The Experts below are selected from a list of 360 Experts worldwide ranked by ideXlab platform
Susan M. Wolf - One of the best experts on this subject based on the ideXlab platform.
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return of individual research results and Incidental Findings facing the challenges of translational science
Annual Review of Genomics and Human Genetics, 2013Co-Authors: Susan M. WolfAbstract:The debate over return of individual research results and Incidental Findings to study participants is a key frontier in research ethics and practice. This is fundamentally a problem of translational science—a question of when information about an individual that is generated in research should be communicated for clinical attention, particularly as technologies such as whole-genome sequencing and whole-exome sequencing are increasingly used in clinical care. There is growing consensus that investigators should offer participants at least those individual Findings of high clinical importance and actionability. Increasing attention to what information biobanks and secondary researchers owe people who provide data and specimens offers an opportunity to treat these source individuals as research partners. Cutting-edge issues include return of results in pediatric populations and return to kin and family, both before and after the death of the proband, as well as how to manage Incidental Findings in clinical ...
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respecting patient autonomy in clinical genomics new recommendations on Incidental Findings go astray
Science, 2013Co-Authors: Susan M. Wolf, George J. Annas, Sherman EliasAbstract:Exome and whole genome sequencing is rapidly moving into clinical application to aid diagnosis and treatment, an eagerly awaited development. However, a startling policy statement by the American College of Medical Genetics and Genomics (ACMG) may prove to be a stumbling block. (1) Rather than reconfirming the well established principles of patient autonomy and informed consent in this new domain of clinical genomics, as in medical genetics and in medical practice more broadly, the policy statement recommends an abrupt change. Whenever clinical sequencing is undertaken to look for a “primary finding” (i.e., “a pathogenic alteration in a gene or genes that are relevant to the diagnostic indication for the sequencing was ordered”), the ACMG calls for laboratories to perform a “deliberate search for pathogenic and likely pathogenic variants” on an additional “minimal list” of 57 specified genes and report results without seeking patient consent. These “Incidental Findings” (also termed “secondary Findings”) are “results that are not related to the indication for ordering the sequencing but that may nonetheless be of medical value or utility to the ordering physician and the patient.” However, the ACMG addresses only “the results of a deliberate search” for specific variants, not other genetic Findings discovered unexpectedly, which is how the term “Incidental Findings” is more widely used. (2–4) The ACMG then calls for clinicians to report the results of the deliberate search for Incidental Findings in the 57 genes to the patient, with no opportunity for the patient to decline unwanted information. The only choice the patient has is to decline sequencing altogether, even if medically indicated. The ACMG imposes these testing and reporting requirements even when the patient is a child who has no medical need for these results during his or her childhood. The ethical and legal problems raised are profound. We urge the ACMG to reconsider the report.
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the past present and future of the debate over return of research results and Incidental Findings
Genetics in Medicine, 2012Co-Authors: Susan M. WolfAbstract:The past, present, and future of the debate over return of research results and Incidental Findings
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managing Incidental Findings and research results in genomic research involving biobanks and archived data sets
Genetics in Medicine, 2012Co-Authors: Susan M. Wolf, Brian G Van Ness, Mildred K Cho, Robert C Green, Frances P Lawrenz, Jeffrey P Kahn, Brittney N Crock, Laura M Beskow, Michael F Christman, Ralph HallAbstract:Managing Incidental Findings and research results in genomic research involving biobanks and archived data sets
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the past present and future of the debate over return of research results and Incidental Findings
Social Science Research Network, 2012Co-Authors: Susan M. WolfAbstract:In this introduction to a symposium on managing Incidental Findings and individual research results in genomic research involving biobanks and archived data sets, the principal investigator of the underlying National Institutes of Health (NIH)-funded project discusses the roots, current state, and likely future of this debate. The roots lie in the recognition that research participants are not mere means to scientific progress but vulnerable individuals. After key position papers on return of Incidental Findings and individual research results by investigators, the debate has now turned to the more complex question addressed in this symposium — how large-scale research using biobanks and archived data sets should approach Incidental Findings and individual research results. Where is the debate headed next? The answer lies in the history itself, a history of progress toward recognizing the humanity and informational needs of research participants. Increasingly, participants will be offered individual information. Limits will be set, to preserve the capacity to perform research and to protect participants from faulty information. And not all studies and biobanks will undertake individual return. It will take research and work to tailor return to serve participants’ needs and research realities. But debating return is the next step toward recognizing those who contribute specimens and data as partners in the research process.
Lincoln L Berland - One of the best experts on this subject based on the ideXlab platform.
