[Federal Register: January 9, 2006 (Volume 71, Number 5)]
[Notices]
[Page 1429-1430]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja06-34]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0507]
Agency Emergency Processing Under Office of Management and Budget
Review; Guidance on Informed Consent for In Vitro Diagnostic Device
Studies Using Leftover Human Specimens That are Not Individually
Identifiable
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for emergency processing under the
Paperwork Reduction Act of 1995 (the PRA). FDA believes, and is
preparing a guidance document explaining, that it is possible in
certain circumstances for In Vitro Diagnostic (IVD) device studies to
be conducted using leftover specimens obtained without informed consent
while protecting the human subjects who are the source of such
specimens. This notice solicits comments on the proposed collection of
information associated with the guidance document entitled ``Guidance
on Informed Consent for In Vitro Diagnostic Device Studies Using
Leftover Human Specimens that are Not Individually Identifiable.''
DATES: Fax written comments on the collection of information by
February 8, 2006. FDA is requesting approval of this emergency
processing by January 17, 2006.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, rm. 16B-26, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of
this proposed collection of information under section 3507(j) of the
PRA (44 U.S.C. 3507(j)) and 5 CFR 1320.13. The Center for Devices and
Radiological Health (CDRH) intends to issue a guidance document that
addresses an immediate need of the research community. CDRH's guidance
will identify the circumstances when the agency intends to exercise
enforcement discretion regarding the informed consent requirements.
These requirements normally apply to all FDA-regulated clinical
studies, including studies using only leftover human specimens that are
not individually identifiable. The agency intends to issue this
guidance because the existing requirements are bringing a halt to a
class of very valuable research that can produce new diagnostic tests,
without appreciably adding protection for human subjects.
With respect to the following proposed collection of information,
FDA invites comments on the following topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Guidance on Informed Consent for In Vitro Diagnostic Device Studies
Using Leftover Human Specimens That are Not Individually Identifiable
FDA's investigational device regulations are intended to encourage
the development of new, useful devices in a manner that is consistent
with public health, safety, and with ethical standards. Investigators
should have freedom to pursue the least burdensome means of
accomplishing this goal. However, to ensure that the balance is
maintained between product
[[Page 1430]]
development and the protection of public health, safety, and ethical
standards, FDA has established human subject protection regulations
addressing requirements for informed consent and institutional review
board (IRB) review that apply to all FDA-regulated clinical
investigations involving human subjects. In particular, informed
consent requirements further both safety and ethical considerations by
allowing potential subjects to consider both the physical and privacy
risks they face if they agree to participate in a trial.
Under FDA regulations, clinical investigations using human
specimens conducted in support of premarket submissions to FDA are
considered human subject investigations (see 21 CFR 812.3(p)). Many IVD
device studies are exempt from most provisions of part 812 (21 CFR part
812), Investigational Device Exemptions (IDEs), under Sec.
812.2(c)(3), but FDA's regulations for the protection of human subjects
(parts 50 and 56 (21 CFR parts 50 and 56)) apply to all clinical
investigations that are regulated by FDA (see Sec. Sec. 50.1 and
56.101, and section 520(g)(3)(A) and (g)(3)(D) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360j(g)(3)(A) and (g)(3)(D))).
FDA regulations do not contain exceptions from the requirements of
informed consent on the grounds that the specimens are not identifiable
or that they are remnants of human specimens collected for routine
clinical care or analysis that would otherwise have been discarded. Nor
do FDA regulations allow IRBs to decide whether or not to waive
informed consent for research involving leftover or unidentifiable
specimens.
FDA intends to notify the public, in a level 1 guidance document
issued under the good guidances practices regulation (21 CFR 10.115),
of the circumstances in which it intends to exercise enforcement
discretion as to the informed consent regulations for clinical
investigators, sponsors, and IRBs. In the guidance document, FDA
recommends that sponsors of studies that meet the conditions maintain
documentation of how these conditions were met and of the types of
human subject protection procedures followed by the specimen provider
to ensure that the subject cannot be identified.
Sponsors that wish to follow the recommendations of the guidance
will substitute use of records to demonstrate conformance to this
enforcement discretion policy in place of the more detailed and
patient-specific records for obtaining and documenting informed
consent. Most fundamentally, this means collecting and maintaining
information about the protections that are in place to prevent the
identification of the specimens, since making sure that the specimens
are not identifiable is key to obtaining FDA's enforcement discretion.
FDA intends to exercise enforcement discretion when all the
following are true:
The investigation meets the IDE exemption criteria at
Sec. 812.2(c)(3);
The study uses leftover specimens, that is, remnants of
specimens collected for routine clinical care or analysis that would
have been discarded if not used in the study;
The specimens provided to the investigator are accompanied
by only minimal clinical information such as age, gender, and existing
laboratory result;
The specimens are not individually identifiable;
The specimens are provided to the investigator(s) without
identifiers and the supplier of the specimens has established policies
and procedures to prevent the release of personal information;
The individuals caring for the patients are different
from, and do not share information with, those conducting the
investigation; and
The study has been reviewed by an IRB in accordance with
21 CFR part 56.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual
No. of Recordkeepers per Record Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
600 1 600 4 2,400
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The recommendations of this guidance impose a minimal burden on
industry. FDA estimates that 600 studies will be affected annually.
Each study will result in one recordkeeping per year, estimated to take
4 hours to complete. This results in a total recordkeeping burden of
2,400 hours (600 x 4 = 2,400).
Dated: January 3, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-73 Filed 1-6-06; 8:45 am]
BILLING CODE 4160-01-S