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CHAPTER FIVE: 5200 RESEARCH POLICIES July 2010 5200 HUMAN PARTICIPANT RESEARCH PREAMBLE: This section outlines the considerations, legal and ethical, that need to be taken into account in any research that involves human subjects. It was original to the 1979 Handbook and was revised in July of 1995, and again in July 2003, to reflect changes in applicable federal law. In 2009 the Human Assurances Committee (HAC) was renamed to Institutional Review Board (IRB). In February of 2010 it has been rewritten in accordance with federal law and University policies. For further information, contact the Research Office (208-885-6651). [rev. 7-03, 1-09, 7-10] CONTENTS:
A.
General Policy, Legal Authority and Ethical Principles
C.
Scope of Responsibility and Authority
E.
Organization and Membership of the IRB
F.
IRB Standard Operating Procedures
A. GENERAL
POLICY, LEGAL AUTHORITY AND ETHICAL PRINCIPLES
A-1. GENERAL
POLICY.
The
University of Idaho, in the course of carrying out its teaching, research, and
service missions, engages in human subject or participant research across a wide
array of academic disciplines [and administrative functions]. Recognizing that
engaging in research involving human participants imposes responsibility for
safeguarding the rights and welfare of these persons, the University of Idaho
(University) is committed to the protection of human research participants
through compliance with applicable federal and state regulations and observance
of ethical principles for the conduct of human research, (that are recognized
and adopted by the University through its federal-wide assurance). This policy
governs all human participant research performed under the auspices of the
University.
A-2.
LEGAL
AUTHORITY.
All
research subject to this policy shall be conducted in accordance with federal,
state, and local law. In fulfilling its commitment to protect the rights and
welfare of human research participants, the University applies the regulations
promulgated by the United States Department of Health and Human Services (HHS)
for Protection of Human Subjects (45
C.F.R. 46). Under the approved federal-wide assurance
(FWA00005639) provided by the University to HHS, all human participant research,
regardless of funding source, and the oversight of such research shall be
performed in a manner that complies with the regulations set forth by HHS at 45
C.F.R. 46. The University also complies with human participant research
regulations established by the Food and Drug Administration for clinical
investigations involving drugs, biologics, medical devices, and other test
articles. (21
C.F.R. 50;
56;
312, and
812). The University acts in
conformance with other federal laws and regulations germane to human participant
research and with state and local law that serves to elucidate and supplement
federal regulations for human subject research.
A-3.
ETHICAL PRINCIPLES.
Consistent with its federal-wide
assurance, the University shall be guided by the ethical principles governing
the evaluation and conduct of research involving human participants, whether or
not such research is subject to federal regulation, set forth
in The
Belmont Report: Ethical Principles and Guidelines for the Protection of
Human Subjects of Research of the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research at the
www.hhs.gov website.
While the principles announced in The
Belmont Report serve to guide human participant research at the University,
these principles are never held to or construed so as to supersede any local,
state, or federal law or to supersede any regulations or policies promulgated by
federal agencies.
B. COVERED
ACTIVITIES.
B-1. HUMAN PARTICIPANT RESEARCH
ACTIVITIES.
Irrespective of funding source, all activities that
meet the criteria for: (i) “research” involving “human subjects,” as defined in
HHS regulations (45 CFR 46.102), or (ii) a “clinical investigation” involving
“human subjects” or “subjects,” as defined in FDA regulations (21 CFR 50.3; 21
CFR 56.103; 21 CFR 312.3; 21 CFR 812.3), shall be subject to this policy.
a. HHS Definition of “Research” Involving “Human Subjects:”
(1)
“research:” a systematic investigation, including research development,
testing, and evaluation, designed to develop or contribute to generalizable
knowledge. [45 CFR 46.102(d)].
This includes qualitative research
methods such as constructivist, participatory and action research that may not
be considered generalizable. It also
includes other methodologies that may not be considered generalizable but have
the intent of adding to a body of knowledge.
Note: Certain activities by policy
do not fall under the definition of research and are not subject to IRB review
and approval. For example projects
carried out as part of coursework with the sole intent of teaching students
research skills may be covered under the Course-Related Research Practica
policy. Projects carried out
as part of a University Quality Improvement or Quality Assurance project may be
covered under the policy for such activities.
(2) “human subject:” a living individual about whom an investigator (whether professional or student) conducting research obtains (i) data through intervention or interaction, or (ii) identifiable private information [45 CFR 46.102(f)].
(i)
“Intervention” includes
both physical procedures by
which data are gathered (for example, venipuncture) and manipulations of the
subject or the subject’s environment that are performed for research purposes.
(ii)
“Interaction” includes communication or interpersonal contact between
investigator and subject. (iii) “Private information” includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
b.
FDA Definition of “Clinical
Investigation” Involving “Human Subjects” or “Subjects:”
(1) “clinical investigation” (deemed by the FDA to be synonymous with “research”): any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under section 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. [21 CFR 50.3(c); 21 CFR 102(c); 21 CFR 312.3(b); and 21 CFR 812(h)]. (i) “Test article” is defined as any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to FDA regulation. [21 CFR 50.3(j) and 56.102(l)]. (2) “human subject” or “subject:” an individual who becomes a participant in research, either as a recipient of a test article or as a control. [21 CFR 50.3(g) and 56.102(e)]; a human who participates in an investigation, either as a recipient of the investigational new drug or as a control. [21 CFR 312.3(b)]; or a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. (21 CFR 812.3).
