Environmental Factor, April 2006, National Institute of Environmental Health Sciences
IRB Members: Service on the Sidelines
The NIEHS Institutional Review Board is, perhaps, at the core of the NIEHS intramural mission. Its members provide a service directly related to the NIEHS mission -- taking environmental health research into the arena of human health. Members meet monthly to review proposed research involving human participants. All such studies require IRB approval. Ongoing studies require initial IRB approval, and continuing review is an annual requirement.
Researchers with such aspirations submit packets of information containing an application approved by branch chiefs, the Scientific Review Committee and the NIEHS clinical director, along with the study protocol, informed consent documents, all study questionnaires, brochures, advertisements, press releases and any other printed outreach material that will be given to participants, IRB approvals from cooperating institutions, details about the specific demographics and exclusions for the study, a list of risks and benefits associated with the study, a list of anticipated complications and side effects as well as a plan to address them, and information on how investigators intend to protect study participants.
When reviewing continuing studies, the IRB may request the protocol be rewritten or modified to reflect suggested changes.
Jane Lambert, the IRB administrator, coordinates the meetings and prepares material packets for distribution to IRB members. More information on the IRB and the submission process can be found at http://dir.niehs.nih.gov/dirosd/ocr/irb/irb_help.html.