The ethics of involving persons with cognitive impairments and/or mental illness in research continues to gain academic and public attention. Concerns about the ability of such persons to provide ethically and legally valid consent and about the appropriateness of their research involvement in certain categories of studies have resulted in publication of guidelines, position papers, standards, and court decisions. These analyses address not only when and from whom informed consent may be obtained but also under what conditions it is ethically (...) permissible to involve persons in research who are too decisionally impaired to provide their own consent.It is an advance in research ethics that there is heightened appreciation of the need for greater protections for, and possibly research participation limitations on, persons unable to give their own consent. In our zeal to protect potentially vulnerable subjects, however, we must craft new protections carefully. Prudence is required in shaping and implementing any new protections. (shrink)

We examined the efficacy of including a research intermediary (RI) during the consent process in reducing participants' perceptions of coercion to enroll in a research study. Eighty-four drug court clients being recruited into an ongoing study were randomized to receive a standard informed consent process alone (standard condition) or with an RI (intermediary condition). Before obtaining consent, RIs met with clients individually to discuss remaining concerns. Findings provided preliminary evidence that RIs reduced client perceptions that their participation might influence how (...) clinical and judicial staff view them. This suggests that using RIs may improve participant autonomy in clinical studies. (shrink)

The ethics of involving persons with cognitive impairments and/or mental illness in research continues to gain academic and public attention. Concerns about the ability of such persons to provide ethically and legally valid consent and about the appropriateness of their research involvement in certain categories of studies have resulted in publication of guidelines, position papers, standards, and court decisions. These analyses address not only when and from whom informed consent may be obtained but also under what conditions it is ethically (...) permissible to involve persons in research who are too decisionally impaired to provide their own consent.It is an advance in research ethics that there is heightened appreciation of the need for greater protections for, and possibly research participation limitations on, persons unable to give their own consent. In our zeal to protect potentially vulnerable subjects, however, we must craft new protections carefully. Prudence is required in shaping and implementing any new protections. (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)

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)