On the Way to Better Informed Consent for Clinical Research

To fulfill ethical requirements, each year, millions of people (Krall, 2009) engage in an informed consent discussion before joining clinical trials, ‎weighing both possible risks and benefits of the trial participation when making their choice to take part in the proposed study.
However, studies suggest many research participants do not understand these risks and benefits (Guarino et al., 2006Bergenmar et al., 2008Jefford et al., 2011Koh, 2012Montalvo & Larson, 2014) even ‎after they have agreed to join a research study.

A poor understanding of risks may lead to future regret concerning joining the trial, and may cause participants to leave the trial before it ends. This may negatively affect all of the study findings (Stryker et al., 2006Meneguin & Cesar, 2012). Worst of all, this poor communication of risk information may result in physical or psychological harm to research participants (Shalala, 2000Buchanan, 2013).

To solve this problem, we need to better understand what happens during the informed consent process. Nurses, as a part of a research team, play an increasingly active role in obtaining informed consent from potential participants (Banner & Zimmer, 2012Tomlin et al., 2014Cresswell & Gilmour, 2014), while providing detailed explanations of the study protocols and finding answers to participants’ questions.

Like others, I am concerned about these issues, so I am studying the perceptions and experience of research nurses regarding the communication of risks and benefits. Nurses’ voices are markedly under-represented in research literature discussing communication of risk information to the research participant. My study aims to address this gap while also developing a better understanding of how to improve the informed consent process. I am looking for nurses’ opinions and experiences to address some shortcomings in the informed consent process.

If you currently are, or have ever been, a research nurse on a clinical trial research team and have ever participated in obtaining informed consent, I invite you to complete my survey of Nurses’ Opinions Regarding the Informed Consent Process in Research. Your anonymous responses will contribute to a greater understanding of the process, which can lead to recommendations for needed improvements. You can take the survey by clicking on the link below.


Please forward this link to research nurses you know, even if you are not a nurse.
I plan to share the findings on this blog and look forward to a rich discussion of ways to improve the informed consent process.

If you have questions or comments, please contact me at Nusbaum.l@husky.neu.edu.

By Lika Nusbaum , RN, MN, Nursing PhD Candidate, faculty member at the Department of Nursing, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel