Notice on Implementation of Office for Human Research
Protections (OHRP) Guidance on Research Involving Coded
Private Information and Biological Specimens
Notice Number:NOT-OD-04-069 (Follow-up to this Notice, see NOT-OD-05-020)
Key Dates Release Date: September 17, 2004
Issued by National Institutes of Health (NIH), (http://www.nih.gov/)
On August 10, 2004, OHRP issued Guidance on Research
Involving Coded Private Information of Biological
Specimens, which is available at
http://www.hhs.gov/ohrp/policy/cdebiol.html. This guidance is addressed to Institutional
Review Boards (IRBs), Investigators, and funding
agencies.
This guidance will affect the way the NIH and the
applicant institutions process applications involving
coded private information and biological specimens from
human donors. At this point, the National Institutes of
Health (NIH) is assessing how best to implement the OHRP
Guidance while taking into consideration the
requirements defined in Title 45 CFR Part 46 (Protection
of Human Subjects) for funding agencies
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.120). We are also trying to assess the impact
of this policy change on the NIH clinical research
portfolio.
In order to minimize confusion for applicants
considering projects involving coded private information
and biological specimens, the NIH will require grant
applications and contract proposals to adhere to
existing procedures described in the PHS 398 and in
applicable Requests for Proposals (RFPs) until new
instructions are announced. Additionally, reviewers
will continue to use existing instructions in evaluating
these applications and proposals.
The NIH will develop appropriate instructions related to
this guidance with the expectation that implementation
will occur with the January 10, 2005 receipt date. In
preparation for implementation, all appropriate forms
and announcements will be modified and training for
reviewers will be provided.
To reiterate, the Guidance announced on August 10 by
OHRP regarding coded private information and biological
specimens will not be implemented by the NIH prior to
the January 10 receipt date.
If you have questions about the OHRP Guidance, please
contact OHRP by email at [email protected].
If you have questions about the NIH plans for
implementation, please contact the Office of Extramural
Programs, Office of Extramural Research, Office of the
Director, NIH by email at [email protected].
