[Federal Register Volume 71, Number 236 (Friday, December 8, 2006)]
[Notices]
[Pages 71169-71172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20849]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Draft Guidance on Engagement of Institutions in Human Subjects
Research
AGENCY: Office for Human Research Protections, Office of Public Health
and Science, Office of the Secretary, HHS.
ACTION: Notice.
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SUMMARY: The Office for Human Research Protections (OHRP), Office of
Public Health and Science, is announcing the availability of a draft
guidance document entitled, ``OHRP Guidance on Engagement of
Institutions in Human Subjects Research.'' The draft guidance document
would revise and replace two existing OHRP guidance documents on the
engagement of institutions in human subjects research: (1) The January
26, 1999 document on ``Engagement of Institutions in Research, and (2)
the December 23, 1999 document on ``Engagement of Pharmaceutical
Companies in HHS Supported Research.'' To facilitate public review of
the draft guidance document, OHRP has developed a table presenting a
side-by-side comparison of OHRP's draft revised guidance document and
the current guidance documents on the engagement of institution in
human subjects research, which is available on the OHRP Web site at
http://www.hhs.gov/ohrp/requests/.
OHRP's current engagement guidance documents and the proposed draft
guidance document provide examples of when institutions generally would
be considered to be engaged or not engaged in human subjects research.
The draft document is intended primarily for institutional review
boards (IRB), research administrators and other relevant institutional
officials, investigators, and funding agencies that may be responsible
for the conduct, review and oversight of human subject
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research that is conducted or supported by HHS. OHRP will consider
comments received before issuing the final guidance document.
DATES: Submit written comments by February 6, 2007.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled, ``OHRP Guidance on Engagement of
Institutions in Human Subjects Research,'' to the Division of Policy
and Assurances, Office for Human Research Protections, The Tower
Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Send
one self-addressed adhesive label to assist that office in processing
your request, or fax your request to 301-402-2071. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance. Submit written comments to ENGAGEMENT GUIDANCE
COMMENTS, Office for Human Research Protections, The Tower Building,
1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may
be sent via e-mail to [email protected]. or via facsimile at 301-
402-2071.
FOR FURTHER INFORMATION CONTACT: Mr. Glen Drew, Office for Human
Research Protections, Department of Health and Human Services, The
Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852;
301-496-7005; e-mail [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Department of Health and Human Services (HHS), through OHRP,
regulates research involving human subjects conducted or supported by
HHS in regulations codified at 45 CFR part 46. The HHS human subject
protection regulations stipulate substantive and procedural
requirements for the conduct of HHS-conducted or -supported research,
including requirements for review and approval by an IRB before
research involving human subjects may begin, criteria for IRB approval
of research, and requirements for informed consent or the waiver of
informed consent.
The HHS protection of human subjects regulations at 45 CFR
46.103(a) require that each institution ``engaged'' in human subjects
research that is conducted or supported by HHS provide OHRP with a
satisfactory assurance that the institution will comply with the
regulations, unless all the research meets one or more of the
categories for exemption from the regulatory requirements under 45 CFR
46.101(b). The Federalwide Assurance (FWA) is the only type of
assurance currently accepted by OHRP. The FWA generally identifies
required policies and procedures for the institution and describes the
activities to which the regulations apply.
On January 26, 1999, the Office for Protection from Research Risks
(OPRR), OHRP's predecessor office, issued guidance on ``Engagement of
Institutions in Research.'' OPRR later issued guidance on ``Engagement
of Pharmaceutical Companies in HHS Supported Research,'' dated December
23, 1999.
OHRP is proposing to replace these two documents with a single
document, ``OHRP Guidance on Engagement of Institutions in Human
Subjects Research,'' draft dated October 27, 2006. This guidance is
only applicable to research projects that have been determined to
involve human subjects and that are not exempt under the HHS
regulations at 45 CFR 46.101(b). Once an activity is determined to
involve non-exempt human subjects research, this guidance can be used
to determine whether an institution involved in some aspect of the
research would be considered ``engaged'' in human subjects research,
and would thus need to submit an FWA to OHRP. Like OHRP's existing
guidance documents on engagement, this draft document provides: (1)
Examples of activities that, in general, would result in an institution
being considered engaged in a human subjects research project; and (2)
examples of activities that, in general, would result in an institution
being considered not engaged in a human subjects research project. The
draft guidance document proposes modifications to the set of examples
of when an institution generally would be considered engaged or not
engaged in human subjects research. The proposed modifications include
combining, clarifying, and changing existing examples, as well as
adding further examples and explanation.
