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1. What is convened IRB review?
2. How are new applications assigned for review?
3. Do changes in research require convened review?
4. What action may the IRB take at a convened meeting?
5. Can institutional officials disapprove IRB approved research?
6. If a project is disapproved by an IRB, is there an institutional appeal process?
In accordance with DHHS regulations 45 CFR Part 46 and FDA regulations CFR Title 21 Part 56, convened IRB review is required for the majority of new applications submitted to the JHM IRBs. A convened meeting is one at which a majority of members must be present, including a member whose primary concern is in a non-scientific area, before official actions may be taken. In order for the research application to be approved, it must receive approval of a majority of those members present at the meeting. The processing time for a protocol requiring convened review varies, depending upon how complete the application is at submission. The minimum amount of time to process an application is three to four weeks.
Staff assign applications to an IRB for review by either a convened process or an expedited review process (See the IRB website section on expedited review process. New applications that require convened review are scheduled for review as agenda workload allows; therefore, a deadline for submission does not exist. Once assigned to a convened review process, the application is scheduled for discussion. The principal investigator may, at the discretion of the IRB, be asked to attend the convened meeting to facilitate discussion. Each of the JHM IRBs, except for JHM ACH IRB, has convened meetings weekly, with few exceptions, such as cancellation due to University holidays or inclement weather. The JHM ACH IRB meets once a month.
The review will address all the criteria listed in DHHS regulations 45 CFR 46.111 and FDA regulations 21 CFR 56.111: that risks to subjects are minimized through sound research design and are reasonable in relation to anticipated benefits and knowledge gained; that the selection of subjects is equitable such that no population or subpopulation bear an imbalance of the burden of research or enjoy an inequitable share of the benefits; that the informed consent process and documentation plan is appropriate; that the safety of the study is protected by an appropriate plan and monitored by an independent party, if needed; that the privacy of subjects and the confidentiality of study data is protected; and that adequate protections are in place for vulnerable populations. The IRB will evaluate whether resources are adequate to protect participant’s rights and welfare.
Changes in research represent either minor changes or major changes. If a change is categorized as a major change, convened review will be required. See IRB website guidance on changes in research for details on major and minor changes.
The IRB may act on an application in one of four ways:
- The application may be approved;
- The application may be approved with administrative changes that must be completed by the PI;
- The application may be tabled pending submission of revisions; or
- The application may be disapproved.
After an application is approved, no changes, amendments, or addenda may be made without re-review and approval by the IRB unless there is an emergent need to protect participant safety (See guidance on changes in research for information on this exception). Written notification of actions taken at the convened meeting is provided to the PI. Attached to the standard approval notice is the final approved version of the consent form(s). The approval date for the application and consent forms is specified by the IRB, and approval will expire at the end of the stated dates. If a consent form is revised in association with an interim review, it is valid only until the original approval date for the project expires.
An application approved by the IRB may be subject to further review and approval or disapproval by officials of Johns Hopkins Medicine, JHU, JHU School of Nursing, or the Kennedy Krieger Institute.
In cases where the IRB disapproves an application, the IRB will provide its rationale for the action taken. The investigator may request an appearance before the IRB to present arguments for reversal of the decision. If an application is disapproved, a new application should be submitted, including proposed changes based on the advice of the IRB.
Institutional officials cannot approve a protocol that has been disapproved by the IRB. EFFECTIVELY, THEREFORE, THERE IS NO POSSIBILITY OF APPEAL OF IRB DISAPPROVAL TO A HIGHER UNIVERSITY, HOSPITAL, OR KENNEDY KREIGER INSTITUTE LEVEL.