ABSTRACT Persons generally must give their informed consent to participate in research. To provide informed consent persons must be given information regarding the study in simple, lay language. Consent must be voluntary, and persons giving consent must be legally competent to consent and possess the capacity to understand and appreciate the information provided. This paper examines the relationship between the obligation to disclose information regarding risks and the requirement that persons have the capacity to understand and appreciate the information. There (...) has been insufficient attention to the extent to which persons must be able to understand and appreciate study information in order to have their consent deemed valid when the information is provided in simple, lay language. This paper argues that (1) the capacity to understand and appreciate information that should be deemed necessary to give valid consent should be defined by the capacity of the typical, cognitively normal adult and (2) the capacity of the typical, cognitively normal adult to understand and appreciate the concept of risk is limited. Therefore, (3) all things being equal, potential subjects must possess a limited capacity to understand and appreciate risk to be deemed competent to consent to research participation. (4) In some cases investigators ought to require that persons possess a greater than typical capacity to understand and appreciate risk. (shrink)

Sixty-five undergraduates participating in a wide range of psychological research experiments were interviewed in depth about their research experiences and their views on the process of informed consent. Overall, 32% of research experiences were characterized positively and 41 % were characterized negatively. One major theme of the negative experiences was that experiments were perceived as too invasive, suggesting incomplete explication of negative aspects of research during the informed consent process. Informed consent experiences were viewed positively 80% of the time. However, (...) most of the participants had a limited view of the purpose of informed consent: Less than 20% viewed the process as a decision point. Results suggest a number of common pitfalls to standard informed consent practices that have not generally been recognized. Results are discussed in terms of both ethical and methodological implications. Suggestions for improving the informed consent process are also provided. (shrink)

An issue of ongoing concern to clinical investigators, medical ethicists, and institutional review board members is the problem of obtaining informed consent in research that involves people with mental illness as research participants. Although the presence of a mental disorder per se does not render a person incapable of giving informed consent, some individuals afflicted with significant cognitive impairment, formal thought disorder, substantial anxiety or depression, or a variety of other symptoms may be impaired in their capacity to comprehend consent (...) disclosures and therefore to exercise consent to research participation in a competent manner.The stakes surrounding this informed consent issue are significant. On the one hand, the inclusion in research of participants who are not capable of giving informed consent may result in their exposure to unwarranted risks and significant harm. These concerns may be exacerbated in certain clinical trials in which patients are required to discontinue their medications during “washout periods” at the onset of a study, or are randomly assigned to a placebo treatment and remain off medication for extended periods. (shrink)

A series of studies investigated the capacity of children between the ages of 7 and 12 to give free and informed consent to participation in psychological research. Children were reasonably accurate in describing the purpose of studies, but many did not understand the possible benefits or especially the possible risks of participating. In several studies children's consent was not affected by the knowledge that their parents had given their permission or by the parents saying that they would not be upset (...) if the children refused. In contrast, other studies found that children were much more likely to stop their participation if the experimenter said explicitly that she would not be upset if they stopped. We suggest that experimenters should pay more attention to describing the possible risks and benefits of participation in research, and that they should also make it clearer to children that they are free to stop once they have begun. (shrink)

Although many people choose to sign consent forms and participate in research, how many thoroughly read a consent form before signing it? Across 3 experiments using 348 undergraduate student participants, we examined whether personality characteristics as well as consent form content, format, and delivery method were related to thorough reading. Students repeatedly failed to read the consent forms, although small effects were found favoring electronic delivery methods and traditional format forms. Potential explanations are discussed and include participant apathy, participants trying (...) to save time by not reading the consent form, and participant assumptions about consent forms. (shrink)

This study explored the challenges of informed consent and understanding of the research process among Black and Latino men under community supervision. Between February and October 2012, we conducted cognitive face-to-face interviews using open-ended questions on the significant areas of research participation among 259 men aged 35 to 67 under community supervision in Bronx, New York. Content analysis of the open-ended questions revealed limited knowledge concerning the understanding of research participation. The study participants appeared to generally understand concepts such as (...) compensation after research participation and confidentiality. Participants demonstrated a lack of understanding of certain aspects of the research process—informed consent, human subject, Institutional Review Board, and clinical trials. These findings are informative to researchers conducting studies with criminal justice populations and Institutional Review Boards reviewing research studies. (shrink)

It is the researcher's responsibility to provide accurate, complete, and unbiased verbal and written information yet, as this essay discusses, challenges to meaningful research consent abound in the communication between researcher and subject. This discussion of these challenges is far from exhaustive, but it will flag some of the potholes that researchers must anticipate on the sometimes rocky road to eliciting meaningful consent. These include, but are not limited to, inadequate scientific literacy, poorly written consent forms, and even the deployment (...) of scientific terms and seductive acronyms like CURE and MIRACL. Studies with acronyms, for example, enroll five times as many patients as those without, are more likely to be published by prestigious journals, and have higher Jadad methodologic quality scores although they are no more likely to conclude with positive findings. Other barriers to researcher-subject communication include: widely differing beliefs and customs, semiotics, socioeconomic status, iatrophobia, and dramatically different histories of treatment in the medical-research arena. (shrink)

Objective: The objective of the current study was to maximise the amount of information children and adolescents understand about the risks and benefits associated with participation in a biomedical research study.Design: Participants were presented with one of six hypothetical research protocols describing how to fix a fractured thigh using either a “standard” cast or “new” pins procedure. Risks and benefits associated with each of the treatment options were manipulated so that for each one of the six protocols there was either (...) a correct or ambiguous choice.Participants and setting: Two hundred and fifty one children, ages 6–15 , and 237 adults were interviewed while waiting for a clinic appointment at the Hospital for Sick Children.Results: Using standardised procedures and questionnaires, it was determined that most participants, regardless of age group, were able to understand the basic purpose and procedures involved in the research, and most were able to choose the “correct” operation. The younger children, however, showed an overall preference for a cast operation, whereas the older participants were more likely to choose the pins.Conclusions: By creating age appropriate modules of information, children as young as six years can understand potentially difficult and complex concepts such as the risks and benefits associated with participation in biomedical research. It appears, however, that different criteria were used for treatment preference, regardless of associated risks; older participants tended to opt for mobility whereas younger participants stayed with the more familiar cast operation. (shrink)

We analyzed a sample of 356 forms containing information that Colorado law legally requires both licensed and unlicensed therapists to disclose to clients. The majority of forms contained the legally mandated information; fewer forms contained ethically desirable information. The average readability grade level was 15.74, corresponding to upper-level college, and 63.9% of the forms reached the highest (most difficult) readability grade of 17 +. Therapists are obeying the law, but do not appear to be taking advantage of the opportunity to (...) provide their clients useful information in an accessible way. (shrink)

This study examined possible ways to ensure that participants provide fully informed consent for online surveys. Participants were randomly assigned to read either a traditional informed consent or one of three modified versions: enhanced, consent for each key element, or a combination of these two. Those who read the combination version scored higher on a comprehension quiz, guessed at fewer questions, and were more likely to read all of the informed consent than those who received the traditional version. These findings (...) suggest that comprehension can be improved by adopting alternatives to the traditional informed consent. (shrink)