SOP H100: IRB Functions and Responsibilities

• The Institutional Review Board (IRB) exists primarily to provide protection for human subjects who participate in research.  The university has an obligation to ensure that all research involving human subjects meets regulations published in the United States Code of Federal Regulations (CFR), under Title 45, Part 46 and where applicable, 21, Part 50 and 56. It is not the intent of the university or the IRB to interfere in any manner with competent, ethical, and sound research involving human subjects. However, the university must ensure that its personnel act in compliance with federal, state, university system, as well as its own institutional regulations because the manner in which university researchers conduct research reflects upon our professional, personal, and community commitments to the ethical and scientific standards of conduct.  
• The main focus of the committee, when reviewing research protocols, is on identifying the risks which may exist for participants. However, one of the ethical justifications for research involving human participants is the social value of advancing scientific knowledge and promoting human welfare. If a research study is so methodologically flawed that little or no reliable information will result, it is unethical to put participants at risk or even to inconvenience them through participation in such a study. To this extent, the IRB must also consider the soundness of the methodology that is proposed for a research study, so that it can determine whether “risks to subjects are reasonable in relation to … the importance of the knowledge that may reasonably be expected to result” [Federal Policy §46.111(a)(2)].
• IRB approval means that the IRB has determined that the potential risks to human subjects are, in its collective opinion, acceptable. Further, it means that the research may be conducted at the institution within the constraints set forth by federal and institutional requirements.
• The role of the IRB is dictated by the ethical principles set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (otherwise known as The Belmont Report). https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
• Persons conducting research involving human subjects have both an ethical and a professional obligation to ensure the safety, protection, and rights of participants. It is the intent of Georgia Southern University through the Institutional Review Board (IRB) to assist those engaged in research involving human subjects to conduct their research along ethical guidelines that reflect professional as well as community standards.  Georgia Southern recognizes its duty and obligation to protect the rights and welfare of human beings who are subjects in research regardless of the source of funding.
• It is likely that all possible contingencies may not have been foreseen nor considered in the development of these guidelines and procedures. The IRB requires the cooperation of the university’s research community in establishing the means to assure adequate protection of human subjects involved in research.   Therefore, the IRB invites input from investigators and other interested parties regarding the revisions and updates to these guidelines and procedures.

• The role of the IRB is further defined by federal statute, specifically the HHS Regulations for the Protection of Human Subjects at Title 45 Code of Federal Regulations Part 46 and where applicable, 21, Part 50 and 56.  The HHS regulations are intended to implement the basic ethical principles governing the conduct of human subject research as set forth on The Belmont Report.  The Food and Drug Administration (FDA) has a separate set of regulations governing human subjects research (21 CFR Part 56 — IRB’s and 21 CFR Part 50 — Informed Consent). The basic requirements for IRB’s and for informed consent are congruent between the HHS and FDA regulations.
  • HHS regulations include additional protections for vulnerable populations as subparts of 45 CFR Part 46:
  • Subpart B – Additional HHS Protections for Pregnant Women, Human Fetuses and Neonates involved in Research.
  • Subpart C – Additional HHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects.
  • Subpart D – Additional HHS Protections for Children Involved as Subjects in Research.

• Georgia Southern University IRB adopts and adheres to the HHS regulations as described above.  These regulations may be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html.
• Where applicable, the University adheres to FDA regulations for covered research.  https://www.fda.gov/science-research/good-clinical-practice-educational-materials/comparison-fda-and-hhs-human-subject-protection-regulations
• According to 45 CFR 46.109:
  •         An IRB must review all research activities covered by the HHS regulations, including proposed changes in previously approved human subjects research, and have the authority to approve, require modifications to secure approval, or disapprove any research activity.
  •         An IRB must conduct continuing review of approved research at intervals appropriate to the degree of risk.  Full board research requires continuing review at intervals not less than once per year. GS will evaluate the need for and conduct continuing review for expedited research as required by current regulation.
  •         An IRB has the authority to suspend or terminate approved research that is not being conducted in accordance with the IRB’s requirements, or that has been associated with unexpected serious harm to subjects.
  •         Any suspension or termination of approval must include a statement of the reason for the IRB action and must be reported promptly to the investigator, appropriate institutional officials, and where required, HHS or FDA.
  •         Research approved by the IRB may be subject to further review and approval or disapproval by institutional officials.  However, institutional officials may not approve the conduct of human subject research covered by HHS regulations that has not been approved by the IRB.

