by Avery Avrakotos, education and policy coordinator

The poster presentations for the 2012 Advancing Ethical Research (AER) Conference will soon be announced. To help tide you over while you wait to explore the latest innovations in human subjects protections at the 2012 AER Conference, I sat down with Mike Linke who participated in the poster presentations at the 2011 AER Conference.

In 2011, Mike and his colleagues conducted phone surveys with research participants in order to gauge perceptions of disclosures about fees and honoraria paid to investigators on consent forms and whether or not these disclosures influenced participation decisions. The results of the study suggested that research participants were concerned about financial relationships in research, but that other factors had greater influence on their likelihood to participate.

Avery Avrakotos (AA): It’s been a year since you presented this abstract at the 2011 AER Conference.  How has your research since evolved?
Mike Linke (ML): Upon further analysis of the data, it became clear that disclosure language was not the only piece of information in the informed consent documents that participants had problems understanding. It was also evident that what participants recall from the consent process does not always reflect the real content of the informed consent document itself. We are now planning to conduct debriefing interviews with actual participants in clinical trials to develop a better understanding of the informed consent process and how it relates to information provided in the informed consent document.

AA: What challenges have you faced in implementing your research? 
ML: The institutional review board (IRB) has always concentrated on keeping consent forms as uncomplicated as possible. We have increased our vigilance to ensure participants are able to understand the information being provided. The IRB has discussed implementing a mandatory post-consent comprehension evaluation procedure for all studies; however, we have not implemented this for several reasons. The main argument against implementing a comprehension tool is that this type of evaluation may result in investigators “teaching to the test.” This could take away from the overall consent process and not really improve participants’ understanding. The IRB is continuing to discuss methods to improve the consent process and hopes to use information gained from interviews with participants to develop methods that will lead to development of improved consent documents and processes.

AA: What is one principle that has guided you in your research?
ML: This research was undertaken to develop what information participants in clinical trials understand and retain from informed consent documents. Therefore, in this research, we focused on the principle of respect for persons. This principle dictates that, participants must be given the information they need to make a truly informed consent to participate in a research study.

Thank you for sharing, Mike! Readers, we hope that you will be able to join us at the 2012 AER Conference to explore the efforts of this year’s poster presenters.