The case of Henrietta Lacks illustrates the history of dubious practices in medical research, and provides one of many examples that have contributed to the ongoing efforts to improve the ethical standards of medical research so that those who contribute research material are treated fairly. This is an issue that involves a range of actors, including governmental and international agencies which make the policies and research institutions like Stevens that must follow them.
"Informed consent" is defined as:
Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment. (Medical Subject Headings glossary, introduced 1973)
The process by which the term was coined and made standard in medical research began in 1947 and continued throughout the rest of the 20th century.
U.S Code of Federal Regulations subsections on Human Subjects
With the Belmont Report as the guiding document, during the 1980s the Department of Health and Human Services and the Food and Drug Administration revised and aligned their federal regulations regarding human subject research. This was codified in the Federal Procedure for Protection of Human Subjects, known as the "Common Rule," in 1991, which became subpart A of Title 45 of the Code of Federal Regulations, Part 46 (45 CFR 46), the regulations for the Dept. of Health and Human Services. Fifteen federal agencies revised their codes to align with the Common Rule, and each agency's regulations included the Common Rule as their own subpart A.
An update to the Common Rule was proposed in 2011, citing The Immortal Life of Henrietta Lacks as an example of the need for explicit consent regarding the use of biospecimens. This proposal was updated and revised per the results of multiple open comment sessions, and finally adopted in January 2017, taking effect in January 2018.
Stevens policies and procedures:
U.S. governmental agencies: