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3.1 Institutional Review Board Membership

Sinai Health System's IRB shall have sufficient expertise to review the broad variety of research in which SHS staff become involved, be knowledgeable about all relevant regulatory requirements, and make every effort to be impartial and objective in its reviews.

3.2 General Composition

The Chair/ Vice-Chair of the IRB will obtain recommendations from relevant Department Chair or Directors of SHS for appointments to the IRB. The IRB chair, with concurrence with MSH's President, will appoint IRB members to satisfy the following federal requirements (45 CFR 46.107, 38 CFR 16.107 and 21 CFR 56.107):

  • The IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by Sinai Health System.
  • The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
  • The IRB members shall possess the professional competence necessary to review specific research activities.
  • The members shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas.
  • If the IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
  • The IRB will make every nondiscriminatory effort to ensure that it does not consists entirely of men or entirely of women, including the consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender.
  • The IRB will not consist of entirely of members of one profession.
  • The IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
  • The IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
  • IRB must exclude members who participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
  • The IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB

3.3 Criteria for Membership

Criteria for membership include the willingness to serve, and familiarity with research design and procedures or other expertise that is relevant to the protection of human subjects. IRB members shall familiarize themselves with SHS' institutional commitments, mission statement, codes of professional conduct and practice. Please refer to section 3.2 for additional background on membership criteria.

3.4 Duration of Terms for Physicians/ Scientists

The physicians/scientist members will be appointed for a term of 2 years. The IRB Chair will review re-appointments and in concurrence with MSH's President, extend terms for 2 years.

3.5 Duration of Terms for Non-Scientist/ Community Member (s)

The Chair will appoint the non-scientist/community member (s) of the IRB for a term of an unspecified duration.

3.6 General Membership Responsibilities

IRB members are responsible for ensuring that the rights and welfare of research subjects are protected. IRB members will vote to approve, require modifications in (to secure approval), disapprove, or defer approval of research projects submitted to the IRB. Members are expected to attend IRB meetings (Refer to 2.18), review materials ahead of scheduled meetings, serve as general reviewers on all other research projects that are reviewed and discussed at convened meetings of the IRB. IRB members may also be asked to participate in ad hoc committees of the IRB to discuss and develop policies on various issues.

3.7 Appointment of IRB Chair, Co-Chair (s), Length of Service and Duties

The IRB Chair and vice-Chair (s) will be appointed by the President of Mount Sinai Hospital for a term of 2 years. Reappointment of chairs/ Vice-chairs will be reviewed at the end of the appointed terms. In the absence of the Chair, all duties of the Chair will be assumed by the Co-Chair(s).

  1. The Chair and Co-Chair (s) are expected to have the background and reputation that engenders respect from the IRB members, the IRB staff, investigators, research coordinators and SHS administration.
  2. The Chair and Co-Chair (s) are expected to have the leadership, management and interpersonal skills that allow them to be role models as well as fair and impartial leaders of the IRB.
  3. The Chair and Co-Chair (s) are expected to have an in depth understanding of the ethical issues, institutional policy, and federal, state and local regulations that are applicable to research that is reviewed by the IRB.
  4. The Chair and Co-Chair (s) will work with Sinai Health System's Research Institute to develop and implement research policies and projects, select educational/IRB software, and develop sound education programs for the SHS professionals engaged in research.
  5. The Chair and Co Chair (s) will report to the President of Mount Sinai Hospital and coordinate research initiatives with Sinai Research Institute Chair.
  6. When applicable, the Chair will seek guidance from the SHS legal department.
  7. The Chair will represent the the IRB in discussions with federal, state and local authorities
  8. The IRB Chair and will coordinate with Sinai Health Systems Research Institute Chair the IRB's annual operating budget and financial transactions.
  9. The Chair will seek guidance from the Office of Ethics and Compliance on issues requiring additional ethical guidance.
  10. The Chair will be responsible for directing the IRB administrative staff to ensure that the operation of the IRB is in compliance with all applicable regulatory requirements.
  11. The Chair will have primary responsibility for conducting the IRB meetings to ensure that they are efficient and effective.
  12. The Chair will be a full member of the IRB but will not vote.
  13. The Co-Chair (s) will be a full member (s) of the IRB and will vote.
  14. The Chair and Co-Chair (S) will assist the IRB administrative staff in drafting letters from the IRB to investigators regarding IRB decisions.
  15. The Chair and Co-Chair will work with IRB members, institutional officials, and investigators to ensure that the rights and welfare of research subjects are adequately protected.
  16. The Chair and Co-Chairs will be responsible for reviewing all research that can be categorized as "Expedited", all adverse events, and all advertisements.
  17. The Chair and Co-Chair (s) will be responsible for the preliminary review of new and continuing research
  18. The Chair and Co-Chair will be responsible for revisions, final reports, and applications of all new and continuing research, as well as revisions, and final reports subsequent to review by the IRB.
  19. The Chair and Co-Chair (s) will be responsible for composing the minutes to reflect the review of projects at convened meeting.
  20. The Chair or Co-Chair will sign official IRB correspondence; however, correspondence with regulatory authorities will be signed by the IRB Chair unless the correspondence is urgent and the Chair is not available.
  21. The Chair and Co-Chair (s) will select investigators whose research projects will be audited by external (or internal) auditors and, upon receipt of the final report from the auditors will review the audit reports of SHS research projects with the individual investigators.

