Human Research Protection Program: Policy
Policy and Procedures for Exempt Research
Adopted By: All Campus IRB
Adoption Date: August 4, 2005
Revised: December 4, 2008
Purpose: This
document describes UW-Madison’s policy for determining whether studies are
exempt from applicable federal, state, and local regulations and the
University’s policies and procedures and describes the process by which these
determinations are made.
Policy
I. UW-Madison IRBs follow the federal
Common Rule, which lists six categories of research that are eligible for
exemption from IRB review. UW-Madison IRBs apply these six exemption
categories only to protocols determined by an IRB reviewer to be no more than
minimal risk. [45 CFR 46.101(b)(1)–(6)] For
additional guidance on the application of these exemptions, the IRBs may
consult: OHRP Compliance
Activities: Common Findings and Guidance #27; OHRP
Guidance on 45 CFR 46.101(b)(5), 48 FR 9266-9270, March 4, 1983.
II. UW-Madison IRBs also apply the FDA
regulations exempting from IRB review clinical investigations involving taste
and food quality evaluations and consumer acceptance studies and emergency use
of test articles. [21 CFR 56.104(c) and (d)]
The Common Rule exemptions in 45 CFR 46.101(b)(1-5) do not apply to
FDA-regulated research.
III. The UW-Madison IRBs do not exempt
research projects involving:
A. deception
B. the collection of identifiable data concerning individuals engaged in
illegal or stigmatizing behaviors (e.g., illicit drug use, child abuse,
alcoholism, or gambling)
C. interactions or interventions with the cognitively impaired or
institutionalized individuals (e.g., in a mental health facility, nursing home,
or halfway house)
IV. The six exemption categories at 45 CFR 46.101(b)(1)–(6) do not apply to
research involving prisoners, Subpart C. See, 45 CFR 46.101(i) footnote 1.
However, UW-Madison’s Health Sciences IRBs allow an exemption for non-federally
funded medical records research that does not specifically target prisoners
when a further invasion of privacy (e.g., more extensive review of a record)
would be required to eliminate prisoners from the pool of records.
V. The exemption for research involving
survey or interview procedures or observation of public behavior [45 CFR
46.101(b) (2)], does not apply to research with children, Subpart
D, or research with viable neonates, Subpart
B, except for research involving observations of public behavior when the
investigator(s) do not participate in the activities being observed. See, 45 CFR
46.101(i) footnote 1 and 45 CFR
46.205(d).
NOTE: The Department of
Veterans Affairs (VA) prohibits the application of this exemption category to
any research project in which disclosure of a subjects’ responses outside of
the research could cause loss of insurability as well as risk of criminal or
civil liability or damage to the subjects' financial standing, employability,
or reputation.
VI. The exemption for research and demonstration projects conducted by or subject to the
approval of department or agency heads and designed to study, evaluate, or
otherwise examine: (i) public benefit or
service programs; (ii) procedures for obtaining benefits or services under
those programs; (iii) possible changes in or alternatives to those programs or
procedures; or (iv) possible changes in methods or levels of payment for
benefits or services under those programs [45 CFR 46.101(b)(5)}, must also satisfy additional OHRP
requirements as set forth in http://www.hhs.gov/ohrp/humansubjects/guidance/exmpt-pb.htm.
VII. IRB review is not required if an
activity is not “research” or does not involve “human subjects,” as those terms
are defined in federal regulations, state law or institutional policies. For
more information, see, UW-Madison’s Defining Human Subjects Research Policy.
However, IRB review is required for both Humanitarian Use Devices and the
Emergency Use of Test Articles, even when the use does not constitute
“research.”
VIII. Research that qualifies as exempt
under one of the federal categories must nonetheless satisfy the UW-Madison’s
ethical standards for the protection of human research subjects. See,
UW-Madison Federalwide Assurance (http://info.gradsch.wisc.edu/research/compliance/humansubjects/8.fwa.htm).
IX. At UW-Madison, only the full IRB or an
experienced IRB member or experienced, professional IRB staff, not the
investigator, can determine whether proposed research involving human
intervention/interaction or identifiable private information is eligible for
exemption from IRB review. “Experienced” means has received training relative
to the exemption categories and possesses the expertise needed to review the
proposed research. Although federal regulations do not require certification
of IRB review for exempt research, UW-Madison requirements regarding review of
such research are, nevertheless, binding on investigators.
X. The IRB reserves the right to not
exempt a protocol and to require full review by the convened IRB or expedited
review by an IRB member or subcommittee, particularly if the research may
involve a sensitive population or sensitive topic.
XI. If a protocol is determined to be
exempt from IRB review, continuing review of the project by an IRB is not
required unless the research changes so that the exemption category no longer
applies.
