The NIEHS IRB reviews NIEHS intramural studies involving human subjects research. New ProtocolsAll human subjects research need IRB approval. Scientists with new protocols involving human subjects research should seek out the NIEHS IRB Administrator and/or NIEHS IRB Chair early in the review process for guidance. IRB Initial Review of new protocols requires the Clinical Research Protocol: Initial Review Application (http://www.niehs.nih.gov/about/orgstructure/boards/irb/docs/1195.pdf) (673K) form with attachments.
All protocols for review should be submitted in complete form at least 4 weeks prior to these meeting dates to be considered for review. See NIEHS IRB Meeting Schedule (http://www.niehs.nih.gov/about/orgstructure/boards/irb/meetings.cfm) for due dates. Continuing Review - for Protocols Previously ApprovedAfter the initial IRB approval, protocols must have Continuing Review by the NIEHS IRB at least annually or more frequently if determined necessary by the IRB. IRB Continuing Review of previously approved protocols requires the Clinical Research Protocol: Continuing Review Application form with attachments. Continuing Review Application (NIH 1195-1) must be signed by:
Among the required attachments are:
* Subject Accrual Tables are relatively new (3/99). Cumulative Enrollment and Enrollment Since Last Review have always been required. Now one must include this information by gender and ethnicity. Contact the IRB Administrator (lambert@niehs.nih.gov) for a copy which you can save on your computer, and then use in Microsoft Word. At the annual review, the IRB may request that the protocol be rewritten to reflect the changes or consolidate the amendments. The NIH Protocol Coordination Service sends out 120-day and 60-day reminders of this annual Continuing Review to the NIEHS PI. The NIEHS Office of Human Research Compliance sends out 90-day, 60-day, and 30-day reminders of this annual Continuing Review to the NIEHS PI. Note the due date,and plan your annual review for the NIEHS IRB meeting at least 30 days prior to your NIH Continuing Review due date, in order that your protocol not be terminated by NIH prematurely. All protocols for review (New and Continuing) should be submitted in complete form at least 4 weeks (Initial Review) or 3 weeks (Continuing Review) prior to these meeting dates to be considered for review. For your convenience the following zip files contain the required forms needed for New and Continuing Reviews.
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