Office of the Clinical Director

Institutional Review Board

The NICHD Institutional Review Board (IRB) is charged with reviewing for approval all clinical trials proposed by investigators in the NICHD Intramural Research Program. Patient safety and human subjects protection are the foremost goals of the IRB. The NICHD IRB meets monthly on the third Wednesday from 1-5 pm.

NICHD IRB Membership

Gilman Grave, Chair
Karim Calis, Vice-Chair

Voting Members

Gilman Grave, NICHD
Karim Calis, FDA
Aiyi Liu, NICHD
Gwenyth Wallen, Clinical Center
Melissa Meredith, NHGRI
John Pollack, Clinical Center
David Frankfurter, George Washington University
Lisa Horowitz, NIMH
Meg Keil, NICHD
Marva Moxey-Mims, NIDDK
Frank Witter, Johns Hopkins University
Karel Pacak, NICHD
Lynn Hardesty, Clinical Center

Alternate Members

Andrea Gropman, NHGRI
Brenda Hanning, NICHD
Sharon Jackson, NIAID

Procedures for Recruitment and Rotation of Members of the NICHD IRB

Introduction

The NICHD Institutional Review Board (IRB) is composed of 15 to 20 members including physicians, scientists and lay members. The IRB Chair, Vice-Chair and members are appointed by the NICHD Clinical Director and Scientific Director.

Individuals with a combination of training and experience in areas relevant to our protocols, as well as exposure to clinical research issues are sought as members. Due to the breadth and scope of our clinical trials, racial, ethnic, cultural and gender diversity on the board is highly desirable, as is representation from physicians and scientists from other NIH institutes and outside institutions.

Lay members from the community also are recruited to the NICHD IRB. Representing non-medical, non-scientific professions, the lay membership may include representatives from patient advocacy groups, parents or grandparents, or members of the clergy, lawyers and others. What we especially value from our lay members is their perspective and insight on the human, social, ethical and legal aspects of our clinical research.

Recruitment of Members

Recruitment of IRB Members is a formal process. When the Clinical Director identifies a qualified individual, an invitation and introductory message is sent, typically by email. If the individual accepts the invitation, his/her resume is requested, and when received, is forwarded together with a nominating memo signed by the Clinical Director to the Office of the Scientific Director. Following approval and signature by the Scientific Director, the packet is forwarded to the NIH Office of Human Subjects Research (OHSR). In the OHSR, a memo from the NIH Deputy Director for Intramural Research (DDIR) is generated in which the appointment is formally proposed. All appointments are for a specific term, between one and three years, in accordance with the NIH Multiple Project Assurance. The length of the term is now indicated in the memo from the Deputy Director. Next, the prospective member undertakes a brief computer-based training program relevant to serving on an institutional review board, following which IRB service may begin.

Rotation of Members

At the completion of their terms, members rotate off the IRB, unless their continued service is requested by the Clinical Director in consultation with the Scientific Director. In the latter case, terms may be renewed.

Approximately one month before members are scheduled to rotate off, the Clinical Director informs OHSR and a memo from the DDIR is generated, thanking the member for his/her service.