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unit 1 pt 3 - What constitutes human What constitutes human...

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Unformatted text preview: What constitutes human What constitutes human research research activities? Human Research Activities How You and the IRB Work Together • Research versus standard practice • Research versus innovative practice • Research versus quality control • Research versus case reports versus case reports Norma Epley Assistant Director, HRPP Division of Research Integrity & Compliance of Research Integrity Compliance 2 Th The Belmont Report What What Is It? The Belmont Report Belmont Report • Public attention drawn to abuses of human participants in biomedical experiments especially during WW II experiments, especially during WW II National Commission For the Protection of Human Subjects Protect Subjects of Biomedical and Behavioral Research Research • During Nuremberg War Crime Trials, Nuremberg Code drafted Nuremberg Code drafted • Nuremberg Code set standards for judging physicians and scientists who conducted experiments on concentration camp prisoners 3 Belmont Report 4 Belmont Report • Does not make specific Does not make specific recommendations recommendations • Part B of the Report describes the basic ethical principles • Is a statement of policy for the Department of Health and Human Services Services • General judgments that serve as a basic justification for the ethical th prescriptions prescriptions and evaluations of human actions • Attempts to summarize the basic ethical principles principles identified by the Commission in the course of its deliberations 5 6 Ethi Ethical Principles upon which all of the which all of the regulations are based re Three Basic Ethical Principles Respect for Persons It is intended to be used as guidelines for resolving ethical problems that surround human research activities Beneficence Justice 7 8 Investigator Top 10 10 Responsibilities How Do You Apply these th Principles Principles 1. Design Ethical Research 2. Protect participants by Complying with federal regulations/institutional policies 3. Obtain prior IRB Approval 4. Comply with all IRB conditions & requirements requirements 5. Obtain Informed Consent/Assent • Share responsibility between Share responsibility between the the Principal Investigator, the IRB, IRB, the facility, the research personnel, and the participant personnel, and the participant 9 Investigator Top 10 10 Responsibilities Responsibilities 10 Why Is There An IRB? Nuremburg Trials 6. Document Informed Consent/Assent 7. Implement Research As Approved and Obtain Prior Approval for Modifications 8. Submit Progress Reports 9. Report Unanticipated Problems 10. Retain Records for 3 years after study closes* PHS Syphilis Trial Willowbrook Hepatitis Trial Jewish Chronic Disease Hospital Cancer Trial Milgram Deception Study 11 12 What is the IRB What is the IRB ? Is it Even Important? PI’ PI’s are responsible for appropriately training research personnel •Train individuals obtaining informed consent (they should be able to answer consent (they should be able to answer questions questions the potential participants may have about the research) have about the research) • Institutional Review Board (may have other names) • Federally mandated peer review committee Federally mandated peer review committee for for human subject research • Institution must provide IRB for review of human human subject research if it is to receive federal funds or conduct FDA-regulated FDAresearch research •Use technology or innovative approaches approaches in obtaining informed consent 13 14 PI PI Responsibilities in Obtaining Informed Consent Respect • Both the PI and the research personnel who interact with the participant participant must build a relationship with that person •Be sensitive to participants’ needs • Each person comprehends differently responds differently differently, responds differently, and has different needs •Obtain IRB approval for substantive changes and plan to re consent when changes and a plan to re-consent, when necessary necessary •Make adjustments in the process, as necessary necessary 15 PRINCIPAL INVESTIGATOR PRINCIPAL INVESTIGATOR’S RESPONSIBLITIES RESPONSIBLITIES FOR KEY PERSONNEL 16 The Facility What The Facility – What Responsibilities Responsibilities Does it Have? • Ensures that each person interacting with research participants (e.g., consenting individuals and/or collecting data) are properly trained about the collecting data) are properly trained about the specific specific study to be able to answer questions and deal with unanticipated events • If a facility routinely has research conducted there, it must file with the Office for Human Research Protections Office for Human Research Protections for for a Federal Wide assurance • Ensures that each person working on the research project project has completed human research protections training within the past 12 months • If a facility only occasionally has research conducted there, it must sign an Inter-institution agreement with the an an Inter institution agreement with the an Institution Institution holding an FWA and providing IRB oversight • Maintains all educational certificates for each key personnel involved in the research 17 18 The IRB Must Adhere to…. IRB Adh So To Whom Does the IRB Wh th IRB Answer? Answer? • Federal regulations – Department of Health and Human Services Federal Code of Regulations [45 CFR 46] – Food and Drug Administration Regulations Food and Drug Administration Regulations [21 [21 CFR 50, 56, 312, 600, 812] – Veterans Affairs Federal Code of Regulations and Handbooks [38 CFR 16 and Handbook 1200.5] • Congress • Office for Human Research Office for Human Research Protections Protections • State laws laws • Institutional Policies and Procedures • Professional ethics • The Public 19 20 ...
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