September 2025

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 an Institutional Review Board (IRB) to have at least five members.  Membership appointments shall be made to incorporate the following regulatory requirements:

•  Varied backgrounds, including: professional expertise; diversity of race, gender, and culture; sensitivity to local community issues and attitudes.
• Expertise required to provide relevant information and context for specialized areas of research and experience in working with various types of research participants, including vulnerable populations.
• An individual with a primary interest in science.
• An individual with a primary interest that is nonscientific in nature.
• At least one member who is not affiliated with Johns Hopkins Medicine (JHM) and who is not part of the immediate family of someone who is affiliated with JHM.

A JHM IRB that reviews studies involving investigational or marketed drugs, biologics, botanicals, complimentary or alternative medicines, or gene transfer will have an appointed member from the Organization’s respective Pharmacy & Therapeutics (P&T) committees.  When the appointed P&T member is unable to attend an IRB meeting, the IRB will request the attendance of or a written consult from a P&T/IRB member from another JHM IRB.

JHM IRBs shall also include a member who has an appointment on the Berman Institute of Bioethics.  This member’s attendance is not necessary for the purposes of attaining a quorum for convened IRB meetings.

The Institutional Official (IO) has the authority to appoint all members and alternate members of the JHM IRBs.  The factors that the IO will consider for the IRB leadership appointments at the Chair and Co-Chair level include: academic status and record of leadership, clinical or research 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 and may include input from Division and Department leadership and the Dean of the School of Medicine as appropriate.  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 non-scientific IRB members or from the broader research community. Individuals responsible for business development – the raising of funds or the garnering of support for research on behalf of the Institution – may not serve as members of a JHM IRB or be involved in its daily operations. As part of the formal member appointment process, a copy of the resume or CV for the prospective member is provided to the IO for review to establish that the candidate has adequate professional experience. Additionally, each candidate has a meeting with the IO prior to formal appointment to determine their capacity and professional competence to serve as an IRB member in their designated role.

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.  Conflict of interest shall be defined in accord with JHU policy and shall include for JHM IRB members:

• Involvement in the design, conduct, or reporting of the research other than being an investigator or co-investigator, and
• Involvement of immediate family members in the design, conduct, or reporting of the research other than being a principal investigator.

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.  If consultants are invited to provide information to the IRB, they may not serve in this capacity if they have a conflict of interest.  Conflict of interest shall be defined in the same manner as that for IRB members. 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 IRB member evaluation surveys.  After review of the IRB member evaluation surveys, the IO and Associate Dean for Human Research Protections will provide feedback to the IRB Chairs/Co-Chairs on evaluation results at a meeting of the IRB Chairs and the Chairs will share evaluation results with IRB members at a Board meeting.  Individual performance meetings will be held in the event of any significant issues relating to the performance of individual committee members or Chairs/Co-Chairs and may include the IRB Chairs, Associate Dean for Human Research Protections and IO as needed.  Any adjustment in membership will be determined in the Spring of each year and as otherwise necessary.

At a minimum, one nurse of the Johns Hopkins Health System will be appointed to a JHM IRB.

Office of Human Subjects Research (OHSR) Staff

Staffing levels for the OHSR are determined by the IO and the OHSR is overseen by the Associate Dean for Human Research Protection and Director of the Human Research Protection Program.  OHSR staff shall include administrative personnel (pre- and post-team coordinators and analysts) to process applications to the JHM IRBs, consent form specialists, human research compliance associates, research compliance monitors, and supervisory staff charged with ensuring consistency and efficiency in operations and compliance.  Personnel in the Johns Hopkins All Children’s Hospital OHSR, which will be primarily responsible for administration of the JHM ACH IRB, will have a direct reporting relationship to the Associate Dean for Human Research Protections and Director of the Human Research Protections Program.