• The IRB reviews all research involving human subjects conducted by faculty, staff and/or students of Georgia Southern University.  In addition, any research or related activity that involves the use of Georgia Southern University time, facilities, resources, and/or students is covered by these IRB policies. 
• Human subjects research sponsored by an outside agency that utilize Georgia Southern University resources are considered to be under the auspices of both Georgia Southern University and the outside agency.  In this case, approval (or in some cases cooperation) must be obtained from committees for the protection of human subjects of both Georgia Southern University and the outside agency unless a single IRB or IRB authorization agreement (reliance agreement) is in place.  
• No data collection or any other aspect of human subject research may take place prior to IRB approval.  Failure to comply with these restrictions may result in disallowance of the research, denial of publication rights, and may result in further disciplinary action by the University.  In addition, researchers must comply with institutional policy governing human subjects data collection and resource allocation, (i.e., the GS survey distribution policy).

• The IRB approves protocol content as presented to the Board.  It is imperative that the investigator conduct the research in the approved manner.  
  • Any deviation from the approved protocol may result in immediate termination by the IRB approval and may incur disciplinary or legal action by the University if subjects are determined to have been harmed by changes in the approved methodology.
  • Special Note on Student Research – Student-conducted research is deemed to be the responsibility of the supervising faculty member.  As such, the IRB and the University hold the faculty member accountable for the conduct of the research and for the management and retention of all appropriate documentation relating to the study.
• Investigators have the primary responsibilities for protecting the rights and welfare of human research subjects and are responsible for complying with all applicable provisions of the GS institution’s Assurance.
• Investigators are expected to be knowledgeable about the requirements of the HHS regulations, applicable state law, the GS institution’s Assurance, and institutional policies and procedures for the protection of human subjects.  Maintaining current training will assist the researcher in remaining current.
• Investigators are responsible for:
  •  Conducting their research according to the IRB-approved protocol and complying with all IRB determinations.
  •  Obtaining and documenting the informed consent of each subject or each subject’s legally authorized representative, unless the IRB has waived one or more of these requirements.
  •  Ensuring that each potential subject understands the nature of the research and participation.
  •  Providing a copy of the IRB-approved informed consent document to each subject or the subject’s legally authorized representative at the time of consent, unless the IRB has specifically waived this requirement.  All signed consent documents are to be retained for the longer of 3 years after the completion of the research or the life of the identifiable data unless a longer period is specified by University retention policy..
  •  Promptly reporting proposed changes in previously approved human subject research activities to the IRB.  The proposed changes may not be initiated without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects.
  • Reporting progress of approved research to the IRB as often as, and in the manner, prescribed by the IRB.
  • Promptly reporting to the IRB any unanticipated problems involving risks to subjects or others or any serious or continuing non-compliance with the HHS regulations or determination of the IRB.
  • Faculty and Student researchers maintain personal responsibility for research or related activities involving the use of human subjects that are conducted without the use of Georgia Southern time, resources and/or students and without the use of their Georgia Southern credential or affiliation.

