Risk Evaluation and Mitigation Strategy Programs to Promote Appropriate Medication Use and Knowledge: Patient 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 #: 2021P001132
Date:

June 24, 2021

To:

Sarpatwari, Ameet
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: Patient
Experiences with REMS Programs

Version/Number:
Version Date:
Sponsor/Funding/Support: Proposal Title: Risk evaluation and mitigation strategy (REMS)
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
(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.)

IRB Approval Date:
06/24/2021
Approval/Activation Date: 06/24/2021
Next Review:
Expedited Check In
Official Version Generated from the Mass General Brigham Human Research System
06/24/2021 16:17

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

IRB Expiration Date:

06/24/2023

This project has been reviewed and approved by the MGB 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 documents were reviewed and approved by the IRB:
Protocol Summary, 06/11/2021
Adverse Event Log
Advertisement, (8)
Consent Fact/Information Sheet
Instrument/Questionnaire, (2)
Consent Fact/Information Sheet
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
Official Version Generated from the Mass General Brigham Human Research System
06/24/2021 16:17

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

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.

Study Staff Added:
 Brown, Beatrice, BWH > Medicine > Pharmacoepidemiology, Research Assistant
 Chin, Kristyn, BWH > Medicine > Pharmacoepidemiology, Research Assistant
 Feldman, William, BWH > Medicine > General Medicine, Co-Investigator
 Kesselheim, Aaron, MD, BWH > Medicine > Pharmacoepidemiology, Co-Investigator
 Lee, Su Been, BWH > Medicine > Pharmacoepidemiology, Research Assistant
 Mitra-Majumdar, Mayookha, Mass General Brigham, Research Coordinator/Manager
 Sarpatwari, Ameet, 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
Non-study Staff Removed:
 Patel, Neeraj, BWH > Medicine > Pharmacoepidemiology
Financial Delegate:
 Fund #123748 - Sarpatwari, Ameet
Questions related to this project may be directed to Fred Syllien | Tel: 857-282-1905 | Email:
[email protected]
cc:
Beatrice Brown, Research Assistant, Pharmacoepidemiology, Medicine
Ameet Sarpatwari, Principal Investigator, Pharmacoepidemiology, Medicine
Kristyn Chin, Research Assistant, Pharmacoepidemiology, Medicine
Su Been Lee, Research Assistant, Pharmacoepidemiology, Medicine
Rylie Garrison, Pharmacoepidemiology, Medicine
Official Version Generated from the Mass General Brigham Human Research System
06/24/2021 16:17

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

Lily Bessette, Pharmacoepidemiology, Medicine
Winta Tekle, Pharmacoepidemiology, Medicine
Lewis Seton, Pharmacoepidemiology, Medicine

Official Version Generated from the Mass General Brigham Human Research System
06/24/2021 16:17