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The Site’s Side: IRBs what is a site to do?
Introduction
I read with interest the beginning of this series titled
“Sites – It’s Where the Patients Are!” and “
The List”. What a great start to a conversation amongst some of the major players in the clinical trials arena. But I believe one of the crucial players was not mentioned – the IRB. I have seen a great shift in how sponsors and sites interact with the IRBs in the past few years some of which enhance the volunteers participation but some of which I find concerning. So this is where I will take off from
Dan’s blog…
IRBs Today
We now see most, if not all, independent IRBs
AAHRPP Accredited so they have to meet certain rigorous criteria to get the accreditation and stay in compliance. Much of the criteria has to do with human subject protection which enhances the sites’ ability to provide that protection with some assurance from an accredited IRB. How closely AAHRPP monitors the IRBs’ compliance with the standards I don’t know but I do think it’s a good start to have that accreditation in place.
I am not altogether sure what criteria sponsors and CROs use to select an IRB but sometimes it seems that cost may be the overriding factor. We are all now aware of the fiasco with
Coast IRB (
update). I suspect the choice to use Coast by many sponsors was based on their fees. I’m sure I can speak for most sites and say we hope to never have to deal with that kind of situation again or the publicity that accompanies it. Other criteria seem to be an IRB that will make the whole review and approval process easy and fast. Easy is not always best in terms of human subject protection.
Issues facing sites…
What I am seeing more of is the pharma companies making changes to the protocol and using a newsletter, conference call and/or memos to document the change instead of doing a protocol amendment. In one case the sponsor made some significant protocol changes by memo, which was then approved by the IRB. The sponsor then sent an email saying the site should just tell the study subjects about the changes and that a new ICF will come out soon – is that really informed consent? But what is the site’s recourse if the sponsor and IRB both approve it? Another situation occurred in which some information was given about how the study drug should be taken by the subjects on a conference call but that information was not in the protocol. It was stated that the subjects may experience some adverse effects if the drug was not taken with a meal. No IRB representative was on the call so they didn’t know this information was being given to the sites but it could affect not only the participant’s experience but the quality of the data being generated. Not sure how or if this information was passed along to those sites who were not in attendance on this particular call. In a third case the site received an updated informed consent with new safety information but was told they could not use it to consent subjects until it was approved by the sponsor. This was written in the protocol so the site was in a real quandary – if they consent the subject with the most current form they have a protocol violation but if they don’t then they are not in compliance with the federal regulation. Most importantly, the site is then putting the subjects at greater risk by not giving them the most up-to-date safety information. The site chose to stop screening until the sponsor approved the ICF so volunteers had to be rescheduled.
Closing Thoughts…
I could probably go on with more examples for pages but I think I have made my point. More and more research sites are stuck between needing to please the sponsor from whom they get their work and funds, following IRB policies and making sure they are in compliance with the federal regs as well as adhering to high standards for human subject protection. This is happening often enough that it is raising concerns about how much the sponsor influences the IRB to cut corners in order to save money. This puts the subject’s at higher risk and the sites with tough choices to make. This raises several questions for me: How do the sites become partners in the choice for the IRB used? How do we as sites keep this” shift” from becoming the new norm? How do we ensure all the players are using the same rules so we have a clear understanding of the process during the site selection process?
About the Author
Yvonne P. McCracken, MPH, CCRC, is Founder, President and Chief Executive Officer of
Carolinas Research Associates, an Investigative Site Network founded in 1996 and located in Charlotte, NC. Carolinas Research Associates works with board certified, private practice physicians in the Charlotte area and major pharmaceutical companies to offer qualified volunteers access to clinical studies.
Ms. McCracken received a Masters of Public Health in Health Policy and Administration from the University of North Carolina at Chapel Hill and is a Certified Clinical Research Coordinator. She has been involved with clinical research since 1992 in the positions of research coordinator, site manager, business owner and consultant. She has implemented clinical research programs for numerous private practice physicians and large medical groups. She has provided consultation and training services to academic medical centers, private practice groups, and pharmaceutical companies.
Ms. McCracken is currently a member of the Clinical Trials Transformation Initiative, which is a partnership between the FDA and Duke University, as well as the Drug Information Association and the Associates of Clinical Research Professionals.
Ms. McCracken presented at the Clinical Research Conference in Taipei, Taiwan sponsored by ACRP and OHRP and was a speaker at the FDA’s Clinical Investigator Training Course in November 2010. Ms McCracken is a speaker and moderator at forums for the various research organizations including Institute for International Research (IIR), ACRP and DIA.
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