Where research was once strictly confined to one laboratory or office, investigators now widely share and compare their plans, analyses, and results. With the advent of genomic knowledge, researchers are seeking to understand the genetics and genomics of complex human disease. They are combining their efforts into international consortia in order to take on problems that face individuals around the world, such as cancer and malaria — problems that are too large to solve by one country alone. These consortia bring (...) together diverse research groups from different parts of the world to focus on a common goal. Their projects may all focus on one disease or condition, but examine it from different perspectives and share the newly gained information with each other and the wider scientific community. (shrink)

Researchers do not owe their subjects the same level of care that physicians owe patients, but they owe more than merely what the research protocol stipulates. In keeping with the dynamics of the relationship between researcher and subject, they have limited but substantive fiduciary obligations.

ABSTRACT This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants to be (...) permitted access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)

This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants to be permitted (...) access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)

Investigators and institutional review boards should integrate plans about the appropriate disclosure of individual genetic results when designing research studies. The ethical principles of beneficence, respect, reciprocity, and justice provide justification for routinely offering certain results to research participants. We propose a result-evaluation approach that assesses the expected information and the context of the study in order to decide whether results should be offered. According to this approach, the analytic validity and the clinical utility of a specific result determine whether (...) it should be offered routinely. Different results may therefore require different decisions even within the same study. We argue that the threshold of clinical utility for disclosing a result in a research study should be lower than the threshold used for clinical use of the same result. The personal meaning of a result provides additional criteria for evaluation. Finally, the context of the study allows for a more nuanced analysis by addressing the investigators' capabilities for appropriate disclosure, participants' alternative access to the result, and their relationship with the investigators. This analysis shows that the same result may require different decisions in different contexts. (shrink)

Currently, the return of results in the domain of biobanking constitutes an ethical and legal quagmire, whether it involves population or specific clinical research studies. In light of the fact that population biobanks are often not seen as distinct from those biobanks created for disease research, as well as the uncertainty as to what “return of results” means concretely, this lexicon attempts to demystify the terminology. The terms — results, return, clinical significance, and utility — are discussed. Through an analysis (...) of international and national normative guidance on this issue, the authors propose a concordance of meaning and a simplified lexicon. (shrink)

The last few years have witnessed the growth of large-scale, population genomics biobanks, which serve as longitudinal, gene-environment databases for future yet unspecified research. An international consortium, the Public Population Project in Genomics, builds harmonization tools for such biobanks and has catalogued numerous studies — at least 139 with over 10,000 banked participants and 34 with over 100,000. As their potential use for translational, clinical research draws near, it is opportune to clarify the duties of such biobanks to communicate results (...) to participants. To identify the potential obligations, some demystification of the terminology surrounding the return of results as found in international and national norms on biobanking generally is essential. On the whole, our proposed lexicon is based on a study of norms as found in national and international policies but excludes debates found in the literature. (shrink)