• Membership will be consistent with the CFR, Title 45, Part 46, Section 46.107.   
  • The committee shall consist of at least five members with varying backgrounds.
  • Members are expected to have appropriate professional expertise, maturity, and experience to thoroughly review a variety of research activities conducted at Georgia Southern University.  They should also be sensitive to relevant professional standards, community attitudes and diversity, applicable laws, and institutional requirements.
  • All appointments are 12 month appointments; including potential for reviews during summer months regardless of teaching status.
  • Each member, including the chair, will maintain current documentation of approved training in the protection of human research subjects as a condition of service.
  • Members of the committee are appointed by the Institutional Official named by the President of the University.   The GS Institutional Official is the Provost and Vice President for Academic Affairs, who acts upon recommendations from the Director of the Office of Research Integrity in consultation discipline area Chairs and Deans.
  • The committee shall include a diverse mix of faculty from a similar mix of scholarship disciplines to the research reviewed by the Board.   The committee shall include at least one member whose primary concerns are in a non-scientific area and one member who is not affiliated with GS.  These roles may be held by the same person.
  • Georgia Southern faculty who serve on the IRB must be full-time tenure track faculty member.  Preference will be given to faculty who have 3 or more years of service to Georgia Southern (including service under the name of Armstrong States University) or equivalent experience at a similar institution.
  • The IRB Administrator will impanel and register individual boards as necessary to meet the needs of current research on GS campuses.    Each board will review expedited research via email. Full board studies will be reviewed by a committee meeting on Statesboro Campus with remote access from Armstrong Campus.  
  • The committee structure includes a primary member and alternate member appointed from each represented discipline. The appointed board members may serve as a primary member, responsible for full board attendance and expedited reviews, or an alternate member, responsible for expedited reviews and full board attendance in the absence of the primary member.  Members of each cohort may switch roles at the beginning of each semester by mutual agreement within the cohort and notification of the IRB administrator.  
  • Each committee shall have faculty leadership in the form of a committee Chair.  Associate chairs and Assistant chairs may be appointed to fully support the committee structure.  Chairs,Associate and Assistant chairs may be appointed to serve one or more committees simultaneously.
  • Members are appointed for a continuing term of at least 3 years. The term of service may be renewed.
    • Committee service renewal will be based upon the need of the committee for the discipline represented by the faculty member in conjunction with annual committee member productivity reviews and new faculty integration needs.
    •   Annual service letters will be provided to document service.
  • The current structure consists of the following:
    •   IRB-A: Social and Behavioral (00004564)
    •   IRB-B: Social and Behavioral (00007863)
    •   IRB-M: Medical (000101300)
  • Should any IRB member, including the chair, conduct himself/herself in a manner that disrupts the work of the IRB,  or calls into question his/her ethical or professional competence, or fails to conduct reviews and committee work in an equitably timely fashion,  that member may be removed from the IRB by the Chair in consultation with the IRB administrator. The IRB administrator will seek recommendations for a replacement member from the chair of the needed discipline.  

• The chair(s) and associate chair(s) of the Georgia Southern IRB will be appointed by the Provost upon the recommendation of the Office of Research Integrity.   Preference in appointment will be given to full professors.
• The chair must hold the doctoral degree, be a tenured member of the Georgia Southern faculty, and possess the professional competence necessary to review research activities, ascertain their acceptability in view of institutional commitments and regulations and applicable law as well as standards of professional conduct and practice.  The committee chair will be responsible in adverse event and non-compliance investigations, and complaint inquiries with the support of the IRB administrator.    The Chair will participate in IRB faculty training and IRB promotional events. Full professor status is preferred for this position.
• The IRB Associate-chair will be a Georgia Southern faculty member who holds a doctoral degree and is tenured.  This individual will have all associated responsibilities and obligations of the chair when the chair is unable to serve in that capacity or when the chair is an investigator on a research project being considered or reviewed by the IRB.  The duties and responsibilities of the Associate-chair include participation in all investigation and faculty training responsibilities of the Chair upon request.  The Associate chair will maintain the same as for any IRB member except when assuming an authorized role of the chair.
• Assistant Chairs will be appointed from the board membership to serve as support for the Chair and Associate chair.  Assistant chairs will be provided with additional training to support advancement to the Associate and Chair positions. The duties and responsibilities of the Assistant-chair are the same as for any IRB member except when acting in support of the Chair and Associate-chair

