QA Talk - Research Misconduct - Part 1

As many of you know, I specialize in conducting audits of research investigators and various entities in the pharmaceutical and biotechnical industry. I've been auditing for more than 10 years now and in doing so I have been involved with 3 investigator sites guilty of research misconduct (as defined by the Office of Research Integrity or ORI) and countless sites guilty of sloppy practices that looks as bad as research misconduct. These sites were located in Canada, India and the United States. These are only the sites that were discovered because they were unlucky (or lucky depending on your point-of-view) enough to be chosen for an audit.


Do you know that most people go through this job for 20 to 30 years and never identify research misconduct? And I have personally identified 2 and assisted with 1 in less than 5 years. Is research misconduct on the rise or has it been there all along and we've been missing it?

Could you identify alleged research misconduct (i.e. fraudulent practices) if you saw it? Do you know what to look for and how to assess what you find?

I'll be the first to admit that research misconduct is not easy to identify and once you've found it - oh, the work involved! I've spent anywhere from 2 weeks to 1 month investigating misconduct.

In a series of articles on this blog, I will tell you how most of my discoveries come about and then I'll tell you how I handled them.

HEY CRA's! LISTEN UP!!!

Do you know that if you're the CRA for a site that's found to be fraudulent, the FDA could hold you responsible for not identifying the problem?

For one of the sites reported to the Agency, I attended the FDA inspection. The inspector made a point of assessing the CRA's monitoring reports to the site. The investigator also questioned the CRA's experience, and wanted to know why the CRA did not find the problem before I found it. Well, I could not answer that because I honestly did not know. But another colleague told me that the CRA working a clinical site for his company was cited by the FDA for not discovering the misconduct "early enough" in the monitoring practices. I don't know a lot about that situation but I will say that I can imaging any "run-in" with the FDA or any other regulatory agency have got to be pretty unnerving. Finding yourself in a position of defending your expertise, in fact, your performance cannot be stress-free. Additionally, it does not bode well with your company who is probably looking for a scape goat anyway.

For the site where I discovered miscoduct - when I made my report to that company's senior management, the first question asked was "Why didn't the monitors catch this?" then it moved on to "Why didn't the project manager catch it - afterall, they visited the site, too?" The one thing I've learned in the corporate environment is that somebody must always be "blamed". Now, from my standpoint (it's the QA in me), I'm thinking: "How bad is it? Were any subjects hurt? Can the PI be brought into compliance?" Then I realized that management was still stuck on finding a scapegoat so I had to wait for them to play catchup to me. (lol)

Anyway, from my experience, I would caution you to take your monitoring duties seriously and if you don't know the regulations governing monitoring practices, you really should learn them. Compliance is about more than making sure the investigator's site is following the sponsor's instructions (which sometimes contradicts the approved protocol).

In Part 2 of this series, I will discuss "discovering" the misconduct and how it was handled afterwards.

Until then.......

Have a Quality day!