UAMS Human Research Advisory Committee
Procedures for Study Review
July 31, 2002
Studies Exempt from Review
Research activities involving human subjects that are exempt from the
requirement to receive HRAC full or expedited review are identified below (45
CFR46.101 (b) (1-6); 38 CFR16.101 (b); 21 CFR56.103-104; 45 CFR). See HRAC policy
1.4 for examples of exemptions.
conducted in established or commonly accepted educational settings,
involving normal educational practices, such as research on regular and
special education instructional strategies, or research on the effectiveness
of or the comparison among instructional techniques, curricula, or classroom
involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures or observation
of public behavior, unless:
obtained is recorded in such a manner that human subjects can be identified,
directly or through identifiers linked to the subjects and
b. Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
This exemption does not apply to research involving children unless the research is limited to observation of public behavior when the investigators do not participate in the activities being observed [45 CFR46(d)].
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b) above, if:
human subjects are elected or appointed public officials or candidates for
public office or
statute(s) require(s) without exception that the confidentiality of the
personally identifiable information will be maintained throughout the research
involving the collection or study of existing data documents, records,
pathological specimens, or diagnostic specimens, if these sources are
publicly available or if the information is recorded by the investigator in
such a manner that subjects cannot be identified, directly or through
identifiers linked to the subjects.
a. To qualify for this exemption the data, documents, records, or specimens must be in existence before the project begins.
this exemption, an investigator (with proper institutional authorization) may
inspect identifiable records, but may only record information in a
Investigator A wishes to
screen blood samples at a rural hospital for incidence of HIV infection. She
does not want to draw specimens specifically for this purpose; rather she
proposes to use specimens that were drawn for some other purpose but which
remain in the hospital laboratory. If Investigator A proposes to use specimens
that had been drawn prior to the initiation of her research and are, for some
reason, "on the shelf," the protocol will qualify as exempt, assuming the
other requirements are met (i.e.,
the sources are either publicly available or the information is recorded by
the investigator in such a manner that subjects cannot be identified, directly
or through identifiers linked to the subjects). If she proposes to use
specimens that will be drawn after the start date of her project for reasons
unrelated to her research, the protocol is not exempt from HRAC review, even
though the specimens will be drawn regardless of her use of the excess blood.
The protocol may, however, qualify for expedited review.
Suppose Investigator B wishes
to examine court records of involuntary commitments to psychological
institutions. If he uses court records that were on file before the initiation
of his research, the protocol will qualify as exempt. If he proposes to use
records filed after the initiation of the project, the protocol is not exempt
from HRAC review, although it may qualify for expedited review.
demonstration projects which are conducted by or subject to the approval of
federal Department or Agency heads, and which are designed to study, evaluate,
or otherwise examine:
a. Public benefit or service
this exemption is for federally supported projects and is most appropriately
invoked with authorization or concurrence by the funding agency. The following
criteria must be satisfied to invoke the exemption for research and
demonstration projects examining "public benefit or service programs."
i. The program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act)
ii. The research or demonstration project must be conducted pursuant to specific federal statutory authority.
iii. There must be no statutory requirement that an Institutional Review Board review the project.
The project must not involve significant physical invasions or
intrusions upon the privacy of participants.
b. Procedures for obtaining benefits or services under those programs;
c. Possible changes in or alternatives to those programs or procedures;
changes in methods or levels of payment for benefits or services under those
food quality evaluation and consumer acceptance studies if:
a. wholesome foods without additives are consumed or
a food is consumed that contains a food ingredient at or below the level and for
a use found to be safe, or agricultural chemical or environmental
contaminant at or below the level found to be safe, by the Food and Drug
Administration or approved by the Environmental Protection Agency or the Food
Safety and Inspection Service of the U.S. Department of Agriculture.
Children, Prisoners, Fetuses,
Pregnant Women, or Human In Vitro Fertilization. These exemptions do not apply to
research involving prisoners, fetuses, pregnant women, or human in vitro
fertilization [45 CFR46.101(b)]. The for research involving survey or
interview procedures or observation of public behavior, does not apply to
research with children, except for research involving observations of public
behavior when the investigator(s) do not participate in the activities being
observed (See HRAC policy
17.1, and policy
The HRAC may not create new
categories of this exempt research. The HRAC may only determine which
activities qualify for an exempt review.
Investigators do not have the authority to make an independent
determination that research involving human subjects is exempt and must contact
the HRAC concerning the status of proposed research or changes in ongoing
research. The Chair or his or her
designee of an appropriate HRAC Committee will review requests for
Results of reviews will be promptly conveyed in a letter by the HRAC Office to the investigator, the Chair of the Committee, and to other appropriate institutional offices. If the proposed research activities do not meet the criteria for exemption, the HRAC Office will promptly convey in a letter outlining any additional information and the proper category for review (e.g., full or expedited) to the investigator.
Continuing Review. Studies receiving
exempt status are not required to have continuing reviews.
Request for Changes in Study
Design. Any proposed or anticipated changes in
an exempt study must be submitted to the HRAC for approval prior to initiation
of the change. The research
proposal will then be evaluated for appropriate HRAC review. For Claims for Exemption that were
approved more than one year before the amendment was submitted, the investigator
must submit a new HRAC Claim for Exemption incorporating the proposed