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University Policy 131

Research Involving Human Subjects

Initially approved:    March 9, 2020
Reviewed: February 7, 2024

Policy Topic:  Research and Sponsored Activities
Administering Office:  Office of Research Administration


Western Carolina University (WCU) recognizes its responsibility to produce and disseminate knowledge in accordance with its Mission. When non-human models are insufficient, use of human subjects in research is an integral aspect of scholarly activity at WCU. WCU is committed to performing research with humans in an ethical manner that is compliant with regulatory requirements. WCU applies the Federal Policy for the Protection of Human Subjects to all research involving human subjects (45 C.F.R. § 46). The Federal Policy is referred to as the Common Rule. The Common Rule describes baseline ethical standards for the protection of human subjects used in research. This policy sets forth the principles and responsibilities for research projects involving human subjects.

This policy covers all faculty, staff, students, and volunteers intending to conduct research using living individuals, or pre-existing data containing identifiable private information among living people, under the authority of the WCU Institutional Review Board. This policy applies to all research, funded and unfunded.


Human Subject: A living individual about whom an investigator (whether professional or student) conducting research:

  1. obtains information or bio specimens through intervention or interaction with the individual, and uses studies, or analyzes the information or bio specimens; or
  2. obtains, uses, studies, analyzes, or generates identifiable private information or identifiable bio specimens.

Federal Wide Assurance: an agreement with the Federal Government that Western Carolina University will comply with the federal regulations for the protection of human subjects in research.

Institutional Review Board: declarative body established to protect the rights and welfare of human subject research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Research Personnel: any individual who is involved in conducting human subjects research studies. Such involvement may include:

  1. obtaining information about living individuals by intervening or interacting with them for research purposes;
  2. obtaining identifiable private information about living individuals for research purposes;
  3. obtaining the voluntary informed consent of individuals to be subjects in research; or
  4. studying, interpreting, or analyzing identifiable private information or data for research purposes.


The Institutional Review Board (IRB) is established and acts in accordance with the policies set forth by the United States Department of Health and Human Services, Public Health Services Act. The primary charge of the IRB is the protection of the rights and welfare of human research participants. This is accomplished by ensuring (1) the rights and welfare of the research subjects are protected effectively, (2) the risks to subjects are reasonable when considering the potential benefits of the research, (3) the selection of subjects is equitable, and (4) informed consent will be obtained and, when appropriate, documented. The IRB is empowered to review and approve, require modifications or disapprove any research involving the use of human subjects. The IRB has the authority to suspend or terminate any human subjects research that is not conducted in accordance with IRB requirements and established procedures.

The Chief Research Officer is the Institutional Official responsible for oversight of human subjects protection, and serves as the signatory official on the WCU Federal Wide Assurance agreement filed with the Department of Health and Human Services Office of Human Research Protection (OHRP). The Institutional Official appoints members to the IRB and ensures the Board’s autonomy to remain free from undue influence in decision making.


  1. Review by the IRB
    A research project must be reviewed by the IRB if it meets the definition of human subjects research. Researchers may not conduct human subjects research without approval or exemption determination by the IRB.  Voluntary, informed consent must be received from each human subject prior to the commencement of research, unless a waiver is approved by the IRB.
  2. Procedures for Review
    Information regarding standard operating procedures of the IRB and guidance for determining whether specific research requires IRB review, can be found at Research personnel are responsible for adhering to the guidelines and should read the standard operating procedures prior to submitting an application for review. Violation of research guidelines by the University or a researcher jeopardizes the University’s Federal Wide Assurance agreement and threatens the University’s federal funding.
  3. Required Training
    WCU requires completion of training for research personnel on the protection of human subjects and the ethical principles of research for all human subject research, regardless of funding status.


This policy shall be reviewed and revised as necessary every three (3) years.


University Policy 56 – Ethics in Research

45 C.F.R. § 46.115

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