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Navigating the IRB

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Navigating the IRB

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    1. Navigating the IRB

    2. IRB: An Alternate Reality?

    3. Research Wheel of Fortune

    4. Learning Objectives Describe the role of the IRB in clinical research Describe some principles of ethical human search Discuss how to work with your IRB Discuss the differences between clinical research and clinical care

    5. Take Home Points Research with human subjects is not easy; it is complicated IRB is PRO-research�intended to help, not hinder IRB staff are highly skilled and knowledgeable and service oriented

    6. Start at the beginning�training CITI Training CITI = Collaborative Instructional Training Initiative Web-based training for investigators Subject protection Link at IRB website Registration is trickiest part

    7. Role of the IRB is to: Protect research participants by reviewing human subject research from the standpoint of its ethical conduct

    8. Why do IRBs exist? Public (dis)trust�is the bottom line

    9. Why wouldn�t the public trust clinical researchers?

    10. M.H. Pappworth �No physician is justified in placing science or the public welfare first and his obligation to the individual, who is his patient or subject, second. No doctor, however great his capacity or original his ideas, has the right to choose martyrs for science or for the general good.� Pappworth M.H. Human Guinea Pigs: Experimentation on Man; Boston: Beacon Press, 1967; pg. 27

    11. Resources for Protecting Human Subjects Ethical Codes Nuremberg Code Declaration of Helsinki Belmont Report Federal Regulations Regarding Informed Consent Regarding IRB�s IRB Standard Operating Procedures Internal policies governing how your IRB does business

    12. Ethical Principles in Belmont Report Respect for Persons Informed consent, privacy and confidentiality, special protections for vulnerable populations Beneficence Do good; do no harm Minimize risks, balance risks and benefits Justice Select research participants equitably Share the risk; share the benefit

    13. Where do the regulations come from? The Government of the United States I am a visual learner- so it is very helpful for me, and I hope for you, to see how these agencies fit together by looking a couple org charts. Here we have DHHS listed under the Executive Branch of our federal government I am a visual learner- so it is very helpful for me, and I hope for you, to see how these agencies fit together by looking a couple org charts. Here we have DHHS listed under the Executive Branch of our federal government

    14. Department of Health & Human Services Under DHHS you will find the Inspector General, the NIH and the FDA. The FDA regulations include 21CFR50 and 56. You will also find OCR- which has the HIPAA regulations- 21CFR 160 and 164. Under the Assistant Secretary for Health you will find the Office of Public Health Sciences and under them you will find OHRP . The OHRP regulation we deal with most is 45CFR46 which is also known as the common rule. Believe me, it took us HOURS and HOURS of internet searching trying to figure all this out. You would think the fed gov website would have this org chart, but it does not exist. . I finally called someone I knew at OHRP and waived the white flag-Under DHHS you will find the Inspector General, the NIH and the FDA. The FDA regulations include 21CFR50 and 56. You will also find OCR- which has the HIPAA regulations- 21CFR 160 and 164. Under the Assistant Secretary for Health you will find the Office of Public Health Sciences and under them you will find OHRP . The OHRP regulation we deal with most is 45CFR46 which is also known as the common rule. Believe me, it took us HOURS and HOURS of internet searching trying to figure all this out. You would think the fed gov website would have this org chart, but it does not exist. . I finally called someone I knew at OHRP and waived the white flag-

    15. DHHS Regulations: OHRP 45 CFR 46, Subpart A: Adopted in 1981 Became known as Common Rule in 1991 Subpart B- Protections pertaining to research, development, and related activities involving fetuses, pregnant women and human in vitro fertilization Subpart C- Protections pertaining to biomedical and behavioral research involving prisoners as subjects Subpart D- Protections for children involved as subjects in research

    16. Food & Drug Administration Separate regulations 21 CFR 56 � IRBs 21 CFR 50 � Informed consent Based primarily on use of FDA regulated products: drugs, devices, or biologics

    17. FDA & DHHS Regulations Basic requirements for IRBs and for Informed Consent are similar Differences in applicability DHHS based on federal funding FDA regulations based on FDA-regulated products ( study involves a drug, device or biologic)

    18. Ethics versus Regulations Both intend to protect human subjects Belmont report does not mention how human subjects are to be protected Federal regulations scarcely mention ethics nor the function of ethics in protecting human subjects IRBs must �put a hand in each glove�

    19. Distinction between clinical practice & clinical research Clinical practice, defined: interventions that are designed solely to enhance the well-being of an individual patient and that have a reasonable expectation of success Clinical research, defined: activity designed to test a hypothesis, permit conclusions to be drawn, and thereby develop or contribute to generalizable knowledge; usually described in a formal protocol that sets forth an objective and a set of procedures

    20. The blurred line� Confusion between research and care Distribution of possible risks & benefits is different in research versus therapy Therapeutic misconception Misunderstanding by patients that they will benefit, even after informed consent Blurred roles of physician and researcher Potentially conflicting role is difficult for patients to understand

