IRB Review Ensuring Patient Safety and Scientific Quality

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Job Bridges
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1 IRB Review Ensuring Patient Safety and Scientific Quality

2 Ensuring Patient Safety IRB REVIEW

3 IRB - defined An administrative body composed of scientists and nonscientists 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. Penslar RL, Porter JP. Office for Human Research Protections. Institutional Review Board Guidebook. Updated 6 February,

4 REGULATIONS FDA 21 CFR 56 - IRBS 21 CFR 50 Protection of Human Subjects DHHS 45 CFR part 46 Subpart A (known as the Common Rule) 46 CFR CFR HIPAA

5 History: The COMMON RULE Tuskegee Syphilis Study National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research 1981 DHHS Code of Federal Regulations (title 45,part 46) 1991 Subpart A the Common Rule Rules for Informed Consent Rules for operations of IRBs

6 The COMMON RULE 45 CFR 46, Subpart A Regulations that govern federally-funded research 3 basic requirements to protect human subjects Informed Consent IRB Review Institutional assurances of compliance with regulations

7 Background: Patient Safety Measures to protect human subjects incorporated into all aspects/stages of clinical investigation Most clearly embodied in two critical trial activities: The first is the requirement to obtain voluntary, legally effective informed consent from each study subject. The second, is the requirement for independent, ethical review of each clinical trial.

8 Kefauver-Harris Amendments 1962 Amendment to the Federal Food, Drug, and Cosmetic Act (FDC Act or the Act) clinical investigators have been required to obtain the informed consent of subjects who participate in FDA-regulated research. IRB review has been a for all FDAregulated research studies, since 1981.

9 IRBs do not operate in isolation, but rather, they act as part of a larger system intended to collectively ensure the protection of human subjects.

10 PROTECTION RESPONSIBILITIES Protecting the rights, safety, and welfare of human subjects who participate in biomedical research is shared by: The Sponsor overall trial conduct The Monitor verifies the information provided to the sponsor The IRB - ensuring that the research is ethical and that the rights, safety, and welfare of the subjects are protected The FDA - oversight responsibilities for the entire process The Investigator site conduct Public/Subjects

11 IRB Accountability The *Belmont Report: 3 Ethical Principles RESPECT Respectful interactions: institution, IRB, investigators BENEFICENCE minimizing risk of noncompliance & maximizing benefits of collegial interactions = continued research through protections of rights and welfare of subjects JUSTICE equal distribution of responsibility *The Federal Register, 1978, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

12 Ensuring Scientific Quality IRB REVIEW

13 IRB Responsibility to Evaluate Scientific Quality Federal research regulations Based on ethical principles: Nuremberg Code Declaration of Helsinki Characteristics of ethical research Risks to subjects are minimized Potential benefits of research justify the potential risks

14 Examples: Study Design Requiring Revision Revision without compromise in study persuasiveness = decrease in subject risk Study design flaws so significant that value nearly zero Study question unimportant or previously answered = risk > benefit

15 Tasks involved in Evaluating Study Design Evaluating design details Qualifications of investigator Value of proposed study Code of Federal Regulations. Title 45A Department of Health and Human Services; Part 46 Protection of Human Subjects. Updated 1 October 1997.

16 Criteria for IRB APPROVAL Title 45 Part , Subpart A, Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

17 Criteria for IRB APPROVAL Title 45 Part , Subpart A, Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.

18 Criteria for IRB APPROVAL Title 45 Part , Subpart A, Selection of subjects is equitable.

19 Criteria for IRB APPROVAL Title 45 Part , Subpart A, Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by

20 Criteria for IRB APPROVAL Title 45 Part , Subpart A, Informed consent will be appropriately documented, in accordance with, and to the extent required by

21 Criteria for IRB APPROVAL Title 45 Part , Subpart A, When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

22 Criteria for IRB APPROVAL Title 45 Part , Subpart A, When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Criteria for IRB APPROVAL Title 45 Part 46.

23 Criteria for IRB APPROVAL Title 45 Part , Subpart A, When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

24 IRB Review Ensuring Patient Safety and Scientific Quality Questions?

Ethical Principles in Clinical Research. Christine Grady Department of Bioethics NIH Clinical Center

Ethical Principles in Clinical Research Christine Grady Department of Bioethics NIH Clinical Center 1 Ethical principles Are these studies ethical? How do we know? Ethics of clinical research The goal