Policy 2510A

INSTITUTIONAL RESEARCH INVOLVING HUMAN SUBJECTS AND ANIMALS

References: U.S. Department of Health and Human Services (HHS), the Office for Human Research           Protections (OHRP) 45 CFR 46, Subparts A, B, C, and D, the Food and Drug Administration (FDA) 21 CFR Parts 50, 56, 312. Family Educational Rights and Privacy Act of 1974 (FERPA or the Buckley Amendment). U.S. Department of Agriculture Animal Welfare Act (1966), Regulation (C.F.R., 2009) and policies, the Health Research Extension Act (1985), the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS, 2002), the Guide for the Care and Use of Laboratory Animals (NRC, 2011), the Guide for the Care and Use of Agricultural Animals in Research and Teaching (2010), Animal Welfare Act and Regulations (AWAR). National Institute of Health (NIH) IDeA Networks of Biomedical Research Excellence (INBRE), and Wyoming INBRE, National Institute of General Medical Sciences of the National Institutes of Health.

The Board of Trustees recognizes that Western Wyoming Community College (the College) is not a research-based institution, but acknowledges that there will be instances where the involvement of human subjects (e.g., students and employees) or animals in research is an integral part of the advancement of educational and scientific research. This policy guides the review and approval of requests to involve human subjects from the College community. This policy also requires the College to ensure animal facilities and programs involved in research maintain the highest standards of animal care and use, and to be operated in accordance with applicable federal, state, and local laws, regulations, policies, and guidelines.

The College shall strive to accommodate investigatory endeavors in an ethical manner. However, the safety of its students and employees shall be the College’s central priority. The Board expects that an Institutional Review Board (IRB) shall be one of the standing committees assembled by the College President. All research on human subjects by external investigators must be reviewed and approved by the College’s Institutional Review Board (IRB).

The College shall assure that all of its activities related to human subject research, regardless of funding source, will be guided by the ethical principles in The Belmont Report.  The College further assures that all of its activities related to federally-conducted or federally-supported human subject research will comply with the Terms of Assurance for Protection of Human Subjects for Institutions within the United States.

The College shall assure that all of its activities related to animal research, regardless of funding source, will be guided by the ethical principles in the NIH Guide for the Care and Use of Laboratory Animals.  The faculty and students will comply with all training protocols. 

Definitions
External investigators: Those who conduct research for the purpose of a report or study requested by an institution or agency other than College faculty, students and staff.

Adopted: May 13, 2021

Procedure 2510A.1

RESEARCH INVOLVING HUMAN SUBJECTS

References:     Board Policy 2510A: Research Involving Human Subjects and Animals

Western Wyoming Community College (the College) shall assemble an Institutional Review Board (IRB) to document its written processes according to Federal Protection of Human Subjects Regulations 45 C.F.R. 46.115(a)(6), 45 C.F.R. 46.103(b)(4), and 45 C.F.R. 46.103(b)(5). All research projects involving human participants conducted by faculty, staff, and students associated with the College must receive IRB approval prior to initiating the research.

• For more information about the United States Department of Health and Human Services (HHS) policy for the Protection of Human Subjects, researchers must adhere to: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
• For more information about basic ethical questions in the conduct of research consult The Belmont Report at: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html.

The procedures set forth are provided so that researchers may better understand the reasons for ethical review of research with human participants, the primary ethical principles that govern such research, and the statutory basis of these principles. This document also contains information that should be sufficient to allow researchers to submit an acceptable research proposal for IRB review. The description of information that must be submitted and helpful templates may be accessed at: https://www.westernwyoming.edu/student-life/campus-amenities/hay-library/undergraduate-research.php.

Adopted: May 13, 2021

Procedure 2510A.2

RESEARCH INVOLVING ANIMALS

Reference:  Board Policy 2510A:  Research Involving Human Subject and Animals

Western Wyoming Community College (the College) is committed to the highest ethical standards of animal care and use. This procedure outlines the principles that govern the humane conduct of activities involving live vertebrate animals, procedures that ensure compliance with external regulations and the responsible use of College resources. This procedure establishes roles and responsibilities of those individuals who are involved in the care and use of animals in research, testing and teaching.

Definitions:

Animal:  Any living, non-human, vertebrate animal (mammal, bird, reptile, amphibian, or fish), unless otherwise specified.

Animal Facility:  A College-owned and operated facility where vertebrate animals are housed or held for a 12-hour period or more.

Investigator:  The individual who uses, or supervises the use of, live vertebrate animals on a project.

Principal Investigator (PI): Individual with primary responsibility for a project, including designing and implementing research, teaching, or testing activities involving live, vertebrate animals.

Guiding Principles

As a member of the University of Wyoming INBRE program, the College is committed to providing opportunities to its students to, “enhance biomedical research capacity, expand and strengthen the research capabilities of biomedical faculty, and provide access to biomedical resources for promising undergraduate students throughout the eligible states.” College faculty and students will be afforded the opportunity to conduct research with vertebrate animals in an ethical, humane and sensitive manner.

The INBRE Coordinator shall:

• Ensure that users requesting access to the facility are appropriately trained in the policies and procedures related to the facility.
• Ensure that all animal handlers working in the facility have completed the required Collaborative Institutional Training Initiative (citiprogram.org) (CITI) online classes in proper use of animal research prior to commencing research.
• Provide information to visitors on potential risks associated with entrance to each animal facility.
• Accompany visitors in animal facilities.
• Adhere to all research protocols involving vertebrate animals. All research must be approved by the University of Wyoming’s Institutional Animal Care and Use Committee  (IACUC), and that PI’s must submit all reports and documentation as required by the UW IACUC.
• Ensure timely and accurate reporting to external regulatory agencies.
• Maintain records in accordance with regulatory requirements.

Adopted: May 13, 2021