Title: Research%20Ethics
1Research Ethics
2Review Boards
- IRB Institutional Review Board
- Human subject protection
- IACUC Institutional Animal Care and Use
Committee - Animal subject regulations
3History 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
4Nazi 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
5Nazi 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)
6Nuremberg 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
7Code 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
8Code 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
9Code 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)
10Declaration 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
11Historically abused populations
- Mentally ill
- Developmentally challenged
- Children
- Active military
- Prisoners
- Immigrants
- Minority populations
- Uneducated or minimally educated
- Elderly
12Tuskegee 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
13Radioactive 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
14The 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
15U.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
16Belmont Report 1979Ethical Principles and
Guidelines for the Protection of Human Subjects
- Three basic ethical principles
- Respect for persons
- Beneficence
- Justice
17Respect 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
18Beneficence
- Assessment of risks and benefits
- Do not harm
- Maximize possible benefits and minimize possible
harms
19Justice
- Fairness or distribution
- Are risks distributed equitably?
- Who should bear the burdens?
- Who receives benefits?
20Applications
- Informed Consent
- Assessment of Risks and Benefits
- Selection of Subjects
21U.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
22The 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
23WOU 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
24What 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. -
25Research 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