1. 0 Ethics Lecture Research

2. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Disclosures  The speaker has no financial interest in the subject matter of this presentation and is not representing the Ethics Committee of the American Academy of Ophthalmology with this presentation  For questions about the material contained herein or about the Academy’s ethics program in general, please contact the ethics program manager, Mara Pearse Burke at ethics@aao.orgethics@aao.org

3. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Why is this Topic Important?  Integrity of the profession  Engenders patient prust  Validates research results, transparency and responsibility to the public and patients.

4. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY What constitutes research, when is IRB approval required and how is this obtained?

5. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Research  Research is a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”. (Common Rule Title 45 Code of Federal Regulations Part 46)  Research is distinguished by the intent to test a hypothesis or to add to a body of knowledge

6. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY What Constitutes Research?  Most recent cohesive definition and code for research conduct is the 1991 Code of Federal Regulations known as The Common Rule  Title 45 Public Welfare Department of Health and Human Services, Code of Federal Regulations Part 46 Protection of Human Subjects  Unifies internationally respected principles from: Nuremberg Code, 1949 World Medical Association Declaration of Helsinki, 1964 Belmont Report, 1979

7. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Research  Whether in an academic setting or a private practice setting, IRB approval and oversight are necessary for prospective or retrospective research that will be submitted for presentation or publication

8. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Institutional Review Boards  Institution or local hospital  Private, centralized review boards Western IRB Sterling IRB Institutional Review Board Services  Three types of IRB review: Full Expedited Exempt

9. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Full Review  Required for any study that would be considered to have greater than minimal risk any new drug or device or evaluation of diagnostic or therapeutic regimens  All prospective evaluations of even seemingly minimal risk interventions would fall in to this category  All submissions for full review undergo full member ethics board review and recommendation

10. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Expedited Review  Applied to situations felt to be of little or no risk to subjects  May be reviewed by a subcommittee  The definition of minimal risk according to the Office for Human Research Protections (OHRP) and the FDA is: “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in the daily life or during performance of routine physical or psychological examinations or tests”

11. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Expedited Review  Retrospective chart reviews without any identifying features  Non-invasive studies  Observational studies  Required regardless of whether the research is done in an institution or a private practice, and regardless of its funding source  Remember that research is: any “systematic investigation designed to develop or contribute to generalizable knowledge”

12. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Exempt Review  Reserved for studies that have no or minimal associated risk and have no associated identifying data  Examples: Educational assessment programs or evaluations of educational strategies Data review of completely de-identified information

13. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Exempt Review  Submissions may be reviewed by an administrator and not warrant full board review  Determination of exempt status is not made by the submitter, but by an IRB after review of the appropriate paperwork  Applications for exempt status need to be completed, submitted and the responses kept on file

14. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Practical Aspects  Private practitioners may conduct retrospective reviews of their own data without IRB approval  However, if plan to publish or submit data as study results, the sponsoring organization (journal or society meeting) will likely require IRB approval or a written exemption for the study from an IRB  If it is the intent to publish and present it is a good idea to seek IRB approval or exemption ahead of time and be fully prepared

15. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Code of Ethics Rule 3 – Research and Innovation  Research and innovation shall be approved by appropriate review mechanisms to protect patients from being subjected to or potentially affected by inappropriate, ill-considered, or fraudulent basic science or patient-oriented research.  Basic science and clinical research are conducted to develop adequate information on which to base prognostic or therapeutic decisions or to determine etiology or pathogenesis, in circumstances in which insufficient information exists.

16. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Code of Ethics Rule 3 – Research and Innovation  Appropriate informed consent for research and innovative procedures must recognize their special nature and ramifications. In emerging areas of ophthalmic treatment where recognized guidelines do not exist, the ophthalmologist should exercise careful judgment and take appropriate precautions to safeguard patient welfare.

17. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Common Rule Title 45 Code of Federal Regulations Part 46  http://www.hhs.gov/ohrp/humansubjects/gui dance/45cfr46.html http://www.hhs.gov/ohrp/humansubjects/gui dance/45cfr46.html