Jones, Martha F

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Washington University School of MedicineDigital Commons@BeckerHuman Research Protection Program (HRPP)Education Human Research Protection Office2010Researching research seminar: ethical framework inresearch involving human participantsMartha F. JonesWashington University School of Medicine in St. LouisFollow this and additional works at: http://digitalcommons.wustl.edu/hrpoedThis Presentation Paper is brought to you for free and open access by the Human Research Protection Office at Digital Commons@Becker. It has beenaccepted for inclusion in Human Research Protection Program (HRPP) Education by an authorized administrator of Digital Commons@Becker. Formore information, please contact engeszer@wustl.edu.Recommended CitationJones, Martha F., "Researching research seminar: ethical framework in research involving human participants" (2010). Human ResearchProtection Program (HRPP) Education. Paper 18.http://digitalcommons.wustl.edu/hrpoed/18 Researching Research Seminar Ethical Framework in Research Involving Human Participants Martha F. Jones, MA, CIP Executive Director, Human Research Protection Office (HRPO) October 27, 2010 History of Ethical Regulations  • Nuremberg Code (1948) – Developed following Nuremberg Trials which judged human experimentation conducted by the Nazis – Identified basic ethical principles • Voluntary and informed consent • Favorable risk/benefit analysis • Right to withdraw without penalty  History of Ethical Regulations  • The Thalidomide Experiment (1962) – Investigational drug used in 1950s to treat variety of unpleasant symptoms in pregnancy  – Not standard practice to inform patients of investigational treatment – Scientific correlation: birth defects in large percentage of women who took thalidomide – Public reaction (outrage)   History of Ethical Regulations  • The Thalidomide Experiment (1962) – FDA amendment requiring investigators to obtain informed consent from potential subjects before administering investigational medications – Legislative milestone in history of research regulation in U.S. • Federal agency authorized to establish and enforce specific ethical standards for the conduct of research   History of Ethical Regulations  • Other renowned studies – Willowbrook Hepatitis Studies (1950s) – Milgram Studies of Obedience to Authority (1960s) – San Antonio Contraception Study (early 1970s) – Tearoom Trade Study (early 1970s) – Tuskegee Syphilis Study (1932-1972)a – Havasupi Tribe (1989 – 2010)   History of Ethical Regulations  • 1973: Congressional Hearings on Quality of Health Care and Human Experimentation  – National Research Act of 1974 • Established modern IRB system for regulating research involving human participants • Established the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research – The Belmont Report (1978)  History of Ethical Regulations  • The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research – Respect for Persons (autonomy) – Beneficence – Justice  History of Ethical Regulations  • The Belmont Report – Respect for Persons – Moral requirements: autonomy • Individuals should be treated as autonomous agents • Individuals with reduced autonomy are entitled to protection – Voluntary participation – “Informed” consent – Privacy and confidentiality protected   History of Ethical Regulations  • The Belmont Report – Beneficence – Moral requirements: do unto others as you would have them do unto you • Risks are justified by potential benefits to individual/society • Risks must be minimized (do no harm – and beyond!) • Manage conflicts of interest   History of Ethical Regulations  • The Belmont Report – Justice  – Moral requirements: equal distribution of risks among those who would reap benefits • Vulnerable subjects are not targeted • Those who will benefit are not systematically excluded  History of Ethical Regulations  • Federal Policy for Protection of Human Subjects (1981) – Codified by U.S. Department of Health and Human Services at Title 45, Part 46 (45 CFR 46) – Subpart A, basic provisions (Common Rule) – Subpart B, pregnant woman, fetuses and neonates – Subpart C, prisoners – Subpart D, children • Based on FUNDING   History of Ethical Regulations  • Food and Drug Administration – Clinical investigations of drugs and devices  • New drugs or devices • New use of approved drugs or devices – Define IRB responsibilities (21 CFR 56) – Define Investigator/Sponsor responsibilities (21 CFR 50) • Based on OVERSIGHT AREA  Students as Researchers – the IRB Institutional Review Board (Washington University Human Research Protection Office (HRPO) • Independent committee comprised of at least 5 members from relevant academic disciplines and at least one non-affiliated member • Role: protect research participants • Authority: approve, require changes to study procedures, or disapprove proposed research • Autonomy: decisions are final. University officials cannot approve a project that has been disapproved, suspected, or terminated by HRPO.  Students as Researchers – the IRB • Must have necessary experience and expertise to evaluate proposed research projects. • Must be diverse in terms of race, gender, cultural backgrounds, and include members from the local community. • Charge: review all research involving human participants for compliance with institutional policies; state, local, and federal laws; ethical principles in Belmont Report • Part of bigger system,  Human Research Protection Program : Chancellor, Vice Chancellor for Research, Deans, Department Heads, all investigators, grants & contacts offices, other research compliance committees  Students as Researchers – the IRB    If you are conducting research involving human participants,  you must have IRB approval to do so  before you begin to collect data. Students as Researchers • Conducting or assisting in research projects involving human participants – Working in a lab (directed research) – Independent research (Senior Honors Thesis) • Must have Faculty Sponsor familiar with research topic or methods  Students as Research Participants • Academic setting – WU Mission: promotion of learning by students and faculty – Teaching: transmission of knowledge – Research: creation of new knowledge – Students are integral in transmission and creation of knowledge – Recruitment flyers on campus; Research Participant Registry – Student Pools (Psychology, Business)  Students as Research Participants • IRB responsibility to student participants – Ensure voluntary participation: protect against coercion and undue influence • Coercion – will it affect my grade if I do not participate? • Undue influence – will I get a better grade if I participate?  Students as Research Participants • Pools (Psychology Dept and Olin School) – Written policies on their websites – Links on HRPO website – Reviewed by HRPO according to ethical principles and regulatory requirements – Include safeguards to ensure voluntary participation – Equity; alternatives • Faculty research – Discourage involvement of own students as participants – Allowed in past when participation is anonymous  Students as Research Participants • What you should expect when asked to participate in research – Informed consent • May be oral or written • Explain purpose, what you will be asked to do, time commitment, compensation (if any) • Describe risks (if any) • Describe benefits (to you, to society) • How your privacy will be protected • How confidentiality of data (information you provide) will be maintained • Who to contact with questions, concerns  Resources for Student Researchers and/or Student Participants HRPO http://hrpo.wustl.edu/       Resources for Student Researchers and/or Student Participants • Faculty Sponsor – Familiar with ethical and regulatory requirements of human research – Discuss research ethics with students – Advise students conducting international studies on understanding local customs and ethics – Monitor student projects, provide oversight, be available for questions – Assure that any unexpected or adverse events are reported to the HRPO  Resources for Student Researchers and/or Student Participants • Provost – Code of Conduct – http://provost.wustl.edu/code_of_conduct  • Vice Chancellor for Research – Institutional Official for human research – http://research.wustl.edu/Pages/default.aspx  

Researching research seminar: ethical framework in research involving human participants

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Researching research seminar: ethical framework in research involving human participants

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