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Policy No: 2073
Responsible Office: Research Compliance and Assurance
Last Review Date: 01/29/2021
Next Required Review: 01/29/2026
Policy No: 2073
Responsible Office: Research Compliance and Assurance
Last Review Date: 01/29/2021
Next Required Review: 01/29/2026

Human Subjects Research

1. Purpose

The University of South Alabama is committed to the ethical principles for the protection of human subjects in research set forth in the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and protections provided in 45 CFR Part 46.

The Institutional Review Board (IRB) was established in accordance with federal regulations governing the use of human subjects in research. The IRB is charged with the responsibility for review, approval and surveillance of all research involving human subjects conducted in connection with the University. The human subjects protection program ensures that (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.

2. Applicability

This policy applies to all faculty, staff and students conducting any research activity involving human subjects, regardless of the funding source.

3. Definitions

Not Applicable 

4. Policy Guidelines

The University of South Alabama IRB policies and procedures are available as individual, stand-alone policies, for the ease of access to topic-specific information for the research community. The detailed policies and procedures are posted on the Human Subjects website.

The University of South Alabama IRB operates under the University’s Federal wide Assurance (FWA00001602) under the Office of Human Research Protections (OHRP).  This assurance applies to all Research with Human Subjects in which the University is engaged, regardless of the site of the activity. Administrative responsibility for overseeing these functions has been delegated to the Office of Research Compliance and Assurance.

University personnel involved in human subject’s research are required to submit research protocols for review and approval to the relevant IRB. Human research protocols cannot commence without approval of the IRB.  Annual review is initiated by the IRB.  Additionally:

  • All approved studies are subjects to audit of compliance at any time;
  • Unanticipated problems involving risks to subjects, adverse events, or other problems must be reported to the IRB for evaluation;
  • Any revisions or amendments to the approved research activity must be submitted to the IRB prior to their implementation for review and approval;
  • Those studies that may qualify for exemption must still be submitted to the IRB for a final determination of exemption;
  • All requests for University of South Alabama to serve as the IRB of record for an unaffiliated investigator (non-USA employee) should be referred to the USA IRB office.

5. Procedures

Implementing procedures or additional guidance related to this Policy may be found on the Human Subjects website as individual, stand-alone policies and procedures.   

6. Enforcement

The Vice President for Research and Economic Development has been designated as the Institutional Official (IO), which is responsible and has oversight for all human subject research activity. The IO delegates responsibilities to the IRB Committee(s) to fulfill the University’s federal obligations to ensure compliance. 

The Office of Research Compliance and Assurance provides for the day-to-day oversight and enforcement of policy.

7. Related Documents

University Related Documents:

University of South Alabama Human Subjects website

Federal Requirements:

45 CFR part 46 (including subparts A, B, C and D)

21 CFR part 50

21 CFR part 56

21 CFR part 312

21 CFR part 314

21 CFR part 812

ICH Good Clinical Practice (E6)