Human Subjects Review Board Policies
All research involving the use of human research subjects (participants) must be reviewed and approved by the Samford University Institutional Review Board before the research can be initiated.
Samford University is committed to the ethical treatment of all human participants in research conducted by faculty, staff and students. The Samford University Institutional Review Board (IRB) is responsible for reviewing all research involving human participants done under the auspices of the university to ensure that human participants are treated in a just and ethical manner.
- The IRB has the authority to approve, require modification to, or disapprove research involving human participants. Samford University administration may override an IRB approval, but may not override an IRB denial.
- The IRB is responsible for auditing on-going human participant research on campus. Research projects may be randomly selected for auditing, or a decision to audit may be made by the IRB based on the complexity of the project, potential risk to participants, or a history of non-compliance with IRB regulations.
Federal Guidelines for Treatment of Human Participants in Research
Samford University complies with the regulations of the:
- United States Department of Health and Human Services for the Protection of Human Research Subjects (Part 46 of Title 45 of the Code of Federal Regulations, as amended), and
- Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (also known as the Belmont Report)
Samford University is required to report to the Office for Human Research Protections any violations, including: research conducted without prior IRB approval, research conducted without informed consent, more than minor change in research protocol without IRB notification and approval, or any unanticipated adverse outcomes. If you are aware of any violations of IRB regulations, please contact the IRB chair (IRB@samford.edu) and the provost’s office.
Policies Governing IRB Review
- The process for reviewing IRB proposals is explained on the “Submitting a Proposal” page. For additional detail on review procedures, meetings, notifications, audits, and reporting research violations, please email the chair at IRB@samford.edu.
- IRB decisions will be reported in writing to the investigator and to the University. Electronic records of all proposals submitted, correspondence with investigators, and IRB decisions will be archived. All records shall be retained for at least three years.
- IRB approval must be renewed annually, and renewal may be required more frequently than once a year if the project involves participant risk.
- Informed consent should be acquired and documented for all research participants or the participants’ legal representative, unless explicitly waived by the IRB.
- No changes in research protocol and procedures may be made following IRB approval unless change is to prevent immediate hazard to research participants. All other changes must be submitted and approved by IRB prior to implementation.
- Research investigators must complete the NIH Training prior to submitting to IRB.
Membership of Human Subjects Review Board
The board shall have at least 10 members, including at least one faculty member from each academic Division, at least one member with an advanced degree in a health-related profession, and at least one community member who is not affiliated with Samford University and has no immediate family member affiliated with Samford University. At least one of the IRB members must be a non-scientist who represents the interests of those who have no experience in science or research.
|Arts & Sciences||Don Bradley, Brad Bennett, Drew Hataway (chair)|
|Education||Monique Witherspoon, Peggy Connell, Erin Gilchrist|
|Nursing||Moniaree Jones, Cyndi Cortes|
|Pharmacy||Roger Lander, Greg Gorman, Rachel Slaton|
|Public Health||Suresh Mathews|
|Health Related Professions||Mallory Marshall|
|Outside Representative||Carol Beall|