Reports through VP Academic Administration
The Institutional Review Board is a subcommittee of the Academic Research Committee and acts to
facilitate the conduct of ethical academic research campus wide.
Membership:
Seven members appointed by the Academic Research Committee. The Director of the Center for Teaching Excellence, Chair. Three Academic Research Committee members appointed for a one year renewable term, one appointee each selected from the following areas: Science/ Math (Biology, Chemistry, Computer Science, Math, and Physics) Life Sciences (Academic Technology, Faculty Development/On–line Campus, Business, Education, Journalism & Communication, Nursing, Physical Education, Psychology, Social Work, and Technology). Liberal Arts (English, History, Library, Modern Languages, Music, Religion, and Visual Art & Design). The Academic Research Committee Chair, ex officio, a veterinarian (not affiliated with Southern), and a physician (not affiliated with Southern).
Functions:
- To recommend to the Academic Research Committee (ARC) policies and procedures for the conduct of academic research involving human subjects, animals and plants campus-wide.
- To review all academic research proposals to determine whether they are exempt from IRB approval.
- To review for approval, all non-exempt academic research proposals involving human subjects, animals and plants.
- To ensure compliance with legal, regulatory, and ethical mandates and provisions relating to research involving human subjects, animals and plants.
- To coordinate with the ARC, with Academic Administration and with the dean of Graduate Studies in maintaining records of on-going academic research.
- To coordinate with the ARC, with Academic Administration and with the dean of Graduate Studies in maintaining records of ethics training of faculty and students.
Responsibilities: The IRB:
- Complies with approved policies and procedures that ensure the integrity of campus-wide exempt and non-exempt academic research.
- Provides certified research compliance training for faculty and students involved in academic research.
- Makes available to faculty and students the necessary IRB applications needed for IRB approval;
- Provides assistance needed by faculty and students in completing the necessary IRB applications.
- Reviews to approve, exempt, require modifications to secure approval, or disapprove all research activities proposals covered by this policy.
- Conducts review of on-going research at intervals appropriate to the degree of risk, but not less than once per year.
- Reviews proposed changes in research activities to ensure that changes in approved research, during the period for which IRB approval has been given, continues to comply with IRB protocols.
- Requires that information given to subjects as part of informed consent is in accordance with policy.
- Requires or waive documentation of informed consent.
- Notifies, in writing, investigators and the institution of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision, and give the investigator an opportunity to respond in person or in writing.
- Monitors and provides additional safeguards when vulnerable subjects (minors, mentally incompetent, prisoners, economically disadvantaged, pregnant females) are involved in the research in order to protect against coercion or undue influence.
- Conducts its review of potentially sensitive research (except when an approved exempt or expedited review procedure is used) at convened meetings where a majority of the members of the IRB are present.
- Approves potentially sensitive research only with the concurrence of a majority of those members in attendance or with an e-vote.
- Reports to the Graduate Dean and Academic VP any continuing or serious matters of non-compliance by investigators with the requirements and determination by the IRB.
- Suspends or terminates approval of research that is not in compliance with the IRB’s determinations or has been associated with unexpected serious harm to subjects.
- Maintains up to date records of all research conducted at SAU.
Records: The IRB through the ARC SharePoint Website
- Retains copies of all research proposals reviewed, scientific evaluations, if any, that accompany proposals, approved sample consent documents, approved advertising or other solicitations for subjects, progress reports and injuries to subjects.
- Maintains minutes of all IRB meetings which shall be in sufficient detail to show meeting attendance, actions taken by the IRB, the vote on these actions, including the number of members voting for, against, and abstaining, the basis for requiring changes in or disapproving research, and a written summary of the discussion of controversial issues and their resolution.
- Maintains records of IRB training programs including faculty and student completion of CITI training.
- Maintains records of continuing review activities.
- Retains copies of all correspondence between the IRB and investigators.
- Maintains listings of all IRB members identified by name, earned degrees and their professional representative capacity.
- Maintains a manual and website outlining IRB procedures and provides all IRB applications and forms.