74-000
BOT 3-31-04, 04-30-09
Institutional Review Board (IRB) and Institutional Animal Care and Use Committee
(IACUC) (Policy)
Purpose
Oglala Lakota College recognizes that the Oglala people, and many other peoples in
North America and on other continents who have been subject to colonization, have been
subjected to research practices that are ethically and morally reprehensible. The review
process at Oglala Lakota College is informed by an appreciation for that historical
background in addition to federal law and generally acceptable ethical principles.
In order to comply with ethical principles and with federal guidelines concerning the
protection of human and animal subjects, research conducted under the auspices of
Oglala Lakota College is subject to a review process in order to insure that it meets
required legal and ethical standards. Oglala Lakota College’s Institutional Review Board
must review all clinical and behavioral research involving human subjects conducted at
or through Oglala Lakota College in order to assure that the research complies with
ethical standards and federal law.
Oglala Lakota College’s Institutional Animal Care and Use Committee (IACUC) must
review all research involving animal subjects in order to comply with ethical standards
and federal law. The IACUC’s overall task is to determine whether a project’s societal
benefit justifies any animal pain and suffering that it might cause, and whether whatever
animal pain or suffering occurs will be kept to a minimum.
Nothing in this Policy or statement of Purpose should be construed as creating an
impediment to research. Oglala Lakota College encourages research. This policy is
designed to support research and to insure that research is conducted with due regard for
protection of human and animal subjects.
Part I: Protection of Human Subjects – the Institutional Review Board (IRB)
A. Definition of Research
Oglala Lakota College adopts, for the purposes of human subjects protection, the federal
definition of research:
“A systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge.
Activities which meet this definition constitute research for purposes of this
policy, whether or not they are conducted or supported under a program
which is considered research for other purposes. For example, some
demonstration and service programs may include research activities.” 45
CFR 46.102
B. Covering Regulations:
45CFR46 Protection of Human Subjects
C. Ethical principles:
Ethical principles reflect cultural and social bases for the goal of protecting human
subjects. The Lakota values of respect and generosity are foundation stones and they
overlap substantially with the internationally recognized principles that formed a basis for
legal regulation of research. Those include 1, respect for persons: individuals are
autonomous agents, and persons of diminished autonomy are entitled to protection; 2,
Beneficence: Persons are treated in an ethical manner not only by respecting their
decisions and protecting them from harm, but also by making efforts to secure their well-
being (do no harm, maximize benefits, minimize potential harm); 3, Justice: Who ought to
receive the benefits of research and bear its burdens? An injustice occurs when some
benefit is denied without good reason or when some burden is imposed unduly (cf.
Belmont Report, 1979 US Dept. H.E.W.)
D. Scope: What is subject to IRB Review
1. Generally, any Oglala Lakota College research that uses humans, human tissue,
surveys of human subjects, or human subjects’ records requires IRB review, irrespective
of its funding source. The IRB’s charge extends to research in the social and behavioral
sciences as well as research in the health and biological sciences.
2. Specifically, IRB review and approval is required for any research involving human
subjects that meets any of the following criteria:
a) research is conducted by University faculty, adjunct faculty, staff, students;
b) research is performed on the premises of the Oglala Lakota College, including
Piya Wiconi, college centers, and He Sapa Learning center;
c) research is performed with or involves the use of facilities or equipment belonging
to Oglala Lakota College;
d) research involves Oglala Lakota College students, staff, or faculty
e) research satisfies a requirement imposed by Oglala Lakota College for a degree
program or for completion of a course of study
f) research is certified by a college administrator to satisfy an obligation of a faculty
or consultant appointment at Oglala Lakota College, including clinical or adjunct
appointments
g) research is conducted by or under the direction of any employee or agent of
Oglala Lakota College, in connection with his or her institutional responsibilities;
h) research using data on human subjects gathered in earlier projects require IRB
review.
E. IRB Membership and Articulation within Oglala Lakota College
1. Composition and selection of members: IRB committee membership will
be comprised of no less than seven persons, at least five of whom represent a
minimum of five of the departments at OLC that conduct research or that may
conduct research, and at least two of whom are chosen from the community on Pine
Ridge Indian Reservation. The departments including those listed in the catalog or
organizational chart of the College, as well as other programs which do not fall under
a specific department, can select delegates. Each department and program is
encouraged to select a delegate. It will be the responsibility of the Vice President for
Instruction to insure that the departments and programs select sufficient
representatives for the IRB and to insure that the IRB delegates chosen by the
departments and programs reflect diversity in gender and ethnicity (this diversity
requirement is per 45CFR46). The OLC representatives will collectively select the
community delegates to the IRB. Community delegates must not be employees or
otherwise affiliated with Oglala Lakota College, nor can they be spouses or OLC
employees or Board members. At least one of the community delegates must not be
related in the degree of immediate family to any employee or Board member of the
college.
2. Delegates (members) of the IRB Committee, including the community
delegates, will serve on the IRB for two years. Terms of delegates are renewable by
their respective departments. Terms of the community delegate(s) are renewable at
the discretion of the IRB committee members. When their terms expire, or when a
member leaves or resigns, the vacancy will be filled by one of the academic
departments or by a community member duly chosen in accord with No. 1 above.
