Study design ethical issues

D. An ethical issue arises when one includes medically underserved patients in a study without providing them with the level of care available to others. Problems with noncompliance, while potentially damaging to a study, do not pose ethical problems in medically underserved populations not encountered elsewhere. Effective study design can overcome problems with generalizing from one population to the next. Subjects everywhere should be... 

A basic ethical issue in several areas of psychiatric research is whether participants are able to provide informed consent, particularly for protocols entailing medication washout and/or placebo treatment. The majority of psychiatric patients who are asked to participate in clinical trials have adequate capacity to provide consent. Thus, in a study specifically designed to examine the capacity of schizophrenic patients to give informed consent, cognitive dysfunction and negative symptoms (apathy and avolition). but not psychotic symptoms (hallucinations, delusions), were found to be associated with impaired decisional capacity (Moser et al., 2002). These features are probably not unique to schizophrenia but are likely to apply to many other forms of illness. 

Despite the extensive experience with biomedical ethics, the infrastructure of institutional review boards (IRBs), and the equivalent for protection of human subjects (Schulte et al. 1997 but see Soskolne 1997), it is essential to address questions of ethics that may be particular to the design of biomonitoring studies. In this section, the committee considers some practical and research issues in biomonitoring ethics but makes no pretense that the list is exhaustive. Ethical issues can stop specific studies, and the field in general, dead in their tracks. Therefore, it is incumbent on investigators, policy-makers, and others to consider these issues carefully. 

A topic linked to ethics but with its own issues and strategies is communication. The committee is convinced that communication starts with the study proposal and continues through study design. Each of the many constituencies associated with a proposed study requires careful consideration in planning communication strategy and content. Most biomonitoring studies will eventually have applications, and researchers need to anticipate potentially affected communities and plan for communication with them. 

Each study component has an ethical aspect. The ethical aspects of a clinical trial cannot be separated from the scientific objectives. Segregation of ethical issues from the full range of study design components demonstrates a flaw in understanding the fundamental nature of research involving human subjects. Compartmentalization of ethical issues is inconsistent with a well-run trial. Ethical and scientific considerations are intertwined (p. 4). 

Sample-size estimation therefore has an important ethical component. There are ethical issues involved in recruiting both too few and too many subjects (Matthews, 2006). Recruiting too few subjects means that the study may be underpowered and unable to detect a treatment effect of interest that actually exists. Such a design is scientifically inadequate to answer the research question of interest (i.e., to address the primary objective of the trial). It is also unethical. Subjects may have taken part in a study that did not have a chance of detecting a treatment effect that may have existed, and thus their expectation that participation may add to the knowledge base about the investigational drug was violated. 

Human data are preferred for determining the potential health effects of exposure. However, human studies are often limited by ethical issues in collecting data and by their complexity in establishing exposure conditions and associated effects. Consequently, it is important to understand the various human study designs and their strengths and limitations (see chapter 6). 

To achieve either of these designations, the coordinator must sit for an examination following specified amounts of either full-time or part-time experience by the date of the examination as defined by either organization (www.acrpnet.org and www.socra.org). The examinations test knowledge in study conduct, regulations and ethical issues. 

The design of randomized clinical trials introduces ethical issues.Usually, study designs prevent the treatment from being modified because of the need to collect sufficient data to allow valid statistical inference. Ethically, clinicians are required to provide their patients with the best available treatment however, the justification for a randomized clinical trial is simply that the best treatment is not yet known. 

The committee deliberately incorporated discussion of communication and ethical considerations into this chapter not only because these issues present some of the most significant challenges with respect to interpretation and use of the biomonitoring data (key considerations in the committee s charge), but because it was the committee s intent to prompt readers to consider these issues as intrinsic in the design of biomonitoring studies. 

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