A year and a half after the original bill left the House of Representatives, the much-discussed and highly anticipated 21st Century Cures Act became law on December 13, 2016. The legislation went through more than a few changes in those seventeen months; it expanded from four sections to twenty-five and from 362 pages to 966.
Many articles already have discussed the Cures Act—including one from our regulatory division, Kinetiq. I’ll look specifically at sections of the law that may interest the clinical research and ethics committee communities. (See the end of this blog for more articles to check out.)
Important Cures Act Sections for Researchers and the Ethics Community
Section 2012: Privacy Protection for Human Research Subjects and
Section 2013: Protection of Identifiable and Sensitive Information
These two sections aim to bolster protections of “identifiable, sensitive” information that investigators collect from research subjects. For federally funded research, research subjects must receive a statement about the protections of their data, and the DHHS may require the same requirements for other research (i.e., privately-funded). The law says that investigators cannot reveal sensitive information without research subjects’ express permission. These privacy requirements apply to information and to biological samples.
Section 2034: Reducing Administrative Burden for Researchers
This section focuses mainly on conflict of interest (COI) policies for government-funded research. Within two years, DHHS now must harmonize all research agencies’ COI reporting policies. This requirement includes coordinating minimum reporting thresholds across agencies. (It’s worth noting that late in the process Congress removed language that would have decreased income reporting requirements under the Sunshine Act.)
Section 2038: Collaboration and Coordination to Enhance Research and
Section 2044: Sense of Congress on an Increased Inclusion of Underrepresented Populations in Clinical Trials
These sections lay out increased attention to and additional reporting requirements for increasing the representation of minority populations and women in clinical research.
Section 2041: Task Force on Research Specific to Pregnant Women and Lactating Women
Under this section, DHHS has 90 days to form a task force to consider research and knowledge gaps regarding women who are pregnant or lactating. The task force will need to assess where knowledge gaps exist and how to close them, but it must also consider when pregnant or lactating women should be excluded from research.
That is a perennial hard question: how do we learn more about treatments and pregnancy while protecting mothers, fetuses, and infants from risks within research?
Section 2063: Accessing, Sharing, and Using Health Data for Research Purposes
Health and Human Services must issue guidance regarding how to access (but not remove or copy) protected health information (PHI) for research purposes.
Title III, Subtitle A: Sections 3001 – 3004
These four sections require the FDA to support the patient experience in clinical trials. Trials must include statements about patient experiences; the FDA must issue guidance about collecting reports of patient experiences in clinical trials; and the FDA must report in 2021, 2028, and 2031 about the progress it has made.
Section 3023: Protection of Human Subjects
The Cures Act calls for harmonizing of human subject protection regulations between the FDA and the rest of the federal government (that is, the Common Rule).
This section also requires that the government reduce “duplication of effort” in human subjects protections. It suggests but does not mandate central IRB and cooperative IRB reviews as ways to do that. The Cures Act also requires that any new processes accommodate local considerations and encourage community engagement from local sources.
This section of the Cures Act added formal definitions to the lexicon of IRB reviews:
- “Lead Institutional Review Board” is an IRB which oversees multiple sites in a study.
- Any references to “institutional review board” mean a lead IRB as well as a local IRB.
Section 3024: Informed Consent Waiver or Alteration for Clinical Investigations
The Cures Act introduces the possibility of waiving or altering informed consent for some FDA-governed research. This decision could mark a major step in the required harmonization of regulations; the rules around waivers of informed consent are some of the significant differences between FDA and Common Rule requirements.
The law sets two requirements for waiving or altering informed consent:
- The research must pose no more than minimal risk to participants; and
- Other measures to protect study volunteers must be in place.
The bill does not specify who will confirm decisions about minimal risk or appropriate safeguards, but the requirements seem consistent with determinations that IRBs already make.
Section 3056: Institutional Review Board Flexibility
The Cures Act removes “local” from any references to “institutional review board” for device studies, allowing studies of devices to use central (or lead) IRB review. This change aligns device regulations for IRB review with those for drug studies.
Those are some clinical research-focused highlights of the Cures Act. We’ll see how the FDA, HHS, and others do at implementing them in the coming months and years. In the meantime, here are some more articles about the new law.
- A section-by-section summary of the Cures Act (House of Representatives)
- “Cures Act Gains Bipartisan Support That Eluded Obama Health Law” (New York Times)
- “Congress’s Cures Breakthrough” (Wall Street Journal)
- “The 21st Century Cures Act—A View from the NIH” (New England Journal of Medicine)
- “21st Century Cures: Winners and Losers” (StatNews)
- “America’s new 21st Century Cures Act will speed up drug approvals. Is that a good thing?” (Public Radio International)
- “Congress passes 21st Century Cures Act, boosting research and easing drug approvals” (Washington Post)
- “Cures Law Requires FDA, HHS to Harmonize Regs” (Bloomberg)
- “Passage of Cures Act comes at expense of preventive health funding” (Modern Health Care)
- “The 21st Century Cures Act: A huge handout to the drug industry disguised as a pro-research bounty” (L.A. Times)
- “As the dust settles on Cures, what will it mean for biopharma R&D?” (Fierce Biotech)
- “21st Century Cures: Examining Medical Device Provisions” (Via Lexology)