A full review of proposed research shall take place at convened meetings at which one-third, or seven (7) of the members of the IRB one of whom must be non-scientist must be present. In order to approve research, the IRB shall determine that all criteria for approval are satisfied. In order for the research to be approved, it shall receive the approval of a majority of the members present at the meeting. Most research follows the full review and approval process.
Expedited review allows Wofford College to use an abbreviated review procedure for research proposals and teaching involving human subjects. To qualify for expedited review, two criteria must be met.
For example: An audio tape on which subjects are asked to speak common words for the purpose of measuring voice timber would qualify for expedited review. A tape of a therapy session with a patient would not qualify for expedited review. Although the research involved an audio tape, the sensitive nature of the contents would require a full review.
Additionally, expedited review may be used when there are minor changes in previously approved research during the period (one year or less) for which approval is authorized.
The IRB will have responsibility for determining what does or does not meet the criteria for expedited review. Expedited review may be carried out by the IRB Chair or by one or more reviewers designated by the Chair from among members of the IRB. When conducting an expedited review, IRB members may exercise all of the authorities of the IRB, except that the reviewer(s) may not disapprove the research. A research activity may be disapproved only after a full IRB review has been conducted.
All IRB members must be advised of research proposals that have been approved using expedited procedures at the next regularly scheduled meeting.
Continuing review of research must be conducted at intervals appropriate to the degree of risk, but not less than once per year. The IRB cannot approve a research project for more than 12 months. All reviews for continuation will be conducted by expedited review, if no changes have been made to the research protocol and no adverse or unexpected reactions or side effects have occurred or are expected. (However, the full IRB will be given the opportunity to review the continuation/renewal report.) In all other instances, continuing review will be conducted by the full IRB.
If the investigator, during the course of conducting the research, revises the research protocol (e.g., makes changes to the informed consent form, survey instruments used, or number and nature of subjects), the principal investigator will notify the IRB Chair immediately. The Chair will determine the need for additional review, the type of review full or expedited and notify the IRB members.
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