Biomedical subjects

Neal Dickert

Publications and source records attributed to Neal Dickert.

4 recordsLinked to original sources

PubMed2005

Ethical goals of community consultation in research.

In response to the traditional emphasis on the rights, interests, and well-being of individual research subjects, there has been growing attention focused on the importance of involving communities in research development and approval. Community consultation is a particularly common method of involving communities. However, the fundamental ethical goals of community consultation have not been delineated, which makes it difficult for investigators, sponsors, and institutional review boards to design and evaluate consultation efforts. Community consultation must be tailored to the communities in which it is conducted, but the purposes of consultation-the ethical goals it is designed to achieve-should be universal. We propose 4 ethical goals that give investigators, sponsors, institutional review boards, and communities a framework for evaluating community consultation processes.

Community Participation↗

PubMed2005

An analysis of U.S. practices of paying research participants.

BACKGROUND: Despite controversy about paying research subjects, little is known about actual practices in the U.S., including what type of studies offer payment, to what type of subjects, and how amounts are determined. OBJECTIVE: To document current U.S. practices regarding payment to research subjects. METHODS: The protocols and consent forms of 467 studies offering payment to research subjects approved by 11 IRBs across the U.S. were reviewed to analyze how they describe and justify payment to subjects. RESULTS: Money was offered in a wide variety of study types, from short term physiologic studies to large clinical trials of therapeutic interventions, to both patient (61%) and healthy (24.4%) subjects or both (14.6%). Dollar amounts varied widely and were infrequently explicitly described as based on time (19%) or procedures (12%). Unexplained variation in dollar amounts occurred in similar studies or in the same (multi-site) study at different sites, and for similar procedures across studies sometimes even within one site. Although the range was wide ($5-$2000), total amounts were usually modest (overall median $155), and almost always described in the consent form (94.4%) and usually as pro-rated (73%). CONCLUSIONS: Both patient and healthy subjects are offered payment in a wide variety of types of research in the U.S. Variation in the dollar amounts offered is largely unexplained.

Choice Behavior↗

PubMed2002

Paying research subjects: an analysis of current policies.

BACKGROUND: Few data are available on guidelines used by research organizations to make decisions about paying subjects. OBJECTIVE: To analyze existing guidance regarding payment of research subjects and to identify common characteristics and areas for further research. DESIGN: Descriptive content analysis of policies. MEASUREMENTS: Written policies and rules of thumb about paying subjects from 32 U.S. research organizations. RESULTS: Of 32 organizations, 37.5% had written guidelines about paying subjects; all but 1 reported having rules of thumb. Few (18.8%) were able to provide a confident estimate of the proportion of studies that pay subjects. Organizations reported that investigators and institutional review boards make payment decisions and that both healthy and ill subjects in some studies are paid for their time (87%), for inconvenience (84%), for travel (68%), as incentive (58%), or for incurring risk (32%). Most organizations require that payment be prorated (84%) and described in the consent document (94%). CONCLUSIONS: Most organizations pay some research subjects, but few have written policies on payment. Because investigators and institutional review boards make payment decisions with little specific guidance, standards vary.

Advertising↗

PubMedDate not supplied

Excluding particular information from consent forms.

Although the informed consent process is crucial to protecting human research subjects, there are cases when particular information within the consent form may present risks to those subjects. In this paper, we examine a case in which including the sponsor's name on the consent form may allow the form to serve as a surrogate for subjects' HIV status. There is no literature addressing the ethical acceptability of excluding particular information from consent forms, and there exists little regulatory guidance on this issue. We argue that excluding information from the consent form is, in fact, obligatory when that information is disclosed orally during the consent process but its presence on the form poses risks to the subjects the consent process is designed to protect. Further, we argue that the regulations ought to be amended to reflect this obligation.

Communication↗