IRB committee members will select a chair from among the delegates representing
the academic departments. The chair will serve for one year. The IRB Committee
may choose other officers as it deems appropriate.
3. Quorum and voting: A simple majority of delegates to the IRB Committee
constitutes a quorum, except that no decision can be made in the absence of a
delegate from the community. Each delegate has one vote, including the Chair of the
Committee.
4. Articulation within OLC: IRB Committee is a permanent committee of the
college. It’s minutes and proceedings are available to college employees. IRB
Committee is not a part of the Governance System (Piya Wiconi Okolakiciye) of
Oglala Lakota College. IRB decisions can be reviewed by OLC administration.
Decisions of an IRB to disapprove research cannot be overturned by OLC officials,
nor can OLC officials approve of research that the IRB has not approved (cf.
45CFR46.112).
F. IRB Application Process
Applications for IRB review of proposed research will be made to the IRB Committee of
OLC, and will be submitted in accordance with protocols set by the IRB Committee for
the following three categories of research: 1, exempt (no disruption in the daily life of
human subjects and no risk – still requires application to the IRB); 2, expedited (minimal
risk to human subjects); and 3, full review (more than minimal risk potential).
G. IRB Review Process – IRB Committee responsibilities and duties
1. Temporal considerations – IRB committee will meet monthly to review
applications. Applications shall be handled expeditiously and notifications to
applicants will be made not later than one working day following the IRB
committee consideration. IRB Committee will conduct continuing review of
research covered by this policy at intervals appropriate to the degree of risk, but
not less than once per year.
2. Record keeping – IRB committee will be responsible for maintaining records of all
applications, minutes of meetings, decisions, and replies to applicants for IRB
review. Specifically, and in accord with 45CFR46, it is the responsibility of the
IRB Committee to maintain:
(1) Copies of all research proposals reviewed, scientific evaluations, if any,
that accompany the proposals, approved sample consent documents,
progress reports submitted by investigators, and reports of injuries to
subjects.
(2) Minutes of IRB meetings which shall be in sufficient detail to show
attendance at the meetings; actions taken by the IRB; the vote on these
actions including the number of members voting for, against, and abstaining;
the basis for requiring changes in or disapproving research; and a written
summary of the discussion of controverted issues and their resolution.
(3) Records of continuing review activities.
(4) Copies of all correspondence between the IRB and the investigators.
(5) A list of IRB members in the same detail as described in §46.103 (b)(3).
(6) Written procedures for the IRB in the same detail as described in
§46.103 (b)(4) and §46.103 (b)(5).
(7) Statements of significant new findings provided to subjects, as required
by §46.116 (b)(5).
(b) The records required by this policy shall be retained for at least 3 years,
and records relating to research which is conducted shall be retained for at
least 3 years after completion of the research. All records shall be
accessible for inspection and copying by authorized representatives of the
Department or Agency at reasonable times and in a reasonable manner.
3. Notification – IRB committee is responsible for replying expeditiously to all
requests for IRB reviews. Notification will include any suggestions, and specific
reasons for disapproval, including recommendations to overcome problems.
Notification will be made to applicants and will be reflected in the minutes of the
IRB Committee. IRB Committee minutes will be posted electronically and will be
made available in hard copy by the Chair of the IRB.
4. The IRB Committee will publish protocols for application for an IRB review, for
each category of risk, and will post those protocols, and application forms, as a
link to Oglala Lakota College’s website under the heading IRB. Those links will be
available to the OLC community not later than 30 days after the effective date of
this Policy. Elements of IRB Review will minimally include the following:
a) Review the Informed Consent Form. Respect for persons requires that
subjects, to the degree that they are capable, be given the opportunity to
choose what shall or shall not happen to them. This opportunity is provided
when adequate standards for informed consent are satisfied;
b) Review the Application Form: does the abstract description agree with the
description in the consent form? Do the rationale and experimental design
suggest that useful information is likely to result? Are there risks to the
subjects? Is there a realistic chance of benefit?
c) If federally funded, does the abstract match the grant application?
Part II: Protection of Animal Subjects: The Institutional Animal Care and Use
Committee (IACUC)
A. Regulations
9CFR1 subchapter A (Animal Welfare)
B. Scope: What is subject to review
The IACUC committee reviews any use of live animals in research, teaching, service or
display by faculty, staff, or students affiliated with Oglala Lakota College, regardless of
where the activity occurs and of the activity’s funding source.
Many of the animals covered in IACUC review are used in research, including
agricultural research (such as the study of food and fiber production or diet manipulation)
as well as medical, biological, and behavioral research. Some animals may be acquired
and/or pastured by Oglala Lakota College, but some are free-ranging wildlife, or client-
owned animals.
Animals used in educational settings are also protected by IACUC review. Examples
include those used to teach agricultural techniques, animal husbandry, and medical and
veterinary procedures.
In short, all animals used by College personnel for College purposes or owned by Oglala
Lakota College come within the scope of the IACUC’s review. These animals are
involved in a variety of uses and in a range of disciplines.
