The Office for Human Research
Protections (OHRP) is requesting approval of the Department of
Health and Human Services (HHS) Subpart C Research Certification
Form. This form will facilitate collection of information relevant
to an institutional request for OHRP authorization of research
involving prisoners; the information in the form will be entered
into OHRP’s prisoner research database, and will be used by OHRP to
draft a response certification letter back to the institution. This
is a new information collection request. The respondents for this
collection are institutions or organizations operating
Institutional Review Boards (IRBs) that have approved enrollment,
or are planning to approve enrollment, of prisoners in human
subjects research conducted or supported by HHS.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.