May 2005 JHM IRB Members It is the policy of the Organization to follow the Federal regulations, 45 CFR 46.107 and 21 CFR 56.107, that require the Institutional Review Board (IRB) to have at least five members. Those members shall have the following characteristics: - Varied backgrounds, including: professional expertise; diversity of race, gender, and culture; sensitivity to local community issues and attitudes.
- Ability to ascertain the acceptability of proposed research scientifically, and in terms of institutional commitments and policies, applicable law, and standards of professional conduct and practice.
- Expertise required to provide the IRB with information not only about specialized areas of research, but also about working with various types of research participants, including vulnerable populations.
At least one member of the IRB must have a primary interest in science; and at least one must have a primary interest that is nonscientific in nature. Each IRB must have at least one member who is not affiliated with Johns Hopkins and who is not part of the immediate family of someone who is affiliated with Johns Hopkins. Each JHM IRB that reviews studies involving investigational or marketed drugs, biologics, botanicals, complimentary or alternative medicines, or gene therapy, will have an appointed member from the Organization’s respective Pharmacy & Therapeutics (P&T) committees. The IO has the authority to appoint Chairs and co-Chairs of each IRB, the members and alternate members of the IRBs. The factors that the Vice Dean will consider for the leadership appointments (Chairs and co-Chairs) include: academic status and record of leadership, clinical expertise, willingness to commit the time required, experience with IRB and human research protection issues, administrative abilities, and personal capacity to listen and guide multiple opinions expressed in a meeting format. The IO will also take into account member expertise with NIH Study Section review of scientific merit, statistical design expertise, and protocol development expertise. The IRB members with scientific expertise will be selected in consultation with the IRB Chairs, Division and Department leadership, and the Dean of the Medical School. The IO will consider the range of scientific expertise required on the IRBs based upon the types of applications submitted. The non-scientific members will be selected based upon recommendations from current and former nonscientific IRB members. Any IRB member who has a conflict of interest with a matter under IRB review must recuse him or herself from consideration of that issue. The IRB may invite consultants with special expertise or experience in working with vulnerable populations to present information before the IRB or participate in meeting deliberations. Consultants may not vote with the IRB. The IO will periodically assess the performance of individual members, and will ask members to evaluate the performance of the Chairs and Co-Chairs. These assessments will be conducted by survey and by personal interview. Any adjustment in committee membership will be determined in the Spring of each year. Membership selection shall be nondiscriminatory such that no selection is made on the basis of gender. 45 CFR 46.107(b) OHSR Staff The OHSR staff shall include administrative personnel to manage the processing of the applications to the JHM IRB and managers to establish operating procedures to promote consistency and efficiency. The operations staff will be under the Director of Operations. The Director of Human Subject Research Compliance, with two Regulatory Affairs Specialists (with law degrees), will address regulatory compliance issues, develop policies and procedures, address subject and investigator complaints, and assist with FDA and DHHS inquiries and audits. |
