The recruitment of human research
subjects into NIH funded studies is critical to the success of the
agency's mission to enhance health, lengthen life, and reduce the
burdens of illness and disability. However, human research subjects
are often concerned about the potential negative consequences of
access to their research data by individuals outside the research
team. This situation can make it difficult to recruit subjects for
research projects on sensitive topics. Recognizing this problem, in
1970, Congress enacted legislation to permit the Department of
Health and Human Services (DHHS) to issue Certificates of
Confidentiality (CoCs) to authorize covered researchers to protect
the privacy of research subjects by withholding their names and
identifying characteristics from those not connected with the
research. The legislation was initially limited to research on the
use and effect of drugs. Since then, the scope of the CoC
legislation has been expanded several times, most recently in 1988.
1997, DHHS delegated the authority to issue CoCs to NIH and the
other DHHS agencies that fund research. The Director of NIH further
delegated this authority within NIH to the individual NIH
Institutes and Centers (ICs). NIH's Office of Extramural Research
(OER) is responsible for coordinating this activity across NIH. The
information to be collected via the electronic CoC application
system will be used by the NIH IC's to determine eligibility for a
CoC and to help create the actual Certificate that will be issued
to the requesting organization. Additionally, the system will
assist NIH staff with the administrative management of requests,
for example, by tracking progress of requests and key dates
(receipt of request, issuance of CoC, expiration dates.
Additionally, OER will use the data from the system for routine
internal program monitoring for NIH.
US Code:
42
USC 241(d) Name of Law: US Public Health Service Act
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.
Form 1 CoC Applicants- Federal
Attach 2 Supplemental Document for the CoC SSA.doc
CoC Applicants- Federal