INSTITUTIONAL REVIEW BOARD

The mission of the Institutional Review Board (IRB) is to ensure that vital, university research can be conducted in full compliance with both the letter and the spirit of regulations designed to protect the rights and welfare of human subjects.  Both ARC and IRB are charged to monitor research to ensure all human subjects involved with research are protected from undue risk and from deprivation of personal rights and dignity.  This protection is assured by consideration of three principles that are the basis of ethical research:

1. That voluntary participation by the subjects, indicated by free and informed consent, is assured by the investigators;

2. That an appropriate balance exists between potential benefits of the research to the subject or to society andthe risks assumed by the subject; and

3. That there are fair procedures and outcomes in the selection of research subjects.

All faculty and staff (both full-time and part-time) using human subjects or identifiable, private information about human subjects to conduct research within the course and scope of their duties are required to have prior approval from the IRB. Projects must be approved regardless of whether or not the research is funded and regardless of the source of funds.  Southern Researchers must apply to the IRB when conducting research other than for institutional reports. They must fill out the appropriate forms when using human subjects and vertebrates, or identifiable, private information about human subjects to conduct research within the course and scope of their duties, are required to have prior approval from the IRB before research is initiated. Please see this manual for complete details as to which forms are required. 

For student class-based research the research professor who has completed CITI training and is qualified to approve student research may obtain IRB coverage for all students in their class by completing IRB forms C, D, and E.  These forms allow the university to keep track of student research from the IRB application and approval phases to the completion phase for the professor and students in the professor’s class.

All projects must be approved. This policy also applies to students whose research is conducted under the advisement of a faculty member.  All research proposals must be reviewed by the IRB and no individual other than the IRB Chair may exempt a proposal from further review. 

Research is defined as:  “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities, which meet this definition, constitute research for purposes of this policy, whether they are conducted or supported under a program, which is considered research for other purposes. For example, some demonstration and service programs may include research activities” (Code of Federal Regulations, 45 CFR 46.102d).

A Human Subject means:  “A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information” (Code of Federal Regulations, 45 CFR 46.102f).

1. 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.

2. To review all academic research proposals to determine whether they are Exempt, Expedited or require Full Review approval from IRB:

   • Exempt studies are those with no risk to subjects.
   • Expedited studies are those with minimal risk to subjects.
   • Full Review studies are those which involve more than minimal risk to the subjects and require review by the full IRB committee membership.
     
     

3. To consider whether:

   • Risks to subjects are minimized
   • Selection of subjects is equitable
   • Informed consent is sought from each subject
   • Risks are reasonable in relation to anticipated benefits
   • Informed consent is appropriately documented
     
     

4. Review for approval, all non-exempt academic research proposals involving human subjects, animals and plants.

5. To ensure compliance with legal, regulatory, and ethical mandates and provisions relating to research involving human subjects, animals and plants.

6. To coordinate with the ARC, with Academic Administration and with the Dean of Graduate and Professional Studies in maintaining records of on-going academic research.

7. To coordinate with the ARC, with Academic Administration and with the Dean of Graduate and Professional Studies in maintaining records of ethics training of faculty and students.

1. Complies with approved policies and procedures that ensure the integrity of campus-wide exempt, non-exempt, and full review academic research.

2. Provides certified research compliance training for faculty and students involved in academic research involving human subjects, animals or plants, and other as described.

3. Makes available to faculty and students the necessary IRB applications needed for IRB approval.

4. Provides assistance needed by faculty and students in completing the necessary IRB applications.  An explanation of application forms is available in the IRB Policy Manual. 

5. Reviews to approve, exempt, request modifications to secure approval, or disapprove all research activity proposals covered by this policy.

6. Conducts review of on-going research at intervals appropriate to the degree of risk, but not less than once per year.  

7. Reviews proposed changes in research activities as requested on Form B to ensure that changes in approved research continues to comply with IRB protocols during the period for which IRB approval has been given.

8. Requires that information given to subjects as part of informed consent is in accordance with policy.

9. Requires or waives documentation of informed consent.

10. 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 for the research activity. If the IRB disapproves a research application, 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.

11. 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.

12. 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.

13. Approves potentially sensitive research only with the concurrence of a majority of those members in attendance or with an e-vote.

14. Reports to Academic Administration and Dean of Graduate and Professional Studies any continuing or serious matters of non-compliance by investigators with the requirements and determination by the IRB.

15. 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.

16. Archives records of all IRB actions related to research conducted at the institution.

1. 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. The IRB through the ARC SharePoint.

2. 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.

3. Maintains records of completion of the Collaborative Institutional Training Initiative (CITI) modules which have been identified by ARC for faculty and student completion.  These CITI modules are accessed through the IRB eClass site.  Modules have been identified as most appropriate and necessary for completion prior to conducting research in the areas of: Science/Math, Life Sciences and Liberal Arts.   

4. Maintains records of continuing review activities.

5. Retains copies of all correspondence between the IRB and investigators.

6. Maintains listings of all IRB members identified by name, earned degrees and their professional representative capacity.

