Institutional Review BoardValdosta State University RESEARCH ETHICS Orientation for IRB Members Session 1: The Regulations and the Role of The IRB Presented.

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  • Slide 1
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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)?
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  • 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
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  • 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 Knowledgeable in standards of professional conduct and practice Outside consultants may be used Alternate members may serve as proxies for designated voting members at convened meetings (but not as expediters) Members with conflicting interests may not participate in protocol reviews.
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  • Institutional Review BoardValdosta State University IRB Jurisdiction The IRB has jurisdiction over research conducted by VSU Faculty members Staff Students in any location On the VSU campus At another institution or organization In a community setting In a foreign country
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  • Institutional Review BoardValdosta State University IRB Authority The IRBs decision to deny approval of a protocol cannot be overridden by the President, any member of the administration, or the Board of Regents. The IRBs decision is final.
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  • Institutional Review BoardValdosta State University IRB Educational Resources CITIProgram online tutorial OHRP website and printed materials VSU website
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  • Institutional Review BoardValdosta State University CITIProgram.orgCITIProgram.org Training for Researchers Basic Course 1.Introduction 2.History and Ethical Principles SBR 3.Defining Research with Human Subjects SBR 4.The Regulations and the Social and Behavioral Sciences SBR 5.Basic Institutional Review Board (IRB) Regulations and Review Process 6.Assessing Risk in Social and Behavioral Sciences SBR 7.Informed Consent SBR 8.Privacy and Confidentiality SBR 9.VSU Module (SBR = Social and Behavioral Research)
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  • Institutional Review BoardValdosta State University CITIProgram.orgCITIProgram.org Training for Researchers Additional Required (?) Modules Based on Research Design 1.Research with Children - SBR 2.Research in Public Elementary and Secondary Schools - SBR 3.Vulnerable Subjects Research Involving Pregnant Women and Fetuses in utero 4.Research with Prisoners - SBR 5.Research with Protected Populations Vulnerable Subjects: An Overview 6.International Research 7.Group Harms: Research with Culturally or Medically Vulnerable Groups 8.Records-Based Research 9.Genetic Research in Human Populations 10.HIPAA and Human Subjects Research (personal medical information) 11.Internet Research - SBR 12.Workers as Research Subjects A Vulnerable Population
  • Slide 26
  • Institutional Review BoardValdosta State University Additional Training for IRB Members CITIProgram.org IRB Reference Resource (all IRB modules) OHRP Human Subjects Assurance Training Module 1 - HHS Regulations & Institutional Responsibilities Module 2 - Investigator Responsibilities & Informed Consent Module 3 - Human Research Protections Program Module 1 is strongly recommended for the Institutional Official. All three modules are required for the IRB Chair and the IRB Administrator. All IRB members are invited to complete the modules. http://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp
  • Slide 27
  • Institutional Review BoardValdosta State University Other Resources for IRB Members OHRP (http://www.hhs.gov/ohrp/)http://www.hhs.gov/ohrp/ Institutional Review Board (IRB) Guidebook On-Line http://www.hhs.gov/ohrp/irb/irb_guidebook.htm Policy and Guidance http://www.hhs.gov/ohrp/policy/index.html Frequently Asked Questions (FAQs) http://www.hhs.gov/ohrp/faq.html VSU IRB Website Policy and procedures, guidance, forms, membership, meeting dates http://www.valdosta.edu/ospra/HumanResearchParticipants.shtml
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  • Institutional Review BoardValdosta State University Federal Definitions Research is a systematic investigation intended to develop or contribute to generalizable knowledge The regulations do not define systematic or generalizable knowledge Systematic: adj. Methodical in procedure or plan (a systematic approach) (a systematic scholar); marked by thoroughness and regularity (systematic efforts) Merriam-Webster Dictionary Generalizable Knowledge infers a quantitative methodology which allows generalization of research findings to a larger population. For VSU IRB purposes, a systematic investigation intended to advance disciplinary knowledge is also included in the definition of research Includes qualitative research See handout on qualitative and quantitative research.
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  • Institutional Review BoardValdosta State University Federal Definitions Human Participant is a living individual about whom the investigator obtains Data through intervention or interaction with the individual and/or Identifiable private information
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  • Institutional Review BoardValdosta State University Federal Definitions Intervention includes Physical procedures such as specimen collection and physical measurements Manipulation of the participant Manipulation of the participants environment Interaction includes Direct communication with the participant (such as interviewing or conducting a focus group) Interpersonal contact with the participant (such as surveying)
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  • Institutional Review BoardValdosta State University Federal Definitions Private Information is Information about behavior that the p...

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