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Week 14 - Ethics in Public Health

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Ashley Conway

on 3 October 2016

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Transcript of Week 14 - Ethics in Public Health

1. Informed consent
2. Standard of care
3. Ethical review
4. A plan for after research ends

Remaining ethical in the search for a cure
TEDTalk. Boghuma Kabisen Titanji: Ethical
riddles in HIV research. (11:11)
Week 14 - Public Health Ethics
Revisiting the Tuskegee Study of Untreated Syphilis
Cultural Icon
a symbol of what it means to conduct unethical research on human beings
Framework
for public health ethical concerns
Historical and cultural importance
1. Premise of the study
2. Research design
3. Use of deception
4. Social pressure to enroll
5. Lack of informed consent
Members of "vulnerable populations"
Research in a context of unavailable health care
Research conducted in a social environment of racism and prejudiced cultural attitudes

National Research Act - 1974
Mandates the establishment of Institutional Review Boards (IRB) to review all federally funded grants involving human subjects.

U.S. Department of Health and Human Services issues revised regulations on human subjects research referred to as Common Rule (Title 45 Code of Federal Regulations). Many institutions not legally obligated to abide by the Common Rule have adopted it and many states have similar regulations. The Common Rule defines eight elements needed for a person to give "informed consent" to participate in a research project.
The Department's Institutional Review Board (IRB) assures the protection and safety, rights and welfare of human subjects in research.

The IRB approves human subjects research projects that adhere to the ethical principles set forth in The Belmont Report (Respect for Persons, Beneficence and Justice) and the Federal regulations for the protection of human subjects, including Title 45, Part 46.

New Jersey Department of Health
1978 - National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research - The Belmont Report summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence ("do no harm", and justice. Three primary areas of application are also stated. They are informed consent, assessment of risks and benefits, and selection of subjects.
1947 - The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War.
1964 - World Health Organization - The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document of human research ethics. 1975 revision clearly stated that "concern for the interests of the subject must always prevail over the interests of science and society" as well as establishing the system of IRB.
When faced with an ethical dilemma what choices do you have?
- NJ DoH
Centers for Disease Control and Prevention. U.S. Public Health Service Syphilis Study at Tuskegee: http://www.cdc.gov/tuskegee/index.html

Jennings, B., et al (eds). Ethics and public health: Model curriculum. Association of Schools of Public Health.

State of New Jersey, Department of Health. Institutional Review Board: http://www.state.nj.us/health/irb/index.shtml
Ashley Conway
Principles of Public Health
Fall Semester 2013
Bloustein School of Planning and Public Policy
Rutgers, The State University
1. A statement that the study involves research,
and description of that research and its purposes

2. A description of the reasonably foreseeable risks

3. A description of the reasonably expected benefits

4. A Disclosure of appropriate alternatives

5. A statement about maintenance of confidentiality

6. An explanation of possible compensation in case of injury, if the study involves more than minimal risks

7. Information about how subjects can have questions answered

8. A statement that participation is voluntary
- DHHS
- Jennings et al
When faced with an ethical dilemma, what choices do you have?
Others?
Full transcript