Faculty Handbook

32. Faculty Research

32.1. Institutional Review Board

Jurisdiction of the Institutional Review Board 

1. All research conducted by faculty, students and staff of Bacone College that involves human subjects must be approved by the Institutional Review Board (IRB). This requirement applies to unfunded research, research funded by the federal government, and research funded by other sources.

2. Certain kinds of research involving human subjects require limited Institutional Review Board review and approval. These categories of exempt research are described in the Code of Federal Regulations, 45CFR46.104.

1. Investigators who wish to conduct exempt research should obtain confirmation from the Institutional Review Board that the research is, in fact, exempt.

2. To obtain such confirmation, investigators should inform the Institutional Review Board of exempt research which they are proposing by submitting the request for exemption form.

3. The Institutional Review Board will send the investigator a memo confirming or not confirming that the research is exempt.

4. Research  to meet degree requirements must either be exempt as defined above or must be approved by the Institutional Review Board. 

5. Classroom  activities and laboratory exercises in which the students serve as subjects should be limited to exempt procedures. Lists of such exempt procedures including the information in section B above should be submitted to the committee before they are carried out.

Rules and Regulations Governing the Institutional Review Board 

1. The Board operates under rules defined in the Code of Federal Regulations 45CFR46, March 8, 1983 and The Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects of Research) prepared by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Board will usually meet monthly, on the third Thursday of the month, and will consider all proposals submitted one week prior to the meeting. Proposals are due by noon on the second Thursday of the month.

Approval and Disapproval of Proposals 

1. Except  for research exempted or waived under Section 104 of the Federal Policy, all human subject research will be reviewed, prospectively approved, and subjected to continuing oversight, as applicable. The Institutional Review Board will have authority to approve, require modifications in, or disapprove the covered human subject research. For a proposal to be approved, its benefits must outweigh the risks to the subjects, it must conform to the ethical principles in the Belmont Report and there must be appropriate methods for obtaining informed consent from the subjects. In summary:

1. The need to do experiments in humans as opposed to experimental animals must be demonstrated.

2. Risks to subjects must be minimized.

3. Risks must be reasonable in relation to anticipated benefits of research.

4. Selection of subjects must be fair.

5. There must be procedures for obtaining and documenting informed consent.

6. There must be provisions to protect the privacy of subjects and maintain confidentiality of records.

7. There must be appropriate additional safeguards to protect the rights of children, economically or educationally disadvantaged persons, severely ill persons, mentally ill persons and prisoners.

8. The Bacone College IRB operates by consensus. To be approved, a protocol must receive a majority vote (>50%) from the members present at a meeting, as long as there is a quorum present at the meeting. To achieve a quorum, at least one more than half the number of regular IRB members (i.e., a majority), including a nonscientist, must be present. The IRB cannot review research if a quorum is not present. The board may lose quorum if members recuse themselves due to a conflict, or if the nonscientist has to leave the room.  If the quorum is lost, then the protocol being considered will be tabled until it can be reconsidered at a meeting where sufficient members are present to meet a quorum, even with recusals. Any member’s request for clarification or revision of an application will be documented in the IRB’s final decision. The numbers of members voting For or Against will be recorded in the minutes.

9. Consultants: The IRB may use non-member consultants for advice and information in specialized areas as needed. These consultants may be BACONE COLLEGE faculty, staff, or students, or may be unaffiliated with BACONE COLLEGE. The IRB Chair is responsible for arranging for the use of formal consultants. The formal consultants may be asked to present their assessments in writing or to attend IRB1. Except  for research exempted or waived under Section 104 of the Federal Policy, all human subject research will be reviewed, prospectively approved, and subjected to continuing oversight, as applicable. The Institutional Review Board will have authority to approve, require modifications in, or disapprove the covered human subject research. For a proposal to be approved, its benefits must outweigh the risks to the subjects, it must conform to the ethical principles in the Belmont Report and there must be appropriate methods for obtaining informed consent from the subjects. In summary:

1. The need to do experiments in humans as opposed to experimental animals must be demonstrated.

2. Risks to subjects must be minimized.

3. Risks must be reasonable in relation to anticipated benefits of research.

4. Selection of subjects must be fair.

5. There must be procedures for obtaining and documenting informed consent.

6. There must be provisions to protect the privacy of subjects and maintain confidentiality of records.

7. There must be appropriate additional safeguards to protect the rights of children, economically or educationally disadvantaged persons, severely ill persons, mentally ill persons and prisoners.

8. The Bacone College IRB operates by consensus. To be approved, a protocol must receive a majority vote (>50%) from the members present at a meeting, as long as there is a quorum present at the meeting. To achieve a quorum, at least one more than half the number of regular IRB members (i.e., a majority), including a nonscientist, must be present. The IRB cannot review research if a quorum is not present. The board may lose quorum if members recuse themselves due to a conflict, or if the nonscientist has to leave the room.  If the quorum is lost, then the protocol being considered will be tabled until it can be reconsidered at a meeting where sufficient members are present to meet a quorum, even with recusals. Any member’s request for clarification or revision of an application will be documented in the IRB’s final decision. The numbers of members voting For or Against will be recorded in the minutes.

9. Consultants: The IRB may use non-member consultants for advice and information in specialized areas as needed. These consultants may be BACONE COLLEGE faculty, staff, or students, or may be unaffiliated with BACONE COLLEGE. The IRB Chair is responsible for arranging for the use of formal consultants. The formal consultants may be asked to present their assessments in writing or to attend IRB meetings in person or by phone. Consultants do not vote during IRB meetings and are bound by the same confidentiality and conflict of interest disclosure requirements as all other attendees at an IRB meeting. In addition, IRB members may directly contact non-member colleagues for information that would be helpful for their reviews; in this case, the IRB member will remind the colleague of confidentiality obligations and will document in the electronic system that an informal consultation took place. 

10. Within 10 days of Board review, investigators will receive written notification of approval, disapproval or the changes necessary before approval will be given. Reasons for disapproval will be communicated to the investigator.

11. Approvals are for a period of one year, unless the Board votes to impose a shorter period of approval. Approximately one month prior to expiration of approval, the IRB will send renewal forms to the investigator to be returned for reapproval prior to the expiration date. Protocols can be renewed for up to 5 years.

12. Investigators will be given an opportunity to appeal any disapprovals or unfavorable decisions of the Board.