XII. If a protocol is determined to be
exempt from IRB review, it is not subject to the rules on informed consent;
however, the IRB may ask a researcher to provide subjects with an information
sheet or take other steps to ensure that the subject knows he or she is being
invited to take part in a research study.
XIII. The HIPAA Privacy Rule
regulations [45
CFR Parts 160 and 164] apply to exempt research using protected health
information (PHI) just as they do to any other research. Frequently, exempt
research will satisfy the HIPAA Privacy Rule requirements for use of a limited
data set or a waiver of authorization, both of which require IRB review.
Privacy Rule requirements do not apply to exempt research using information
that has been de-identified. See, HIPAA Privacy Rule Research Guidance.
XIV. Documentation for exemption
determinations must include a citation to the specific regulatory category
justifying the exemption.
Procedure
XV. Common Rule Exemption Requests
A. Applying for Exemption
1. An investigator who believes that proposed research is eligible for
exemption from IRB review must submit an application for exemption on the form
provided by the IRB office. The investigator must include all materials
requested in the application form. The IRB office may request additional
information from an investigator before making an exemption determination.
B. Review of Exemption
1. General Review Procedures
a. Exemption determinations can be made by
experienced IRB members or experienced, professional IRB Staff, except for VA
studies, which require IRB member review. Exemption determinations may also be
made by the full IRB. The method of review depends upon, among other factors,
the timing of submission of the application, the workload of the IRB, the
expertise required to review the proposal, and the potential sensitivity of the
application. “Experienced” means has received training relative to the
exemption categories and possesses the expertise needed to review the proposed
research.
b. For Veterans Administration protocols, the
IRB Chair or an IRB member designated by the Chair is required to make all
exemption determinations.
c. The IRB reviewer may request modifications to
a protocol in order for the protocol to qualify for an exemption.
d. The IRB reviewer that determines that
research qualifies as exempt also assures that exempt research satisfies the
UW-Madison’s ethical standards for the protection of human research subjects.
See, UW-Madison Federalwide Assurance (http://info.gradsch.wisc.edu/research/compliance/humansubjects/8.fwa.htm).
e. Even if a protocol meets the technical
requirements of one of the authorized exemptions under federal law, if the IRB
reviewer concludes that the protocol poses risks to subjects that are not
adequately addressed, the IRB reviewer will request that the investigator
address the risks before the exemption will be granted or may refer the
exemption request to the full IRB for further review.
2. Review Procedures used by Specific IRBs
a. For exemption requests submitted to the SBS IRB
and ED IRB, a member of the IRB staff (who are voting members of the IRB)
reviews the protocol and the exemption request and determines whether the
research qualifies as exempt and that the exempt research meets the criteria
that human subjects are protected. The IRB staff reserves the right to refer
an exemption request for full IRB review or for expedited review by an IRB
subcommittee.
b. Generally, all exemption requests relating to
health sciences are submitted to the MR IRB. For exemption requests submitted
to the MR IRB, determinations that the research qualifies as exempt and that
the exempt research meets the criteria that human subjects are protected are
made by the IRB director or a member of the IRB professional staff or by the
full IRB, whichever method of review can be performed most promptly based on
the timing of the exemption request and the workload of the IRB.
c. If a protocol is submitted to the full IRB as
an Initial Review Application, but qualifies for an exemption, the full IRB
will make the exemption determination.
C. Grant or Denial of Exemption
1. For exemption requests, the IRB tracks protocol number and title, the
name of the investigator, a brief description of the protocol, and whether the
request was granted or denied. If an exemption is granted, the specific
regulatory category on which the exemption is based, including a citation to
the applicable federal regulation, is noted both in documentation to the
applicant and in the tracking system. A letter or email indicating the
decision made on the exemption request is sent to the investigator. A copy of
the letter or email is kept on file by the IRB as are the application for
exemption and all supporting materials provided to the IRB by the investigator.
2. If an exemption request is granted, the investigator need have no
further contact with the IRB about the research in question unless the research
changes so that the exemption category no longer applies. If the research
study does change so that the exemption category no longer applies, the
investigator is required to submit an application for initial review.
3. If an exemption request is denied, the investigator may request IRB
reconsideration by revising the application for exemption or may resubmit the
protocol by filing an application for initial review. At the discretion of the
IRB office, if the research does not qualify for an exemption, but the
exemption application includes sufficient information for full or expedited
review, the IRB director may forward the protocol to the expedited panel or the
full IRB.
XVI. FDA Exemption Requests
A. Emergency Use of Test Articles
1. See, UW-Madison Emergency Use of Test Articles Policy.
B. Taste and food quality evaluations and consumer acceptance studies
1. See, Section XV of this policy, “Common Rule Exemption Requests,”
above.
