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Human Subject Research

Human Subjects Research Ethics and Compliance

Research involving human subjects must adhere to strict ethical and regulatory guidelines to protect participants' rights, welfare, and privacy. At Tennessee State University, all human subjects research must comply with federal regulations, institutional policies, and ethical principles outlined in the Belmont Report:

  • Respect for Persons – Ensuring informed consent and voluntary participation.
  • Beneficence – Minimizing risks and maximizing benefits.
  • Justice – Fair selection and equitable treatment of participants.

Institutional Review Board (IRB) Approval

Before beginning any research involving human subjects, investigators must obtain approval from the Institutional Review Board (IRB) to ensure compliance with:

  • Federal regulations (e.g., Common Rule, FDA, HIPAA).
  • Informed consent requirements for participant understanding and voluntary agreement.
  • Risk minimization strategies to protect privacy and confidentiality.

Researcher Responsibilities 

  • Submit research protocols for IRB review and approval.
  • Obtain informed consent from participants before involvement.
  • Ensure confidentiality and secure data storage.
  • Report adverse events or protocol changes to the IRB.
  • Complete human subjects research training.

For more information please visit the Institutional Review Board (IRB) website.

Resources and Compliance Requirements

IRB Submission Process: Submission information

Informed Consent Guidelines: Informed Consent Template

Human Subjects Research Training: CITI Programs

To report IRB concerns or seek assistance with human subjects research, contact Dr. Monique McCalllester, IRB Chair, at irb@tnstate.edu