Expedited Review Process
Expedited Review Process
An Expedited Review is conducted by RIC and at least 1 experienced IRB member designated by RIC or IRB chairperson to conduct the review. The IRB member conducting the Expedited Review may exercise all of the authorities of the IRB except that the reviewer may not disapprove the research. The reviewer shall refer any research protocol, which the reviewer would have disapproved to IRB for Full Board Review. The reviewer may also refer other research protocols to the IRB for Full Board Review whenever the reviewer believes it warrants.
Once the review process is complete, a letter will be sent to the researcher notifying him/her of the result of the Expedited Review. The letter will include the specific category of review and expiration date. In addition, at the next convened IRB meeting, RIC will inform IRB members of research protocols, which have undergone an Expedited Review. A vote to approve the studies will be taken. Any member may request a study be reviewed by the IRB in accordance with Full Board Review procedures. A vote of the members shall be taken concerning the request and the majority shall decide the issue.
Ongoing IRB oversight is required for projects that undergo an Expedited Review. Any changes to a study require submission of an Amendment for IRB review and approval prior to implementing changes. Researchers of Expedited studies must submit a Continuing Review (Renewal) prior to the expiration date issued by the IRB. Any occurrence of an Unanticipated or Adverse Event must be promptly reported to the IRB.
Expedited Review Categories
Expedited review is applicable for research activities that involve no more than minimal risk to the human participants and fall into one or more of the nine expedited categories defined by the federal regulations.
Clinical studies of drugs and medical devices only when condition (a) or (b) is met:
- Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
- Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
Examples of Commonly Expedited Research
The following types of research are commonly processed under Expedited Review:
- Studies involving the collection of identifiable information in surveys, interviews, or focus groups
- Studies involving collection of hair or saliva samples
- Studies of blood samples from healthy volunteers
- Studies involving the analyses of voice recordings
- Studies of existing pathological specimens or data with patient identifiers
The expedited review procedure cannot be used in the following circumstance:
- Where identification of the participants and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.