In 1974, the United States Department of Health, Education, and Welfare (HEW) issued regulations known as 45 CFR 46, which established ethical guidelines for the protection of human subjects in research.

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Prior to the issuance of 45 CFR 46, research involving human subjects was often conducted with little oversight or regulation. This led to several high-profile cases of abuse and exploitation of research participants, including the infamous Tuskegee syphilis experiment.

45 CFR 46: A Landmark In Human Subjects Protection

45 CFR 46 was issued in response to growing concerns about the ethical treatment of human subjects in research. The regulations established a set of minimum ethical standards that must be followed by all researchers who conduct federally funded research involving human subjects.

These standards include:

• The requirement that researchers obtain informed consent from participants before they can participate in a research study.
• The requirement that researchers protect the privacy of participants and keep their data confidential.
• The requirement that researchers minimize the risks to participants and maximize the potential benefits.
• The requirement that researchers establish an institutional review board (IRB) to oversee research involving human subjects.

The Impact Of 45 CFR 46

45 CFR 46 has had a profound impact on the field of human subjects research. The regulations have helped to protect research participants from abuse and exploitation, and have contributed to the development of a more ethical and responsible research environment.

In addition, 45 CFR 46 has served as a model for human subjects protection regulations in other countries around the world. Today, most developed countries have their own regulations that are based on the principles of 45 CFR 46.

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Issued In 1974 45 Cfr 46 Raised To Regulatory Status

The Future Of Human Subjects Protection

45 CFR 46 has been in place for over 40 years, and it has stood the test of time. However, the field of human subjects research is constantly evolving, and there are new challenges that are emerging.

One of the biggest challenges is the increasing use of big data and artificial intelligence in research. These technologies have the potential to revolutionize research, but they also raise new ethical concerns. For example, how can we ensure that big data and AI are used responsibly and that the privacy of research participants is protected?

Another challenge is the globalization of research. Today, research is often conducted across multiple countries and jurisdictions. This can make it difficult to comply with different ethical standards and regulations.

Despite these challenges, the fundamental principles of 45 CFR 46 remain as relevant today as they were when they were first issued. The protection of human subjects in research is essential to the ethical conduct of research and the public trust in research.