scholarly journals Empirical Analysis of Current Approaches to Incidental Findings

2008 ◽  
Vol 36 (2) ◽  
pp. 249-255 ◽  
Author(s):  
Frances Lawrenz ◽  
Suzanne Sobotka
Keyword(s):  
Empirical Analysis ◽  
Incidental Findings ◽  
Scientific Literature ◽  
Human Subjects ◽  
Human Subjects Research ◽  
Potential Health ◽  
National Human ◽  
Multidisciplinary Working ◽  
Imaging Research ◽  
Object Of Study

Researchers in the health sciences regularly discover information of potential health importance unrelated to their object of study in the course of their research. However, there appears to be little guidance available on what researchers should do with this information, known in the scientific literature as incidental findings (IFs). The study described here was designed to determine the extent of guidance available to researchers from public sources. This empirical study was part of a larger two-year project funded by the National Human Genome Research Institute (NHGRI) to generate guidance on how incidental findings should be managed in human subjects research, especially genetics, genomics, and imaging research. We generated empirical analysis of publicly available guidance and consent forms to help guide a multidisciplinary Working Group of experts in their formulation of normative recommendations reported in this symposium.

scholarly journals Incidental Findings in Human Subjects Research: What Do Investigators Owe Research Participants?

2008 ◽  
Vol 36 (2) ◽  
pp. 271-279 ◽  
Author(s):  
Franklin G. Miller ◽  
Michelle M. Mello ◽  
Steven Joffe
Keyword(s):  
Brain Imaging ◽  
Incidental Findings ◽  
Human Subjects ◽  
Clinical Care ◽  
Research Participant ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Potential Health ◽  
Imaging Research ◽  
General Topic

A physician-investigator conducting brain imaging research to study the pathophysiology of depression detects a suspicious finding in a healthy volunteer that suggests a possible brain tumor. Must the investigator disclose this finding to the research subject? Further, is there a duty to ensure that brain scans performed to answer research questions are evaluated clinically to identify potential health problems? If so, what in the nature of the investigator-subject relationship gives rise to such an obligation?Investigators and Institutional Review Boards (IRBs) commonly struggle with the question of how to address incidental findings — that is, “a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of the study.” A working group convened by the National Institutes of Health has recommended that brain imaging research studies should establish protocols for handling incidental findings. However, there is little ethical guidance available to steer such efforts, and practices appear to vary widely. Although several articles have catalogued the ethical dilemmas surrounding incidental findings, with the exception of seminal work by Henry Richardson and Leah Belsky on the more general topic of researchers’ obligations to provide ancillary clinical care to research subjects, systematic ethical analysis of the incidental findings problem is lacking.

scholarly journals Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations

2008 ◽  
Vol 36 (2) ◽  
pp. 219-248 ◽  
Author(s):  
Susan M. Wolf ◽  
Frances P. Lawrenz ◽  
Charles A. Nelson ◽  
Jeffrey P. Kahn ◽  
Mildred K. Cho ◽  
...  
Keyword(s):  
Incidental Findings ◽  
Human Subjects ◽  
Research Participant ◽  
Institutional Review Boards ◽  
Expert Evaluation ◽  
Human Subjects Research ◽  
Potential Health ◽  
Consent Forms ◽  
Institutional Review ◽  
Research Analysis

Researchers, institutional review boards (IRBs), participants in human subjects research, and their families face an important but largely neglected problem — how should incidental findings (IFs) be managed in human subjects research. If researchers unexpectedly stumble upon information of potential health or reproductive significance, should they seek expert evaluation, contact the participant’s physician, tell the research participant, or respond with some combination? What should consent forms and the entire consent process say about how IFs will be handled in research? What should IRBs require?

scholarly journals Understanding Incidental Findings in the Context of Genetics and Genomics

2008 ◽  
Vol 36 (2) ◽  
pp. 280-285 ◽  
Author(s):  
Mildred K. Cho
Keyword(s):  
Incidental Findings ◽  
Human Subjects ◽  
Association Studies ◽  
Human Migration ◽  
Genomic Research ◽  
Human Subjects Research ◽  
Research Results ◽  
Yield Information ◽  
Individual Research Results ◽  
Genetics And Genomics

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 (even if the purpose of the study is not medical). 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.

