What do I Have to Report to the IRB

1. What do I Have to Report to the IRB? (and Other Mysterious Things!)

2. �If we knew what it was we were doing, it would not be called research, would it?� ~Albert Einstein Marie Curie with Albert Einstein

3. Objectives Participants will be able to identify the major reporting requirements of IRB�s Participants will be able to identify how to report events to the IRB Participants will be able to identify non-compliance issues in reporting

4. What Does the Seton Office of Research Administration Do? It is the responsibility of the Seton Office of Research Administration: To protect and provide guidance to our patients involved in research, our physicians, and the organization as a whole. To manage and educate our Institutional Regulatory Boards, Researchers, Research Team Members.

5. What is an IRB? Institutional Review Boards (IRB) � The primary responsibility of IRB is to protect human subjects. The board evaluates the safety and ethical issues surrounding potential research. The board is concerned with adequate research subject informed consent, potential risks and benefits to research subjects, protection of human subject rights, and potential ethical and financial impact of research studies. The IRB is also charged with the responsibility of evaluating the science, methodology, design, and statistical validity and reliability of potential research studies. These boards are monitored directly by the DHHS.

6. Primary Responsibilities of IRB�s Institutional Review Boards Review Requirements as required by law include but are not limited to: 1) Risk must be minimized 2) Risk/Benefit ratio must be reasonable 3) Selection must be equitable 4) Informed consent must be documented 5) Data must be monitored to ensure subject safety 6) Confidentiality must be maintained 7) Vulnerable populations must be protected

7. What Else Is the IRB Concerned With? Patient/Human Subject Protection and Safety Confidentiality Investigator Protection Institutional Protection Research Integrity Public and Institutional Trust

8. Ethics Nuremberg Code 1947 Informed Consent, i Risk, Results Valuable Declaration of Helsinki 1964 Independent Review, Preserve Confidentiality Belmont Report 1979 Respect for Persons, Beneficence, Justice

9. Ethics Research Timeline 6th Century B.C. to Present Things still go wrong despite our best efforts Nicole Wan - 1996 Jessie Gelsinger � 1999 Ellen Roche � 2001 Transparency and Effective Communication and crucial between researchers and IRB�s