Expedited Review of Human Subjects Research- POL020
| Review/Revised Date: 1/21/2019
Policy Owner: Vice President for Research
| |
DEFINITIONS
Minimal risk means 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.
POLICY STATEMENT
The UAB IRB will review qualified human subject research using expedited procedures in accordance with federal regulations. An expedited procedure refers to review of research involving human subjects by the IRB Chair or by one or more experienced IRB reviewers designated by the Chair from among members of the IRB in accordance with PRO104 Procedure for Qualifications and Composition of IRBs and OIRB Staff, and with 45
Some or all of the research appearing in the “Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review” published by the Department of Health and Human Services (DHHS) and the reviewer finds that:
- The research involves no more than minimal risk.
- The research is not “classified” research.
- The identification of the participants or their responses will not reasonably place them at risk of criminal or civil liability or be damaging to their 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.
Minor changes in previously approved research during the period (of 1 year or less) for which approval is authorized.
Limited IRB review is relevant to certain exemptions (Categories 2, 3, 7, and 8). The IRB will use the expedited review procedure to review research where limited review is a condition of exemption. The expedited review procedure will apply to IRB applications for initial review, continuing review, minor modifications of previously approved research, and where limited review is a condition of exemption, and expedited status update (ESU), as appropriate. (See also PRO120 Procedure for Initial Review Using the Expedited Process; PRO150 Procedure for Continuing Review of Research by the Expedited Process; PRO148 Procedure for Review of Modifications to Previously Approved Research by the Convened IRB.) A reviewer using expedited procedures will exercise all authorities granted to the IRB except the reviewer may not disapprove the research. If the reviewer cannot approve the research (with or without modifications to secure approval) using expedited procedures, (s)he will refer it to the convened IRB for review. The requirements for informed consent process or for altering or waiving the requirement for informed consent process apply to non-exempt research reviewed under the expedited procedure. Also, consultants may assist the IRB in review of research undergoing expedited review. Research approved using expedited procedures will undergo continuing review at intervals appropriate to the degree of risk unless it no longer meets the regulatory criteria.
Research approved initially via convened IRB review may later qualify for expedited review. This may occur if the reviewer finds that:
Limited IRB review is relevant to certain exemptions (Categories 2, 3, 7, and 8). The IRB will use the expedited review procedure to review research where limited review is a condition of exemption. The expedited review procedure will apply to IRB applications for initial review, continuing review, minor modifications of previously approved research, and where limited review is a condition of exemption, and expedited status update (ESU), as appropriate. (See also PRO120 Procedure for Initial Review Using the Expedited Process; PRO150 Procedure for Continuing Review of Research by the Expedited Process; PRO148 Procedure for Review of Modifications to Previously Approved Research by the Convened IRB.) A reviewer using expedited procedures will exercise all authorities granted to the IRB except the reviewer may not disapprove the research. If the reviewer cannot approve the research (with or without modifications to secure approval) using expedited procedures, (s)he will refer it to the convened IRB for review. The requirements for informed consent process or for altering or waiving the requirement for informed consent process apply to non-exempt research reviewed under the expedited procedure. Also, consultants may assist the IRB in review of research undergoing expedited review. Research approved using expedited procedures will undergo continuing review at intervals appropriate to the degree of risk unless it no longer meets the regulatory criteria.
Research approved initially via convened IRB review may later qualify for expedited review. This may occur if the reviewer finds that:
- The research involves no more than minimal risk.
- The research is not “classified” research.
- The identification of the participants or their responses will not reasonably place them at risk of criminal or civil liability or be damaging to their 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.
And
- The research is permanently closed to enrollment of new subjects, all subjects have completed all research-related interventions, and the research remains open only for long-term follow-up of subjects. Such determinations will be documented in the expedited review procedure;
- All remaining research activities are limited to data analysis. Such determinations will be documented in the expedited review procedure; or
- The convened IRB determines that the research involves no greater than minimal risk and that no additional risks have been identified. Such determinations will be documented in the minutes.
Or
- The research is not “classified,” and
- Where no subjects have been enrolled and no additional risks have been identified.
A list of actions taken through expedited review procedures will be provided to the convened IRB. Upon such requests, the research will be reviewed by the convened IRB. The expedited procedures will not apply to research involving prisoners.