The NIEHS IRB reviews NIEHS intramural studies involving human subjects research.
New Protocols
All 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.
Initial Review Application must be:
Initialed by all investigators (FAX is acceptable), and signed by:
Principal Investigator
PI's Branch Chief
Scientific Review Committee (Bill Schrader or Dale Sandler)
Details of the efforts you will make to safeguard and protect your proposed research subjects,
The risks and benefits of your human subjects research, and
Complications or side effects you anticipate and how you propose to deal with them.
All protocols for review (New and Continuing) should be submitted in complete form at least 3 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 Approved
After 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:
Cumulative subject enrollment (gender by ethnicity)
Subject enrolled since the last review (again, gender by ethnicity)
Short Narrative Statement to the IRB, including:
a concise statement regarding protocol progress to date,
the reason(s) for continuing the study,
any scientific developments that bear on the protocol, especially those that deal with risks, burdens or benefits to individual subjects,
changes in the protocol which are substantive (These must be received and approved before they can be implemented by the IRB.),
summarize all amendments to the protocol approved during the past review period,
provide a copy of the current protocol which includes all amendments.
Clearance OF NIH Investigator Personal Financial Holdings Form or PFC (3/19/08)
* 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 (numerous) 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.
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