The Law of Incidental Findings in Human Subjects Research: Establishing Researchers' Duties

University of Minnesota, MN, USA.
The Journal of Law Medicine & Ethics (Impact Factor: 1.1). 02/2008; 36(2):361-83, 214. DOI: 10.1111/j.1748-720X.2008.00281.x
Source: PubMed


Research technologies can now produce so much information that there is significant potential for incidental findings (IFs). These are findings generated in research that are beyond the aims of the study. Current law and federal regulations offer no direct guidance on how to deal with IFs in research, nor is there adequate professional or institutional guidance. We advocate a defined set of researcher duties based on law and ethics and recommend a pathway to be followed in handling IFs in research. This article traces the underlying ethical and legal theories supporting researcher duties to manage IFs, including duties to develop a plan for management in the research protocol, to discuss the possibility of and management plan for IFs in the informed consent process, and to address, evaluate, and ultimately offer to disclose IFs of potential clinical or reproductive significance to research participants when they arise.

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    • "Incidental findings were defined as previously undiagnosed medical conditions that were discovered unintentionally and were unrelated to the current medical condition.14) Also radiographs with incidental findings of patients referred from local clinics were defined as incidental findings. "
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    ABSTRACT: Background Despite the wide use of knee radiography in children and adolescent patients visiting the outpatient clinic, there has been no analysis about the prevalence and type of incidental findings yet. This study was performed to investigate the incidental findings on knee radiographs in children and adolescents according to age. Methods A total of 1,562 consecutive patients younger than 18 years of age were included. They who visited Seoul National University Bundang Hospital's outpatient clinic with a chief complaint of knee pain or malalignment between 2010 and 2011. We reviewed the knee radiographs and analyzed the prevalence and type of incidental findings, such as metaphyseal lucent area, epiphyseal cortical irregularity, osteochondroma and Harris growth arrest line. Results The mean age of the patients was 10.2 years (range, 1 month to 18 years). We identified 355 incidental findings in 335 patients (21.4%) and 98 abnormal findings (6.3%). The most common incidental finding was metaphyseal lucent area (131, 8.4%), followed by epiphyseal cortical irregularity (105, 6.7%), Harris growth arrest line (75, 4.8%), and osteochondroma (44, 2.8%). An epiphyseal cortical irregularity tended to have a higher prevalence at younger age (p < 0.001) and the prevalences of metaphyseal lucent area and Harris growth arrest line were also higher at a younger age (p = 0.001 and p < 0.001, respectively). However, the osteochondroma tended to have a higher prevalence at an older age (p = 0.004). Conclusions This study describes the incidental findings on knee radiographs in children and adolescents and provides effective information from a viewpoint of an orthopedic doctor. The authors recommend considering those incidental findings if unfamiliar findings appear on a knee radiograph in the pediatric outpatient clinic.
    Full-text · Article · Sep 2014 · Clinics in orthopedic surgery
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    • "Incidental findings (IFs) have been defined as findings with potential health or reproductive importance to individuals discovered during diagnostic testing or during research but falling outside the diagnostic indication for which the test was ordered (Wolf et  al. 2008). A recent publication (March 2014) from the Medical Research Council (MRC) and the Wellcome Trust in the UK provides a clearer framework about IFs from research settings (MRC and Wellcome Trust 2014) and reflects the ongoing effort to provide clear guidance. "
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    ABSTRACT: Unprecedented progress in sequencing technologies and decreasing cost have brought genomic testing into the clinical setting. At the same time, the debate in the literature concerning the return of incidental findings (IFs) has made this an important issue internationally. These developments reflect a shift in genetics that will also affect smaller countries, such as Greece, that are just starting to implement these technologies and may look to other countries for examples of good practice. Ten in-depth interviews were conducted with Greek experts in clinical sequencing. Previous experiences and attitudes toward IFs and clinical sequencing were investigated as well as views on the existing policy regarding managing genetic information generated through testing. . Interviews were analysed using thematic analysis. All participants reported the lack of any legal or other supportive mechanism. IFs are currently managed at a "local" level, i.e. within the clinic or the laboratory in an ad hoc way. All participants thought that clinically valid and actionable IFs should be returned, but always with caution and in respect to patients' wishes, although several experts reported returning IFs according to their clinical discretion. Experts reported that most patients ask for all tests available but they felt that more counselling is needed to understand and manage genetic information. Due to the lack of any supporting mechanisms, professionals in Greece, even those with established experience in the field of genetic and genomic testing, have difficulties dealing with IFs. All experts agreed that it is now time, before the full integration of genomic testing into everyday clinical practice, for guidance to help Greek physicians work with patients and their families when IFs are discovered.
    Full-text · Article · Jul 2014 · Journal of community genetics
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    • "In addition to disclosing the risks and benefits of research, the Common Rule also requires researchers to minimize risks and ensure that these are reasonable in relation to the anticipated benefits . This suggests that investigators at least ought to have a plan for how to deal with significant findings to ensure that the risks of disclosure or nondisclosure are minimized (Wolf et al. 2008). It does not, however, create an obligation to disclose. "
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    ABSTRACT: Genomic researchers are increasingly faced with difficult decisions about whether, under what circumstances, and how to return research results and significant incidental findings to study participants. Many have argued that there is an ethical, maybe even a legal obligation to disclose significant findings under some circumstances. At the international level, over the last decade there has begun to emerge a clear legal obligation to return significant findings discovered during the course of research. However, there is no explicit legal duty to disclose in the United States. This creates legal uncertainty that may lead to unmanaged variation in practice and poor quality care. This paper discusses liability risks associated with the disclosure of significant research findings for investigators in the United States.
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