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- 1. Reportable Event? The University of Iowa Human Research Protection Program
- 2. New Procedures for Reportable Events Martha F. Jones, MA, CIP IRB Chair, (IRB-01/IRB-02) and Director, Human Subjects Office Suzanne Bentler, MS IRB Administrator Office of the Vice President for Research The University of Iowa http://www.research.uiowa.edu/hso/
- 3. Overview/Key Changes April 1, 2006: New procedures begin Use of new forms including expanded reporting requirements “Old” AE forms in HawkIRB no longer available (except as update function) Projects still in paper will continue to use “old” paper reporting forms. ALL documentation must be submitted in electronic format. We will no longer accept hard copy documentation for REF forms. Unique identifier for each event – you must use the UPDATE function Updated procedures available on HSO website in Investigator’s Guide (Chapter 7.C): http://www.research.uiowa.edu/hso/ The University of Iowa Human Research Protection Program
- 4. What are the regulatory reporting requirements? Different requirements for Sponsors Investigators IRBs Different requirements depending on type of study and funding FDA Drug Device Federal The University of Iowa Others? Human Research Protection Program
- 5. IRB Reporting Requirements: DHHS & FDA Institution (IRB) must follow written procedures for prompt reporting to the IRB, institutional officials, FDA, department/agency heads of Unanticipated problems involving risks to subjects or others Serious or continuing noncompliance with regulations or the requirements or determinations of the IRB Suspension or termination of IRB approval The University45 CFR 46.103(b)(5) DHHS: of Iowa FDA: 21 CFR 56.108(b) Human Research Protection Program
- 6. Investigator Reporting FDA – Drug Studies 21 CFR 312.64(b) An investigator shall promptly report to the sponsor any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug. If the adverse effect is alarming, the investigator shall report the adverse effect immediately. The University of Iowa Human Research Protection Program
- 7. Sponsor Reporting FDA – Drug Studies 21 CFR 312.32(c) The sponsor shall notify FDA and all participating investigators in a written IND safety report of: (A) Any adverse experience associated with the use of the drug that is both serious and unexpected; or (B) Any finding from tests in laboratory animals that suggests a significant risk for human subjects including reports of mutagenicity, teratogenicity, or carcinogenicity. The University of Iowa Human Research Protection Program
- 8. FDA Drug Definitions Associated with the use of the drug There is a reasonable possibility that the experience may have been caused by the drug The University of Iowa Human Research Protection Program
- 9. FDA Drug Definitions (continued) Serious adverse drug experience Any adverse drug experience occurring at any dose that results in any of the following outcomes: Death A life-threatening adverse drug experience (immediate risk of death) Inpatient hospitalization or prolongation of existing hospitalization A persistent or significant disability/incapacity A congenital anomaly/birth defect Important medical events not resulting in the above may be serious when, based upon the appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent oneIowa outcomes The University of of the listed above. Human Research Protection Program
- 10. FDA Drug Definitions (continued) Unexpected adverse drug experience Any adverse drug experience, the specificity or severity of which is not consistent with the current investigator brochure or risk information described in the general investigational plan or elsewhere in the current application Refers to NOT PREVIOUSLY OBSERVED Do not interpret as “not anticipated”, for example based on pharmacological The University of Iowa properties Human Research Protection Program
- 11. Investigator Requirements FDA – Device Studies 21 CFR 812.150(a)(1) An investigator shall submit to the sponsor and to the reviewing IRB a report of any unanticipated adverse device effect occurring during an investigation The University of Iowa Human Research Protection Program
- 12. Sponsor Requirements FDA – Device Studies 21 CFR 812.150(b)(1) A sponsor who conducts an evaluation of an unanticipated adverse device effect under 21 CFR 812.46(b) shall report the results of such evaluation to FDA and to all reviewing IRB’s and participating investigators The University of Iowa Human Research Protection Program
- 13. FDA Device Definition Unanticipated adverse device effect Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application…or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. The University of Iowa Human Research Protection Program
- 14. What is NOT Required? Immediate reporting of IND safety reports/outside safety reports UNLESS The report itself or the interpretation of the report by the UI PI represents a change in the risks or potential benefit associated with the study Unanticipated problem (e.g. new risk) The University of Iowa Human Research Protection Program
- 15. What if Sponsor requires additional reporting? Indicate the IRB does NOT act as the DSMB for any study Policy will be posted on HSO website Reports not required by regulation or UI IRB policy will NOT be accepted by UI IRBs Sponsor must provide the federal regulation (not guidance) for requiring IRB review if disagree Summary of non-reportable events may be The University of Iowa submitted with Continuing Research Human Review Protection Program
- 16. The REF Forms Reportable Event Form The University of Iowa Human Research Protection Program