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public
behavior (including visual or auditory recording) if at least ONE of the following criteria is met:
Official Version Generated from the Mass General Brigham Human Research System 10/05/2021 09:13
[Reissued 10/19/21 11:40AM to correct citation in regulatory language, by MJG46]

Mass General Brigham IRB
Mass General Brigham
399 Revolution Drive, Suite 710
Somerville, MA 02145
Tel: 857-282-1900
Fax: 857-282-5693

(i) The information obtained is recorded by the investigator in such a manner that the identity of the
human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the
subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing,
employability, educational advancement, or reputation; or
ANCILLARY COMMITTEES
1. Nursing (BWH) : Approved
2. MCA (MGB) : Review not needed
As Principal Investigator, you are responsible for the following:

1. Ensuring that this project is conducted in compliance with the exemption determination.
2. Ensuring that all study staff have completed the required human research education
requirements through the Collaborative Institutional Training Initiative (CITI).
3. Submission of significant proposed changes to this project to ensure that the project
continues to meet the criteria for exemption.
4. Submission of Exempt Check-In as required by institutional policy.
Questions related to this project may be directed to [email protected]
cc:
Ameet Sarpatwari, Ph.D, JD, Principal Investigator, Pharmacoepidemiology, Medicine

Official Version Generated from the Mass General Brigham Human Research System 10/05/2021 09:13
[Reissued 10/19/21 11:40AM to correct citation in regulatory language, by MJG46]