F. Duties and Responsibilities
While no regulation requires assignment of duties to specific parties, it is useful to all involved to understand who has primary responsibility for some duties.
1. Northeast Georgia Health System Administration
Provide meeting space, office space, supplies, and secretarial support as necessary to accomplish the tasks of the NGHS IRB.
45 CFR 46.103(b)(2)
Provide sufficient budget to meet IRB operational, educational and instructional needs.
45 CFR 46.103(b)(2)
Appoint an Institutional Review Board Coordinator to serve as an "Institutional Officer" as described in the National Institute of Health (NIH) and FDA regulations. This person is the lead contact person for the DHHS Office of Human Research Protections (OHRP).
45 CFR 46.103(c)
As needed, provide direction, guidance, information and support to the IRB
- Work to assure that IRB opinions are trusted and respected.
Appoint the IRB members from recommendations submitted by the established Board so as to provide
- A board with sufficient expertise, diversity, and independence to impartially review protocols, and
- A board that will offer diverse opinions about local conditions.
- Appoint the IRB chair from recommendations submitted by the established Board.
- e. Hear appeals from IRB decisions and complaints filed against it. IRB disapproval cannot be overturned by any other institutional entity.
2. IRB CoordinatorThe IRB coordinator:
- Is not a member of the IRB.
Supports and facilitates all IRB processes and will, at the least:
- Provide protocol materials to IRB members for review at least 7 days prior to a scheduled meeting,
- Generate minutes from each meeting for approval of the IRB and signature of the chair,
- Structure monthly "Standing Reports" for dissemination of information to the Board regarding activities that do not require full board action (e.g. Expedited Reviews; Facilitated Reviews; review activities of the National Cancer Institute’s Central Institutional Review Board (CIRB) in relation to active and inactive studies within the NGHS IRB’s jurisdiction).
Generate correspondence from each meeting and, as necessary, obtain the chair’s signature within the next five business days, and
21 CFR 56.109(e)
Provide courtesy notice to approved investigators regarding the impending expiration of IRB approval.
OPRR Reports 95-01
- Provides for communication(s) between researchers and members.
Receives inquiries from research participants regarding participation in the study and/or with complaints and has the authority to appropriately support the subjects.
45 CFR 46.116(a)(7)
- Maintains IRB files in conformance with regulatory requirements.
Compares revised ICDs to changes requested by the IRB at the time of Full Board Review, Facilitated Review or Expedited Review. When revised ICD reflects evidence of the requested change(s):
- Stamp the ICD with the date the NGHS IRB requested revisions were evident; and, notify the Principal Investigator that enrollment in study may begin or may be resumed.
- Stamp ICDs containing approved CIRB content with the date of CIRB approval and, as needed, stamp the ICD with the date NGHS IRB requested revisions were evident.
g. Report, via monthly Standing Reports, information related to CIRB: continuing reviews; non-local SAE reviews; and/or, amendment/modification reviews.
Exception: "Major Modifications", as defined by NGHS IRB, will be reviewed via Facilitated Review as stipulated in these policies and procedures (see Section III. C.3)
- In consultation with the IRB Chair, prepares the IRB annual report.
- Provides interpretation and application of federal regulations.
- Develops, implements and interprets policies and procedures.
- At least annually, reviews the materials sent to investigators (i.e. guidelines, forms, letters, etc.) for compliance with these Policies and Procedures and new regulatory or societal needs.
- Oversees compliance with federal regulations, state/local laws, institutional policy, and IRB procedures.
- Responds to regulatory agencies’ audits.
3. NGHS IRB
Conducts an objective and timely review of each study presented to it by making a decision to approve, request modifications, or disapprove each study presented.
45 CFR 46.109(a)
Uses the NGHS Operating Procedures, the criteria for review required by the FDA and DHHS, as well as, the ethical principles of the Belmont Report and the World Medical Association in considering decisions.
Determines if expert advice, not available among members, is required.
45 CFR 46.107(f)
Determines the date of continuing review at intervals appropriate to the degree of risk, but not to exceed an interval greater than once per year.
OPRR Reports 95-01
45 CFR 46.109(e)
- Per 21 CFR 812, determines if a device can be considered to be a non-significant risk device
4. IRB Chair
The Chair should be a known leader and a respected member of the community. The chair need not be a physician or an active member of the staff. The person appointed as chair should have time available to carry out the duties of the chair. Responsibilities include, but are not limited to:
- Presides at all meetings and conducts meetings in an orderly manner.
- Votes as an IRB member.
- Authorizes ‘Called Meetings’ as needed.
- Suspends studies when issues of non-compliance appear to place participants at risk.
- Conducts expedited and facilitated reviews, as defined in federal regulations, and exercises all of the authority of the IRB except disapproval.
- Designates one or more experienced reviewers, from among members of the IRB, to assist with expedited and facilitated reviews.
Meets and communicates with the IRB Coordinator on a regular basis to review/discuss reports, concerns, and activities; and, as necessary, to sign correspondence and reports of IRB action.