The Management of Incidental Findings in Neuro-Imaging Research: Framework and Recommendations

2010 ◽  
Vol 38 (1) ◽  
pp. 117-126 ◽  
Author(s):  
Erica K. Rangel
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Incidental Findings ◽  
Incidental Finding ◽  
Human Subjects ◽  
Research Participant ◽  
Diagnostic Techniques ◽  
Resonance Imaging ◽  
Potential Health ◽  
The Brain

With improved diagnostic capability and accuracy, the fields of medicine, neuroscience, psychiatry, and psychology have benefitted remarkably from the dramatic advancements in neuroimaging technology. Not only can surface and subsurface structures of the brain be mapped with incredible anatomical detail (with magnetic resonance imaging), now neural activity can be imaged across time as the brain responds to different stimuli (with functional magnetic resonance imaging). These sophisticated techniques have been a vital element in the recent increase in neuroimaging-based research. This increase, while producing new diagnostic techniques and improved treatment mechanisms for neurological disease, has also led to a new dilemma for human subjects researchers: how should incidental findings be managed? An incidental finding (IF) is a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of this study.

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

2008 ◽  
Vol 36 (2) ◽  
pp. 361-383 ◽  
Author(s):  
Susan M. Wolf ◽  
Jordan Paradise ◽  
Charlisse Caga-Anan
Keyword(s):  
Incidental Findings ◽  
Ct Colonography ◽  
Human Subjects ◽  
Human Subjects Research ◽  
Whole Genome Analysis ◽  
The Family ◽  
Genomic Microarray ◽  
Human Participants ◽  
Head Computed Tomography ◽  
Critical Challenge

Technology has outpaced the capacity of researchers performing research on human participants to interpret all data generated and handle those data responsibly. This poses a critical challenge to existing rules governing human subjects research. The technologies used in research to generate images, scans, and data can now produce so much information that there is significant potential for incidental findings (IFs), findings generated in the course of research but beyond the aims of the study. Neuroimaging scans may visualize the entire brain and even the entire head; computed tomography (CT) colonography research may visualize the entire torso, from the base of the lungs to the pubis; genetics studies may reveal “extra” and sometimes unwanted information about the family, such as misattributed paternity and undisclosed adoption; and genomic microarray research increasingly involves whole-genome analysis (WGA) revealing an individual’s complete genotype, with enormous potential for uncovering unexpected information about an individual’s genetics and risks of developing future conditions.

scholarly journals Incidental findings in human subjects research: Is ignorance really bliss?

2021 ◽  
Author(s):  
◽  
Hannah Brown
Keyword(s):  
Informed Consent ◽  
Incidental Findings ◽  
Research Study ◽  
Human Subjects ◽  
Informed Choice ◽  
Research Participant ◽  
Informed Consent Process ◽  
Human Subjects Research ◽  
Research Participants ◽  
Minimum Standards

<p>Human subjects research has the potential to produce information beyond the aims of the research study. This information may, nevertheless, have health or reproductive significance for the research participant. With the development of sophisticated technologies, these occurrences, known as incidental findings (IFs), are becoming increasingly common. As yet, however, there is no consensus on how IFs in human subjects research should be managed. This paper examines the current law and guidelines relating to human subjects research, and in doing so determines that research participants are inadequately informed about IFs. Consequently, their ability to make an informed choice about and provide informed consent to research procedures is compromised. After addressing the ethical and practical issues most salient to IFs, a framework for their management is developed. The framework sets out the information that should be discussed with research participants during the informed consent process. Recommendations for how this framework should be implemented are then made. The paper concludes that guidelines establishing minimum standards for communicating the possibility and presence of IFs are urgently required so that the rights of research participants are sufficiently protected.</p>

scholarly journals Incidental findings in human subjects research: Is ignorance really bliss?

2021 ◽  
Author(s):  
◽  
Hannah Brown
Keyword(s):  
Informed Consent ◽  
Incidental Findings ◽  
Research Study ◽  
Human Subjects ◽  
Informed Choice ◽  
Research Participant ◽  
Informed Consent Process ◽  
Human Subjects Research ◽  
Research Participants ◽  
Minimum Standards

<p>Human subjects research has the potential to produce information beyond the aims of the research study. This information may, nevertheless, have health or reproductive significance for the research participant. With the development of sophisticated technologies, these occurrences, known as incidental findings (IFs), are becoming increasingly common. As yet, however, there is no consensus on how IFs in human subjects research should be managed. This paper examines the current law and guidelines relating to human subjects research, and in doing so determines that research participants are inadequately informed about IFs. Consequently, their ability to make an informed choice about and provide informed consent to research procedures is compromised. After addressing the ethical and practical issues most salient to IFs, a framework for their management is developed. The framework sets out the information that should be discussed with research participants during the informed consent process. Recommendations for how this framework should be implemented are then made. The paper concludes that guidelines establishing minimum standards for communicating the possibility and presence of IFs are urgently required so that the rights of research participants are sufficiently protected.</p>

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