This form gets modified frequently. Do not use old forms. The current version is dated 6-04. As NIH continues to add sections this form, it has gotten quite crowded, and sections are easily missed. We provide here a 'walk through' for your convenience.
This is a 4-part form, and thus an original must be submitted. However we provide here, in Adobe Acrobat, an electronic copy (http://www.niehs.nih.gov/about/orgstructure/boards/irb/docs/1195.pdf) (673K) for reference (which you should print out now), and an annotated electronic copy (http://www.niehs.nih.gov/about/orgstructure/boards/irb/docs/1195anno.pdf) (673K) which has explanations of the various sections. Double-click on the numbered blue boxes on the annotated electronic copy for these explanations. (Note: The annotated copy refers to an older version of the document, but much of this still applies)
The Initial Review Application must be initialed by all investigators (FAX is acceptable), and signed by:
a version of the study protocol in Standard Format (http://www.niehs.nih.gov/about/orgstructure/boards/irb/docs/standard_format.pdf) (24K),
all informed consent documents,
all study questionnaires, brochures, and any printed materials distributed to study subjects,
IRB approvals from cooperating institutions,
Federal Wide (FWA) or Multiple Project (MPA) Assurance (see Assurances at http://www.hhs.gov/ohrp/ (http://www.hhs.gov/ohrp/)),
details of projected enrollment of protocol subjects:
projected number of subjects by gender and ethnicity/race,
age ranges,
exclusions.
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.
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