How Will Proposed Changes to the Common Rule Affect Commercial Life Sciences Firms?
The announcement of regulatory changes can fill life sciences companies with trepidation. More often than not, the implementation of such updates would require resources and manpower that organizations cannot provide without significant investment or reallocation. However, it seems like tightening guidelines are becoming the norm in the life sciences industries.
The latest set of regulations to join this trend is the Federal Policy for the Protection of Human Subjects, or the Common Rule. As the name implies, the Common Rule is intended to oversee the well-being and privacy of people who participate in scientific research. First passed in 1981, the last update to the policy took place in 1991. But in the twenty-five years since those alterations were made, we have seen significant technological and medical advances.1 In order to maintain the original purpose of the policy, experts generally agree that an overhaul is long past due.
Proposed Changes to the Common Rule Will Bring Regulations in Line with Current Technologies
To that end, the United States Department of Health and Human Services, as well as fifteen other regulatory bodies, issued a Notice of Proposed Rulemaking (NPRM) to revise the Common Rule. The proposed changes to the Common Rule make modifications to two major areas: the requirements for biospecimen research and data security safeguards. At first glance, it seems like these changes won’t affect commercial life sciences organizations. After all, the Common Rule generally applies only to research funded by the federal government. In reality, however, the NPRM could have far-reaching effects upon all sectors of the life sciences field.
To be prepared, commercial life sciences organizations need to track the progress of the NPRM and determine potential ramifications should these alterations be accepted.2 The reasons for this include:
- While the changes would not directly affect commercial life sciences firms, many of those same organizations fund projects conducted at institutions that also carry out research funded by federal sources. If the changes necessitate modifications to existing protocols, it is likely the alterations will apply across the board in these facilities regardless of funding source.
- The FDA has already announced the intention to modify its regulations to fall in line with the NPRM since the policy aligns with the agency’s overall mission. Because many commercial life sciences firms develop products that fall under the jurisdiction of the FDA, the amendments could have a larger effect than previously anticipated depending on how the FDA proceeds.
- As part of its amendments affecting biospecimen research, the NPRM seeks to increase the efficiency of the review process. If the conditions outlined previously do occur, then life sciences companies will need to ensure that their own internal review processes are streamlined with minimal bottlenecks so as to comply with external requirements.
Unsurprisingly, the open commenting period for the NPRM revealed many concerns about the potential amendments.3 While it remains to be seen whether the changes will slow or even inhibit research, there is no denying that the prospect of implementation is a daunting one. As we’ve seen with other regulatory changes or expansions, agency expectations are often strict in terms of timetables and deadlines.
Nevertheless, we can expect that some form of these amendments will go through once the exact terms have been clarified and adjusted. At the very least, we should anticipate more stringent guidelines covering data security, which has become a huge concern in a modern market where organizations span the globe. In preparation for these changes, life sciences companies should look at their organizational processes and confirm whether they’re robust enough to support compliance in the face of changing regulations.
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- “Clinical Research to Implement Long Overdue Changes to the “Common Rule” for the Protection of Human Subjects,” December 28, 2015, http://blog.legalsolutions.thomsonreuters.com/government/clinical-research-to-implement-long-overdue-changes-to-the-common-rule-for-the-protection-of-human-subjects/ ↩
- “Impact of Proposed Federal Research Regulation Amendments (the Common Rule NPRM) on Life Sciences Companies,” November 13, 2015, http://www.bna.com/impact-proposed-federal-n57982063532/ ↩
- “‘The future of human health’ may ride on a bureaucratic change most people are ignoring,” January 5, 2016, http://www.techinsider.io/proposed-common-rule-changes-go-unnoticed-2016-1 ↩