Common Rule Infographic

by Jim Gearhart

Research Resolutions for the New Year

The holidays are upon us again! The decorations are out, music in public places has noticeably more jingling to it, while shopping lists and social calendars have a decidedly festive bent. Pumpkin spice flavors have eased, and eggnog has found its way back on the shelves.

All this suggests that not only is it time to reflect on the past year, but also to look forward, and start thinking about resolutions for next year. Here is a short list of suggestions for your medical research-related commitments.

  1. Keep Current: Did those two years of preparation for the new Common Rule whiz by for you, too? Now that 2019 is upon us, the Common Rule’s 2018 Requirements will be in effect soon. We’ll doubtlessly see continuing conversations throughout the year as the research world puts the 2018 Requirements into practice.
  2. Meet a Reasonable Person: The Common Rule is borrowing a concept from the legal world to assess informed consent language. Get to know the idea of the Reasonable Person to see how it might affect consent forms in 2019 and beyond.
  3. Get Your IT Systems Checked: Research in the 21st century relies on an ever-growing list of computerized integrations, and regulators want assurances that those technology solutions check all the boxes for safety and security. But you don’t have to do that all yourself; a resolution in 2019 can be to understand how third-party attestation for Part 11 compliance can ease your technology compliance challenges.
  4. Know Your Neighbor: The United States and Canada share more than just the world’s longest land border. In medical research the two countries share the same fundamental goal of protecting human subjects, but they do differ in some of the particulars. Resolve to learn more about research on the other side of the border in areas such as minimal risk research and regulating biospecimens.
  5. Stay in Harmony: The 21st Century Cures Act urged regulatory agencies to continue harmonizing their rules for conducting human subjects research. 2019 could be a big year for those rules to start looking more alike; keep an eye out for more FDA harmonization with the Common Rule, possibly even including cooperative research under a single IRB.
  6. Go Mobile: Get ready for more decentralized trials, as device technology and the regulatory environment increase the practicality of remote trials. Apple’s ResearchKit will turn four, health trackers proliferate, the FDA endorsed Apple Watch’s electrocardiogram, and more health care apps are appearing all the time.

Keep these resolutions in mind and be sure to check the Quorum Knowledge Center for industry news, analysis, and opinion.

Tags: , , , , , , , , ,