Ethical Research Issues: Going Beyond the Declaration of Helsinki

La Vaque and Rossiter made a strong, supported argument that it is unethical to use a no treatment control group in a research study if a known, effective treatment is available. Their argument is based on the supposition that the Declaration of Helsinki is the ethical world standard for research with humans. Their argument appears to be straightforward, but is not simple to apply. The issues are very complex, include issues not discussed in their argument, and can lead to a different conclusion as pointed out in this paper. The World Medical Association developed the Declaration of Helsinki as one of their official policies. The Declaration of Helsinki, however, is not accepted as the world ethical standard, as demonstrated by its lack of adoption by many professional associations or even by the United States Federal Government. Perhaps it is not mentioned because its ethical provisions are aspirational rather than mandatory as implied by La Vaque and Rossiter. Researchers and clinicians should also be aware of other ethical issues not directly discussed in the La Vaque and Rossiter paper. The Belmont Report is the basis for the ethical protection of human research subjects for at least 17 federal agencies and does not mention the Declaration of Helsinki. The Belmont Report mentions several ethical principles that form the basis for informed consent, risk/benefit assessment, confidentiality of data, subject selection, Institutional Review Boards, and other protections needed when doing research with human subjects. At least 2 of these core principles have direct implications to the discussion related to the use of placebo controls. The ethical principle of fidelity is also important in guiding research activities with human subjects. Researchers should be familiar with the La Vaque and Rossiter argument, the Belmont Report, and the federal policies developed to implement the provisions of that report, for example, Regulation 45 CFR 46.     

The Effectiveness of Neurofeedback and Stimulant Drugs in Treating AD/HD: Part II. Replication

This study replicated T. R. Rossiter and T. J. La Vaque (1995) with a larger sample, expanded age range, and improved statistical analysis. Thirty-one AD/HD patients who chose stimulant drug (MED) treatment were matched with 31 patients who chose a neurofeedback (EEG) treatment program. EEG patients received either office (n = 14) or home (n = 17) neurofeedback. Stimulants for MED patients were titrated using the Test of Variables of Attention (TOVA). EEG (effect size [ES] = 1.01–1.71) and MED (ES = 0.80–1.80) groups showed statistically and clinically significant improvement on TOVA measures of attention, impulse control, processing speed, and variability in attention. The EEG group demonstrated statistically and clinically significant improvement on behavioral measures (Behavior Assessment System for Children, ES = 1.16–1.78, and Brown Attention Deficit Disorder Scales, ES = 1.59). TOVA gain scores for the EEG and MED groups were not significantly different. More importantly, confidence interval and nonequivalence null hypothesis testing confirmed that the neurofeedback program produced patient outcomes equivalent to those obtained with stimulant drugs. An effectiveness research design places some limitations on the conclusions that can be drawn.     

The Effectiveness of Neurofeedback and Stimulant Drugs in Treating AD/HD: Part I. Review of Methodological Issues

The paper examines major criticisms of AD/HD (Attention Deficit/Hyperactivity Disorder) neurofeedback research using T. R. Rossiter and T. J. La Vaque (1995) as an exemplar and discusses relevant aspects of research methodology. J. Lohr, S. Meunier, L. Parker, and J. P. Kline (2001), D. A. Waschbusch and G. P. Hill (2001), and J. P. Kline, C. N. Brann, and B. R. Loney (2002) criticized Rossiter and La Vaque for (1) using an active treatment control; (2) nonrandom assignment of patients; (3) provision of collateral treatments; (4) using nonstandardized and invalid assessment instruments; (5) providing artifact contaminated EEG feedback; and (6) conducting multiple non-alpha protected t tests. The criticisms, except those related to statistical analysis, are invalid or are not supported as presented by the authors. They are based on the critics' unsubstantiated opinions; require redefining Rossiter and La Vaque as an efficacy rather than an effectiveness study; or reflect a lack of familiarity with the research literature. However, there are broader issues to be considered. Specifically, what research methodology is appropriate for studies evaluating the effectiveness of neurofeedback and who should make that determination? The uncritical acceptance and implementation of models developed for psychotherapy, pharmacology, or medical research is premature and ill-advised. Neurofeedback researchers should develop models that are appropriate to the technology, treatment paradigms, and goals of neurofeedback outcome studies. They need to explain the rationale for their research methodology and defend their choices.     

The New Paradox in Marine Scientific Research: Regulating the Potential Environmental Impacts of Conducting Ocean Science

Concerns about the negative effects of marine scientific research are in clear juxtaposition to the beneficial role that scientific knowledge plays in enhancing the understanding of the oceans and protecting the marine environment. This presents a regulatory paradox that is examined in this article in light of the legal framework in the 1982 United Nations Convention on the Law of the Sea. The article traces how these general principles in the Convention are elaborated in soft law instruments for the promotion of environmentally sustainable research practices. It also looks at an example of state practice in this area by examining regulatory measures instituted in the Canadian Endeavour Hydrothermal Vent Marine Protected Area.