Research Ethics. Review Boards IRB – Institutional Review Board  Human subject protection IACUC – Institutional Animal Care and Use Committee  Animal

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  • Research Ethics

  • Review BoardsIRB Institutional Review BoardHuman subject protection

    IACUC Institutional Animal Care and Use CommitteeAnimal subject regulations

  • History Leading up to IRBsNazi War Crimes 1942-46

    Sterilization experiments-wanted to find ways to sterilize large populations to ensure supremacy of the Aryan raceDried plant juice was put into flour that was fed to the general population which was supposed to sterilize women.Intra-uterine injections of a silver nitrate solution were given to women without their consent during routine physical examinationsMen stood at a counter to complete forms while being exposed, without their knowledge, to sterilizing doses of X-radiation

  • Nazi War Crimes 1942-46

    Typhus fever vaccine experimentsNazi physicians were under great pressure to develop an effective vaccine for typhus fever to administer to German troopsBuchenwald concentration camps: prisoners were used in experiments to test the vaccine Between 1942 & 1943, over 700 prisoners were subjected to these experiments and 154 died

  • Nazi War Crimes Tribunal (1947)Fundamental ethical principles for the conduct of research involving human subjects were codified into the Nuremberg Code

    10 conditions that must be met before research involving human subjects is ethically permissible

    First internationally recognized code of research ethics (not a law)

  • Nuremberg Code:1) Voluntary consent of human subjectsLegal capacity to give consentAbility to exercise free choiceShould have knowledge of research to make informed decisionNature, duration, purpose of the projectMethod and means by which it is conductedAll inconveniences and hazards to subjectEffects upon subjects health or person that may come from participation

  • Code cont.2) No study permitted if reason to believe death or disabling injury will occur

    3) Degree of risk should not exceed importance of problem

    4) Adequate protection for human subjects to avoid, even remove, possibilities of injury, disability, or death

  • Code cont.5) Study shall yield fruitful results that cannot be obtained from other methods

    6) The scientific design must be sound so that anticipated results justifies the study

    7) Study should avoid unnecessary physical and mental suffering and injury

  • Code cont.8) Study conducted by scientifically qualified persons

    9) Subjects can discontinue at any time

    10) Investigator should terminate study if continuation of experiment is likely to result in injury, disability, or death to subject (including mental harm)

  • Declaration of Helsinki, 1964Adopted by the World Medical Assembly, Helsinki, Finland

    Recommendations guiding physicians in biomedical research involving human subjects

    Included a principle that stated: in case of physical or mental incapacity for subject to give informed consent or in case of a minor, responsible relative or legal guardian

  • Historically abused populationsMentally illDevelopmentally challengedChildrenActive militaryPrisonersImmigrantsMinority populationsUneducated or minimally educatedElderly

  • Tuskegee Syphilis StudyBegan in 1932 to study the natural history or progression of syphilis400 black men with syphilis, 200 not infectedRecruited without informed consentStudy continued until 1972 when news reached public via the national pressFormal presidential apology 1997

  • Radioactive Milk Research1946-1956, experiments performed on 19 boys (mentally impaired) at a state school in Massachusetts by Harvard and MIT researchers

    Boys thought they were participating in a science club

    Fed radioactive forms of iron and calcium in their milk by researchers who wanted to learn about the digestive system and the bodys ability to digest minerals

  • The Willowbrook Study1963-1966, studies carried out at the Willowbrook State School (mentally handicapped children)

    Gain understanding of the natural history of infectious hepatitis and test the effectiveness of an agent for inoculating against hepatitis

    Parents were provided information describing drug administration as vaccinations.

    Children were deliberately infected with hepatitis virus

  • U.S. Government Regulations1974 Congress passed the National Research Act

    Establishment of IRBs to review all US Dept. of HHS funded research involving human subjects

    Established National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

    Belmont Report issued in 1979

  • Belmont Report 1979Ethical Principles and Guidelines for the Protection of Human SubjectsThree basic ethical principles

    Respect for persons

    Beneficence

    Justice

  • Respect for PersonsIndividuals treated as autonomous agents and that persons with diminished autonomy are entitled to protection

    Implement respect for persons through informed consentInformationComprehensionVoluntary nature

  • Beneficence Assessment of risks and benefits

    Do not harm

    Maximize possible benefits and minimize possible harms

  • Justice Fairness or distribution

    Are risks distributed equitably?

    Who should bear the burdens?

    Who receives benefits?

  • Applications: Informed Consent

    Assessment of Risks and Benefits

    Selection of Subjects

  • U.S. Government Regulations1981-20001981: Title 45 Code of Federal Regulations, Part 46: Protection of Human SubjectsBelmont Report embodied in this regulation

    1983 Subparts B-D added to 45 CFR 46

    1991 Common Rule17 Federal agencies adopted 45 CFR 46

    2000 Educational Requirement on the Protection of Human Subjects

  • The Common Rule (Federal Policy) is also codified at:

    Department of AgricultureDepartment of EnergyNational Aeronautics and Space AdministrationDepartment of CommerceConsumer Product Safety CommissionInternational Development Cooperation Agency, Agency for International DevelopmentDepartment of Housing and Urban DevelopmentDepartment of JusticeDepartment of DefenseDepartment of EducationDepartment of Veterans AffairsEnvironmental Protection AgencyNational Science FoundationDepartment of Transportation

  • WOU Sponsored Research Office

    http://www.wou.edu/provost/oirsp/index.php

    Training: Protecting Human Research Participants (PHRP)http://phrp.nihtraining.com/users/login.php

    Institutional Review Board (IRB)http://www.wou.edu/provost/irb/Application_IRB.pdf

  • What needs to be reviewed?

    If the proposed research activity involves human participants and may contribute (e.g., through publication, presentation, or dissemination outside the WOU community) to "generalizable knowledge", then the activity will require review and approval by the WOU Institutional Review Board before any recruitment or research involving human participants may begin.

    IRB review and approval is required for ALL research projects involving human participants, regardless of the source of funding for the project or the level of risk posed to participants.

  • Research Review Categories

    Faculty completing an IRB application designate a prediction of the type of review needed, (Exempt, Expedited, Full Board). ALL Review categories require IRB approval.

    Only an IRB member can determine actual review necessary.

    Exempt from Full Board ReviewExpedited ReviewFull Board Review

    http://www.wou.edu/provost/irb/DecisionTree.php

    **Important in the consideration of research subjects

    Tuskegee, Nazi experiments

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