Ethical Conduct of Laboratory Experimental Research on Fear and Anxiety: Review and Recommendations

Abstract

Experimental research concerning fear and anxiety often involves exposing human subjects to fear-cue stimuli. Several aspects of fear-cue exposure may generate ethical concerns on the part of institutional review boards (IRBs) charged with protecting human research participants from harm. The goal of this article is to provide researchers with a framework for effectively addressing ethical concerns raised by some fear and anxiety research. We highlight the ethical considerations raised by fear-cue exposure procedures, review the extant research literature relevant to these concerns, make recommendations on how to address IRB ethical concerns, and recommend various research strategies that might clarify the impact (positive or negative) of fear-cue exposures on human subjects participating in anxiety research. IRBs may raise a variety of important concerns about fear-cue exposure research. Some of these concerns can be addressed by adequate justification within the IRB protocol using existing research findings. Further research is needed to address a variety of potential ethical concerns. Such research may help address concerns regarding research involving fear-cue exposure.

Immediate and Delayed Reactions to Trauma-related Laboratory Research Among Rape Survivors and Controls

“…Informed consent, which requires researchers to clarify potential risks and benefits of research participation, is a fundamental component of ethical research. Consistent with Lawyer et al's (2013) recommendation, this research promotes an evidence-based approach to research ethics so that the participants can be comprehensively and accurately informed about the risks and benefits of participating in trauma research. These findings are directly relevant to the Respect for Persons (participants are treated with respect and are allowed informed consent) and Beneficence (research should maximize benefits and reduce risks as much as possible) principles outlined in the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979).…”

“…It is notable that we found similar findings among participants in a laboratory-based experimental study that involved a standardized exposure to a trauma-relevant cue in a study that had no obvious connection with therapeutic outcomes for either the participant or others. Lawyer et al (2013) argued that researchers can readily assuage concerns about participant discomfort when it occurs in the context of a treatment study that provides direct benefits. The results of this study suggest that these findings generalize to trauma-related experimental research contexts that have no direct clinical benefit.…”

“…Research studies like these might include imagining trauma-relevant scenarios (e.g., Foa et al, 2002;Olatunji et al, 2009), viewing trauma-relevant photographs (e.g., Wolf et al, 2009), watching trauma-relevant virtual reality images (e.g., Katz et al, 2020), or coming into contact with real (in-vivo) trauma-relevant stimuli (e.g., Brady et al, 2001). Lawyer et al (2013) pointed out that the ethical concerns regarding potential risks of such studies might be readily offset by direct benefits to the participant if the research takes place in the context of the delivery of bona fide treatment (e.g., Brady et al, 2001). However, the direct benefits of participation in an experimental study that may not offer clinically relevant benefits may be less clear (to the participant or the IRB), even if it provides important information about psychological trauma critical to our understanding of the prevention and treatment of mental health problems.…”

“…An evidence-based approach to trauma-related research ethics is fundamental to the research process so that the risks and benefits of such research are as clear as possible (Campbell et al, 2019; Lawyer et al, 2013). Adopting an evidence-based approach to understanding the research participant experience provides clear guidance on how to design trauma-related studies that minimize risks and maximize the benefits of participation, allows researchers to comprehensively and accurately inform participants about the risks and benefits of participation, and allows researchers to empirically address concerns often raised by Institutional Review Boards (IRBs; see Lawyer et al, 2013; Yeater & Miller, 2014). All of these allow researchers to promote a research experience that contributes to our understanding of trauma-related phenomena but also promotes a research experience that is positive and supportive for trauma survivors, which is consistent with Campbell et al's trauma-informed ethics recommendations.…”

“…Fortunately, a number of qualitative reviews of studies (e.g., Becker-Blease & Freyd, 2006; Lawyer et al, 2013; Legerski & Bunnell, 2010) that examine the impact of asking about trauma experiences suggest that significant participant distress tends to be relatively uncommon and that it dissipates relatively quickly. Moreover, participants in trauma studies often find their participation to be a positive experience for themselves and view it as beneficial for society.…”