Lasting Ethical Implication in Research

Lasting Ethical Implication in Research: The Tuskegee ExperienceSapana PandayWidener University

History of Bioethics Commissions1996-20011974781978-831994-95The Advisory Committee on Human Radiation ExperimentsThe National Commission for the Protection of Human Subjects of Biomedical Behavioral Research200109

2In 1974, after the termination of the Tuskegee Study, the government signed the National Research Act into law and changed its research practices to prevent a repeat of the mistakes made in Tuskegee. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed to identify basic principles of research conduct and suggest ways to ensure those principles were followed, called the Belmont Report (www.cdc.gov/tuskegee/after.htm).

Since then, other bioethics commissions have been established by the president and congress including the past three presidents who have established bioethics commissions to explore ethical issues in science, medicine, and technology. The National Bioethics Advisory Commission was created by President Clinton to examined topics including cloning, human stem cell research, and research involving human subjects. The Presidents Council on Bioethics was established by President George W. Bush to report on stem cell research, human enhancement, and reproductive technologies, among other subjects. And President Barack Obama created the current commission by Executive Order in November 2009. (bioethics.gov/cms/history)

In addition to these presidential commissions, many other advisory bodies with mandates related to bioethical issues have existed within Executive Branch departments and agencies. Those groups have similarly aided the federal governments work in ensuring that scientific research and biomedical regulation and policy proceed with awareness of and sensitivity to ethical considerations. (www.bioethics.gov/cms/history)The Belmont ReportThe Belmont report is a statement of basic ethical principles and guidelines surrounding the conduct of research with human subjects.The report was published in the Federal Register, and reprints provided upon request. This was to ensure that it was readily available to scientists, members of Institutional Review Boards, and Federal employees.

ohsr.od.nih.gov/guidelines/belmont.html

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was charged with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and developing guidelines. The Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings. (ohsr.od.nih.gov/guidelines/belmont.html) The results of the task was the creation of the Belmont Report in 1979.

The Belmont report is a statement of basic ethical principles and guidelines surrounding the conduct of research with human subjects. The report was published in the Federal Register, and reprints provided upon request. This was to ensure that it was readily available to scientists, members of Institutional Review Boards, and Federal employees.(ohsr.od.nih.gov/guidelines/belmont.html)

3Boundaries between Practiceand ResearchThe distinction between practice and research is blurred especially when they occur together.Practice: interventions that are designed solely to enhance the well-being of an individual patient and that has a reasonable expectation of success. Research: an activity designed to test an hypothesis, with the potential to generate generalizable knowledge.

Practice and research may be carried on together when trying to evaluate the safety and efficacy of a therapy.ohsr.od.nih.gov/guidelines/belmont.html

We will now look at the Belmont Report in more detail and list some exerts of the report.

The distinction between practice and research is blurred especially when they occur together.Practice refers to interventions that are designed solely to enhance the well-being of an individual patient and that has a reasonable expectation of success. Research refers to an activity designed to test an hypothesis, with the potential to generate generalizable knowledge.

Practice and research may be carried on together when trying to evaluate the safety and efficacy of a therapy.

4Basic Ethical Principles

ohsr.od.nih.gov/guidelines/belmont.html

The report included at least two ethical convictions regarding the respect for persons: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.

Do not harm and maximize possible benefits and minimize possible harms are two general rules of beneficence.

Benefits and burdens of the research should be equally distributed so that some benefit to which a person is entitled is not denied without good reason or some burden is not imposed unduly. 5Applications

ohsr.od.nih.gov/guidelines/belmont.html

The Belmont Report recommended that researchers get voluntary informed consent from all persons taking part in studies that disclosed sufficient information such as the research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research. Investigators were responsible for ensuring the subjects comprehended this information.

The assessment of risks and benefits determines whether the risks to the subjects are justified.

There also needs to be fair procedures and outcomes in the selection of research subjects. This is especially crucial when dealing with vulnerable subjects.

The National Research Act also required that all Department of Health, Education and Welfare-supported studies using human subjects be reviewed by IRBs, which read study protocols and decide whether they met ethical standards.

6Common Ruleori.hhs.gov/education/products/ucla/chapter2/page04b.htm

In 1991, the US Department of Health and Human Services issued revised regulations on human subjects research that are referred to as the Common Rule. (www.hhs.gov/ohrp/humansubjects/commonrule/index.html) The main elements of the Common Rule include: Requirements for assuring compliance by research institutions.Requirements for researchers' obtaining and documenting informed consent.Requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping.

The Common Rule includes additional protections for certain vulnerable research subjects. Subpart B provides additional protections for pregnant women, in vitro fertilization, and fetuses.Subpart C contains additional protections for prisoners.Subpart D does the same for children.

7it became the standard declaration of ethical principles for research not only in the United States, but in most of the rest of the world.Robert J . Levine, MDProfessor of MedicineYale UniversityCo-Author, Belmont Report

The outcomes of the Belmont Report and the National Research Act can still be seen today with the strong presence of the IRBs at most institutions and informed consent. As stated by Professor Robert Levine, one of the authors of the Belmont Report, it became the standard declaration of ethical principles for research not only in the United States, but in most of the rest of the world.8