The Final Common Rule – The Impact on Biospecimens

Biospecimens are “samples of material, such as urine, blood, tissue, cells, DNA, RNA, and protein from humans, animals, or plants.” Biospecimens are often samples from people used in clinical research and laboratory studies to further advance the field of medicine.

Biospecimens contain molecules that can be analyzed for indications of diseases. Biospecimens may confirm whether a disease is present or absent in a particular person, and research on biospecimens is especially helpful for understanding more about how disease processes may start and progress. This understanding may lead to better detection of diseases at the earliest stages and may permit design of more effective treatments.

Biospecimens are an unbelievable resource enhancing the emerging field of precision medicine. “Precision medicine considers individual differences in genes, environment, and lifestyle to understand how to tailor treatments for each patient . . . allowing doctors and researchers to better predict which treatment and prevention strategies will work for a disease in certain groups of people.”

Every biosample is unique and important for the advancement of a better healthcare model; however, the need for biospecimen donations has been met with privacy concerns.

“The long-term success of biospecimen research depends on addressing concerns such as informed consent, oversight by institutional review boards, large-scale data sharing, privacy and confidentiality, commercialization, access to research results, and the ability to withdraw.” The story of Henrietta Lacks, an individual who had tissue cells removed that unknowingly went toward research, spurred on unprecedented medical advances and started an important discussion about consent and privacy. To address such issues, in 1991 the Common Rule was implemented to protect human subjects, addressing issues such as informed consent, respect for subjects, and a fair risk-reward ratio for subjects. The Common Rule was a necessary step to prevent research abuse, especially in vulnerable populations; however, the effects of the rule burdened progress and resulted in some detrimental effects. Consent forms became too long, and the effects on informed consent resulted in guidelines that were not harmonized; biobanks and institutions affected by the regulation requested change. On the institutional side, the Common Rule impeded the advancement of medicine, on the participant side, studies and potential donors did not even understand the lengthy consent forms originally designed to protect them.

The Common Rule is finally being updated in 2018, along with the General Data Protection Regulation being implemented, biobanks, researchers, and institutions are positioning themselves for change. The rationale for change has been supported by the rapid advancement in technology that has created new ways to de-construct data and identify previously non-identifiable information.

Included in the updates to the Common Rule, frequently referred to as the “Final Rule,” are new requirements for informed consent, the delineation of several new and expanded exempt categories of research, the creation of a new classification of “broad consent,” the introduction of limited Institutional Review Board review, the discontinuation of “continuing review,” and an update to the description of vulnerable populations, in addition to other changes.

Some of the largest updates to the updated Common Rule, dubbed the Final Common Rule, include a concise summary of the information detailed within the consent form and “broad consent.” Under the Final Rule, “broad consent” excluded a controversial that would have mandated consent for the use of de-identified biospecimens. In the process, informed consent has been improved for both the patient and for researchers who are now allowed broad consent for secondary research purposes with biospecimens.

Under the Final Rule, researchers are afforded more options to secure permission to use identifiable data and identifiable biospecimens for secondary studies. . . . The recommendations set forth in the Broad Consent Guidance, including the interpretation of a nonresponse to an offer of broad consent and the ability to combine a broad consent and primary study consent form, are intended to provide researchers helpful flexibility and clarify the regulatory pathway for securing broad consent.

Health care institutions that implement a broad consent program will need to develop extensive broad consent and refusal-tracking systems, these provisions will likely be most relevant to those involved with biorepository or databank studies.” Looking toward the future impact of this legislation, biobanks will have to stay current and re-examine the definition of “identifiable” information every four years in accordance with the mandate. Clarifying what rights individuals have with their specimens will also remain a very important aspect that impacts biobanking, as some individuals are even asking for direct compensation for their specimens. This movement has been dubbed the “biorights” movement, and because biobanking must rely on broad consent, governance systems will have to become increasingly complex to ensure the protection of specimens to meet the standards of the regulations and “biorights” movement. Finally, educating the public about the positive impact biobanking has on the future of medicine, in addition to the complexities behind commercial use and the benefits of individuals signing off on broad consent, will remain at the forefront for biobanks in the wake of new regulation.