The FDA has developed a guidance
document that will inform sponsors, institutional review boards
(IRBs), clinical investigators, and agency staff that the FDA
intends to exercise enforcement discretion, under certain
circumstances, with respect to its informed consent regulations
under 21 CFR 812.2 (c) (3), for in vitro diagnostic device studies
that are conducted using leftover specimens. This guidance responds
to an immediate need of the research community. Sponsors that
follow this guidance should maintain written documentation
demonstrating that they meet the circumstances outlined in the
guidance.
US Code:
21
USC 360j Name of Law: Federal Food, Drug, and Cosmetic 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.