I’m attending the 53rd Annual NCURA (National Council of University Research Administration) in Washington, D.C. I’ve been here since last night, and got started this morning early with a networking breakfast and an interesting session on the recent legal developments in academic research and clinical trials, given by Rachel Nosowsky, J.D. From the University of California.
She flew through a ton of information, but there were several points that were particularly interesting:
1. We are all getting ready for the PHS Financial conflict of interest guidelines that will be going into effect mid-next year. However, you may not realize that FDA COI guidelines soon to follow are more wide ranging and have deeper implications for institutions and investigators. I learned that sponsors under the FDA rules may be interpreted as any supporter of the research study including the institution itself if there is cost share or funding from the university. In addition, “investigator” may end up being considered as any significant person who contributes to data collection, not just the PI or co-investigators.
2. DHHS has proposed updates to the Common Rule (use the Google machine) and the comment period has recently closed. There are two important implications that may come out of this update: first, mandates for a single IRB when conducting multisite trials, and second, increased regulation and privacy controls for research involving biospecimens, due to the inability to truly deidentify data. These provisions alone have a potential to significantly impact research administration practices in biomedical research.
3. Another potential rule that is in the works is the disqualification of investigators rule within DHHS. This has been in the works since April 2011. If enacted, it could impact the status of investigators who are able to participate in research, as well as the status of the research data an investigator that has been found in poor standing has ever touched. This means that an investigator who has accrued a lot of patients to trials over a number of years could have all of their data discarded if one trial is found to be problematic. This could potentially delay or overturn the approval of drugs or devices already on the market.