B-2. EXEMPT HUMAN PARTICIPANT RESEARCH.
Activities that meet the criteria for “human subject
research” described above may nevertheless be exempted from compliance with
federal human participant regulations, if the only involvement of human
participants will be in one or more prescribed categories. For a list of
“exempt” research categories see, [45 CFR 46.101(b)]. The IRB, or designee of
the IRB, shall make the determination as to whether a particular research
activity involving human participants is exempt. Even when research is
determined by the IRB to be exempt, the ethical principles of
The Belmont Report shall be applied by
the investigator to the research activities. C. SCOPE OF AUTHORITY AND RESPONSIBILITY. C-1. INSTITUTIONAL REVIEW BOARD (IRB).
a. The IRB
is the principle mechanism by which the University
ensures that all human participant research activity is planned and conducted in
a manner consistent with applicable law and policy and that the rights and
welfare of human research participants are adequately protected.
b. The responsibilities of the IRB include but are not limited to:
(1) reviewing, approving, requesting modifications, as well as disapproving human subject/participant research, [45 CFR 46.109(a)];
(i) research that has been approved by the IRB may be subject to further review and approval or disapproval by University officials. University officials may not approve research that has not been approved by the IRB (45 CFR 112);
(2) conducting continuing review of
research approved by the IRB, at intervals not less than once per year,
including as necessary observing, or having a third party observe, the consent
process and research activity; or requesting and inspecting
information related to human participant research activity [45 CFR
46.109(e)];
(3) investigating instances of
non-compliance, whether discovered during monitoring by the IRB or reported to
the IRB, including unanticipated problems involving risks to research
participants or others and serious or
continuing noncompliance with this policy or the requirements or determinations
of the IRB;
(4) suspending or terminating approval of
research activity that is not being conducted in accordance with the
requirements established by the IRB for a particular research activity or has
been associated with serious harm to research participants or that is not
otherwise in accordance with federal human subject research regulations or
University policy (45 CFR 46.113);
(5) reporting to appropriate University and federal government officials:
(i) unanticipated problems involving
risks to research participants or others and
serious or continuing noncompliance; and (ii) suspension or termination of IRB Approval [45 CFR 46.103(b)(5)];
(6) developing and implementing administrative policies and procedures to implement this policy.
C-2.
Signatory
Official.
The Signatory Official is the VP of Research and Economic
Development or designee. This
individual cannot be a voting member of the IRB and shall have the legal
authority to represent the University in providing assurance to the federal
government that the University will comply with federal human subject research
regulations and shall be responsible for ensuring that all regulatory and
programmatic requirements for the conduct of human participant research at the
University are met. [45 CFR 46.103(b)(2)(c)].
C-3.
Office of Research Assurances.
The Office of Research Assurances shall provide administrative support necessary
for the IRB to fulfill its duties. [45 CFR 46.103(b)(2)].
C-4. UNIVERSITY INVESTIGATORS (FACULTY, STUDENTS, AND STAFF). Any person who engages in human participant research (See B. Covered Activities, above) under the auspices of the University (including faculty, students, and staff) shall comply with applicable federal, state, and local law, with University policy, and with the requirements of the IRB. D. ORGANIZATION AND MEMBERSHIP OF THE IRB. The IRB shall be organized and its membership determined in accordance with federal regulations and University policy (45 CFR 46.107, 21 CFR 56.107, and FSH 1640.54).
E. REVIEW OF
HUMAN PARTICIPANT RESEARCH.
E-1. The IRB shall conduct initial and continuing
review of human participant research activity, following established procedures
appropriate to the degree of risk involved in the research. IRB review of
research shall be prospective, and no human participant research activity may be
carried out by an investigator without prior approval from the IRB. The IRB
shall not provide retrospective approval of human participant research.
E-2. The IRB,
or its designee, shall review all research that meets the regulatory definition
for human subject research but may be eligible for exemption from further review
and oversight (see B. Covered Activities above). The IRB shall make the final
determination as to whether a particular
research activity involving human participants is exempt. For activities
determined to be exempt, the IRB shall provide the investigator with a
certification of exemption from continuing IRB oversight.
E-3. The IRB, or its designee, shall provide guidance to investigators as to what activities do not constitute human subject research and, therefore, do not require IRB oversight. The IRB shall provide, as necessary, certification to investigators that research activity is not human subject research.
F. UNIVERSITY
OF IDAHO IRB STANDARD OPERATING PROCEDURES.
The administrative policies, guidelines, and procedures developed to implement
this policy shall be set forth in the University of Idaho IRB Standard Operating
Procedures, which shall be maintained and made available to investigators by the
Office of Research Assurances. The University of Idaho IRB Standard Operating
Procedures shall be reviewed and approved by the Signatory Official or designee
in consultation with the IRB.
G. CONTACT INFORMATION. For further information regarding implementation of this policy you may contact the Office of Research Assurances or visit the IRB website.
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