Research%20Ethics

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Research Ethics
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Review Boards

• IRB Institutional Review Board
• Human subject protection
• IACUC Institutional Animal Care and Use
  Committee
• Animal subject regulations

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History Leading up to IRBs

• Nazi War Crimes 1942-46
• Sterilization experiments-wanted to find ways to
  sterilize large populations to ensure supremacy
  of the Aryan race
• Dried 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 examinations
• Men stood at a counter to complete forms while
  being exposed, without their knowledge, to
  sterilizing doses of X-radiation

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Nazi War Crimes 1942-46

• Typhus fever vaccine experiments
• Nazi physicians were under great pressure to
  develop an effective vaccine for typhus fever to
  administer to German troops
• Buchenwald 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

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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)

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Nuremberg Code

• 1) Voluntary consent of human subjects
• Legal capacity to give consent
• Ability to exercise free choice
• Should have knowledge of research to make
  informed decision
• Nature, duration, purpose of the project
• Method and means by which it is conducted
• All inconveniences and hazards to subject
• Effects upon subjects health or person that may
  come from participation

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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

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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

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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)

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Declaration of Helsinki, 1964

• Adopted 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

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Historically abused populations

• Mentally ill
• Developmentally challenged
• Children
• Active military
• Prisoners
• Immigrants
• Minority populations
• Uneducated or minimally educated
• Elderly

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Tuskegee Syphilis Study

• Began in 1932 to study the natural history or
  progression of syphilis
• 400 black men with syphilis, 200 not infected
• Recruited without informed consent
• Study continued until 1972 when news reached
  public via the national press
• Formal presidential apology 1997

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Radioactive Milk Research

• 1946-1956, 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

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The Willowbrook Study

• 1963-1966, 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

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U.S. Government Regulations

• 1974 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

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Belmont Report 1979Ethical Principles and
Guidelines for the Protection of Human Subjects

• Three basic ethical principles
• Respect for persons
• Beneficence
• Justice

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Respect for Persons

• Individuals treated as autonomous agents and that
  persons with diminished autonomy are entitled to
  protection
• Implement respect for persons through informed
  consent
• Information
• Comprehension
• Voluntary nature

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Beneficence

• Assessment of risks and benefits
• Do not harm
• Maximize possible benefits and minimize possible
  harms

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Justice

• Fairness or distribution
• Are risks distributed equitably?
• Who should bear the burdens?
• Who receives benefits?

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Applications

• Informed Consent
• Assessment of Risks and Benefits
• Selection of Subjects

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U.S. Government Regulations1981-2000

• 1981 Title 45 Code of Federal Regulations, Part
  46 Protection of Human Subjects
• Belmont Report embodied in this regulation
• 1983 Subparts B-D added to 45 CFR 46
• 1991 Common Rule
• 17 Federal agencies adopted 45 CFR 46
• 2000 Educational Requirement on the Protection of
  Human Subjects

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The Common Rule (Federal Policy) is also codified
at

• Department of Agriculture
• Department of Energy
• National Aeronautics and Space Administration
• Department of Commerce
• Consumer Product Safety Commission
• International Development Cooperation Agency,
  Agency for International Development
• Department of Housing and Urban Development
• Department of Justice
• Department of Defense
• Department of Education
• Department of Veterans Affairs
• Environmental Protection Agency
• National Science Foundation
• Department of Transportation

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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
  

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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.

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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 Review
• Expedited Review
• Full Board Review
• http//www.wou.edu/provost/irb/DecisionTree.php