Issued in 1974, 45 CFR 46 raised which of the following to regulatory status?

A. US Public Health Service Policy.

B. The 1974 National Research Act.

The answer is A: US Public Health Service Policy.

In 1974, 45 CFR 46 raised 1966’s US Public Health Service policy involving research on humans. The answer is further briefly explained below.

What is 45 CFR 46?

The Code of Federal Regulations of the United States marked as Title 45: Public Welfare, part 46 is better known as 45 CFR 46. This deals with providing protection for human subjects for research work that is either supported by or carried out by various federal agencies and departments.

US Public Health Service Policy

45 CFR 46 helped create a common federal policy to protect the human subjects with the same finding acceptance with the Office of Science and Technology Policy while being issued further by each of the agencies and departments that were listed in the document.

This code has four subparts to it:

  • Basic protection for all subjects of human research.
  • Women, human fetuses, and neonates to get additional protection.
  • Prisoners to be given additional protection.
  • Children also to be provided with additional protections.

Though additional protection for human fetuses is a clause under 45 CFR 46, it applies only to the period of implantation to birth. This regulation is not applicable to embryos prior to implantation.

History behind the 45 CFR 46

Federal protection for subjects of human research was developed only in recent memory. The US was a signing member of the 1964 Helsinki Declaration that prescribed ethical guidelines.

Basic regulations that offered protection for the human subjects in research conducted by the US Department of Health and Human Sciences came into being on May 30, 1974.

However, a federal policy to this effect would take shape only after the National Research Act (Public Law 93-348) was passed on July 12, 1974.

The National Research Act further gave birth to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research which was entrusted with evaluating ethical principles concerning the use of humans as the subject for medical research.

They were also tasked with the development of guidelines for medical, psychological, as well as behavioral research.

The evaluations carried out by this body went on to be published as the Belmont Report in the year 1979 with interim reports such as Research on the Fetus in 1975, Research Involving Prisoners in 1976, and the 1977 Research Involving Children.

Controversy involving the National Research Act

There were several major public scandals that gave birth to the National Research Act with the Tuskegee Syphilis Study being worthy of notable mention.

Conducted between 1932 and 1972, this study had as its subjects 600 African-American males from the low-income group. Many of them were found to have syphilis as a result of the study but were never told about this medical condition.

Though a cure for syphilis had been discovered back in 1950, the subjects were left in the dark about their ailment. Even when doctors diagnosed them with syphilis, they were denied access to proper medical care and treatment.

As a result, many of the subjects ended up dead with the study receiving widespread publicity and criticism. This was the first time the need for protection of rights of human research subjects was brought to public attention.

45 CFR 46: What does the most recent version say?

The latest version of 45 CFR 46 deals with protection for human subjects in all forms of research regulated, conducted, or supported by any federal agency or department within or beyond the shores of the United States. Research based on existing data, or anything to do with public service or benefit programs is given an exception.

There are institutional review boards created as well for review and compliance enforcement. 45 CFR 46 also defines minimal risk which is the minimum risk that the subject will encounter both physically and psychologically. The regulations state that this risk should not exceed what the individual would encounter in daily life.

Informed consent is another area mandated by this regulation where the risks and benefits of the research process should be explained to the human subject.

They should also be made aware of the voluntary nature of their participation with the right to discontinue participation any time they feel like doing so.

About additional protection for pregnant women, fetuses, and newborns

This subpart states that any research being conducted on a pregnant woman should be of direct benefit to either her, the fetus or both. In case no benefit arises, but there are no other means of conducting this research, then too it shall be considered legal.

The woman cannot be induced into terminating the pregnancy by such means as money. Non-viable neonates can be used for research purposes as well subject to certain conditions and approvals from the IRBs. Neonates can be availed for research after delivery provided they are not subjected to any threat to their survival.

Additional protection for prisoners and children

Prisoners need to provide additional protection since they have limited ability to make a well-informed and voluntary decision about participation. The advantage from participation should be reasonable while not influencing his decision-making about weighing up the dangers.

Every prisoner should also be fairly treated, and the terms of the research are explained to them in simple language. Children participating in the research should be benefited while being subjected to minimal risk.

The topic of research should involve understanding and elimination of a serious problem that affects children’s health and welfare.

Parents or legal guardians of these children need to give their consent. For those without a legal guardian, the research should be as prescribed by their status as wards of the state or that of general facilities such as camps or schools where the majority of participants are not part of the former category.

Conclusion

The most recent version of the 45 CFR 46 was revised and brought into effect on June 23 of the year 2005.

It is worth noting, that institutions not based in the US but engaged in research involving human subjects that are not exempted but supported or conducted by any of the federal agencies or departments, will also be brought under the ambit of this regulation.

References

  1. 45 CFR 46- Human subject protection: Retrieved from embryo.asu.edu
  2. Frequently asked questions on 45 CFR 46: Retrieved from hhs.gov
  3. Federal Policy for protecting human subject: Taken from federalregister.gov

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