Convened Review

Convened Review

All research involving human subjects that does not qualify for Exempt or Expedited review is reviewed by the convened IRB. For example, convened review is required for all research that involves

  • greater than minimal risk
  • investigational drugs
  • investigational devices, or
  • prisoners.

All protocols approved by the convened IRB must be submitted for continuing review and approval, as described in Continuing Review & Approval. A final report is also required when the study has ended.

Investigators applying for convened review should become familiar with all sections of this guidebook and the requirements described in them.

Decision Trees

OHRP has published decision trees that are available online to help in determining whether a research proposal fits the criteria for review by the convened IRB.

Deadlines

Usually, the IRB meets each Wednesday. The OIRB posts an annual schedule of meeting dates and the corresponding deadlines on the IRB web site. All materials should be delivered to the OIRB by the time and date shown on the schedule. Please call the OIRB at 934-3789 if you need clarification for meeting and deadline dates around official UAB holidays.

IRB review will be scheduled on the basis of the date and time materials are received. Investigators are not required to attend meetings at which their protocols are reviewed; however, they may be asked to attend to answer questions from the IRB.  If an investigator wishes to attend the IRB meeting, he or she may contact the OIRB approximately 1 week before the meeting or after receiving the e-mail notification of when the protocol will be reviewed. For certain protocols, the IRB may contact the investigator to request that they attend or be available by telephone to answer questions from the IRB members.

Application Process

  1. Obtain the approvals that are required of all investigators (see "Before Applying for IRB Review" in General Information).
  2. Complete the Human Subjects Protocol (HSP), including any additional forms or special approvals that may be required (see Special Approvals). Each numbered item on the HSP requires a response. If an additional item or form is required, that requirement is noted on the HSP. Nevertheless, the following points deserve special mention:
    1. The HSP must indicate whether it is being submitted for convened or expedited review.
    2. The investigator's original signature is required—If the principal investigator is a student, resident, or fellow, include the name and e-mail address of the faculty advisor or course instructor and obtain his or her signature on the HSP.
    3. If the research receives any extramural funding, the HSP must include the OSP Assigned number, and the application must include a copy of the funding application as submitted to the sponsor. Any changes or updated to the funding application must be submitted to the IRB for review regarding the research protocol.
    4. The HSP must indicate whether children (i.e., anyone younger than 19) are eligible. If they are, the description of the informed consent process must include plans for obtaining and documenting the permission of one or both parent(s) and assent from the child-participant, unless a request for waiver is included. (See Children, Minors under "Participant Populations" in General Information, and Informed Consent.) The Special Population Review Form—Children is required and contains more information on consent and assent.
  3. Develop an informed consent process and document that comply with the applicable requirements. (See Informed Consent, and "Participant Populations" in General Information.) The HSP must indicate whether (a) informed consent will be obtained, (b) informed consent will be documented, and/or (c) the investigator requests a waiver or alteration of these or other requirements.
    1. If informed consent will be obtained, include a copy of any form, script, or other materials used in the process.
    2. If informed consent will be documented, include a copy of the document(s) with the most recent revision date.
    3. If informed consent will not be obtained, will not contain all of the required elements, or will not be documented, include the applicable form(s) for waiver: Waiver of Consent, Waiver of Authorization and Informed Consent, and/or Waiver of Informed Consent Documentation.
  4. Include the Protocol Oversight Review Form or IRB-approved equivalent with the appropriate original signatures (see "Before Applying for IRB Review" in General Information). Refer to the departmental review process in the department of the principal investigator's primary appointment.
  5. Include all additional items required by the nature of the protocol, as applicable:
    1. Materials used for recruitment
    2. Documentation of special approvals
    3. Special Population Review Form(s)
    4. Sponsor's protocol
    5. Funding application submitted to sponsor
    6. NIH-approved informed consent document
    7. Completed Form FDA 1572 as submitted to sponsor
    8. Documentation of IRB approval from all other sites engaged in research for the protocol
    9. Verification of Notification of Proposed Research for protocol-related performance sites
    10. Documentation/verification of the sponsor's injury compensation statement
    11. Industry-Sponsored Billing Information Form for industry-sponsored gene therapy/transfer studies, which are usually reviewed by UAB IRB and not by WIRB.

Page updated: May 8, 2013