Emotional reactions to research participation and the relationship to understanding of informed consent disclosure

Abstract

Since 1995 when President Clinton issued Executive Order 12975 instructing the Office for the Protection from Research Risks (OPRR) to review its policies protecting the fights of individuals participating in research, there has been an increased focus on past lapses of research ethics (for example, Tuskegee syphilis study, cold war radiation experiments) and heightened scrutiny on ongoing studies. In May 2000 the OPRR suspended nearly all government-funded human subject research at Duke University Medical Center, claiming administrators failed to correct problems with a research safety oversight (ABC News, 2000). After the death of Ellen Roche, a volunteer in an asthma study at Johns Hopkins University, the OPRR suspended human subject research at that university (ABC News, 2001). There have been an increasing number of institutions sanctioned for failure to adequately protect research participants. Nevertheless, although the risks to participants in social work research rarely include death, these incidents should serve as a constant reminder of the need to examine the adequacy of the profession's research processes and the effect that research has on participants. This study documented the research experiences of women who participated in a study on welfare reform. Specifically, the study examined four issues: (1) the prevalence of adverse emotional reactions among study participants, (2) the extent to which participants understood the consent disclosure, (3) whether the placement of information in the consent form affected participants' understanding of the study, and (4) any relationship between the women's levels of understanding of the consent disclosure and the likelihood of experiencing adverse emotional reactions. It is important for investigators to be aware of the frequency with which study participants experience adverse emotional reactions and to document what stimuli evoke them so that future participants can be better informed of these potential psychological risks. In addition, it is important for researchers to understand if and how the placement of information in consent disclosures affects participants' level of understanding about a study so that the profession can continue to improve its procedures used to convey information about the study to potential participants. One of the foundational principles outlined by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978) in the Belmont Report is beneficence. The Commission used the term to highlight researchers' obligations to protect participants from risk. Risks include physical risks, such as drug side effects that might occur during clinical trials; legal risks, such as possible arrest and prosecution that could result from disclosure of criminal activity if confidentiality is breached; social risks, such as stigma that might occur from participating in a study on mental illness; and psychological risks, such as stress or anxiety that could result from being asked sensitive questions. Risk consists of two components: (1) the probability or prevalence of risk and (2) the magnitude or severity of the risk. The probability relates to the likelihood that a risk will happen, whereas the magnitude refers to the seriousness of the risk should it occur. In biomedical research, consent forms frequently contain specific information on both the probability and severity of risk. An examination of several medical consent forms reviewed by the University of South Florida's Institutional Review Board (IRB) illustrates this point. One disclosure from a study on breast cancer states, Likely side effects are those that occur in more than 5 percent of patients who undergo the procedure. The likely risks associated with this procedure are slight discomfort and/or pain, bruising at the site ... Another consent form from a drug trial on osteogenesis imperfecta in children states, Irritation of the food tube (called the esophagus) leading from the mouth to the stomach occurs in 1-2 percent of adult patients taking a similar dose. …