The IRB is a committee of Cone Health and is responsible to the President, Chief Executive Officer the governing Board of Trustees of Health System. Because the IRB functions under Federal guidelines, it is also subject to advice and review from OHRP and FDA. As noted above, the IRB is organizationally located in the Office of Research Support, on the main campus of Moses Cone Hospital, and is directed by the Medical Director of the Heart and Vascular Center, who also serves as the IRB Chair and Human Protections Administrator for the Health System.
Members Of The IRB
The IRB is currently composed of 21 members and 3 alternates with varying backgrounds. The IRB Board appoints one member to serve as Chair and another of its members as Co-Chair to serve in the Chair's absence. The Chair may accept recommendations from the IRB members to fill vacated positions.
Term of appointment is for three years and is entirely voluntary and without compensation. A member may continue to serve longer than three years if desired, or may vacate a position at any time and for any reason, such as scheduling conflicts, press of occupational obligations, etc. The Health System remains grateful for the service of IRB members, and long service is especially appreciated and valued, reflecting as it does strong commitment to human rights protections.
The Health System provides support staff for the IRB who manage applications for research review, preparation for meetings, recording of minutes and record keeping. Records are kept in accordance with all institutional, State and Federal requirements for IRBs and are available for review by any authorized agency and for reports as may be required or necessary.
Membership Requirements and Qualifications
Members are chosen to be broadly reflective of the community, including representation of the health professions at Cone Health and the affiliated hospitals, but also to reflect representation from non-clinical and non-scientific fields demonstrating gender and cultural/ethnic/racial diversity. The following specifics of member selection shall be satisfied:
- The members shall be sufficiently qualified through experience, expertise, diversity of background, including gender and cultural diversity to be sensitive to community attitudes and cultures so as to promote respect for the IRB's advice and counsel in safeguarding the rights and welfare of human subjects.
- The IRB shall include members of more than one profession.
- The IRB shall include at least two members with expertise in non-scientific areas (law, ethics, religion, etc.).
- The IRB shall include at least two members who are not otherwise associated with Cone Health.
- Additional members may be appointed from time to time as may be deemed necessary to represent new and important constituencies in the community.
- The names and earned degrees of the members of the IRB shall be provided to OHRP. An updated roster shall be provided to OHRP when changes in membership occur.
- Because a quorum is essential at each Board meeting, a member who becomes unable to attend at least 50% of the regular meeting in a year will be asked to rotate off the Board.
Conflicting Interest: U.S. Department of Health and Human Service (HHS) regulations [45 CFR 46.107(e)] stipulate that no IRB member may participate in the IRB’s initial or continuing review of a project in which the member has a conflicting interest, except to provide information requested by the IRB. Except when requested by the IRB to be present to provide information, IRB members will remove themselves from the meeting room when the IRB reviews research in which they have a conflicting interest, and such will be noted in the meeting minutes.
*The PI & Study Coordinator will remain present during voting at the discretion of the IRB
Consultants to the IRBs
The IRB may request the presence and advice of the Principal Investigator, co-investigator or a representative colleague, (or others at the discretion of the IRB) as consultants at meetings to assist in research review. Such consultants are not IRB members and may not vote. Depending on circumstances and requirements of various agencies, consultants may be asked to absent themselves during IRB deliberations and voting on a research protocol being reviewed.
Member Education and Training
Educational materials and references, both printed and electronic will be provided to members of the IRBs from time to time at regular meetings or at special educational sessions. Members are encouraged to become familiar with OHRP’s website (www.hhs.gov/ohrp/) and to take advantage of the educational materials and training modules located there. The Office of Research Support can provide copies of many of these materials to members who may not have access to the Internet. In addition, the Office of Research Support will provide Board members with educational materials and activities at regular meetings and at periodic special sessions to which other interested individuals (investigators, research staff, etc.) may be invited.
Requirements for Investigators
Requirements for Investigators: Any investigator who expects to involve human subjects in a research protocol within Cone Health, its various divisions, departments and units must submit the completed proposal for such research to the Health System’s Institutional Review Board (IRB)--the Committee for Human Research Protections--for review and approval before initiating the project. Investigators must conform to the following requirements:
- It is a requirement of Cone Health IRB, that the Principal Investigator or Sub-Investigator be in attendance to present protocols at Full Board committee
- Review the IRB Procedure Manual
- Review and understand the “Information for Principal Investigators,” which includes the “Instructions for Completing the Application for IRB Review and Approval of a Research Proposal.”
- Complete the Application according to the instructions.
- The IRB requires Principal Investigators, sub-investigators and any member of the investigative team who enroll patients into a protocol to have completed one of the available educational modules prior to submitting a protocol for review. These modules are available through the websites of either the Office of Human Research Protections (www.hhs.gov/ohrp/) or the National Institutes of Health. Upon request, the Principal Investigator, sub-investigator, or investigative designee must then provide the IRB with copies of all certificates, which can be printed out after completion of the module.
Fees For Reviews By The IRB
The Office of Research Support will establish a schedule of charges to be paid by investigators or their sponsors for IRB reviews when the investigator is financially supported by private industry. Investigators performing research sponsored by the NIH and subsidiary agencies (e.g., NCI, CALGB, CCOP, SCCC) or who receive no outside support for their research will not be charged. Charge detail is provided in the Principal Investigator Application Form, Section VII. Research supports that the IRB fees are compatible with that of other research institutions.