No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

The Human Genome Project showed that there is signifcant genetic variation within the population. Current research is accumulating large databases that may reveal genetic variations associated with disease or health risks, even if not intended as part of the study design. These incidental fnd-ings create legal, ethical, and fnancial challenges for researchers. Current federal and international guidelines are not adequate. Plans for dealing with incidental fndings need to be established in the study design and reviewed and approved by the Institutional (...) Review Board. (shrink)

Medical practice is poised to incorporate genomescale testing into treatment decisions. However, broad genome testing in laboratories may lead to discoveries not anticipated, yet highly significant to the health of the patient. Understanding the complexity of our genome and its relationship to our health is an overwhelming task. Currently, much of the effort to unravel this complexity is in the realm of research. However, researchers are often neither qualified nor prepared to deal with incidental findings of genetic abnormalities that influence (...) health and disease. These incidental observations, referred to recently by Issac Kohane et al. as the “incidentalome,” may lead to complex legal, ethical, and financial problems that may seriously complicate the role of the research community in medical genomics. Currently, most genetics researchers, while aware of the potential for incidental findings, simply do not want to deal with them. (shrink)

Background: Expanded newborn screening generates incidental results, notably carrier results. Yet newborn screening programmes typically restrict parental choice regarding receipt of this non-health serving genetic information. Healthcare providers play a key role in educating families or caring for screened infants and have strong beliefs about the management of incidental results. Methods: To inform policy on disclosure of infant sickle cell disorder (SCD) carrier results, a mixed-methods study of healthcare providers was conducted in Ontario, Canada, to understand attitudes regarding result management (...) using a cross-sectional survey (N = 1615) and semistructured interviews (N = 42). Results: Agreement to reasons favouring disclosure of SCD carrier results was high (65.1%–92.7%) and to reasons opposing disclosure was low (4.1%–18.1%). Genetics professionals expressed less support for arguments favouring disclosure (35.3%–78.8%), and more agreement with arguments opposing disclosure (15.7%–51.9%). A slim majority of genetics professionals (51.9%) agreed that a reason to avoid disclosure was the importance of allowing the child to decide to receive results. Qualitatively, there was a perceived “duty” to disclose, that if the clinician possessed the information, the clinician could not withhold it. Discussion: While a majority of respondents perceived a duty to disclose the incidental results of newborn screening, the policy implications of these attitudes are not obvious. In particular, policy must balance descriptive ethics (ie, what providers believe) and normative ethics (ie, what duty-based principles oblige), address dissenting opinion and consider the relevance of moral principles grounded in clinical obligations for public health initiatives. (shrink)

Possibilities for critical social theory and Foucault’s work: a toolbox approach The benefits and constraints of philosophical frameworks using the work of Michel Foucault and critical social theorists, such as Fay, Giroux and McLaren, are examined in the light of their traditions. The reasons nurse researchers adopt these frameworks are explored, as are the tensions between the respective theories. A complementary ‘toolbox’ approach to the research process addresses some of the theoretical and methodological challenges presented by each framework. Such an (...) approach provides distinctive insights into nursing practice that the other has ignored or missed. It is argued that by converging the two frameworks into a toolbox approach, it is possible to examine or deconstruct existing practices, whilst also providing an avenue for nurses to reconstruct or change such practices. (shrink)

Institutional Review Boards are confronted with new challenges in the face of expanding technologies while fulfll-ing their existing regulatory mandate to ensure that plans are in place to protect subjects and to inform them of risks and benefts of research participation. Existing regulations and guidance do not address the issue of incidental fndings , thus leaving awareness of the issue and the application of ethical principles to IRB judgment alone. In order to assure that researchers are aware of the potential (...) for IFs, IRBs must identify which studies are likely to identify IFs and establish what plans should be put into place prior to study initiation to assure the subjects are appropriately informed of the likelihood of IFs, how IFs will be communicated to subjects, and whether the burden of follow-up falls on the researchers or is the subject's responsibility. (shrink)

With rapidly expanding technological capacity, research has outpaced the existing infrastructure of ethical and regulatory guidance. In the area of incidental findings, this is particularly true.The regulations under which most Institutional Review Boards operate were established over 25 years ago and have not been substantially altered in the intervening years. The technology available today that creates the opportunity for IFs was not conceived of, or considered, in the crafting of those regulations. Therefore, little guidance can be derived directly from these (...) regulations. Rather, aspects of existing ethical guidance and regulations can be adapted to assist IRBs and researchers in dealing with issues surrounding IFs. (shrink)

Informed consent represents a cornerstone of the endeavours to make health care research ethically acceptable. Based on experience of qualitative research on power dynamics in nursing care in acute psychiatry, we show that the requirement for informed consent may be practised in formalistic ways that legitimize the researcher's activities without taking the patient's changing perception of the situation sufficiently into account. The presentation of three patient case studies illustrates a diversity of issues that the researcher must consider in each situation. (...) We argue for the necessity of researchers to base their judgement on a complex set of competencies. Consciousness of research ethics must be combined with knowledge of the challenges involved in research methodology in qualitative research and familiarity with the therapeutic arena in which the research is being conducted. The article shows that the alternative solution is not simple but must emphasize the researcher's ability to doubt and be based on an awareness of the researcher's fallibility. (shrink)

: Genetics researchers often work with distinct communities. To take moral account of how their research affects these communities, they need a richer conception of justice and they need to make those communities equal participants in decision-making about how the research is conducted and what is produced and published out of it.

This philosophical inquiry examines the nature of the technology of genetic predisposition testing and its relation to patients as whole persons. The bioethical principles of nonmaleficence, beneficence, autonomy and justice are judged insufficient to resolve issues associated with use. A new principle of ‘sustained being’, drawn from philosophical propositions of Pellegrino, is suggested. The new principle is suited to an evolving practice and is compatible with consequentialist, deontological and relational ethics theories. The notion of ‘taking care’ is related to nursing (...) in genetic health care to form a standard of conduct and a moral imperative to ‘safeguard being’. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. It has been common practice among researchers to notify participants during the informed consent process that no individual results will be disclosed, “incidental” or otherwise. However, as genetic information obtained in research becomes orders of magnitude more voluminous, increasingly accessible online, and more informative, this precedent may no longer be appropriate. There is not yet consensus on (...) the responsibilities of researchers to disclose individual research results to research participants. Empirical research suggests that participants want to know individual research results. On the other hand, the increased resolution and power aforded by new genomic analyses may lead to fndings of statistical, but not necessarily clinical, signifcance. This paper addresses the issues to be considered in deciding whether and how to disclose “incidental” fndings or other fndings of clinical signifcance that arise in the course of human genomic and genetic research. What research results should be ofered, and what should not be ofered? For which research should individual results be ofered to research participants, when should they be ofered, how, and to whom? (shrink)

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. However, no consensus exists as yet on the responsibilities of researchers to disclose individual research results to participants in human subjects research. “Genetic and genomic research” on humans varies widely, including association studies, examination of allele frequencies, and studies of natural selection, human migration, and genetic variation. For the purposes of this article, it is defined broadly (...) to include analysis of DNA collected from humans that has implications for human health. This paper addresses both research results of individual research participants that may be an intended product of the research, as well as unanticipated, “incidental” findings. (shrink)