3.8 Alternate IRB Members

The IRB Chair may nominate, and the President of Mount Sinai Hospital may appoint for two (2) years one or more alternate members to replace regular IRB members who are unable to attend convened meetings of the IRB. Alternate members will be listed on the IRB's official membership roster with an indication of which IRB member (s) the alternate is qualified to replace. Backgrounds of alternates should be similar to those they are designated to replace or they should be able to represent similar interests. Duties of alternates are the same as those of regular members. Alternate members may only vote in place of one of the designated members who is absent from a convened meeting (even though they may qualify to replace more than one absent member.)

3.9 Non-Voting and Ex-officio Guests at the IRB meetings

The IRB Chair and IRB staff who attend the IRB meeting will not vote. The Chair of Sinai Health System Research Institute will be designated ex-officio, non-voting and regularly attend IRB meetings.

3.10 Reporting of Membership to Office for Protection from Research Risks, National Institutes of Health, DHHS

A list of current IRB members must be submitted to the Office for Protection from Research Risks, National Institutes of Health, and DHHS. The Mount Sinai Hospital President's Office will have on file a copy of this list. (45 CFR 46.103 (3))

3.11 Consultants

On an as-needed basis the IRB may invite individuals with expertise in special areas to assist in the review of issues that require knowledge beyond or in addition to that available on the IRB. These individuals may not vote with the IRB 945 CFR 46.107 (f), 36 CFR 16.107 (f) and 21 CFR 56.107 (f):

3.12 Conflicts of Interest

IRB members may not participate in the initial or continuing review of any project in which the IRB member has a conflicting interest, other than provide information requested by the IRB (45 CFR 46.107 (e), 38 CFR 16.107 (e) and 21 CFR 56.107 (e)). Conflicts of interest include, but are not limited to being an investigator on the study under review or holding a financial interest in the study being reviewed. IRB members, including the Chair and co-Chair (s) are required to disclose such interests and must excuse themselves from deliberations, quorum counts and votes on the specific project. The IRB minutes will record those individuals as "absented", not as "abstentions."

3.13 Initial Training, Continuing Education and Professional Development of IRB Members

All new members of the IRB will be provided with an orientation session along with supporting educational materials. IRB members are expected to complete the National Institute of Health (http://cme.nci.nih.gov) web-based education course for researchers and SHS' web-based HIPAA training course. Thereafter, members are expected to remain current with changes in research practice and policy and participate in educational seminars sponsored by Sinai Health System's Research Institute.

3.14 Compensation for IRB members

Sinai Health System will not provide monetary compensation for service as an IRB member. However, due to the significant additional time commitment and responsibilities of the IRB Chair, he/she will be compensated for their IRB responsibilities.

3.15 Liability Coverage:

All members of the SHS will be covered under the Mount Sinai Hospitals Directors and Officers (D & O) Insurance policy for any legal action that may be brought against the committee.

3.16 Professional Support Staff

The IRB Coordinator will provide all necessary administrative support relating to record keeping, scheduling, and professional review of documentation for clarity and conformity to policies and procedures. (45 CFR 46.107; 21 CFR 56.107)

3.17 Attendance

Members who miss three (3) consecutive meetings without a reasonable excuse will be deemed to have resigned from the IRB.

3.18 Removal from the IRB

The Chair may terminate the appointment of any member or alternate of the IRB when it is demonstrated that the member or alternate violate any policy or procedure of the IRB particularly those policies relating to conflict of interest.