To facilitate public review and comments, OHRP has created a
comparison table presenting a side-by-side display of the text from
OHRP's draft guidance document matched with the comparable text from
the 1999 guidance documents. This table is available on the OHRP Web
site at http://www.hhs.gov/ohrp/requests/. The table is not part of the
draft guidance document.
II. Electronic Access
Persons with access to the Internet may obtain the draft guidance
document on OHRP's Web site at http://www.hhs.gov/ohrp/requests/.
III. Request for Comments
OHRP is making its draft guidance document available for public
comment. OHRP's revised guidance document on the engagement of
institutions in human subjects research will be finalized and issued
after the public comments have been considered.
OHRP is particularly interested in the public's comments on two
examples of activities which would not result in the institution being
considered engaged in a human subjects research project under OHRP's
current draft guidance document:
1 Example B(1): Institutions whose employees or agents release to
the investigators at another institution identifiable private
information or identifiable biological specimens pertaining to the
subjects of the research; and,
2 Example B(7): Institutions (including private practices) not
selected as research sites whose employees or agents administer
clinical trial-related medical services if all of the following
conditions are met:
(a) The institution's employees or agents do not enroll subjects,
or obtain the informed consent of any subject for research
participation;
(b) The institution's employees or agents do not administer the
primary study interventions being tested under the protocol;
(c) The institution's employees or agents provide only services
that either are clinically indicated, or are dictated by the protocol
but not clinically indicated, and would typically be performed as part
of routine clinical monitoring and/or follow-up of subjects enrolled at
a study site by clinical trial investigators, such as a blood test,
chest X-ray, CT scan, medical history and physical examination, or an
assessment and reporting of an adverse event;
(d) The investigator(s) from an institution engaged in the research
retain responsibility for oversight of all protocol-related activities
and assure that appropriate arrangements are made for any safety
monitoring and adverse event reporting required under the IRB-approved
protocol;
(e) When appropriate, the informed consent document states that
follow-up data are to be provided to the investigators by the
institution's employees or agents; and,
(f) When providing follow-up data to the investigators, the
institution's employees or agents provide such data to the
investigators in accord with the procedures described in the informed
consent.
Proposed example (B)(1) would represent a modification in OHRP
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policy. OHRP's current guidance document issued in 1999 states that an
institution whose employees or agents release individually identifiable
private information about subjects, for research purposes, without the
subjects' explicit written permission is considered to be engaged in
human subjects research. The proposed modification in guidance is based
on the definition of human subject at 45 CFR 46.102(f), which states in
part, ``human subject means a living individual about whom an
investigator * * * conducting research obtains * * * identifiable
private information.'' (emphasis added). OHRP has concluded that
releasing identifiable private information for research purposes is not
equivalent to obtaining identifiable private information; thus, an
institution releasing such identifiable private information is not
involved in an activity including a ``human subject'' as defined by the
HHS protection of human subjects regulations. Therefore, the revised
example would clarify that an institution, whose employees or agents
release to the investigators at another institution identifiable
private information about living individuals or identifiable biological
specimens that came from living individuals, is not considered engaged
in human subjects research.
Proposed example (B)(7) would represent another modification in
OHRP policy. OHRP's current guidance document states that an
institution (or private practitioner) whose clinical staff provide
protocol-related care and/or follow-up to subjects enrolled at distant
sites by clinical trial investigators in OHRP-recognized Cooperative
Protocol Research Programs (CPRPs) (e.g., the oncology group clinical
trials sponsored by the National Cancer Institute) is not considered to
be engaged in human subjects research provided certain specified
conditions are met. OHRP is proposing two key modifications to this
current example: (1) That the example not be limited to scenarios
involving human subjects research at OHRP-recognized CPRPs; and (2)
that the example exclude an institution whose employees or agents
administer the primary study intervention being tested in the research.
