Controversial U.S. Medical Study Raises Informed Consent Questions

Michael Werner is a Partner in our Washington D.C. office

Regulators Scrutinize Studies Involving Human Subjects for Compliance with Existing Regulations

The recent controversy surrounding a study of newborn babies in universities across the United States demonstrates the importance of compliance with human subject protection regulations in medical research. The U.S. Department of Health and Human Services (HHS) found that many of the nation's most prestigious universities failed to adequately inform parents of newborn children enrolled in a government-funded research study of the risks associated with participation in that study. According to The New York Times, the risks of participation — which included increased chances of blindness or death — "were not properly communicated" to the parents, "depriving them of information needed to decide whether to [have their newborn babies] participate."

The sanctions these universities could face for failure to comply with federal regulations are still to be determined and could be as severe as being temporarily barred from receiving federal research funds. Regardless, the study and the institutions' reputations have been tainted. The HHS report and the attendant publicity will add to the scrutiny faced by research institutions. Thus, it is essential that universities are familiar with the regulations that govern protecting subjects in research.

Current Regulations Protect Human Medical Research Subjects

Research that is funded by U.S. government agencies, such as the National Institutes of Health (NIH), is governed by the regulations found at 45 CFR Part 46. The regulations are enforced by the HHS Office for Human Research Protection (OHRP). These regulations have been adopted by 15 federal agencies and are enforced by each agency for the research it funds with support from OHRP. FDA has similar regulations that are available at 21 CFR Part 56.

It should be noted that human subject protection rules of 45 CFR Part 46 apply to U.S.-funded research even if that research is performed in other countries. In fact, federal regulations state that federal agencies can allow local law to govern only if they find that the protections offered human subjects are issued either by sovereign states or by an organization whose function for the protection of human research subjects is internationally recognized and these protections "are at least equivalent" to those provided by U.S. regulation.1 In these cases, the agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in U.S. regulations.2 Thus, institutions interested in conducting research abroad must still comply with these rules.

Ethical Foundation for Human Subject Protection Regulations

U.S. human subject protection regulations have their ethical genesis in The Belmont Report, written in 1974 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The report established the basic ethical principles and guidelines to resolve ethical problems that surround the conduct of research with human subjects that are still used today.3

The report identified...