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Reporting to the Institution and Government Agencies

September 2004

If a JHM IRB determines that a previous approval of an investigator for research, and/or activities associated with that research should be suspended or terminated, or that a research study has demonstrated unanticipated problems involving risk to human subjects or others, or if a research site has instances of serious or continuing non-compliance with regulations or IRB requirements, the IRB chair must report the problem to Institution officials.  Reports are sent as e-mail notifications to the Assistant Dean for Human Subjects Committees and the Vice Dean for Clinical Investigation with hard copy follow-up by mail or fax.

1. The letter(s) to the Institutional officials must include the following information

a. the research title (sponsor, number, drug and device, if applicable)
b. the name of the principal investigator
c. the site(s) at which the research is being conducted
d. the problem, risk or non-compliance issue(s) prompting the report
e. what action is being taken, or was taken, to remedy the problem
f. whether a suspension/termination is permanent or conditional, if applicable
g. what must be done to resume the research, if applicable

2. The chair(s) will draft the letter(s) and review the text with a senior IRB manager. The letters will be reviewed and signed by the IRB chair.

3. The letter(s) will indicate to whom internal copies (if any) will be sent.

4. Letters to Institutional officials will be filed in the protocol folder, with copies mailed to the department chair and elsewhere, as appropriate (eg:  Legal Counsels' Offices).

5. * Upon receipt of the report from a chair, the Vice Dean for Clinical Investigation and General Counsels will determine if a report must be filed in federal government or with other agencies. If further investigation of the matter is required the Vice Dean for Clinical Investigation or General Counsels may intiate further investigation.  The Vice Dean for Clinical Investigation will draft reports to be sent to OHRP, FDA, and the federal funding agency (when applicable).  The report will include information on further actions to be taken or implemented, a corrective action plan if applicable. Copies of the report will be provided to the institutional signature officials, IRB chairs, General Counsels' offices for JHHS and JHU, and the principal investigator.



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