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THE COMMITTEE ON HUMAN RESEARCH (CHR)
IMPORTANT TIPS FOR PREPARING RESPONSES
TO CONTINGENT AND RETURN LETTERS (Updated
February 2008)
To receive final approval of your CHR application
in the shortest possible time, please follow the guidelines below
in preparing your response to either contingent approval or return
for additional information letters. These tips are for
your information only; do not return this sheet with your response.
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Protocol Comments:
Answer the Committee's concerns about the study protocol point-by-point
in a cover letter attached to each copy of your response. For
example, if there are several major paragraphs in the CHR letter
(labeled "First," "Second," "Third," etc.),
you should address each of these points individually in a separate
numbered or labeled paragraph in your response, then make changes
to the protocol as appropriate. In your letter, answer each
point fully; do not simply refer to changes in the protocol.
All protocol changes should be highlighted or bolded to
make the changes easier and faster to review. If
you disagree with the CHR’s recommendations
and do not wish to make certain changes,
you should explain why in the cover letter.
Without
an explanation, the response will not be complete and approval
may be delayed. |
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Consent Form Comments: You should respond
to all substantive comments regarding the consent form point-by-point
in your cover letter and highlight or bold the changes in the
consent form itself to make them easier and faster to review.
You can respond to typographical and other purely editorial
comments by making the corrections in the consent form and
saying in the cover letter that you have done so. As with
protocol comments, if you disagree with the CHR on a particular
comment
and do not wish to make a requested change, you should explain
why in the cover letter. |
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Treatment and Compensation for Injury: For
biomedical studies, Treatment and Compensation for Injury wording
in the consent form must exactly match that described on the
CHR website at Treatment
and Compensation for Injury Statement: Background and UCSF
Policy. The University has a very strict policy regarding Treatment
and Compensation for Injury with language that must be used
word for word. Your response cannot be approved if the Treatment
and Compensation for Injury wording differs from one of the
UCSF or UCSF/VAMC standards listed in the Guidelines. Call
the office if you have questions about this. |
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Industry-Sponsored Studies: If the study
is industry-sponsored and data may be reviewed by the sponsor
and the Food and Drug Administration (FDA), the Committee will
ask that the sponsor and the FDA be explicitly named in the
consent form's discussion of confidentiality. |
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Additional Modifications: If you intend
to make new modifications to the study as well as respond to
the Committee's comments, please be sure the modifications
are described clearly and separately in your cover letter and
that these modifications are highlighted or bolded in your
protocol and/or consent form. |
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# of Copies: Please staple,
rather than paperclip, the copies. A single staple in the left
hand corner
of each set is all that’s necessary. Contingent
Approvals require submission
of 6 copies of your complete
response and Returns
for Additional Information require submission
of 18 copies of your complete
response to the CHR office at Box 0962. The complete response
includes your 1) cover letter, 2) revised CHR Application,
consent documents, and, if appropriate, 3) your recruitment
materials. |
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Questions: Telephone the CHR office at 476-1814
if any points in the letter are unclear or you have any other
questions about your response. |
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