THE CONDUCT OF HUMAN SUBJECT RESEARCH WITHOUT PRIOR REVIEW BY THE IRB

From time to time, the IRB is made aware of research using human subjects that is being conducted without IRB review and approval of the research protocol. The sources of this information and the procedures that are followed when such information becomes available are outlined below.

SOURCES OF INFORMATION AND DISPOSITION OF REPORTS

The IRB occasionally discovers that human subject research which has not been reviewed by the IRB is being conducted. Investigators may report to the IRB themselves about unapproved human subject research in which they are involved. Other reports are received from faculty, staff, subjects, and anonymous persons.

Reports may be oral or in writing and should include as much pertinent factual data as possible. Reports are transmitted immediately to the Director of the IRB (or to the IRB Chair in the Director's absence).

DETERMINATION OF ALLEGED INFRACTIONS OF INSTITUTIONAL POLICY

The Director of the IRB interviews the investigator to seek additional information to help determine whether or not an infraction of institutional rules has occurred. Emphasis in the interview is placed on fact finding.

If it is determined by the Director of the IRB that no infraction has occurred, no further action is taken.

If it is determined that an infraction has occurred, the investigator is notified in writing of the procedures he or she must follow to comply with institutional policy regarding the review of human subject research. The procedures are outlined below.

DOCUMENTATION AND REVIEW OF NON-APPROVED RESEARCH

Exempt Research (see Section F)

The investigator is required to suspend the exempt research and, if the investigator plans to continue the research to submit a protocol to the IRB within 7 days. If the research has been completed, or if the investigator does not plan to continue the research, the investigator is required to document as fully as possible the research that was conducted without IRB review. This documentation should include a description of the procedures that were followed, the number of subjects studied, and results of the study.

The department chair or the next higher level of administrative authority is notified of the above actions.

When an investigator wishes to continue the non-approved research, and a protocol has been received by the IRB, it is processed in the usual manner for exempt research.

Data collected prior to IRB approval will not be approved for publication or presentation purposes.

If the investigator fails to submit a protocol within the designated time, the IRB sends a written report, including a description of IRB actions, to the department chair or next higher level of administrative authority for appropriate action within 3 days. Failure of the department chair to act or comply, is reported to the President with a recommendation for appropriate actions.

Non-exempt Research (See Section F, Expedited and Full Board Review)

The investigator is required to suspend the research at once. If the investigator plans to continue the research, he or she must submit a complete protocol to the IRB within 7 days. If the research has been completed, or if the investigator does not plan to continue the research, the investigator is required to document as fully as possible the research that was conducted without IRB review. This documentation should include a description of the procedures that were followed, the number of subjects studied, and results of the study and submitted to the IRB within seven days.

If there is a question, because of increased risk to subjects, as to whether the research should be suspended pending completion of protocol submission and approval, the Director of the IRB counsels with the department chair and/or relevant experts. In case of failure to agree on suspension of the research, the determination of the Director of the IRB will be final.

The department chair or the next higher level of administrative authority is notified of the above actions.

When an investigator wishes to continue the non-approved research and a protocol has been received by the IRB, it is processed in the usual manner for non-exempt research. The minutes of the appropriate meeting of the IRB will indicate that the protocol was submitted as a result of determination by the IRB that the investigator had been conducting human subject research without IRB approval.

If the investigator fails to submit a protocol within the designated time, the IRB sends a written report, including a description of IRB actions, to the department chair or next higher level of administrative authority for appropriate action within 3 days. Failure of the department chair to act or comply, is reported to the President with a recommendation for appropriate actions.

Data collected prior to IRB approval will not be approved for publication or presentation purposes.

DETERMINATION OF AN ALLEGED REPEATED INFRACTION OF INSTITUTIONAL POLICY

The procedures outlined in "Determination of Alleged Infractions" above will apply for a repeated alleged infraction. If it is determined by the Director of the IRB that a second or additional infraction has occurred, the IRB promptly notifies the President and the department chair or next higher administrative authority in writing, with the recommendation that the investigator's privilege to do research be suspended at once, that the funding agency be notified of the suspension, and that unused funds be returned. It is also recommended that patients on therapeutic studies be changed to alternate therapy as soon as possible.