7. Maintains a manual and website outlining IRB procedures and provides all IRB applications and forms.

1. Complies with approved policies and procedures that ensure the integrity of campus-wide exempt and non-exempt academic research.

2. Provides certified research compliance training for faculty and students involved in academic research. 

3. Makes available to faculty and students the necessary IRB applications needed for submittal for IRB approval.

4. Provide assistance needed by faculty and students in completing the necessary IRB applications.

5. Reviews to approve, exempt, require modifications (to secure approval), or disapprove all research activities proposals covered by this policy.

6. Conducts review of on-going research at intervals appropriate to the degree of risk, but not less than once per year.

7. Reviews proposed changes in research activities to insure that changes in approved research, during the period for which IRB approval has been given continues to comply with IRB protocols.

8. Requires that information given to subjects as part of informed consent is in accordance with policy.

9. Requires or waives documentation of informed consent.

10. 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.

11. Monitors 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.

12. 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.

13. Approves potentially sensitive research only with the concurrence of a majority of those members in attendance or with an e-vote.

14. 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.

15. 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.

16. Maintains up to date records of all research conducted at SAU.

The Institutional Review Board Chair and Graduate Assistant maintains:

1. 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.

2. Minutes of all ARC/IRB meetings which shall be in sufficient detail to show attendance at the meetings; 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.

3. Records of IRB training programs including faculty and student completion of CITI training.

4. Records of continuing review activities.

5. Copies of all correspondence between the IRB and investigators.

6. A list of all IRB members identified by name; earned degrees and their professional representative capacity.

7. A manual and website outlining IRB procedures; and providing all IRB applications and forms.  https://teams.southern.edu/teams/irb.

Investigators are encouraged to submit IRB applications for approval prior to securing funding; however, if there is insufficient time to do so, proposals may be submitted with the assurance that IRB approval will be sought and received prior to pursing any research related activities.  In these cases, the researcher must articulate the specific portion of the grant that will require IRB approval in the funding application and provide an anticipated start date for these activities. For example, a researcher might apply for a grant with a funding cycle that begins in January; however, there are no activities that require human subjects’ approval until June.  From January to June the investigators might be engaged in planning activities, drafting questionnaires, or offering direct services.  In these types of cases, the investigator would use the following type of language in the grant application:

Any necessary IRB approvals will be secured prior to engaging in any research involving human subjects.  If funded, the project will require IRB approval for the specific purpose of approval of questionnaires that will be used to evaluate the efficacy of the grant activities. It is anticipated that IRB approval would be secured no later than June 1, 20XX, of the university fiscal year and yearly a FORM B will be completed indicating the progress of the funded research grant. See FORM B details on pages 29-30.

For many years, state and federal laws were silent on the issue of human research and experimentation. The situation changed, however, in 1971 with the first of a series of federal regulations. Then the US Department of Health, Education and Welfare (DHEW) issued The Institutional Guide to DHEW Policy on Protection of Human Subjects. These guidelines set the initial review criteria into motion. Three years later, on July 12, 1974, Public Law 93-348 (known as the "National Research Act of 1974") was signed into law, creating the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research, and set the definitive standards of the Institutional Review Board. Section 212 of the law specified, in part, that: 

"The Secretary of DHEW shall by regulation require that each entity which applies for a grant or contract under this Act for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit in or with its application assurances satisfactory to the Secretary that it has established a board (to be known as "Institutional Review Board") to review biomedical and behavioral research involving human subjects...in order to protect the rights of the human subjects of such research." 

The Belmont Report was published on April 18, 1979, by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The report was an outgrowth of intensive discussions held in February 1976 at the Smithsonian Institution's Belmont Conference Center that were supplemented by the monthly deliberations of the Commission that were held over a period of three years. The Belmont Report is a statement of basic ethical principles and guidelines meant to assist individuals in resolving ethical problems that surround the conduct of research with human subjects. 

Two years later, on January 27, 1981, the Food and Drug Administration (FDA) and the National Institutes of Health set the regulatory standards in place for the Protection of Human Subjects and for the Operating Standards of the Institutional Review Boards.

On March 8, 1983, the US Department of Health and Human Services (DHHS), in response to the Belmont Report and the FDA's standards, extensively revised its 1974 basic policy and added new regulations governing additional protection for special classes of human subjects --fetuses, pregnant women, invitro fertilization, prisoners, children, mental and physical disabled or institutionalized individuals, and the elderly. 

In April 1989, the White House Office of Science and Technology ordered all governmental agencies to adopt the DHHS policy as their own, with the Office for Human Research Protections (OHRP) of the National Institutes of Health as the coordinating agency. On June 18, 1991, OHRP issued its revised policies for the Protection of Human Subjects and two months later, on August 19, 1991, the regulations became effective, with the OHRP becoming the coordinating agency for 19 US governmental agencies to ensure that institutions comply with the federal regulations, which protect human subjects in research. The regulations are known as the Model Federal Policy of 1991 or simply by its legal citation, 45 CFR 46.