The Department of Health and Human Services (HHS) has issued long awaited, comprehensive update on how medical research should be conducted. The Common Rule, 45 CFR 46 subpart A, issued 26 years ago and established basic protections for human subjects in research conducted by or supported by the HHS and other federal agencies and departments. The revised Common Rule was released in draft form in 2015. The Final Rule as then issued in January 2017 with new direction on a number of aspects to clinical research. What is most interesting to KCAS, and the rest of the Bioanalytical world, is the Final Rule dropped a controversial requirement mandating the broad informed consent from research subjects in the use of their leftover, de-identified blood, urine and tissue samples. In the original Common Rule proposal, the informed consent requirement would have required laboratories to obtain or confirm record of the patient’s informed consent granting the continued use and research on these samples – an arduous task when you consider the documentation retention and tracking, especially with multi-site, late phase studies that often enroll thousands of patients.
The rationale for the original proposed rule requiring informed consent was well-intentioned. A renowned, historic case where tumor tissue from a patient named Henrietta Lacks was used without informing her. Henrietta’s cancer cells became one of the most important cell lines in cancer research. These cells, referred to as HeLa, became invaluable in basic research, paving the way in the development of advances such as the polio vaccine. However as important and valuable to society as these cells were, they were obtained without informing the patient (of which the family only learned more than 20 years after her death and two years after her name was published as the source of HeLa cells in a scientific journal). This event has influenced the adoption of ethical guidelines and legal regulations for biomedical research that in present day generally requires researchers to obtain voluntary, informed consent from individuals before performing experimental study procedures. The Common Rule is an evolution of other notable ethical guidance mandates such as the Nuremburg Code (Nuremburg Military Tribunal), Declaration of Helsinki (World Medical Association), National Research Act (which created Institutional Review Boards, prompted by the Tuskegee Study), and the current form is most influenced by the Belmont Report written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
The biospecimen provision in the proposed Common Rule successfully argued by numerous research institutions, Contract Research Organizations, and scientists would have had a negative impact on future research. Institutional Review Boards (IRBs) are expected to provide proper disclosure in the informed consent process on how biospecimens may be used in clinical research. With this provision in place, the Final Rule did not require laboratories to obtain confirmation of consent.
KCAS agrees with the language adopted in the Final Rule, since it strikes a realistic balance. This also underscores the importance for industry and institutions to provide meaningful comments in the regulatory review period. In seeking clarification on these recent revisions, KCAS wanted to establish a more concrete answer to this question for the same reason we do many things – we look out for our customers and their best interests. Many within our industry may or may not have even been aware that the Common Rule revisions had taken place; but we did. We wanted to ensure the revisions addressed concerns that many of our customers might have.