On December 13, 2016, President Obama signed into law the 21st Century Cures Act. Passed as the Cures Act, the sweeping law aims to foster innovation, reduce administrative burdens, and otherwise enhance the nation’s approach to healthcare, medicine, and research.
Though there had been vigorous lobbying and debate over the bill over the past two years, there was ultimately broad bipartisan support for the legislation, with only 26 Representatives and five Senators voting against the final bill.
The final legislation includes a number of provisions relevant to human subjects research and oversight. In this post, I highlight the most relevant and noteworthy.
Not surprisingly, some of the law’s measures are aimed at streamlining research review and increasing IRB flexibility. The Cures Act requires the Department of Health and Human Services (HHS) and FDA to harmonize their human subject research regulations to avoid unnecessary duplication and delays within three years of the law’s enactment. Of course, what such harmonization will look like depends on whether we see a conclusion to the NPRM process and a revision of the Common Rule (a process that took a step forward January 4 when a version of the new Rule went to the Office for Management and Budget (OMB) for regulatory review.)
Though earlier versions of the bill had included a mandate for the use of single IRB review for multisite research, the final version stopped short of a requirement, and merely encourages the voluntary use of joint, shared, or outsourced review for multisite research subject to HHS and FDA regulations. Legal experts suggest this language is intended to remove regulatory barriers to using single IRB review. Similarly, the law explicitly eliminates the FDA requirement that a local IRB always be used for medical device trials. And in a move that is sure to be welcomed by both the research and research oversight communities, the Cures Act provides the FDA with the flexibility to waive or alter informed consent requirements for minimal risk clinical investigations for both drugs and devices, bettering aligning FDA’s rules with the flexibility provided under the Common Rule.
The law also includes several provisions focused on the inclusion of historically under-represented groups in research. It establishes a task force on research with pregnant and lactating women charged with submitting a report to Congress on the gaps in knowledge around such research and the associated ethical issues that arise when including pregnant and lactating women clinical research. HHS will be required to take into consideration the recommendations of the task force and may issue updated regulations accordingly. In another section, the law encourages the new National Institute on Minority Health and Health Disparities to include strategies for bolstering the representation of under-represented populations in clinical trials in its strategic plan.
The Cures Act also reflects the trend towards increased data sharing. Specifically, it allows the Director of the NIH to require award recipients to share their research data in ways that are consistent with applicable laws and regulations, including those concerned with the protection of human subjects. The legislation also requires the Secretary of HHS to submit reports to Congress about outreach activities designed to encourage compliance with ClinicalTrials.gov requirements and enforcement actions HHS has taken to ensure compliance with the registration and results submission requirements.
New privacy protections for human research subjects are also a component of the new law. The Secretary of HHS is required within one year to convene a working group to study “the uses and disclosures of protected health information for research purposes” under the Health Insurance Portability and Accountability Act (HIPAA). Another section of the law extends certificates of confidentiality, previously available only by special request, to all researchers conducting federally funded research that involves the collection of identifiable, sensitive information,
It’s also worth noting that, in a section on reducing administrative burden for researchers, the Cures Act includes several of the recommendations made in Part I of the National Academy of Science, Medicine, and Engineering’s report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. In particular, the law tasks HHS with a review of financial conflict of interest policies and regulations and calls for the director of the OMB to create, within one year, an advisory committee known as the Research Policy Board to “provide Federal Government officials with information on the effects of regulations related to Federal research requirements.” The Board, which will include up to 10 federal representatives and between 9 and 12 representatives of academic, private, and nonprofit institutions, is tasked with making recommendations on research regulations and policies with an eye toward harmonization and minimization of administrative burden.
Interestingly, the recommendations from the second half of the National Academies report, including the recommendation to withdraw the NPRM to revise the Common Rule and convene a new commission to craft a Belmont-like report outlining a new ethical, legal, and regulatory framework for human subject research, do not appear in the Cures law.
While the Cures Act also authorizes $4.8 billion in funding for three of the Obama Administration’s large research endeavors, the Precision Medicine Initiative, the BRAIN Initiative, and Vice President Biden’s Cancer “Moonshot,” Congress must re-appropriate these funds each fiscal year. And this is not the only area of uncertainty raised by the new legislation. While the law includes deadlines and timeframes for some changes, such as the creation of the Research Policy Board and the harmonization of FDA regulations and the Common Rule, it does not include timeframes for many others, including the provision allowing NIH to require data sharing and a handful of measures requiring FDA to streamline drug development and device approval processes. In some of these areas, it may be years before the Act is fully implemented.
Nor is the new law being universally welcomed. Some of the most vocal opponents of the law, including consumer advocacy groups such as Public Citizen and lawmaker Senator Elizabeth Warren, charge that Cures weakens FDA oversight of drugs and devices, threatening the public’s health; that it is overly friendly to the pharmaceutical industry; that it does not include adequate support for basic research; and that the law does not, as promised in earlier versions of the bill, guarantee NIH funding, but rather makes that funding and hence many of its proposed initiatives, subject to the annual appropriations process.
There is of course a lot more to the Cures Act than I have touched on here; whatever one thinks of its merits, there is no question it’s an ambitious piece of legislation that could have widespread implications for medicine and research. I welcome you to share your reactions to passage of the Cures Act, and what you think it might mean for your work, in the comments section.