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 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 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.

Acoustic Separation and Biomedical Research: Lessons from Indian Regulation of Compensation for Research Injury

2015 ◽  
Vol 43 (1) ◽  
pp. 105-115
Author(s):  
Megan E. Larkin
Keyword(s):  
Clinical Trials ◽  
Biomedical Research ◽  
Human Subjects ◽  
Research Participation ◽  
Ethical Conduct ◽  
Critical Component ◽  
Human Subjects Research ◽  
Indian Central ◽  
Legal Restrictions ◽  
Human Participants

In early 2013, the Indian Central Drugs Standard Control Organisation, under supervision of the Health Secretary, introduced new rules governing the conduct of clinical trials involving human participants. Among other provisions, the rules require that sponsors of research compensate participants who are injured during the course of their research participation. The rules presumably were drafted to protect citizens from harm caused by biomedical research without unduly restricting access to the benefits that research can provide. While requiring compensation for injury is widely-acknowledged as a critical component of ensuring ethical conduct of human subjects research, in this case the legal restrictions do not match the ethical justifications that support a compensation requirement. To see this, it is important to examine the context in which the rules were written, the justifications for rules of this type, and what mechanisms are available to bring the effects of the rules into alignment with the norms their passage sought to promote.

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 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 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>

The Patient in Patient Safety: Contemporary Issues, From COVID-19 to Citizen Science

2021 ◽  
Vol 10 (1) ◽  
pp. 301-303
Author(s):  
Elizabeth Lerner Papautsky ◽  
Richard J. Holden ◽  
Rupa S. Valdez ◽  
Jordan Hill ◽  
Janetta Brown
Keyword(s):  
Social Media ◽  
Patient Safety ◽  
Citizen Science ◽  
Human Subjects ◽  
Lessons Learned ◽  
Human Subjects Research ◽  
Research Strategies ◽  
Face To Face

In the 4th panel on the topic of The Patient in Patient Safety, we highlighted topics of current relevance and facilitated a reflection session. The objective was to highlight the ways in which the COVID-19 pandemic has impacted patient ergonomics research and work, with particular focus on safety. After a topic overview, panelists presented their work on overcoming challenges to human subjects research created by the suspension of face-to-face activities during the COVID-19 pandemic. A facilitated reflection and brainstorming session using Miro followed. We used questions to elicit examples of patient and caregiver roles in safety during the pandemic and research strategies and challenges. These questions were also distributed on social media prior to the event. The panel served as an opportunity to share lessons learned.

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