Expedited review is for research activities that involve no more than minimal risk to human subjects and fall into designated categories. The Code of Federal Regulations [45 CFR 46.102(l)] defines minimal risk as meaning that “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
Examples of research that may be reviewed by expedited review include (but are not limited to):
- The collection of data through non-invasive procedures.
- Research on individual or group behavior characteristics.
- The collection of data from voice, video, or imaging recording made for research purposes.
- Minor changes in previously approved research during the approval period.
- Continuing review in certain circumstances.
In an expedited review, the standard requirements for informed consent and continuing review still apply. The reviewer, who is either the IRB Chairperson or his/her designee, may exercise all of the authorities of the IRB except that s/he may not disapprove the research; ‘proposed disapprovals’ will be referred to the full board for review and disposition. Additionally, the full IRB must be notified of all protocols approved using the expedited review process, and thus the full IRB has the authority to question any approval granted.
The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ 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. In addition, the expedited review procedure may not be used for classified research involving human subjects or for research involving prisoners, as noted below.
To apply for an expedited review, the investigator must submit a complete application, including supporting documentation such as:
- Consent forms;
- Recruitment materials;
- Surveys or interview questions;
- Application for Expedited Review;
- Supplemental applications, if the research involves a vulnerable population.
Expedited review applications are accepted whenever an investigator submits them and are reviewed outside of the regular IRB meeting time.
Research Involving Prisoners
Expedited Review will not be conducted for the initial review of research involving prisoners.
Expedited Review will not be conducted for continuing review unless the following conditions exist:
- Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
- Where no subjects have been enrolled and no additional risks have been identified; or
- Where the remaining research activities are limited to data analysis.