Drug companies are moving their research from academic medical centers to physicians’ private offices. The shift brings in more subjects, and could mean faster and better results. It also changes the physician's relationship to patients, dangles monetary lures in front of physicians, and could produce subjects who don't understand what they're participating in and results that are unreliable.

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)

Clinical research is increasingly conducted in settings that include private physicians’ offices, clinics, community hospitals, local institutes, and independent research centers. The migration of such research into this new, non–academic environment has brought new cadres of researchers into the clinical research enterprise and also broadened the pool of potential research participants. Regulatory approaches for protecting human subjects who participate in research have also evolved. Some institutions retain their own Institutional Review Boards (IRBs), but Independent IRBs, community hospital IRBs and community–based (...) IRBs also fulfill oversight responsibilities. This article sheds light on this evolving world by discussing the findings gleaned from two studies: a study of the decision making processes used by members who serve on different kinds of IRBs and a study of the decision making processes employed by research participants. The article then discusses how the key findings may inform proposed revisions to the Common Rule. (shrink)

In order to facilitate the informed consent process, we suggest recording it. If investigators routinely recorded the consent process—including subsequent testing of participants’ comprehension and reeducation efforts—they could monitor the consent practices of their staff and determine what changes in procedure may be needed. In addition, should the adequacy of consent ever be challenged , investigators would have an easily accessible record of what had transpired. And finally, a pool of data would be created that could be accessed by researchers (...) who study informed consent issues and are interested in identifying ways of further improving the process. (shrink)