OHRP is proposing to broaden the example beyond OHRP-recognized CPRPs
because OHRP does not believe that the conditions specified in example
(B)(7) of the current draft guidance document are unique to clinical
trials conducted under CPRPs. In addition, to better protect human
subjects involved in research, OHRP believes that an institution whose
employees or agents administer the primary study intervention being
tested in the study should be required: (1) To obtain an OHRP-approved
FWA, and (2) to certify to the HHS agency conducting or supporting the
research that the application of proposal for research has been
reviewed and approved by an IRB designated in the FWA, and will be
subject to continuing review by an IRB. Therefore, through example
(B)(7) in the current draft engagement guidance document, OHRP is
proposing to clarify that institutions whose employees or agents
administer the primary study intervention being tested in the study
would be engaged in human subjects research. OHRP does not believe the
requirement for an FWA will be unduly burdensome for such institutions
since OHRP has simplified the assurance process with the implementation
of the FWA, and now permits an institution holding an OHRP-approved FWA
to extend the applicability of its FWA to cover collaborating
independent investigators and collaborating institutional investigators
through an Individual Investigator Agreement (IIA) (see http://www.hhs.gov/ohrp/humansubjects/assurance/guidanceonalternativetofwa.htm).
In addition, OHRP wants to highlight three other proposed changes
in the current draft guidance document:
1. The draft guidance document does not include examples regarding
when ``statistical centers,'' ``operations centers,'' or ``coordinating
centers'' for multi-site research would be engaged in human subjects
research. The existing January 26, 1999 guidance document includes
examples of when such entities would be engaged in human subjects
research (see the January 26, 1999 document on ``Engagement of
Institutions in Research, examples (A)(6) and (A)(7)). OHRP is
proposing to delete these examples in the new engagement guidance
document since OHRP believes that these entities' activities are
subsumed under example (A)(5) in the draft engagement guidance
document, which states that an institution would be engaged in human
subjects research if the institution's employees or agents ``* * *
obtain for research purposes identifiable private information or
identifiable biological specimens from any source * * * .'' In
addition, the January 26, 1999 document provided guidance on what
component(s) of the study would require review by the IRB for the
statistical, operations, or coordinating centers. Because this issue of
IRB review could apply to any institution engaged in a component of a
cooperative research project, OHRP's draft guidance document addressed
this general issue separately at the end of the section III. A.
2. OHRP is proposing that an institution be considered not engaged
in human subjects research in the event the institution's employees or
agents consult or collaborate on the human subjects research by
obtaining coded private information or human biological specimens from
an institution engaged in the research that retains a link to
individually identifying information (such as name or social security
number), if one of several specified conditions is met (see example
(B)(2) in the draft engagement guidance document). OHRP believes this
additional example helps to clarify the distinction and relationship
between: (1) Determining when a research study involving coded private
information or human biological specimens involves human subjects (see
OHRP's August 10, 2004, Guidance on Research Involving Coded Private
Information or Biological Specimens at http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf), and (2) determining whether an
institution is engaged in human subjects research if it receives coded
private information or human biological specimens for a research study
that already has been determined to involve human subjects.
3. OHRP is proposing that an institution be considered not engaged
in human subjects research if the institution's employees or agents
author a paper, journal article, or presentation describing a human
subjects research study (see example (B)(8) in the current draft
engagement guidance document). This is in contrast to the January 26,
1999 guidance document, which suggests that such authorship would make
an institution engaged in human subjects research (see example (B)(2)
in the January 26, 1999 guidance document). OHRP is proposing this
clarification because OHRP believes that for an institution to be
engaged in human subjects research, an institution's employees or
agents must obtain: (1) Data about the subjects of the research through
intervention or interaction with them; or (2) identifiable private
information about the subjects of the research. If the institution's
employees or agents do not obtain such information, the portion of the
activity conducted by the institution does not involve human subjects,
as defined by 45 CFR 46.102(f). Because authorship does not always
involve obtaining such data or information about the subjects of the
research, OHRP does not believe that it is helpful to consider
authorship as a factor in determining whether an
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institution is engaged in human subjects research.
All of the modifications and clarifications proposed in OHRP's
draft guidance document, including those discussed above, are reflected
in the comparison table of the previous guidance documents and the new
draft guidance document on OHRP's Web site at http://www.hhs.gov/ohrp/requests/. OHRP welcomes comments on its draft guidance.
Dated: December 1, 2006.
Melody Lin,
Deputy Director, Office for Human Research Protections.
[FR Doc. E6-20849 Filed 12-7-06; 8:45 am]
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