C. IRB Determinations Requiring Reporting

The following policy outlines the procedure for reporting to the appropriate institutional departments and offices, the institutional official, sponsors, and/or the appropriate regulatory agencies of events determined by the IRB to be:

Following an IRB determination of suspension or termination of research, noncompliance investigations, and UPIRTSOs), a full board Human Subjects Office staff member in collaboration with the IRB Chair prepares a letter for signature by the IRB Chair(s) that contains the following information:

1. The nature of the event (whether or not the event was an unanticipated problem involving risks to subjects or others, serious or continuing non-compliance, or a suspension or termination of approval of research or a combination of these events),
2. The name of the institution conducting the research,
3. The title of the research project and/or grant proposal in which the problem occurred,
4. The name of the Principal Investigator on the protocol,
5. The IRB number assigned to the research project and the number of any applicable federal award(s) such as grants, contracts, or cooperative agreements,
6. A short summary of the project,
7. A detailed description of the problem including the findings of the organization and the reasons for the IRB’s decision,
8. Actions the institution is taking or plans to take to address the problem (e.g. revise the protocol, suspend subject enrollment, terminate the research, revise the informed consent document, inform enrolled subjects, increase monitoring of subjects, increase IRB monitoring of the project, etc.),
9. Plans, if any, for any follow-up action

A full board Human Subjects Office staff member sends a copy of this letter no more than one month following the review and final determination by the convened IRB to:

1. The University of Iowa Institutional Official (Office of the Vice President for Research and Economic Development),
2. Principal Investigator,
3. Division of Sponsored Programs (if applicable)
4. Departmental Executive Officer (Departmental Executive Officer) of the Principal Investigator,
5. Dean of the College of the Principal Investigator,
6. Research Integrity Officer (RIO) if the event involved research misconduct

The letter is also sent to the following federal agencies (as applicable):

1. Office for Human Research Protections, if the study is subject to Department of Health and Human Services regulations or subject to a Department of Health and Human Services Federalwide assurance,
2. Food and Drug Administration, if the study is subject to Food and Drug Administration regulations (21 CFR 50 and 56)
3. If the study is conducted or funded by any Federal Agency other than Department of Health and Human Services that is subject to “The Common Rule”, the report is sent to Office for Human Research Protections or the head of the agency as required by the agency.

For VA Studies reports are also sent to:

1. Office of Research and Development
2. Regional VA Office of Research Oversight
3. VA Privacy Officer, when the report involves unauthorized use, loss, or disclosure of individually identifiable private information
4. VHA Information Security Officer when the report involves violations of VA information security requirements.

Reporting to a regulatory agency does not occur if the event occurred at a site that was not subject to the direct oversight of the organization, and the agency has been notified of the event by the investigator, sponsor, another organization, or other mechanisms.  The Human Subjects Office Assistant Director can provide copies to others as deemed appropriate by the Institutional Official.

For studies reviewed by Western Institutional Review Board, events of serious or continuing noncompliance are reported directly to Western Institutional Review Board and reporting is the responsibility of Western Institutional Review Board.  Reporting of suspensions or terminations made by Western Institutional Review Board are the responsibility of Western Institutional Review Board.  For studies reviewed by Western Institutional Review Board, unanticipated problems involving risks to subjects or others are reported directly to Western Institutional Review Board and reporting is the responsibility of Western Institutional Review Board.  For studies reviewed by Western Institutional Review Board, unanticipated problems involving risks to subjects or others are reported directly to Western Institutional Review Board and reporting is the responsibility of Western Institutional Review Board.