Human Participants
Learning Objectives
Review three basic
principles for treatment of human participants.
Describe the jurisdiction,
mission, composition, and functions of an IRB.
Given descriptions of
projects involving use of human participants in research, the learner will
indicate: a) when and b) why consent for participation is required.
If oversight is required,
the learner will indicate: a) when and b) how institutional oversight is
applied.
Develop consent forms that
meet the basic criteria for IRB approval.
University of Memphis IRB (http://irb.memphis.edu)
University of Memphis
Guidelines for Use of Human Subjects (http://irb.memphis.edu/process.html)
Code of Conduct (http://www.memphis.edu/facultyhandbook/2007FHB_Chapter5.htm#Academic%20Misconduct)
Academic Misconduct (http://www.memphis.edu/facultyhandbook/2007FHB_Chapter5.htm#Academic%20Misconduct)
Office for Human Research
Protections (http://ohrp.osophs.dhhs.gov)
Human Subject Regulation
Decision Charts (http://ohrp.osophs.dhhs.gov/humansubjects/guidance/decisioncharts.htm)
Office of Research Integrity
(ORI) (http://ori.dhhs.gov/)
Previous abuses of human
participants, such as Nazi research on concentration camp inmates and arbitrary
use of medical patients in research hospitals, has dramatized the need for a
structure to protect human participants from abuse and to protect their rights
to self-determination, safety, and dignity. Building on the Nuremberg Code (http://ohsr.od.nih.gov/nuremberg.php3)
which was established in response to Nazi atrocities, research institutions and
funding agencies have developed an ethical framework to protect human participants.
In 1978, the National
Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research issued the Belmont Report (http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm)
which identified three basic principles for the treatment of human
participants: respect for persons, beneficence, and justice. These principles led to procedures to mandate
informed consent of participants, reasonable ratios of benefits to risks, and
equitable selection and treatment procedures.
Particularly vulnerable populations, such as children or the mentally
retarded, must receive special attention.
The
Institutional Review Board (IRB)
Federal law requires
institutions that accept federal funds for research with human participants
formalize means for protecting them.
The administrative unit is the IRB.
The mission of an IRB extends to all research using
human participants as subjects. Although some activities, such as
educational testing for research purposes, may be legally exempted from its
review, the IRB is responsible for all
research with human participants. IRB’s
are empowered to review and approve, reject, postpone, or modify all proposals
for research with human participants. No such research may proceed without IRB
approval.
All research projects with
human participants conducted by faculty, staff, or students associated with The
University of Memphis must receive approval of the project before the research
is begun. If you are collecting
non-public information from other people, you are conducting research with
human participants, and this includes the collection of qualitative data such
as interviews and stories. It also
includes observation of public behavior and phone or mail surveys. Use of people’s records, blood or tissues
samples is research even if those records were not originally collected for
research purposes. Do not assume that
your activity is exempt from review.
Always assume that you need IRB approval and check with the Office of
Research Support Services before
proceeding.
You must comply with UM’s Multiple Project Assurance
(MPA) if you have responsibility for the design and conduct of a research
study, even if the principal investigator is at another university. A project approved at another university IRB
will still need UM IRB review and approval.
One operational definition
of whether or not you have responsibility for the design and conduct of a
research study is whether or not you would expect to be a co-author of
publications stemming from the research.
If the answer to that question is yes, the research project must receive
approval from the UM
IRB. In addition, research with human
participants that is sponsored by UM, uses any property or facility of UM, or
uses UM non-public information to contact or identify prospective participants
must also receive IRB approval.
Instructors using human
participants for class projects must get UM IRB approval for all projects on a
blanket basis for each class.
The mission of the IRB is to
protect the rights and welfare of human research participants. The University of Memphis IRB statement of
mission is found at this site http://academics.memphis.edu/irb/policy.php.
An IRB must consist of at
least five properly qualified members, of whom at least one must be a
scientist, at least one must be a nonscientist, and at least one must be
unaffiliated with the institution, including not having an immediate family
member affiliated with it. The current
University of Memphis IRB membership is listed at this site http://academics.memphis.edu/irb/members.php
Who reports to whom?
The Office for Human
Research Protections (OHRP) of the Department of Health and Human
Services approves the composition of IRB’s and monitors their activities. Within their institutions, IRB’s report to
the Institutional Official, who reports to OHRP. All principal investigators who use human participants report to
the IRB.
Federal Oversight
All oversight agencies
perform at least occasional on-site inspections and/or audits. The FDA conducts these on a regular
schedule, whereas other agencies tend to conduct them sporadically. For federal agencies governed by OHRP,
institutions commit themselves to OHRP oversight, via either a single project
assurance (SPA) or multiple project assurance (MPA). These assurances are agreements to oversee and perform research
on human participants according to federal requirements specified in the Common
Rule and all relevant subparts of Title 45, Part 46, of the Code of Federal
Regulations, Protection of Human Subjects (45 CFR 46 for the Department of
Health and Human Services) and/or other applicable regulations as listed in the
Federal Register ( /humansubjects/guidance/ documents). These assurances are the institution's
responsibility, with OHRP acting periodically to audit institutions (usually
for cause) to assure compliance. See
http://academics.memphis.edu/irb/assurance.doc for the University of Memphis
assurance compliance.
Sanctions
Agencies may respond to
noncompliance by suspending or terminating support of projects and refusing
future funding to noncompliant investigators or institutions.
Examples: Suspension of
NIH-supported research at Duke University and at Johns Hopkins University.