• The Institutional Official is the individual authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Assurance.  The GS Institutional Official is the Provost, and Vice President for Academic Affairs.
• Administratively, the Institutional Official is responsible for:
  • Designating one or more IRB’s that will review research covered by the institution’s Federal-wide Assurance.
  • Providing sufficient resources, space, and staff to support the IRB’s review and record keeping duties.
  • Providing training and educational opportunities for the IRB and investigators.
  • Setting the “tone” for an institutional culture of respect for human subjects;
  • Ensuring effective institution-wide communication and guidance on human subjects research;
  • Ensuring that investigators fulfill their responsibilities;
  • Providing support for enforcement of regulation, policy and procedure.
  • Encouraging all staff engaged in the conduct or oversight of human subject research participate in education activities;
  • Serving as a knowledgeable point of contact for OHRP, or delegating this responsibility to another appropriate individual.
• The Institutional Official can review or disapprove research approved by the IRB for institutional purposes.  However, institutional officials may not approve the conduct of human subject research that has not been approved by the IRB.  The Institutional Official may not intervene in or have input into the review or approval of any study before the IRB.

The University is responsible for:

• Ensuring that all institutions and investigators engaged in its human subject research operate under an appropriate OHRP-approved Assurance for the protection of human subjects.
• For all HHS-conducted or supported research, all of the requirements of the HHS Regulations at 45 CFR Part 46, Subpart A, as well as Subparts B through D, must be met.
• For FDA covered or supported research, all the requirements of 21 CFR Part 50 and Part 56 must be met.
• Developing policies and procedures for effective and efficient administration of a comprehensive Human Research Protections Program (HRPP).
• Ensuring that Assurances are in place and certifications of IRB review are submitted to the appropriate authorities for all HHS-sponsored research, not only for themselves, but also for collaborating performance sites for which the institution has agreed to accept oversight responsibility.
• Implementing appropriate oversight mechanisms to ensure compliance with HHS regulations and effective administration of the HRPP.
• The Institution bears full responsibility for all research involving human subjects covered under its Assurance.

• No member of the committee shall be involved in the initial review or any continuing review of an activity in which the member is a researcher, faculty adviser or a sponsor, except to provide information requested by the committee.
• The committee may invite individuals with competence in special areas to serve as non-voting reviewers when dealing with complex issues. Consultants will be asked to agree to maintain research and board deliberation confidentiality prior to access to the research application.
• A quorum shall consist of a majority of the committee’s membership consisting of ½ of the voting primary plus 1 and will include a non-scientific member. The IRB will conduct official business meetings only if a quorum is present. The IRB administrator and/or the community member serve as non-scientific members.
• The community member shall not have a current formal association with the institution.  Retirees and graduates must have a minimum of a 2 year separation prior to serving in this capacity.
• Alternate members of the board may serve in the absence of a primary member and will be considered to have the cohort vote for that meeting.
• Appropriate administrative assistance and support for IRB functions are provided by the University through the Office of Research Integrity.

• It is the responsibility of each IRB member, including alternate members, to disclose any conflict of interest in a study submitted to the IRB and recuse themselves from review of that protocol.  No member may participate in the discussion or review decision for a protocol in which the member has a conflict of interest, except to provide information or answer questions from the IRB as requested.  Recused members may not be present during a vote on that protocol.
• Definition for conflict of interest:  An IRB member is said to have a conflicting interest whenever that IRB member, or his/her spouse, domestic partner or first degree relative (e.g., child, sibling, or parent):
  • is an investigator or key personnel on the protocol under consideration;
  • acts as an officer or a director of the sponsor or an agent of the sponsor;
  • is involved in the research as a coordinator, protocol consultant and/or primary advisor;
  • has received any of the following from an entity whose financial interests would reasonably appear to be affected by the outcome of the research:
  • non-university salary or other payments for services (e.g., consulting fees or honoraria) exceeding $10,000 over a 12-month period;
  • equity interests (e.g., stocks, stock options or other ownership interests) exceeding $10,000 or 5% of the equity of the entity; or
  • intellectual property rights (e.g., patents, copyrights, royalties from such rights); or
  • has identified him/her self for any other reason as having a conflicting interest (e.g., having a close personal or professional association with the submitting investigator, serving as co-investigator and/or the primary mentor for a student or post doc investigator).

• Reserved