tag:blogger.com,1999:blog-525778292565554519.post6904062124921700760..comments2018-01-03T07:02:32.059-05:00Comments on Institutional Review Blog: Draft Comments on Training RequirementsZachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-525778292565554519.post-25950185109809683942008-09-17T15:59:00.000-04:002008-09-17T15:59:00.000-04:00Thank you for your comment.To answer your first qu...Thank you for your comment.<BR/><BR/>To answer your first question, I was required to complete online ethics courses at Columbia University and George Mason University, which uses the CITI Program. Out of curiosity, I also completed the course at UCLA, and looked at courses offered by other universities. While the UCLA course was better than the others, I found all of them heavy with information that was irrelevant to much social science work and, in some cases, inaccurate or misleading.<BR/><BR/>I am troubled by your description of ethical training at your hospital. As I understand you, first-time investigators cram their ethical study into a short time, perhaps the night before they receive a grant. And IRB members can't find the time to learn about the research whose ethical merit they are judging. If these researchers and reviewers are looking for a quick way to get their ticket stamped, then the CITI Program is just the thing. But you don't claim that such training leads to serious consideration of the ethical challenges posed by each project. Indeed, your proposals for a certification process, recommended curricula, and continuing education suggest that you would like to see both researchers and reviewers spend more time studying.<BR/><BR/>That leads to a second question--what should they learn? You write that "research is all about determining gold standards and comparing novel ideas to them." That's fine, so long as the emphasis is on the plural in standards. I believe that the gold standard for ethical training in genetic therapy is rather different from that in the ethnography of underground economies. And where are novel ideas to come from, if not the researchers who have invested the most in a given scholarly problem?<BR/><BR/>Zachary SchragZachary M. Schraghttps://www.blogger.com/profile/07101709506166167477noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-70489094896745086322008-09-16T23:07:00.000-04:002008-09-16T23:07:00.000-04:00Dear Mr. Schrag,Your response to the OHRP request ...Dear Mr. Schrag,<BR/><BR/>Your response to the OHRP request for public comment in regard to training requirements for investigators is well researched and eloquently drafted. I must ask if you have drafted your response from an academic perspective based on the review of the literature or if you speak from personal Human Research Protection Program (HRPP) training experience? <BR/><BR/>As an individual who has done both, I must share with you, that in my experience in a non-University affiliated community teaching hospital with seven active residency programs requiring scholarly activity, your proposed solution would never occur. Residents are limited to 80 duty hours and a 60 hour limit is under consideration. There is just not enough time left in their schedule to provide HRPP training. The residency program directors just don’t allow it. Another problem we experience is the first time principal investigator who is interested in research or mandated to conduct research that does not know where to begin but has a sponsor ready to send them a regulatory binder the next day. Another is that the IRB members find it difficult to review all the research for the meeting. How would they identify the current literature and then find time to actually read it?<BR/><BR/>In my opinion, your proposal grants the investigators and IRB members the right to self determine what is important and what is not. This lack of knowledge and understanding of the Federal regulations and OHRP guidance has caused the shut down of some prominent academic institutions.<BR/> <BR/>My recommendations are that a certification process should exist for investigators and IRB members. Most study coordinators are (or should be) certified by professional societies such as ACRP and SoCRA. Why shouldn’t the investigators and IRB members have the same requirements? Research is all about determining gold standards and comparing novel ideas to them. A certification process would set the standard and provide the means of measuring the knowledge of the applicant. Recommended curricula could be provided in preparation of the certification and a requirement for continuing education would ensure that the individual would stay current with the regulations and literature. <BR/><BR/>These are just my thoughts on the topic. I find your proposal to be thoughtful but not practical in some environments. I do believe that this is a topic in which there will be no right answer for every situation.<BR/><BR/>Respectfully,<BR/>Melissa SchlenkerAnonymousnoreply@blogger.com