5_Protocol1-4_MCAM_MSBI IRB Approval thru 20191222

APPROVAL OF RESEARCH
Date: 12/17/2018
To: Benjamin Natelson, MD ([email protected])
On 12/14/2018, an Institutional Review Board of the Mount Sinai School of Medicine, in
accordance with Mount Sinai’s Federal Wide Assurances (FWA#00005656, FWA#00005651) to the
Department of Health and Human Services approved the following human subject research from
12/23/2018 until 12/22/2019 inclusive:
Type of Review:

Continuing Request for Approval

Project Title:
Investigator:

Multi-Site Clinical Assessment of Chronic Fatigue Syndrome (CFS)
Benjamin Natelson, MD (Dept: NE - Neurology)

Project Information:

HS#: 16-01467

Sites:
IND or IDE (if any):

Beth Israel
No INDs;No IDEs;

Submission Details (if
any):

Removed personnel: Diana Vu.
Added personnel: Sarah Khan.

Between 11/5/2019 and 11/10/2019, or within 30 days prior to study close, whichever is earlier,
you are to submit a completed FORM HRP-212: Continuing/Final Review Progress Report and required
attachments, in order to request continuing IRB approval or study closure. If IRB continuing review
approval is not granted before the expiration date of 12/22/2019, IRB approval of this research expires
on that date.




The IRB has determined that this research involves no greater than MINIMAL RISK. Minimal
risk means that the probability and magnitude of harm or discomfort anticipated in the research
are not greater in and of themselves than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests (45CFR.46.102;
21CFR50.3k).
The IRB approved this research under expedited review procedure category(ies) 2, 3, 5 and
7

In conducting this research you are required to follow the requirements listed in the Investigator
Manual. If stamped approved consent forms are attached, use copies of these forms to document
consent. IRB approval does not constitute or imply institutional support for the conduct of this research.
Additionally, all required local committee approvals at each research affiliate site must be obtained
prior to initiation.
cc: Study Contact(s): Sarah Khan ([email protected])