C. Membership and Articulation within Oglala Lakota College
1. The IACUC is a permanent committee of Oglala Lakota College. Federal
regulations require that the IACUC have at least five members, although it
typically has more in order to provide a suitable breadth of expertise. One of the
IACUC members must be a veterinarian. It shall be the responsibility of the Vice-
President for Instructional Division to convene a meeting of the faculty, who will
select a minimum of three members of the IACUC. Members must include at
least one community member who is not related, in the degree of immediate
family, to any college employee or Board member and one veterinarian. The
members of the IACUC selected by the faculty and program directors select the
community delegate or delegates to the IACUC and will select the veterinarian
delegate as well.
2. Delegates (members) of the IACUC Committee, including community delegates,
will serve on the IRB for two years. Terms of delegates are renewable by their
respective departments. Terms of the community delegate(s) are renewable at
the discretion of the IACUC committee members. When their terms expire, or
when a member leaves or resigns, the vacancy will be filled by one of the
academic departments or by a community member duly chosen in accord with
No. 1 above. IACUC committee members will select a chair from among the
delegates representing the academic departments. The chair will serve for one
year. The IACUC Committee may choose other officers as it deems appropriate.
3. Quorum and voting: A simple majority of delegates to the IACUC Committee
constitutes a quorum, except that no decision can be made in the absence of a
delegate from the community. Each delegate has one vote, including the Chair of
the Committee.
4. Articulation within OLC: IACUC Committee is a permanent committee of the
college. It’s minutes and proceedings are available to college employees. IACUC
Committee is not a part of the Governance System (Piya Wiconi Okolakiciye) of
Oglala Lakota College. IACUC decisions can be reviewed by OLC
administration. Decisions of an IRB to disapprove research cannot be overturned
by OLC officials, nor can OLC officials approve of research that the IACUC has
not approved.
D. Application process
Researchers initiate IACUC review by submitting an application to the IACUC. The
IACUC must approve a project before investigators can begin work on it. The IACUC
will publish protocols for application for an IACUC review and will post those protocols,
and application forms, as a link to Oglala Lakota College’s website under the heading
IACUC. Those links will be available to the OLC community not later than 30 days after
the effective date of this Policy.
E. Responsibilities of IACUC
1. Assess the project’s societal benefit and treatment of animals and communicate
decisions and requests to the investigator in writing. The project must stand a
reasonable chance of promoting human or animal health, contributing to the good
of society, or advancing the boundaries of knowledge. Determine whether the
investigator has designed the protocol so as to minimize any animal pain and
suffering that occurs. The IACUC can withhold approval from projects in which
pain and suffering are not minimized, even if the project’s benefits outweigh the
pain and suffering.
2. Conduct semiannual inspections of all animal study areas and animal facilities.
The importance of this requirement is underscored by the fact that the Chief
Executive Officer of the institution must certify that the attending veterinarian and
the animal care and use committee have the authority to enter any animal area at
any reasonable time.
3. If a project involves a biohazard, the IACUC assesses the risk to humans and the
need for precautions. (Investigators must list biohazards in the application form.
Biohazards include diseases transmissible from animals to humans, infectious
agents capable of causing disease in humans, biological toxins, radiation, and
recombinant DNA. Investigators can obtain more information on biohazards from
the Department of Environmental Health and Safety.)
4. Each project requires continuing review, typically annual review, although the
IACUC may review projects at other times as well, if circumstances warrant. The
IACUC may ask investigators to revise a project if it determines that animals may
be suffering unnecessarily.
5. Federal regulations allow the IACUC to approve a project for a maximum of three
years. If the research is to continue past this period, the IACUC must review the
proposal prior to the expiration period. The IACUC will notify the investigator two
months before the expiration date.
6. Records management and retention:
a. a copy of the original application submitted to the IACUC,
b. an original of the IACUC’s response,
c. a copy of responses to the IACUC’s stipulations or requests for additional
information,
d. the original notice of final approval,
e. a copy of the Certification of Approval issued by the IACUC to any
funding agencies,
f. copies or originals of all other correspondence with the investigator,
g. copies of completed continuing review forms and attachments,
h. the original notice of renewal of approval and certification, where
applicable, and
i. copies of any inspection reports and follow-up action.
j. Retain the above records for at least three years. These records are
subject to inspection by federal authorities. Sanctions for incomplete or
nonexistent records include suspension of funding, fines, exclusion from
future funding.
7. Certification of IACUC approval
Most federal and private funding agencies will not award a grant for a project
involving animals until an IACUC has certified its approval. Federal agencies, for
example, require certification of approval on the grant application’s face page. It shall
be the responsibility of the IACUC to provide such certification as required by the
funding agencies.
8. Reporting violations and other problems
General concerns about the welfare of animals used by Oglala Lakota College should
also be reported, even if the IACUC has approved the project in which the animals
are used. Federal regulations require the IACUC to investigate all legitimate concerns.
9. Reporting health-related incidents
If anyone suffers an injury (such as an animal bite or sustains injury from a kick, etc.)
or is exposed to a hazardous biological or chemical agent during the course of a
project, the supervisor and if necessary the Department of Environmental Health and
Safety should be contacted immediately.
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