Are research participants truly informed? Readability of informed consent forms used in research

Researchers typically attempt to fulfill disclosure and informed consent requirements by having participants read and sign consent forms. The present study evaluated the reading levels of informed consent forms used in psychology research and other fields (medical research; social science and education research; and health, physical education, and recreation research). Two standardized measures of readability were employed to analyze a randomly selected sample (N = 108) of informed consent forms used in Institutional Review Board-approved research projects at a midwestern university during the 1987-1988 academic year. Results indicate that informed consent forms are typically written at a higher reading level than is appropriate for the intended population and that there are no consistently significant differences in readability among areas of research or between college student and noncollege student participants. Due to the unacceptably high reading level of the consent forms, one must question whether participants can comprehend the information contained in the consent form.     

Is consent for research genuinely informed? Using decision aid tools to obtain informed consent in the global south

Gaining informed consent among marginalized groups that include decisionally incapacitated individuals and those outside of the researcher's own geo-social and ethnic background still challenges many researchers. We suggest that there is a need for consideration of a different approach to research ethics in international settings. Based on extensive field work in West Africa on medical knowledge transfers and patient–healer relationships, this paper will discuss the challenges posed in obtaining informed individual consent in international settings. It is argued that while being on the whole convincing, the top-down approach of the proposed solutions, which clearly dominates the participative approach, fails in building sustainable capacity, decision-making competency, and empowerment in the communities in which the research is conducted. Using appropriate decision aids can help resolve these issues.     

How informed is online informed consent?

We examined participants' reading and recall of informed consent documents presented via paper or computer. Within each presentation medium, we presented the document as a continuous or paginated document to simulate common computer and paper presentation formats. Participants took slightly longer to read paginated and computer informed consent documents and recalled slightly more information from the paginated documents. We concluded that obtaining informed consent online is not substantially different than obtaining it via paper presentation. We also provide suggestions for improving informed consent--in both face-to-face and online experiments.     

Anesthesiological ethics: can informed consent be implied?

Surgical ethics is a well-recognized field in clinical ethics, distinct from medical ethics. It includes at least a dozen important issues common to surgery that do not exist in internal medicine simply because of the differences in their practices. But until now there has been a tendency to include ethical issues of anesthesiology as a part of surgical ethics. This may mask the importance of ethical issues in anesthesiology, and even help perpetuate an unfortunate view that surgeons are "captain of the ship" in the operating theater (leaving anesthesiologists in a subservient role). We will have a better ethical understanding if we see surgery and anesthesia as two equal partners, ethically as well as in terms of patient care. Informed consent is one such issue, but it is not limited to that. Even on the topic of what type of anesthesia to use, anesthesiologists have often felt subsumed to the surgeon's preferences. This commentary takes the case study and uses it as a exemplar for this very claim: it is time to give due recognition for a new field in clinical ethics, ethics in anesthesia.     

Intraoperative conversion to open technique: is informed consent implied?

This case raises issues regarding the anesthesia and surgical components of preoperative informed consent and the differing views of anesthesiologists and surgeons with regards to informed consent, in the context of conversion to open surgery from a minimally invasive approach.     

Hide-and-seek or show-and-tell? Emerging issues of informed consent

This article reviews key philosophical and legal underpinnings of mental health professionals' obligation to obtain informed consent from consumers of their services. The basic components of informed consent are described, and strategies for clinically and ethically appropriate methods of obtaining informed consent are discussed. Emerging issues in informed consent involving duty to assess and protect against client dangerousness, obligations to third parties, and issues of deception are considered as well. The article proposes that part of the process of obtaining informed consent is the cultivation of a treatment environment that emphasizes beneficence and client autonomy.     

Should protections for research with humans who cannot consent apply to research with nonhuman primates?

Research studies and interventions sometimes offer potential benefits to subjects that compensate for the risks they face. Other studies and interventions, which I refer to as “nonbeneficial” research, do not offer subjects a compensating potential for benefit. These studies and interventions have the potential to exploit subjects for the benefit of others, a concern that is especially acute when investigators enroll individuals who are unable to give informed consent. US regulations for research with human subjects attempt to address this concern by mandating strict protections for nonbeneficial research with subjects who cannot consent. Typically, humans who cannot consent, such as children, may be enrolled in nonbeneficial research only when it poses low risks and has the potential to gather information of sufficient value to justify the risks, an appropriate surrogate gives permission on the individual’s behalf and the individual agrees (assents). In contrast, US regulations for nonbeneficial research with nonhuman primates do not include these protections, even though it too involves subjects who cannot consent and who face risks for the benefit of others. Is this difference in regulatory protections justified? Or does the principle of fairness—treat like cases alike—imply that regulations for nonbeneficial research with nonhuman primates should include protections similar to those that apply to nonbeneficial research with humans who cannot consent?     

Consenting to uncertainty: challenges for informed consent to disease screening—a case study

This paper uses chronic beryllium disease as a case study to explore some of the challenges for decision-making and some of the problems for obtaining meaningful informed consent when the interpretation of screening results is complicated by their probabilistic nature and is clouded by empirical uncertainty. Although avoidance of further beryllium exposure might seem prudent for any individual whose test results suggest heightened disease risk, we will argue that such a clinical precautionary approach is likely to be a mistake. Instead, advice on the interpretation of screening results must focus not on risk per se, but on avoidable risk, and must be carefully tailored to the individual. These points are of importance for individual decision-making, for informed consent, and for occupational health.

Gender effects in gaming research: a case for regression residuals?

Numerous recent studies have examined the impact of video gaming on various dependent variables, including the players' affective reactions, positive as well as detrimental cognitive effects, and real-world aggression. These target variables are typically analyzed as a function of game characteristics and player attributes-especially gender. However, findings on the uneven distribution of gaming experience between males and females, on the one hand, and the effect of gaming experience on several target variables, on the other hand, point at a possible confound when gaming experiments are analyzed with a standard analysis of variance. This study uses simulated data to exemplify analysis of regression residuals as a potentially beneficial data analysis strategy for such datasets. As the actual impact of gaming experience on each of the various dependent variables differs, the ultimate benefits of analysis of regression residuals entirely depend on the research question, but it offers a powerful statistical approach to video game research whenever gaming experience is a confounding factor.     

Adlerian-oriented early memory research: what does it tell us?

Of the different approaches to interpreting early memories (EMs), Adlerian-oriented EM research comparatively has shown a most substantial increase in the past 10 years. I examine all Adlerian-oriented EM research appearing from 1981 through 1990. The majority of the research provides a tentative base of support for Adler's (1931) views about EMs. However, several deficiencies in these investigations are identified (e.g., a lack of pilot studies), and some recommendations are made for future EM studies.     

The emerging debate over the shape of informed consent: can the doctrine bear the weight?

Informed consent has traditionally focused on treatment-related issues. However, since the mid-1990s, courts have debated whether informed consent should be stretched to accommodate other concerns. For example, some courts have considered whether economic limitations on treatment availability must be made known to a patient as part of the informed consent process. Other courts have considered whether characteristics of the treatment provider (e.g., experience with a particular procedure) should be disclosed as part of informed consent. Consideration of these issues turns in large part on whether the information in question would be considered "material" to a decision to accept or reject treatment. This article discusses these developments, and suggests that expanding informed consent beyond treatment-related issues in some circumstances may erode trust in the clinical relationship, thus undermining one of the central values of the informed consent doctrine. It concludes with some suggestions on how research could inform this debate.