The Department of Health and Human Services (HHS) and other Federal Departments and Agencies closed the comment period for the Federal Policy for the Protection of Human Subjects notice of proposed rulemaking (NPRM) on January 6, 2016 after extending the initial period due to robust response. The proposed rulemaking is the most sweeping since 1991 when HHS codified The Common Rule, 45 C. F. R. part 46, and recognizes the changed research environment with many multisite studies and the expansion of research with more data accessible through technology. The NPRM seeks to further the principles of autonomy and beneficence by protecting privacy and improving the consent process in the new world of research while creating avenues to lessen the administrative burden and to promote research.
The NPRM proposes to apply The Common Rule to all studies, regardless of funding source, conducted by a U.S. institution that receives federal funding for human subjects research. Currently, The Common Rule applies to studies funded by certain federal agencies. Most significantly, the proposed rules impact the following areas:
Streamlined process – To streamline the process of initiating certain activities the NPRM creates a new category not currently in The Common Rule, exclusions. Exclusions are for activity that is not research, that is low risk and for which there may be statutory protections. Accordingly, no procedures need to occur under the Common Rule to approve of the activity. An example of an exclusion would include quality assurance activities.
The exemptions under The Common Rule are expanded in the NPRM. Exemptions are different than exclusions in that certain procedures need to occur for them to proceed such as recording, privacy safeguards, broad consent, or notice. How HHS ultimately defines adequate notice will be critical in protecting privacy and autonomy rights in exempt research.
As well, a single institutional review board (IRB) would approve all multisite research. Independent IRBs would be held directly responsible for compliance with The Common Rule.
In addition, another streamline in the IRB process is not requiring continuing review of research where there is minimal risk. For instance, continuing review would not be required if a study undergoes expedited review or if there are completed interventions where only data continues to be analyzed. There would need only to be an annual confirmation that there are no changes. An IRB would be able to require continuing review with documentation of the reason for the increased requirement.
Informed Consent – The NPRM mandates a simplified informed consent form with appendices with more detailed information. The goal is to provide potential research subjects all the essential information that a reasonable person would need to consent to participation in research. The NPRM suggests using the reasonable person standard as a means to gauge the protections in the process. Currently, there are recommendations that informed consent forms should to be at no higher than an eighth grade education level, but the consent forms are often mired in so much detail human subjects may not easily comprehend the forms.
Research with Biospecimens – A particularly sweeping area of the NPRM is the protection of biospecimens (e.g., blood or urine) which is reflected in a proposed change in the definition of human subjects to include unidentified biospecimens. Hospitals, providers and laboratories collect biospecimens from patients as part of medical care. Those biospecimens may be stored and used as part of research without the patient’s knowledge. The ethical issue regarding the use of biospecimens in research is well described by Professor Ellen Wright Clayton of Vanderbilt University, “[a] tremendous amount of epidemiological research and other types of investigations have been done in the United States for decades without any informed consent or notification whatsoever….” [i] The proposed rule would require a broad consent template covering the consent for storage and maintenance of the biospecimens and the consent for future unspecified research. An alternative to the broad consent for the use of biospecimens would be a potential waiver of consent by the IRB for compelling scientific research, but consent could not be waived if the human subject declined to sign the broad consent form. Use of the IRB waiver of consent mostly likely would be rare, as proposed in the NPRM.
Secondary Research Use of Data – The NPRM also recognizes the growing business of information technology and the availability of data available for secondary use. Researchers often can find data from sources such as the internet or through mHealth devices. The goal of the NPRM seems to be able to allow the secondary use of data in research or other activities while creating a balance for privacy protections. Secondary research activity excluded from The Common Rule would be a) publically available data (not biospecimens) or data recorded without identifiers; b) data protected through the provisions of the Health Insurance Portability and Accountability Act of 1996, as amended (HIPAA); c) data confined to a single institution and its internal quality assurance programs and d) data through federally conducted research.
Exempt secondary use research proposed in the NPRM would include a) identifiable private information where there is notice, privacy safeguards and use solely for specific research and b) storage and maintenance of data for secondary use where there are privacy safeguards, limited IRB review of the consent process, and specific studies where the individual results will not be provided to the subjects. Again, the procedures for notice will be a critical component of privacy protections with secondary use research.
There has been an overwhelming response to the NPRM which proposes comprehensive changes to The Common Rule. While there is seemingly a streamlined process to allowing certain activities or research to occur in the NPRM, there are areas in need of additional guidance such as the lack of clarity on certain privacy protections. A copy of the NPRM can be found in this link and comments can be found here.
[i] Institute of Medicine (US) Roundtable on Translating Genomic-Based Research for Health, Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Product Development: Workshop Summary, Washington (DC): National Academies Press (US); 2011, 6, Ethical Challenges in the Use of Biospecimens.