The last half century has been characterized by a growth in the regulation of clinical research nationally and internationally. Each area of research on human subjects has been the subject of a vast academic literature and extensive public policy debate, from issues of informed consent to that of regulatory structures. Professor Bernard Dickens has provided an outstanding contribution to this debate internationally through his many innovative and incisive papers in this area. This paper provides an English lawyer’s perspective upon the increasing regulation of clinical research practices and asks – does regulation equate with effective rights protection? From Nuremberg onwards, there has been concern to ensure that research practices are ethical and in accordance with legal principles. So, for example, there have been statements such as the Declaration of Helsinki, which was initially produced in 1964. In the European context in particular, notably influential statements have been the European Convention on Human Rights, which has been followed by the Council of Europe Convention on Human Rights and Biomedicine and, more recently, a Draft Additional Protocol on medical research.

This article explores decision making about social-ethical values issues by members of the public in the context of the recent Canadian federal election, held in late June 2004. All of these issues are sensitive and controversial, and I hesitated to address them in an article that I dedicate, with respect and admiration, to my friend and fellow medical lawyer-ethicist, Bernard Dickens. Over the years Bernie and I have discussed, debated and disagreed on many of them. It speaks to his tolerance, reasonableness and wisdom that those occasions were for me always ones of learning and respect, colored by his inimitable sense of humor. I hope that Bernie feels that, in some small measure, this article reflects those same characteristics, ones that he has modeled for so many of us over the years of his distinguished career.

Though in existence for over thirty-five years, due to the increasing panoply of possible tests. Newborn screening programs are drawing public attention. Many jurisdictions have mandatory newborn screening programs for treatable disorders. Disorders are detected through tests on blood spots drawn from a newborn’s heel soon after birth and verified through a diagnostic test with follow-up. Unbeknownst to most parents, these blood spot cards are also stored thereafter. Indeed, while dried blood spots (DBSs) are primarily used for screening for health problems, experience demonstrates that they can be made useful in various contexts unrelated to screening.

Newborn dried blood spots have taken on a new life as a result of developments in genetics and the increasing ability of bioinformatics to link DNA information with clinical data. Additionally, storage and secondary uses have been documented to occur without parental consent.

Many pediatric research regulations, including those of the United States, the Council for International Organizations of Medical Science (CIOMS), and South Africa, offer similar rules for review board approval of higher hazard studies holding out no therapeutic or direct benefit to children with disorders or conditions (See Table 1). Authorization requires gaining parental permissions and the children’s assent, if that is possible, and showing that these studies are intended to gain vitally important and generalizable information about children’s conditions; it also requires limiting the risks of harm to no more than a “minor increase over minimal risk” and showing the study is commensurable with the children’s experiences. For convenience, these investigations will be called “no benefit, higher hazard” studies.

Despite the existence of these policies for decades, studies show that review boards’ judgments vary about what “no benefit, higher hazard” studies should be approved.

In recent years, shared decision-making has become entrenched in the medical literature and the law as the ideal method for involving patients in decisions related to their health care. Shared decision-making represents a compromise between the opposed extremes of paternalistic interactions that limit patients’ control of their health care, and “informed choice” interactions that require physicians to provide technical expertise only, leaving patients to make all treatment decisions on their own. An implicit goal of shared decision-making is to improve medical care by promoting joint participation of patients and physicians in clinical consultations. The model of shared decision-making may, however, inadequately address the health care needs of lower literate patients, a significant portion of the general population.

As shared decision-making is widely held as a clinical ideal, we highlight the difficulties that physicians might have in implementing shared decision-making with lower literate patients.