Tuesday, May 3, 2011

How Do We Ensure Staff Qualification in Human Subjects Research?

Clinical trials are a human endeavor. They involve humans as subjects and are, necessarily, conducted by humans. (No duh, right?) And, as with all things which we apes undertake, there is potential for error. Clinical trials are generally really, really complex. There are a lot of factors to take into account beyond even the scientific questions under scrutiny. There are logistics of funding and staffing the trials, finding space to carry them out, ensuring adequate supplies, advertising to recruit volunteers, reimbursing subjects for their time and consideration and ensuring that all documents are handled in a timely manner. You have IRB committees reviewing the protocols, consent forms and advertisements. Data Safety Monitoring Boards periodically reviewing data from trials that pose some elevated level of risk to participants. Sponsors may send representatives by to audit the trial sites, not to mention inspections by folks from NIH or FDA. There are lots and lots of people involved.

With so many individuals involved, how can we be sure that they know, at the very least, the basic requirements of human subjects research, like ethics and Good Clinical Practices? How do we ensure that the people running the trials are qualified to do so in a manner that looks out for the well-being of the subjects?

I've mentioned before that I volunteer on an Institutional Review Board committee. We have multiple committees to deal with the large volume of research going on here. Each month, there are dozens of clinical trial protocols being reviewed. Some are small pilot studies; some are part of huge, multi-site trials. Hundreds, if not thousands, of people, adults and children alike, volunteer in these studies to advance medical knowledge. Some may see a direct benefit from participation, but most take part to benefit those who will come after them. Some of the studies pose little or no risk at all. Participants show up, perhaps for a few hours, or even less, and walk out with a small token of appreciation for their time. Other studies may present the risk of very serious injury, perhaps even death. Those are usually treatments studies, comparing a new treatment against an existing one to see if the new option results in better outcomes for patients. In all of these, it is crucial for both those conducting the research and those, like myself, reviewing the research to have, at a minimum, an understanding of the ethical conduct of a human research trial, as well as some understanding of good, quality practices.

My institution requires everyone involved in the conduct or review of human subjects research to be CITI certified. CITI (the Collaborative Institutional Training Initiative) began in 2000 as a way to train research staff in human subjects protections. At the very minimum, we are required to complete the Basic course, which includes reading and understanding several documents that I have brought up before: the href="http://www.hhs.gov/ohrp/policy/belmont.html">Belmont Report, the Nuremberg Code and the Declaration of Helsinki, as well as some introduction to the laws and regulations governing human subjects research. The course presents clinical trial scenarios with some ethical question to be resolved. Certification applicants must correctly answer a minimum percentage to pass. And we need to recertify every two years. For us, if you do not pass, you do not get certified. If you do not get certified, you cannot conduct or review research involving human subjects.

Overall, it isn't a difficult certification to obtain. It takes some time, particularly the first time through, but it really shouldn't be that hard for someone to pass. What it does do, however, is that it ensures that researchers and reviewers have, at the very least, been exposed to and demonstrated some understanding of important ethical concepts. They have shown that they are aware of issues of subject protection. It may not guarantee that every single person will conduct their trial ethically, but at the very least it serves to remind them just what their role is, what is really at stake. In human subjects research, the primary, most important thing is not finding the answer to the research question; it is ensuring that everyone who participates, every child, every adult, is treated with dignity, respect and justice. CITI certification means that that goal is more likely to be obtained, that we can have greater confidence in those reviewing and conducting the research.

Do you think that CITI certification should be required of every person that is involved with the conduct or review of human subjects research? Why or why not? Are there other certifications you think should be required? Required certifications that you don't feel are necessary? What do you think are the benefits and/or drawbacks to certification of study/IRB staff? What other ways can we make sure that the people who volunteer are protected and that only the best science is done?

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