Some links will work for NIAID staff only.
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This SOP has internal roles only.
Standard Operating Procedure Table of Contents
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Purpose
To
prohibit the attendance of contractor staff at closed sessions of NIAID Council meetings, scientific review groups, special emphasis panels, and
site visits.
Procedure
In general, contractors may not attend closed sessions of meetings of
Council, scientific review groups, and site visits. However,
they may obtain a waiver under exceptional circumstances.
This regulation enables NIH to ensure confidentiality of trade secrets
and other commercial, personal, or sensitive information.
Furthermore, only federal officials can perform activities the government
defines as "inherently governmental" -- see OMB
Circular A-76.
Peer Review Meetings
Scientific Review Officers
- If a contractor's attendance is required to help the scientific
review officer (SRO) oversee
the meeting, request a waiver from the
DEA director. Include a justification in the request. A contractor
may attend only if there is an overwhelming need.
- Submit the approved waiver and any waivers from program staff to
NIAID's
Committee Management Office (CMO) for the official meeting file.
- Make sure the contractor signs conflict of interest and confidentiality
documents for each meeting and send a copy to the CMO.
- Arrange for the contractor to attend the pre-meeting briefing for
contractors.
Program Officers
- If a contractor is needed to provide critical information about
a peer review to program officials, request a waiver that includes
a justification
from the NIAID deputy director for science management. A contractor is permitted to attend
only if there is no feasible alternative.
- Send a copy of the approved waiver to the SRO before the meeting.
- Make sure contractor signs conflict of interest and confidentiality
documents for each meeting.
- Work with SRO to ensure that contractor attends pre-meeting briefing
for contractors.
Contractors
Contractors who attend closed meetings must:
- Agree to observe NIH confidentiality requirements.
- Sign a nondisclosure agreement prohibiting disclosure of government
business and a non-competition agreement prohibiting the company
from competing
for activities in which the contractor participates.
- Divulge any conflicts of interest following NIH procedures.
- Observe federal government standards of ethical conduct.
- Attend pre-meeting briefing for contractors.
- Make recommendations only to a program officer or SRO.
Contractors must not:
- Invite scientists to serve on a review committee.
- Counsel or discuss results of peer review with PIs.
- Speak or appear to speak for NIH or the government.
- Make a decision that could be construed as binding for the government.
- Take notes that would identify individual reviewer comments from study section meetings.
Committee Management Officer
- Put a copy of waivers associated with peer review meetings in the
official meeting file.
Administrative and Contracting Officers
- Ensure that language in the statement of work is consistent with policies
and regulations governing appropriate tasks for contractors.
Advisory Council
SROs and Program Officers
- In very rare situations, have the NIAID director or deputy director for science management
determine the need for a contractor's expertise at the meeting.
- Obtain NIAID director and Council executive secretary approval before
the meeting.
- Provide documentation of approval to the CMO
and Council executive secretary before the meeting.
- Obtain a Council pass from CMO.
Contacts
DEA Office of the Director
Marvin Kalt, mk74s@nih.gov,
301/496-7291
Anna Ramsey-Ewing, ar15o@nih.gov,
301/435-8536
Scientific Review Program
Hortencia Hornbeak, hhornbeak@niaid.nih.gov,
301/496-8208
Committee Management Office
Mary Nuss, mn28z@nih.gov,
301/451-9896
Office of Acquisitions
Barbara Shadrick, bshadrick@niaid.nih.gov,
301/496-7288 If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.
Links
Center for Scientific Review,
SRO Handbook
Final
report of the EPMC working group
NIH
Policy Manual Chapter 6315-1, Initiation, Review, Evaluation, and Award
of Research and Development Contracts
NIH
Policy Manual Chapter 54514, Role of Staff at Peer Review Advisory
Committee Meetings and Exchange of Information Among Review, Program
and Grants Management Staffs
Office of
Federal Advisory Committee Policy:
Laws, Regulations, Policies and other
Reference Tools Office
of Federal Advisory Committee Policy, Attendance at Closed Sessions
of Meetings of National Advisory Councils, Scientific Review Groups,
and Special Emphasis Panels
Reinvention
of the Role of the Extramural Program Scientist at NIH
Scientific
Peer Review of Research Grant Applications and Research and Development
Contract Projects: Final Rule 42 CFR part 52h
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