Clinical Trial Participants: How to Obtain Informed Consent

              Before enrolling in a clinical trial, human subjects must sign a consent form that details the nature of the study and the types of risks involved.  One survey conducted by CenterWatch determined that 30% of participants did not understand that their study could pose additional risks, and 70% did not know what questions to ask at the beginning of the informed consent process.  Companies can protect themselves in clinical trials through careful preparation of the consent form and extensive investigator training on the consent process.

             The consent document needs to be easy for the participant to read and understand.  The industry standard for consent forms is that they are written at or below an eighth grade reading level.  It is very important that the potential subject is able to understand the information in the form.  It can be challenging to write consent documents, which often need to explain complex medical issues, at such low grade levels.  However, the sponsor and the investigator should treat the task as important.  It should not be left up to the institutional review board to make adjustments.  Rather, sponsors should review any changes that institutional review boards make to ensure that no critical information has been deleted and that the readability and comprehension levels have not been corrupted.

             Researchers should never just hand the consent form to participants to read and sign.  Instead, they need to have face-to-face discussions with them and answer any questions they may have.  After reviewing the consent document with the participant, some investigators test potential subjects to see how much information they actually understood.  If a subject does not appear to grasp the critical points, the researchers need to discuss those issues with them again until they fully understand.  This will help to ensure that true informed consent is obtained from all trial participants.

 Wadlund, Jill.  Heading Off a Clinical Trial Liability Lawsuit.  APPLIED CLINICAL TRIALS. vol. 12, no. 4.

   © 2008 Parsonage Vandenack Williams LLC

 For more information, contact info@pvwlaw.com

Institutional Review Boards for Clinical Trials

       In the United States, clinical trials are reviewed and approved by institutional review boards (“IRBs”).  IRBs are most often composed of physicians, scientists, and lay people.  They review study protocols and consent documents in order to make sure that the participants’ rights are protected, and that the particular study does not pose a burdensome or unnecessary risk to the participants. 

      It is very important for those conducting and participating in clinical trials to know that not all IRBs are equal.  Many IRBs have trouble keeping up with their workload, which could mean that protocols developed by well-regarded doctors and professors at some major institutions are basically automatically approved by the IRBs.  Other IRBs may prove ineffective due to the mix of characters on the board, with lay people intimidated by the stronger personalities in the medical field. 

     Clinical trial providers and their sponsors should screen IRBs as a regular risk management practice.  Sponsor companies may want to prequalify IRBs.  Sponsor companies may also attempt to determine whether all of the members of an IRB are qualified to be on the board.  Companies should try to select IRBs that are working toward accreditation.  Seeking out IRBs that meet these standards is certainly in the best interests of the sponsor.  Sponsors clearly want IRBs to approve their study, but if the IRB does not perform its job properly and something goes wrong during the clinical trial, the sponsor company could be held liable.  As such, screening IRBs is a positive preventive measure that all clinical trials providers and sponsors should consider implementing as a necessary part of their clinical trial procedure.[1]

 

[1] Jill Wadlund, Heading Off a Clinical Trial Liability Lawsuit, APPLIED CLINICAL TRIALS, vol. 12, no. 4, pp. 50-53.

 

 

© 2008 Parsonage Vandenack Williams LLC

 

For more information, contact info@pvwlaw.com

 

How to Avoid a Clinical Trial Liability Lawsuit

 Over the past few years, litigation against the clinical trial industry has significantly increased.  The most well-known suit was filed against the University of Pennsylvania by the family of Jesse Gelsinger, an 18-year-old man who died after participating in a 1999 gene therapy trial.  Later information revealed that the investigator in charge of the trial held a majority interest in a biotech company that stood to make millions of dollars if the experiments proved successful.  While some of the financial interests were disclosed to the family, major issues were raised regarding whether Gelsinger received unbiased medical information.  Cases like Gelsinger can no longer be treated as isolated incidents. 

 

Although only a few cases receive lots of publicity, many others are not usually publicized.  The targets of litigation are most often the clinical investigators and research institutions that conducted the trials.  However, the companies that sponsor trials also face risks when something goes wrong.  For this reason, pharmaceutical companies need to take aggressive measures to make sure that the clinical trials they sponsor are not looked at with disfavor and to protect themselves against even the appearance of conflicts of interest.  The more steps that sponsor companies take towards a best practice approach to conducting clinical trial, the better their insurance program may be, and the less likely they are to face a potential lawsuit.

 

Some companies may view the trend toward litigation as a short-term issue.  But based on the growing number of clinical trial and the increasing level of interest in this form of litigation by plaintiff law firms, it is most likely a continuing trend.  Thus, companies involved in the clinical trials and their sponsorship must take legal and other measures to protect themselves from potential liability and to avoid conflicts of interest.  Clinical liability insurance can help to offset some, but not all, of the cost related to an occurrence that leads to an expensive liability lawsuit.

 

By following the best practice procedures, companies will have more leverage to obtain a better liability insurance program.  Additionally, sponsor companies might have more success in finding subjects when they have a positive reputation for excellent clinical trial safety efforts.   And finally, investors will place greater importance on the way that companies manage clinical trial liability exposures and will likely prefer those companies that show top-notch research processes and integrity.[1]

 

[1] Wallund, Jill.  Heading Off a Clinical Trial Liability Lawsuit, Applied Clinical Trials, vol. 12, no. 4, 50-53 (April 2003).

 

 

© 2008 Parsonage Vandenack Williams LLC

 

For more information, contact info@pvwlaw.com