Dive Brief:
- A joint group of federal departments have been working to overhaul the rules governing human participation in medical research trials since 2011 and now have 519 pages of proposed regulations.
- The Chronicle of Higher Education reports there are three key policy changes, including that studies conducted by multiple institutions need only undergo one ethical review and studies featuring low-risk tasks for human participants need no review at all.
- The revised rules also require researchers to simplify consent forms so they use lay descriptions of risks and benefits that participants can understand, leaving more complicated terminology to appendices.
Dive Insight:
The regulations were jointly developed by 16 federal departments and agencies. They will be published in their final form after the 90-day review period and will eventually affect medical trials involving human subjects at all institutions that receive federal money. The Chronicle reports most of the new regulations would take effect one year after they are approved. The provision about partner institutions needing a single ethical review will be delayed three years, along with one about restricting reuse of medical specimens without explicit donor consent. That regulation might have something to do with the continued use of Henrietta Lacks' cancer cells.