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PPM 74-000 IRB Institutional Animal Care and Use on www.olc.edu

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                                                                                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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