21 CFR 56.109(e)
5. IRB Member
- Regularly attends meetings. Should a member anticipate his/her absence, it is the member's responsibility to provide the IRB Coordinator with longest possible notice of inability to attend.
- Using all of one’s area of expertise, contributes to a thorough discussion of each agenda item.
- Considers the approval criteria offered in the regulations and the Belmont report.
- As designated by IRB Chair, conducts expedited and facilitated reviews, as defined in federal regulations, and exercises all of the authority of the IRB except disapproval.
- Maintains confidentiality regarding any information contained in any review. Members of the IRB should not communicate directly (outside the meeting situation) with sponsors or investigators about IRB deliberations except with the express permission of the chair.
Reveals any potential conflict of interest as soon as it is recognized. No member of the IRB may participate in an initial or continuing review of any project in which the member has conflict of interest, except to provide information to the IRB. A member with a conflict of interest must abstain from participation in deliberation and voting on that protocol.
45 CFR 46.107(e)
The Researcher/Investigator is the ultimate protector of the participant’s rights and safety. The investigator's responsibility for the study may not be delegated with impunity. Although duties may be delegated, the investigator is responsible for the conduct of the study.
Researchers/Investigators, at a minimum:
- Assume responsibility for compliance with all federal, state and institutional rules and regulations related to research involving human subjects and human subject-derived information and materials.
- Review and are very familiar with the content of each protocol submitted to the IRB; and, instruct the study staff and sub-investigators about it.
- When acting as Principal Investigator (PI) for a study, assure compliance with NGHS IRB requirements for attendance of IRB meeting at which the study is on the agenda for "Initial Review". (See ‘Section III.C.1 this document for additional details)
- Clarify billing/charging components of the study with the participant in the study and with the appropriate NGHS department(s).
- Obtain approval from other departments/committees that may be impacted/involved in a study prior to submission of a "Review Application" to the IRB Office.
- Provide the IRB with all of the information requested on all "Review Applications" (e.g. Initial Review; Continuing Review).
Conduct studies in conformance with the approved protocol.
21 CFR 312.60
Provide timely information to the IRB regarding:
21 CFR 312.66
All changes/modifications in research activity/protocol for IRB approval prior to implementation. (See ‘Section III. C. 4’ this document for additional information)
21 CFR 56.108(a)(3&4)
Upon completion of a study, a final summary of the study,
21 CFR 56.108(a)(3)
Continuing review, and
OPRR Reports 95-01
45 CFR 46.109(e)
Significant new information related to research activity.
21 CFR 56.109(c)
- Adverse events,
Accept responsibility for actions of sub-investigators and staff with regard to research related activities.
21 CFR 56.102(h)
Discuss issues of consent with the prospective participant in a manner so as to allow the person time and circumstances in which to reach as informed a position as possible.
21 CFR 50 and 45 CFR 46.116 and
Declaration of Helsinki
- Carefully weigh the welfare of individual participant’s needs against the needs of the protocol and places individual participant’s needs before the needs of the protocol.
- Report to the IRB on the outcome of any FDA clinical investigator audit regardless of whether the audit targeted a study reviewed by this IRB.
- Store investigational drugs in accordance with state law, NGHS policy, and protocol procedures.
7. IRB Relationships
Public Health Services (PHS) Funded Research
PHS grants are awarded to institutions rather than investigators. PHS funded research is regulated by the Common Rule found in 45 CFR 46. The recipient institution is responsible for assuring the DHHS Office of Human Research Protection (OHRP) that it maintains an appropriate program for subject protection.
- NGHS awards for research involving outside sites: This institution is responsible for negotiating an assurance and or determining that the external institution has its own human subject protection program.
- NGHS as a research site for awards made to other institutions: The NGHS Administration is authorized to sign an inter-institutional agreement on behalf of NGHS.
Authorized inspector(s) may inspect the IRB. Access will be allowed to those files pertinent to review of regulated activity.
The IRB Coordinator will respond to audits.
- FDA has the right to inspect all IRB’s reviewing studies of test articles and all clinical investigation sites.
- NGHS policy is that investigators should be instructed that all requests for inspections of research records are forwarded to the IRB Coordinator for consideration.
- Public Health Services (PHS) Funded Research
Medical Executive Committee (MEC)
The institution's MEC is, and continues to be, responsible for patient care issues.
Pharmacy and Therapeutics (P&T) Committee(s)
The Director of NGHS Pharmacy and/or designees will receive copies of approved minutes from the IRB’s monthly meetings that reflect the approved protocols using investigational drugs at NGHS. The P&T Committee will receive a report from The Director of NGHS Pharmacy and/or designees related to the IRB’s actions regarding investigational drugs approved for investigators at NGHS.
Radiation Safety Committee (RSC)
If the research involves administration of radioisotopes, approval the RSC must be received prior to final IRB approval.
- Medical Executive Committee (MEC)