Jim Gearhart | Quorum Review IRB

by Jim Gearhart

Top 5 Quorum Blogs of 2017

2017 felt like it had more news than any 12 months could hold. However, after the Feds released the Common Rule in early January, events in research and ethics were relatively quiet as agency leadership transitions, the Affordable Care Act debate, and pharmaceutical pricing dominated the year’s healthcare discussions.

Looking back at our 2017 blogs and which ones attracted the most attention, we see some trends in what was on people’s minds. The implications of the new Common Rule, the 21st Century Cures Act, and guidance on new technologies topped the list of what you checked out most often at our Knowledge Center. The most-read Quorum blogs from 2017 are below.

5. FDA Analyzes Safety Vs Effectiveness (February)
Early in 2017, the Food and Drug Administration (FDA) reported on 22 instances where promising Phase II results failed to carry over into Phase III. The 22 examples of divergent results concerned both new treatments and expanded use of approved treatments.

4. For Electronic Informed Consent, “Just Following the Rules” May Not Be Straightforward (January)
As more sponsors, CROs, and sites began to assess the feasibility of electronic informed consent (eIC or eConsent) forms in research, the FDA and Office of Human Research Protections (OHRP) released a joint guidance in a Q&A format. The guidance captured the two agencies’ expectations for using eIC.

3. 5 NPRM Proposals You Won’t See in Common Rule 2018 (April)
2017 opened with the release of long-awaited changes to the Common Rule. After six years of proposals, counter-proposals, debate, and revisions, the final approved version became official on January 19 and starts going into effect in in 2018. This blog from April looks at what early suggestions did not appear in the final version.

2. FDA Aligns Minimal Risk Consent Policies With the Common Rule (August)
One long-standing discrepancy between rules at the FDA and at OHRP was a differing approach to waiving informed consent for research. Common Rule guidelines provided more opportunities for waivers than FDA rules did, but in July the FDA announced it would allow researchers to apply waivers that previously only existed for Common Rule protocols to FDA research. This marked another step toward policy harmonization between the FDA and OHRP, which the 21st Century Cures Act now requires of both agencies.

1. 21st Century Cures Act—What’s In It For Researchers and IRBs (January)
After years of deliberation, Congress enacted the 21st Century Cures Act in late 2016. The law required changes in many areas of medical research. In this blog from January, we consider 11 sections that could affect how IRBs do their work. The Cures Act laid out an ambitious agenda for updating how we conduct research, from protecting sensitive health information to protecting pregnant women in research to harmonizing research policies across government agencies. This story could easily extend into 2018 and beyond, as agencies face up to the law’s myriad implementation requirements.

Thank you again for tuning in to the Quorum Knowledge Center, where we strive to keep you current on the important issues facing clinical research and ethics. Throughout 2018, we will continue to move research forward together by sharing thoughts and information about regulatory changes and the research industry.

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