Читать книгу 100 Questions (and Answers) About Research Ethics - Emily E. Anderson - Страница 14

For many centuries, research and researchers’ behavior was not systematically regulated by any laws. Although informal standards of conduct existed within certain circles, until quite recently, there were no normative rules or formal mechanisms for guiding, monitoring, or enforcing ethical scientific behavior, or for punishing those who engaged in behavior that we would now consider unethical. In the early 20th century, the first professional codes of ethics, primarily targeting medical researchers, were written in response to the discovery of—and public outrage over—significant harms to research participants. These include the Nuremberg Code, written in 1947 after Nazi doctors were tried in a court of law and found guilty of conducting harmful experiments on prisoners in concentration camps; and the Declaration of Helsinki (2013), first issued by the World Medical Association in 1964, which expanded on the principles outlined in the Nuremberg Code and linked them to the responsibilities of physicians who conduct research. Although at the time they were developed these codes reflected basic, agreed-on best practices for research involving human participants, they were not (and still are not) enforceable.

Ultimately, as more instances of disrespect and abuse of human research participants became known, the American public demanded that the federal government step in and do something. In 1974, President Nixon established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This was in response to a national news story about a government-funded study in Tuskegee, Alabama. Hundreds of Black men with syphilis were followed for decades; but they were neither told they had the disease nor treated, despite the availability of affordable and effective medication. In 1979, the National Commission issued the Belmont Report, which details the three foundational principles for ethical research—respect for persons, beneficence, and justice.

Now, all research funded by the U.S. government must follow federal regulations that were subsequently developed based on these principles. These regulations are published in the Code of Federal Regulations (CFR), which contains all rules and regulations issued by the U.S. government. Several of the CFR’s 50 sections (called “titles”) include subsections relevant to the conduct of research with human participants, such as Title 45 Public Welfare, Part 46 Protection of Human Subjects (issued by the Department of Health and Human Services [DHHS]). Although not mandated by the U.S. government, some academic and other research institutions extend these rules to all research conducted by their employees and students, regardless of funding source.

Federal guidance is regularly reviewed and updated. In January 2017, revisions to 45 C.F.R. § 46 were published by the Office of Human Research Protections (OHRP), the DHHS office responsible for the oversight of human research (http://www.hhs.gov/ohrp/). Title 45 C.F.R. § 46 defines “research” and “human subject.” It also outlines ethical criteria for research conducted with human participants, such as the information that must be told to participants about the research so they can make an informed decision about participation; and the structure, function, and registration of institutional review boards.

More questions? See #3, #8, and #9.