Principal investigators must
possess skills adequate to their proposed research, design research that meets
quality assurance standards and whose benefit to participants or society
justifies the risks to participants, submit fully detailed research plans,
ensure that no human participant be enlisted without prior informed consent,
take all necessary safeguards to minimize risks and to protect the interests of
vulnerable populations, assure the adequate training of their personnel, adhere
to high ethical standards, and comply with all institutional and governmental
regulations. See this site for
information about the University of Memphis IRB http://academics.memphis.edu/irb/process.php.
The IRB is charged with
estimating the risks of harm to participants from participation in research in
comparison with the risks of everyday normal life or of standard alternative
treatments of disorders and the likely benefits to participants or to society,
excluding remuneration and subjective benefits. It will refuse to approve research designs that fail to minimize
risks or in which the risks outweigh the likely benefits.
There are three levels of
review. (1) All experimental
investigations or others deemed to pose nontrivial risk are subjected to full
review at a meeting of the IRB. (2) Some investigations that entail minimal
risks, such as anonymous surveys or surveys involving innocuous material, may
be considered exempt from federal
regulations for the protection of human subjects. Nevertheless, these require the
submission of a request for the research to be classified as exempt (Request
for Exemption Form) . Classification as
exempt is made by the chair of the IRB. (3) Some investigations using certain closely defined
categories of research operation may be reviewed through an
expedited process in which review and
approval is based on an evaluation by a subset of IRB
members. Forms to request review are
available at this location http://academics.memphis.edu/irb/newforms.php.
Approved research projects
remain under IRB oversight until completion.
Principal investigators file an application for continuing review at least
every 12 months or more often if required by the IRB. In addition, principal investigators are
required to file special reports of unforeseen mishaps involving human
participants as they occur.. Information and procedures for reporting
adverse events is located at http://academics.memphis.edu/irb/adverse.php.
All human participants in
research (or their parent/guardian) are
required to indicate their consent by signing a consent form indicating their
understanding of the purpose of the research, of the proposed procedures,
risks, and benefits, and of their rights in the situation, and registering
their consent. Consent must be
informed, in that participants must be given full disclosure of the nature of
their participation (except in rare instances in which deception is scientifically
necessary and justifiable) and must indicate comprehension of the
information. Consent given by
participants may be withdrawn at any time without adverse effects on their
relationship to the research institution.
Participants retain the
right to withhold or withdraw the data they contribute.
Participation must be purely
voluntary. There must be no elements of coercion in securing participants
involvement.
Incentives for participation
must avoid undue inducement that may serve as a subtle form of coercion or at
least undue influence.
Participant selection
criteria must avoid discriminating against classes of humans on the basis of
sex, age, ethnicity, or other major characteristics, except as required for
scientific reasons.
If incentives are extended
to some members of a group, these must not disadvantage other, non-selected
members.
Deception must be justified
by scientific necessity and benefit.
Deceived participants must subsequently be debriefed. Deception is assumed to be rarely necessary.
All research investigations
must protect the privacy of their participants. Data regarding individuals must be stored in a form that prevents
the individuals’ identification.
Participants’ contributions to the research must be kept confidential
except for aggregate reporting or description that removes or alters
identifying information to make it unrecognizable by the participant and by
individuals acquainted with the participant.
Research procedures must
minimize risks to participants consistent with adequately justifiable
scientific necessity. All risks must be
fully and comprehensibly disclosed to participants and receive their consent.
From the beginning of
research operations, principal investigators are responsible for monitoring
operations through periodic analysis of data to assure that the investigation
continues to promote the goals of the research. Principal investigators must also monitor through observations
designed to assure the continuing integrity of research operations, especially
as these may impact research participants.
Deviations from approved
protocols and unforeseen mishaps involving human participants must be reported
by principal investigators to their IRB’s and by IRB’s (or, in the case of the
FDA, by principal investigators) to their institutional officials and on to the
respective funding agencies.
The IRB is required to keep
detailed records of its deliberations and of all research proposals that come
before it and of their disposition.
Principal investigators are
responsible for assuring that their research personnel are adequately trained
for the research operations they perform and for the ethical conduct of
research. They are also responsible for
continuing supervision of the research operations under their purview.
References
for Further Reading
Arboleda-Florez, J. &
Weisstub, D. N. (1997). Ethical research with the mentally ordered. Canadian
Journal of Psychiatry, 42, 485-491.
Batchelor, J. A., &
Briggs, C. M. (1994). Subject, Project or Self? Thoughts on Ethical Dilemmas
for Social and Medical Researchers. Social Science and Medicine, 39, 949-954.
Committee on Science,
Engineering, and Public Policy (1995). On being a scientist: Responsible
conduct in research. Washington, D.C.: National Academy Press.
Mirvis, P. H., &
Seashore, S. E. (1979). Being ethical in organizational research. American
Psychologist, 34, 766-780.
Office for Protection from
Research Risks, National Institutes of Health (1993). Protecting human research
subjects: Institutional Review Board Guidebook. Washington, DC: United States
Government Printing Office.
Ortmann, A., & Hertwig,
R. (1997). Is deception acceptable? American Psychologist, 52,
746-747.
Sieber, J. E. (1992).
Planning ethically responsible research: A guide for students and internal
review boards. Newbury Park, CA: Sage.
Sigmon, S. T. (1995).
Ethical practices and beliefs of psychopathology researchers. Ethics &
Behavior, 5, 295-309.
Swazey, J. P., Anderson, M.
S., & Lewis, K. S. (1993). Ethical problems in academic research. American
Scientist, 81, 542-553.
Taube, D. O., &
Burkhardt, S. (1997). Ethical and legal risks associated with archival
research. Ethics & Behavior, 7, 59-67.
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