1. Federal Regulations Require That the Following Are Promptly Reported

IRB External Reporting #210

PURPOSE

The purpose of this policy is to outline the steps to be taken by AMITA Health and its Institutional Review Board (IRB) to determine if an event is reportable to federal agencies and others and, if reportable, the requirements of filing such a report.

POLICY

1. Federal regulations require that the following are promptly reported:

1.1 Any unanticipated problems that involve risks to subjects or others;

1.2 Any serious or continuing noncompliance with regulations or the requirements of the Institutional Review Board (IRB); or

1.3 Any suspension or termination of IRB approval.

2. It is the responsibility of the IRB Chairperson to provide prompt written notification of any unanticipated problems involving risks to subjects or others, any serious or continued noncompliance, or any suspensions or terminations of IRB approval to the President and CEO and affiliate institutions.

3. In the event IRB approval of a research study is suspended or terminated, the President and CEO will be responsible for the notification of the relevant Federal agencies, sponsors, and other affected AMITA Health facilities and/or departments (see section 6. below).

4. In terms of unanticipated problems involving risks to subjects or others and/or any serious or continuing noncompliance with regulations or the requirements of the IRB, the President and CEO, in consultation with the Director of Compliance and IRB Chairperson will determine if an event is reportable and submit any report on behalf of AMITA Health.

4.1 For a more serious event, the goal is to submit the initial report within 5 working days.

4.2 For a less serious event, the goal is to submit the initial report within two weeks.

4.3 It may be appropriate to send an initial report, and indicate that a follow-up or final report will be followed by the earlier of:

4.3.1 A specific date; or

4.3.2 When an investigation has been completed or a corrective action plan has been implemented.

5. The following information will be included with each reportable event:

5.1 Name of the institution;

5.2 Title of the study and/or grant proposal in which the problem occurred;

5.3 Name of the principal investigator;

5.4 Number of the study assigned by the IRB and the number of any applicable federal award(s) (e.g., grant, contract or cooperative agreement);

5.5 A detailed description of the problem; and

5.6 Actions AMITA Health is taking or plans to take to address the problem.

6. A copy of the report will be shared with government agencies and sponsors to the extent legally and contractually required, and with any others as deemed appropriate by the President and CEO, in conjunction with the Compliance Officer and IRB Chairperson. Possible recipients include:

6.1 Office of Human Research Protections (OHRP) if the study is federally funded and subject to regulation by OHRP;

6.2 Food and Drug Administration (FDA) when the research is subject to regulation by the FDA;

6.3 Funding agency when funded by a government entity (e.g., the Departments of Defense, Education, and Justice);

6.4 Licensing and accrediting bodies, where the report or some portion thereof implicates standards or regulations administered by those bodies;

6.5 Any other external sponsor, when the research is sponsored;

6.6 Principal investigator;

6.7 Other AMITA Health facilities and departments who require notification (e.g., pharmacy, etc.)

7. A copy of the report(s) will be placed in the applicable study file, as well as any other files that are maintained during the investigation to determine whether an event is reportable.

PROCEDURE

A. If the President and CEO has determined that the event is reportable and the investigation cannot be reasonably completed within the timeframes specified above under section 4., an initial report shall be submitted with a follow-up or final report to follow once all investigations have been completed.

B. The IRB Administrative Coordinator will place a copy of the report(s) and any supporting documentation in the applicable study file and retain in accordance with applicable policy.

References:

A.  45 CFR 46.103(b)(5)

B. 21 CFR 56.108(b)

Documentation (Documents & Forms):

Other Related Policy/Procedures:

A.  Adverse Event Reporting

B.  Protocol Deviations / Unanticipated Problems in Human Subjects Research

C.  Allegations of Non-Compliance, Concerns or Complaints

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