Full Board Review
Emory IRB Full Board Review Criteria
Unless otherwise determined to be either Expedited or Exempt research, all human subject research protocols conducted at Emory are reviewed by a fully convened Institutional Review Board. Emory currently has six different boards which meet to review biomedical studies and a board specifically for socio-behavioral research, as well as a board which reviews non-compliance matters. The IRB meeting schedule can be found here.
Each Full Board protocol is assigned two reviewers based on those reviewers' background and expertise. Additional input may be sought, or required, if the research involves any Federally recognized vulnerable populations (see 45 CFR 46 subparts B, C, and D). During the meeting of the convened board, the primary reviewer is responsible for presenting general information about the study, including:
- Study goal
- Study design
- Study procedures
- Safety procedures and considerations
- Qualifications of the Investigators
Following the presentation of the study and discussion of the study by the Board, any voting member may make a recommendation for one of the following motions:
- Approval: For studies which meet Federal and Institutional criteria for approval as laid out in 45 CFR 46.111, including:
- Risks to subjects are minimized
- There is an appropriate risk-to-benefit ratio
- The selection of subjects is equitable
- Appropriate procedures are followed for obtaining and documenting informed consent, or waiving or altering informed consent documentation or procedures
- The research plan has adequate provisions for monitoring the data collected in order to ensure subject safety
- Additional safeguards are included to protect the rights and welfare of any vulnerable populations involved in the research
- Approval Pending: For studies which otherwise meet the above criteria for approval, but for which minor changes are required before approval may be granted. These changes can include anything from minor alterations to the study design to requests for the Investigator to re-write or re-word certain study documents, the consent form, for example. If the Board agrees, review of the Investigator's response to these requested changes may be undertaken by a Designated Reviewer, expediting the process.
- Deferred: For research proposals which require substantive or complex changes, or additional information, before they meet approval criteria. The Board may vote to defer a final decision of approval or disapproval until the Investigators have had time to adequate respond the Board's concerns. Once the Investigator has responded, the study will again be reviewed by a fully convened IRB.
- Disapproval: If a study does not meet approval criteria, and the Board cannot see that a deferral would change the situation, the Board may vote to disapprove a proposed study. If disapproved, no proposed study procedures may take place, and the study may not be re-submitted for review.
- Tabled: If, due to a loss of quorum, or lack of time or expertise, the Board is unable to provide adequate review of a study, then the review may be postponed until another meeting.
For the IRB to pass any of these motions, a majority of the voting members must agree.
As part of the review process, the Board may need to consider additional factors of the study including:
- Vulnerable Populations as codified in 45 CFR 46 subparts B, C, and D
- Subpart B: Does the research involve pregnant women, fetuses, or neonates?
- Subpart C: Does the research use prisoners as subjects?
- Subpart D: Does the research involve children or wards?
- If so, additional consideration of the consent/assent process is required.
- What is the risk level of the study?
- More than minimal
- Certain studies may need to be reviewed more frequently than on an annual basis.
- Is their an IND or IDE?
- If there is an IDE, what is the risk level of the device?
Other considerations, such as Emergency or Compassionate Use of a device or drug, or IND/IDE exemption, or waivers of consent or documentation of consent, may also arise. Each study represents a particular set of goals and procedures which can lead to unique situations for the subjects, and questions for the IRB Members.