3. The HSPC Review Process
The review of research at UCLA is conducted in accordance with
a Multiple Project Assurance (MPA) which is an agreement with the
federal government, approved by the National Institutes of
Health, Office for Protection from Research Risks (OPRR). The MPA
(Please see Appendix
9 for more information) stipulates that UCLA will
protect the rights and welfare of human research subjects through
a review process detailed in 45 CFR 46. Through
the MPA, the HSPCs retain the sole authority at UCLA for the
approval of research with human subjects. HSPC review applies to
research conducted by faculty, students, staff or others, either
on the UCLA premises or utilizing the facilities or resources of
UCLA, as well as research conducted elsewhere by UCLA personnel
in connection with their institutional responsibilities. The
review requirements apply to all research conducted under the
auspices of UCLA, regardless of funding source or University
support.
The Human
Subject Protection Committees
In order to maintain a review process that is responsive to
the concerns of all involved, the federal regulations require
that the HSPC membership reflect experience, expertise and
diversity in academic, research and professional background,
racial and cultural heritage, and a sensitivity to community
attitudes. When the HSPC reviews research involving a vulnerable
category of subjects, such as cognitively impaired individuals or
prisoners, it is required to include one or more individuals
qualified to represent that group, either through personal
experience or experience working with that population.
The Committees are responsible for ensuring that all approved
research complies with the letter and spirit of the human subject
protections regulations as well as the three principles
previously defined in the Belmont
Report, respect for persons, beneficence, and justice.
The HSPCs examine recruitment procedures, proposed remuneration
(in cash or in kind), the informed consent process, and evaluate
the risks and potential benefits to participants outlined in each
protocol. The review will help ensure that investigators recruit
subjects in an equitable, non-coercive manner, that subjects are
fully informed about the risks and benefits entailed in
participation, and that subjects are not exposed to
disproportionate risks.
The review of applications to involve human subjects in
research consists of a process of negotiation
between the investigator and the HSPC. The process of negotiation
begins with the submission of the application to the Committee.
The HSPC creates a dialogue with investigators regarding the
risks and benefits posed to potential subjects participating in
the research, the nature of the consent process, and the document
that represents the legal written part of the consent process,
the informed consent form. The dialogue between the HSPC and
investigators will most often will take the form of
correspondence resulting from the Committee review of the study.
Receiving correspondence from the HSPC is typical and should not
be viewed as a negative comment about the content of the research
nor is it necessarily analogous to disapproval of the study.
The HSPC has the authority to approve, to require modification
in, and to disapprove proposed human subject research. The HSPC
also has the authority to suspend or revoke its approval of
ongoing research [45
CFR 46.113]. Failure to comply with HSPC requirements is
considered serious misconduct and may be subject to sanctions
including possible termination of approved research.
Issues
Considered by the HSPC
The HSPC will consider the following issues when reviewing
requests to involve human subjects in research.
- Study Design:
The HSPC will examine the study design insofar has an
impact on the rights and welfare of the human subjects.
The OPRR indicates in the, Protecting Human Subjects,
Institutional Review Board Guide Book, that,
"...if a research study is so methodologically
flawed that little or no reliable information will
result, it is unethical to put subjects at risk or even
inconvenience them through participation in such a
study." Many experts agree that the HSPC should
approve only research that is both valid and of value.
The Committee may request an expert consultant review or
defer to scientific review committees such as the
JCCC-ISPRC in order to determine whether a study design
places subjects at unnecessary risk.The federal
regulations allow the HSPC to approve a study design that
involves deception or withholding of information if the
strategies are justified and the protocol provides for a
post-study debriefing of the subjects. The HSPC may grant
a waiver of the debriefing requirement if the debriefing
may prove harmful to the subjects. (Please see Chapter 4, "Informed Consent
Requirements: Deception and the Withholding of
Information", for more information.)
- Risks and Benefits:
The HSPC will assess whether the risks to subjects are
reasonable in relation to the anticipated benefits, if
any, to the subjects, and the importance of the knowledge
reasonably expected to result from the research. The
Committee will consider only those risks and benefits
that may result from the research. The federal
regulations do not allow the HSPC to evaluate the
possible long range effect of applying the knowledge
gained through the research. [45 CFR
46.111] (Please see Chapter
5, "Risk/Benefit Assessment" for more
information.)The HSPC is required to review any
possible benefits a subject may derive from participation
in research, and/or the benefits of new knowledge that
may justify asking a person to undertake the risks of the
study. Payment for participation in research is not
considered a benefit.
- Equitable selection of subjects:
The selection of subjects should be equitable and free of
coercion. The HSPC will consider the purpose of the
research and the setting of the research. The Committee
will closely examine research involving vulnerable
subject populations, such as children, prisoners,
subjects with cognitive disorders, or economically or
educationally disadvantaged subjects. Investigators
should indicate in their submission how they will avoid
the appearance of coercion in the recruitment of
subjects. They should also detail any extra precautions
taken to safeguard the rights and welfare of subject
populations. (Please see Chapter
8, "Special Classes of Research Subjects"
for additional information regarding vulnerable subject
populations.)
- Identification of Subjects and
Confidentiality:
The HSPC is required to review the method for prospective
identification of subjects. They will examine the means
of identifying and contacting potential subjects and the
methods for ensuring the subjects’ privacy and
confidentiality. Investigators are required to submit
plans for ensuring the confidentiality of subjects.
(Please see Chapter 4,
"Informed Consent Form Requirements:
Confidentiality"; Chapter 6, "Selection &
Recruitment of Subjects"; Chapter 7, Responsibilities of
Principal Investigators: "Confidentiality"
and "Certificates of
Confidentiality"; and Chapter 10, "Special State
of California Requirements", for more
information.
- The Informed Consent Process:
The HSPC will carefully review the informed consent
process: when, where, and how consent is obtained and any
provisions for the ongoing consent of subjects. (Please
see Chapter 4, "Informed
Consent Requirements" for more information.)
- Qualifications:
The HSPC will examine the qualifications of students
and/or faculty investigators. Procedures requiring
special skills on the part of the investigators,
licensure, accreditation, and/or experience in qualifying
the investigator for the performance of the proposed
procedures are reviewed by the Committee. In addition,
the Committee will consider the facilities and equipment
used to conduct the research and maintain the rights and
welfare of the subjects.
- Additional Review:
The HSPC will determine whether a project requires more
than annual review and may require an appropriate
monitoring procedure that could include monitoring of the
consent process, observation of the research procedures,
and review of research related records. In some
instances, the HSPC may refer review of the research to
an additional committee, such as a Data Safety Monitoring
Board (DSMB) for research with cognitively impaired
subjects, or an Independent Safety Monitoring Board
(ISMB) assigned by the HSPC to monitor individual
projects.
Contact OPRS
October 29, 2004
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