Risk Evaluation and Mitigation Strategy (REMS) Programs to Promote Appropriate Medication Use and Knowledge: Physician 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 #: 2021P002109
Date:

August 20, 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

Title of Protocol:

Risk Evaluation and Mitigation Strategy (REMS) Programs to
Promote Appropriate Medication Use and Knowledge: Physician
Surveys on Experiences with REMS Programs
Version/Number:
V1
Version Date:
08/17/2021
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
IRB Review Type:
Expedited Category/ies:

Expedited

IRB Approval Date:
Approval/Activation
Date:

08/20/2021

(7) Research on individual or group characteristics or behavior (including,
but not limited to, research on perception, cognition, motivation, identity,
language, communication, cultural beliefs or practices, and social behavior)
or research employing survey, interview, oral history, focus group, program
evaluation, human factors evaluation, or quality assurance methodologies.
(Note: Some research in this category may be exempt from the HHS
regulations for the protection of human subjects. 45 CFR 46.101 (b)(2) and
(b)(3). This listing refers only to research that is not exempt.)

08/20/2021

Official Version Generated from the Mass General Brigham Human Research System
08/20/2021 15:39

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

Next Review:
IRB Expiration Date:

Continuing Review
08/20/2022

This project has been reviewed and approved by the Mass General Brigham IRB. During the review of
this project, the IRB specifically considered (i) the risks and anticipated benefits, if any, to subjects; (ii)
the selection of subjects; (iii) the procedures for obtaining and documenting informed consent; (iv) the
safety of subjects; and (v) the privacy of subjects and confidentiality of the data.
Please note that if an IRB member had a conflict of interest with regard to the review of this project,
consistent with IRB policies and procedures, the member was required to recuse him/herself and, if
applicable, leave the room during the discussion and vote on this project except to provide information
requested by the IRB.
The following changes to the study staff have been reviewed and approved by the MGB IRB. No
further action is required.

Study Staff Added:
 Brown, Beatrice, BWH > Medicine > Pharmacoepidemiology, Research Assistant
 Feldman, William, MD, D.PHIL, MPH, BWH > Medicine > Pharmacoepidemiology, CoInvestigator
 Kesselheim, Aaron, MD, BWH > Medicine > Pharmacoepidemiology, Co-Investigator
 Lee, Su Been, BWH > Medicine > Pharmacoepidemiology, Research Assistant
 Mitra-Majumdar, Mayookha, Mass General Brigham, Regulatory Coordinator/Manager
 Sarpatwari, Ameet, Ph.D, JD, BWH > Medicine > Pharmacoepidemiology, Principal
Investigator
 Zakoul, Heidi, BWH > Medicine > Pharmacoepidemiology, Research Assistant
Non-study Staff Added:
 Bessette, Lily, BWH > Medicine > Pharmacoepidemiology
 Garrison, Rylie, BWH > Medicine > Pharmacoepidemiology
 Seton, Lewis, BWH > Medicine > Pharmacoepidemiology
 Tekle, Winta, BWH > Medicine > Pharmacoepidemiology
Financial Delegate:
 Fund #123748 - Sarpatwari, Ameet
The following documents were reviewed and approved by the IRB. A PDF document listing all
documents reviewed and approved by the IRB is available via the “Download” button in Insight.

Protocol Summary
Detailed Protocol

08/17/2021
08/17/2021, V1

ANCILLARY COMMITTEES
Official Version Generated from the Mass General Brigham Human Research System
08/20/2021 15:39

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

1. Nursing (BWH) : Approved
2. MCA (MGB) : Review not needed
As Principal Investigator, you are responsible for ensuring that this project is conducted in compliance
with all applicable federal, state and local laws and regulations, institutional policies, and requirements of
the IRB, which include, but are not limited to, the following:

1. Submission of any and all proposed changes to this project (e.g., protocol, recruitment
materials, consent form, status of the study, etc.) to the IRB for review and approval prior
to initiation of the change(s), except where necessary to eliminate apparent immediate
hazards to the subject(s). Changes made to eliminate apparent immediate hazards to
subjects must be reported to the IRB as an unanticipated problem.
2. Submission of a continuing review submission or institutional status report as required by
the IRB and/or institution to continue the research, and submission of a final report when
the project has been closed or completed.
3. Submission of any and all unanticipated problems, including adverse event(s) in
accordance with the IRB's policy on reporting unanticipated problems including adverse
events.
4. Obtaining informed consent from subjects or their legally authorized representative prior
to initiation of research procedures when and as required by the IRB and, when
applicable, documenting informed consent current IRB approved consent form(s) with
the IRB-approval stamp in the document footer.
5. Informing all investigators and study staff listed on the project of changes and
unanticipated problems, including adverse events, involving risks to subjects or others.
6. When investigator financial disclosure forms are required, submitting updated financial
disclosure forms for yourself and for informing all site responsible investigators, coinvestigators and any other members of the study staff identified by you as being
responsible for the design, conduct, or reporting of this research study of their obligation
to submit updated Investigator Financial Disclosure Forms for this protocol to the IRB if
(a) they have acquired new financial interests related to the study and/or (b) any of their
previously reported financial interests related to the study have changed.
IMPORTANT REMINDER: THE IRB HAS THE AUTHORITY TO TERMINATE PROJECTS
THAT ARE NOT IN COMPLIANCE WITH THESE REQUIREMENTS.
Questions related to this project may be directed to [email protected]
cc:
Beatrice Brown, Research Assistant, Pharmacoepidemiology, Medicine
Heidi Zakoul, Research Assistant, Pharmacoepidemiology, Medicine
Su Been Lee, Research Assistant, Pharmacoepidemiology, Medicine
Official Version Generated from the Mass General Brigham Human Research System
08/20/2021 15:39

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

Mayookha Mitra-Majumdar, Regulatory Coordinator/Manager, Mass General Brigham
Ameet Sarpatwari, Ph.D, JD, Principal Investigator, Pharmacoepidemiology, Medicine
Winta Tekle, Pharmacoepidemiology, Medicine
Lewis Seton, Pharmacoepidemiology, Medicine
Rylie Garrison, Pharmacoepidemiology, Medicine

Official Version Generated from the Mass General Brigham Human Research System
08/20/2021 15:39