On 8th of September, the Federal Register published a notice jointly made by 14 US government agencies including, prominently, the Health and Human Services Department (HHS), the National Science Foundation (NSF), and the Environment Protection Agency (EPA), that announces their intentions to revise the current policies regarding the protection of human subjects. As noticed in the summary of the proposal, the main aim of this policy revision (Notice of Proposed Rulemaking, NPRM) is to “modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991” that will “better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators”. Since the current rules governing research related to human-subjects have been summarily rectified more than 20 years ago, which far predates the age of Omics, genetic diagnostics, and personalized medicine, such revisions and follow-up changes in law are surely necessary to keep everything up to date. Hence, the question is: what regulations will be revised, and how will they affect both industry as well as research?
Whilst the original NPRM article published on the Federal Register is over 130 pages long, it may still be worth the read for decision makers in the fields of both industry and research – at the very least – the executive summary pages and to distill key points that are considered important. For example, the NPRM suggests that only a single ethics review may be required for multiple clinical trials conducted in physically separate sites in the future, as far as they are covered under the same project title. This is especially important for the current trend of pharmaceutical R&D, which tends to be decentralized across establishments and even continents. Previously, it would require a huge amount of time and resources to coordinate multiple ethics committees in different research centers, since each committee is legally bound to their own establishment. Thus, the proposed single-review policy is expected to greatly reduce both time and resources at the administrative level, which is certainly beneficial for the pharmaceutical industry.
However, apart from all the benefits, there are still potential pitfalls lurking within the NPRM, which calls scientists and researchers to actively participate in the policy-making process and make their opinions count. One representative example is that the NPRM now suggests that the storage and distribution of human-related samples require explicit consent from the donors. Currently, such consent is only required when the identities of donors are associated with the samples, and anonymous or purposely de-identified samples are not bound to such restrictions. If rectified, a large amount of samples and their associated data, notably for those who may potentially contribute to a significant portion of the US Precision Medicine Initiative that will eventually include health data from 1 million volunteers, would be rendered inoperative for the difficulties in re-obtaining consents from deceased participants.
To summarize, it is crucial for all academic researchers as well as industry decision-makers to keep a close watch on this policy-making process and, whenever necessary, to make their opinions known to both the bureaucrats as well as the public. Although there is still a few more years until the current NPRM gets rectified, it is never too early to actively participate and make influence on this process, for its vital roles in shaping both the research and the industry for the next 10-20 years.
References:
https://www.federalregister.gov/articles/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects
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