An industry sponsor withdraws funding for a trial. An investigator retires or completes training and can’t continue with the research. Enrollment or implementation issues cripple a study. A data monitoring committee raises safety or futility concerns about a protocol. A regulatory authority suspends or terminates the research due to violations of regulations or laws.

These are among the myriad reasons that human subjects research may be paused or terminated unexpectedly. When this occurs, is it in participants’ best interest to allow some or all of the study procedures, care or treatments to be provided outside of a formal trial? (To clarify, this is not about whether to provide post-trial access to study-related interventions.)

As the fallout from a February cyberattack against Change Healthcare continues, the HHS Office for Civil Rights (OCR) has created a dedicated website and reminded HIPAA covered entities (CEs) using the claims and prescription drug processor as their business associate (BA) that they are required to follow the Breach Notification Rule.

Yes, that generally means universities’ medical schools, teaching affiliates and hospitals that use Change Healthcare to process claims, prescriptions or other transactions that involve protected health information (PHI) must notify OCR, the media and affected patients within 60 calendar days of knowledge of the breach resulting from the Change Healthcare attack.

In December 2022, Julie Kaneshiro—then deputy director of the HHS Office for Human Research Protections (OHRP)—disclosed that the agency had 32 positions but that only 20 were filled, leaving 12 vacant or “on hold,” due to “resource constraints.”^[1] But OHRP’s budget justification documents for fiscal year (FY) 2025—which begins Oct. 1—propose little additional funding and no new employees. Thus, the situation for this critical oversight agency will not improve anytime soon, and it is likely to continue operating with at least seven fewer staff members than OHRP itself said are necessary.

The Advanced Research Projects Agency for Health (ARPA-H), a two-year-old agency modeled after the iconic U.S. Department of Defense (DoD) unit that invented the internet and GPS, is reaching high in its initial projects to solve diverse problems, such as how to repair osteoarthritis in aging joints and how to prevent ransomware from being deployed against rural hospitals.

Renee Wegrzyn, ARPA-H director, said in a presentation at the Public Responsibility in Medicine and Research annual meeting that the agency’s mission is to “accelerate better health outcomes for everyone,” and that involves robust public-private partnerships, plus a nimble, fast-to-act mindset that moves away from traditional grant funding.^[1]

Later this month, the National Science Foundation (NSF) expects to “develop and implement new policy review processes for national security concerns,” as required under the CHIPS and Science Act of August 2022 and recent appropriations legislation.^[1] In announcing its plans March 21, NSF said these “will be made effective in time” for a May 24 deadline imposed by the CHIPS Act.

◆ Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about specific changes and recently issued what Mike Lauer, NIH director of extramural research, called an “uber notice.” Lauer discussed the changes in a recent blog post. They include a simplified review framework applicable to most research project grant applications, revisions to the NIH fellowship application and review process and the use of common forms for biographical sketches and current and pending support. (4/18/24)