    21. Basic Protections for Subjects in Human Research Institutional Assurances IRB Review Informed Consent

    22. What is an institutional assurance? Called an FWA ( Federal Wide Assurance) The documentation of an institutional commitment to comply with Federal regulations and maintain adequate programs and procedures for the protection of human subjects The principle mechanism for compliance oversight by OHRP

    23. What is an institutional review board? Committee established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated

    24. IRB Review The IRB reviews and has authority to approve, require modification in, or disapprove all research activities, including proposed changes in previously approved human research

    25. IRB Continuing Review Conducts continuing review of approved research at intervals appropriate to the degree of risk, but not less than once per year Has authority to suspend or terminate previously approved research that is not being conducted in accordance with IRB requirements, or that has been associated with unexpected serious harm to subjects.

    26. Requirements for approving human subjects research Risks to subjects are minimized Risks to subjects balanced by anticipated benefits to subjects and/or society Equitable selection of subjects Informed consent appropriately obtained Informed consent appropriately documented Adequate procedures in place to monitor subject safety Adequate procedures in place to protect privacy and confidentiality Per federal regulations 45 CFR Part 46.111 (DHHS) and 21 CFR Part 56.111 (FDA)

    27. Informed Consent Unless authorized by IRB, no investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject�s legally authorized representative

    28. It�s NOT just the IRB!!! Human subject protections must span beyond the work of the IRB: The the approved protocol provides the �skeleton� Ethical decision making process Consent forms vs informed consent Conflicts of Interest Financial interests and arrangements Professional (publications; promotion; stature) Vulnerable Populations

    29. IRB protocol review categories Exempt review: for clinical research, mostly involves no-risk research Expedited review: minimal risk research Waiver of consent: usually associated with expedited review Full committee review: reserved for research that poses more than minimal risk to subjects

    30. Required protocol pre-review REQUIRED for protocols, both full board and expedited Email an electronic copy (no signatures) of protocol/consent Email full board forms to Eileen Sembrowich (ecs3b@virginia.edu, 3-6542) Email expedited protocols to Blaise Spinelli (rjs4c@virginia.edu, 4-2546) Five-day turn around, forms emailed back with comments tracked You can then accept changes, get signatures, etc Time management is the key to this! Full board protocols: keep in mind any sponsor requirements/deadlines, full board deadline days

    31. In addition to IRB full board review� If applicable to your research, you might need approvals from other committees Protocol Review Committee (PRC) General Clinical Research Center (GCRC) Radiation Safety Committee (RSC) Institutional Biosafety Committee (IBC) Materials Support Services (Device Studies) SOM Clinical Trials Office (Physician sponsored IND or IDE or physician-sponsored multi-site trials) Contact information found in Protocol Builder

    32. Review by IRB-HSR Full Board

    33. What do IRB-HSR full board members do? Review purpose of study Methods involved Therapeutic or not Recruitment strategies Requests for waiver of consent Data safety and monitoring plans/boards Involvement of minors and other vulnerable populations Use of investigational drugs or devices Discussion of PI�s protocol and consent form content Methods of data analysis Risk benefit analysis HIPAA Privacy board

    34. Process Five possible review outcomes: Approved Approved Pending Minor Modifications Withheld Approval Pending Major Modifications Tabled Rejected Timeframe from submission to comments back takes about two weeks Full board review

    35. Advertisements Modifications Continuing review Adverse event reporting Protocol/grant closure Life after IRB approval�

    36. IRB-HSR Submission Process IRB-HSR website http://www.virginia.edu/vpr/irb IRB Online and Protocol Builder First time using Protocol Builder or just need help? Please contact Karen Mimms, IRB Associate Director, kcm6t@virginia.edu (3-9847) or Margaret Ball, IRB Coordinator, at mnw2h@virginia.edu (3-0639)

    37. Take Home Points Research with human subjects is not easy; it is complicated IRB is PRO-research�intended to help, not hinder IRB staff are highly skilled and knowledgeable and service oriented

    38. IRB versus the Institution? ��the IRB is an agent of its own institution; its purpose is to uphold the value system of the institution. Respect for persons, beneficence, and justice are (or should be) principles that your institution values greatly and not just because they were once published in the The Federal Register.�

    39. Time for discussion �Everything should be made as simple as possible, but not one bit simpler.� -Albert Einstein �USA Today has come out with a new survey � apparently, three out of every four people make up 75% of the population.� -David Letterman

    40. Let�s go to the website(s)�time allowing UVA Office of the Vice President for Research, Institutional Review Boards http://www.virginia.edu/vpr/irb UVA IRB-HSR http://www.virginia.edu/vpr/irb/hsr/index.html IRB Online http://www.irb.virginia.edu/

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