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  • Slide 1
  • Slide 2
  • Institutional Review BoardValdosta State University RESEARCH ETHICS Orientation for IRB Members Session 1: The Regulations and the Role of The IRB Presented by the Office of Sponsored Programs & Research Administration
  • Slide 3
  • Institutional Review BoardValdosta State University Historical Timeline 1947: Nazi War Crimes Tribunal issued Nuremburg Code 1940s: PHS Tuskegee syphilis study Late 1950s Early 1960s: The thalidomide tragedy 1963: Milgrams obedience study published 1964: Declaration of Helsinki/World Medical Assembly 1974: National Research Act (IRB review for federally funded research) 1974: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research established 1979: Belmont Report issued; ethical principles defined 1980: FDA regulations for testing of new drugs and devices codified
  • Slide 4
  • Institutional Review BoardValdosta State University Historical Timeline 1980: FDA regulations for testing of new drugs and devices codified 1981: DHHS human subject protection regulations codified (45 CFR 46) 1991: Federal Policy for the Protection of Human Subjects (Common Rule) 1993: Albuquerque Tribune publicizes 1940s secret radiation experiments 1994: National Bioethics Advisory Commission (NBAC) created 1995: U.S. universities surveyed re: old radiation studies 2000: U.S. Public Health Service mandates researcher education 2001: Office of Human Research Protections (OHRP) established within DHHS 2002: NBAC sunsets 2003: Secretarys Advisory Committee on Human Research Protection established
  • Slide 5
  • Institutional Review BoardValdosta State University Belmont Principles Autonomy (Respect for Persons) Give respect, time, and opportunity to participants to make their own decisions Avoid pressuring or coercing individuals to participate Provide special protections for potentially vulnerable populations (children, elderly, cognitively or emotionally impaired, prisoners, etc.) Be aware of the perception of inequality of roles and/or potential for coercion in relationships Teacher-Student Employer-Employee Counselor-Client Service Provider-Service Recipient
  • Slide 6
  • Institutional Review BoardValdosta State University Belmont Principles Derived Rules from the Principle of Autonomy Securing Informed Consent Ongoing educational process to ensure participants understanding of the research and their willingness to participate Respecting Privacy of the Individual Individuals right to control access to him/herself and to his/her personal information Protecting Confidentiality of Information Agreement made with research participants about how information about the participant will be protected
  • Slide 7
  • Institutional Review BoardValdosta State University Belmont Principles What is private information? Behavior or information is considered private if it occurs in a context in which the individual can reasonably assume that no observation or recording is taking place or can reasonably expect will not be made public (such as medical or educational record) Participants expectations form basis of making distinctions between public and private behavior May have some expectation of privacy, even in a public setting
  • Slide 8
  • Institutional Review BoardValdosta State University Belmont Principles Privacy Concerns in Identification and Recruitment Sampling methods For example, snowball sampling Covert observation or video or audio taping Approaching in a public setting Safety concerns (gang member on the street; domestic violence victim) Recruiting via an employers email system Concerns with sensitive information
  • Slide 9
  • Institutional Review BoardValdosta State University Belmont Principles Thinking Through Privacy Issues Is it a situation in which the participant could reasonably expect privacy? Would reasonable people be offended by such intrusion? Would information gathered place the participant at risk of harm if disclosed? Do benefits of the study justify the possible invasion of privacy? What will the participants be told after the study? Can the study be redesigned to avoid the intrusion? Are there third parties whose privacy would be invaded (for example, asking children about parental drug use or other illegal behavior)?
  • Slide 10
  • Institutional Review BoardValdosta State University Belmont Principles Ensuring Confidentiality If possible, use a study design that assures anonymity (no true identifiers) Must ensure confidentiality and communicate measures to participants if Data are individually identifiable Research topic is sensitive Participants will be audio- or video-taped Data will be used for purposes other than the original study
  • Slide 11
  • Institutional Review BoardValdosta State University Belmont Principles Confidentiality Considerations Is there a real need for identifiers? Can code lists or participant-created identifiers be used? Can identifiers or code lists be destroyed after data collection? Who will have access to the data, now and in the future? How will data be reported (aggregate, pseudonyms, real names?) What will become of video or audio tapes (destruction, used for teaching, shown at meetings, saved for future research)? Protection of data from inadvertent disclosure (authorized staff, computer passwords, locked file cabinets)? Are the data destruction methods appropriate? Federal regulations require retention of data for at least three years
  • Slide 12
  • Institutional Review BoardValdosta State University Belmont Principles Beneficence Secure the well-being of research participants Minimize harm to participants Maximize benefits to participants and to society Carefully balance risks and benefits to the participants
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  • Institutional Review BoardValdosta State University Belmont Principles Derived Rules from the Principle of Beneficence Use the best possible research design Ensure that the researcher is qualified to perform the procedures and handle the risks Refrain from the conduct of research that is without a favorable risk-benefit balance if risk is greater than minimal
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  • Institutional Review BoardValdosta State University Belmont Principles Justice Distribute benefits and burdens of the research fairly and without bias Do not select or restrict participants based on gender, class, ethnicity, socioeconomic status, or language ability (unless justified by study objectives) Avoid selection of participants based on Convenience of researcher Participant availability Compromised position of participants Ability to manipulate participants
  • Slide 15
  • Institutional Review BoardValdosta State University The DHHS Regulations (45 CFR 46) Underpinned by the Belmont Report principles Establishes oversight of federally funded human research Establishes Institutional Review Boards (IRBs) for the protection of human research participants Establishes institutional assurance mechanism
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  • Institutional Review BoardValdosta State University FederalWide Assurance (FWA) Program Federal policy requires that institutions engaged in federally-supported research involving human participants file an Assurance The Assurance formalizes the institutions commitment to protect human subjects The Assurance includes both awardee and collaborating performance site institutions
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  • Institutional Review BoardValdosta State University VSUs FWA VSU has assured DHHS that it: Accepts the ethical principles of the Belmont Report Complies with the Federal Policy for Protection of Human Subjects (the Common Rule) Has adopted all subparts of the regulations (45 CFR 46) Verifies exemptions from the Common Rule Maintains an IRB in accordance with the regulations Requires assurance training of IRB members and staff Requires education of all researchers Applies protections to all participants, regardless of funding source
  • Slide 18
  • Institutional Review BoardValdosta State University VSUs FWA VSU has assured DHHS that it maintains written procedures for: Conducting IRB initial and continuing reviews Approving research involving human participants Ensuring documentation of informed consent Ensuring that proposed protocol changes are reported, reviewed, and approved prior to implementation Reporting findings to the IRB and institution Initial and continuing reviews Adverse events and unanticipated problems Serious or continuing non-compliance with regulations or IRB policies Suspension or termination of protocols
  • Slide 19
  • Institutional Review BoardValdosta State University The Institutional Review Board (IRB) Mandated to safeguard the rights and welfare of research participants by Reviewing research protocols Requiring protocol modifications as necessary Approving or disapproving protocols Ensuring or waiving informed consent and/or documentation of informed consent Conduct continuing review of research
  • Slide 20
  • Institutional Review BoardValdosta State University Constitution of IRB At least five members with varying backgrounds Different professions At least one scientist and one non-scientist At least one non-affiliated (community) member Prisoner or prisoner representative if institution engages in prisoner research Diversity in gender, ethnicity, and cultural background Sensitivity to community attitudes Kno

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