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navigating uncertainty in the management of Incidental Findings
Journal of The American College of Radiology, 2019Co-Authors: Stella K Kang, Lincoln L Berland, William W Mayosmith, Alec J Megibow, Jenny K Hoang, Brian R Herts, Pari V PandharipandeAbstract:Abstract The lack of prospective outcomes studies for many types of Incidental Findings limits our understanding of both their natural history and the potential efficacy of treatment. To support decision making for the management of Incidental Findings, major sources of uncertainty in management pathways can be mapped and analyzed using mathematical models. This process yields important insights into how uncertainty influences the best treatment decision. Here, we consider a classification scheme, grounded in decision science, which exposes various levels and types of uncertainty in the management of Incidental Findings and addresses (1) disease-related risks, which are considered in context of a patient’s competing causes of mortality; (2) potential degrees of intervention; (3) strength of evidence; and (4) patients’ treatment-related preferences. Herein we describe how categorizing uncertainty by the sources, issues, and locus can build a framework from which to improve the management of Incidental Findings. Accurate and comprehensive handling of uncertainty will improve the quality of related decision making and will help guide future research priorities.
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management of Incidental liver lesions on ct a white paper of the acr Incidental Findings committee
Journal of The American College of Radiology, 2017Co-Authors: Richard M Gore, Lincoln L Berland, Elliot K Fishman, Perry J Pickhardt, Koenraad J Mortele, Jeanne M Horowitz, Claus J Fimmel, Mark S Talamonti, Pari V PandharipandeAbstract:The ACR Committee on Incidental Findings presents recommendations for managing liver lesions that are Incidentally detected on CT. These recommendations represent an update from the liver component of the ACR 2010 white paper on managing Incidental Findings in the pancreas, adrenal glands, kidneys, and liver. The Liver Subcommittee-which included five abdominal radiologists, one hepatologist, and one hepatobiliary surgeon-developed this algorithm. The recommendations draw from published evidence and expert opinion and were finalized by informal iterative consensus. Algorithm branches categorize liver lesions on the basis of patient characteristics and imaging features. They terminate with an assessment of benignity or a specific follow-up recommendation. The algorithm addresses most, but not all, pathologies and clinical scenarios. The goal is to improve the quality of care by providing guidance on how to manage Incidentally detected liver lesions.
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management of Incidental adrenal masses a white paper of the acr Incidental Findings committee
Journal of The American College of Radiology, 2017Co-Authors: William W Mayosmith, Lincoln L Berland, Julie H Song, Giles L Boland, Isaac R Francis, Gary M Israel, Peter J Mazzaglia, Pari V PandharipandeAbstract:The ACR Incidental Findings Committee presents recommendations for managing adrenal masses that are Incidentally detected on CT or MRI. These recommendations represent an update to the adrenal component of the JACR 2010 white paper on managing Incidental Findings in the adrenal glands, kidneys, liver, and pancreas. The Adrenal Subcommittee, constituted by abdominal radiologists and an endocrine surgeon, developed this algorithm. The algorithm draws from published evidence coupled with expert subspecialist opinion and was finalized by a process of iterative consensus. Algorithm branches categorize Incidental adrenal masses on the basis of patient characteristics and imaging features. For each specified combination, the algorithm concludes with characterization of benignity or indolence (sufficient to discontinue follow-up) and/or a subsequent management recommendation. The algorithm addresses many, but not all, possible pathologies and clinical scenarios. Our goal is to improve the quality of patient care by providing guidance on how to manage Incidentally detected adrenal masses.
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management of Incidental pancreatic cysts a white paper of the acr Incidental Findings committee
Journal of The American College of Radiology, 2017Co-Authors: Alec J Megibow, Lincoln L Berland, Mark E Baker, Desiree E Morgan, Ihab R Kamel, Dushyant V Sahani, Elliot Newman, William R Brugge, Pari V PandharipandeAbstract:Abstract The ACR Incidental Findings Committee (IFC) presents recommendations for managing pancreatic cysts that are Incidentally detected on CT or MRI. These recommendations represent an update from the pancreatic component of the JACR 2010 white paper on managing Incidental Findings in the adrenal glands, kidneys, liver, and pancreas. The Pancreas Subcommittee—which included abdominal radiologists, a gastroenterologist, and a pancreatic surgeon—developed this algorithm. The recommendations draw from published evidence and expert opinion, and were finalized by informal iterative consensus. Algorithm branches successively categorize pancreatic cysts based on patient characteristics and imaging features. They terminate with an ascertainment of benignity and/or indolence (sufficient to discontinue follow-up), or a management recommendation. The algorithm addresses most, but not all, pathologies and clinical scenarios. Our goal is to improve quality of care by providing guidance on how to manage Incidentally detected pancreatic cysts.
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management of the Incidental renal mass on ct a white paper of the acr Incidental Findings committee
Journal of The American College of Radiology, 2017Co-Authors: Brian R Herts, Lincoln L Berland, Stuart G Silverman, Gary M Israel, Nicole Hindman, Robert G Uzzo, Robert P Hartman, Deborah A Baumgarten, Pari V PandharipandeAbstract:The ACR Incidental Findings Committee (IFC) presents recommendations for renal masses that are Incidentally detected on CT. These recommendations represent an update from the renal component of the JACR 2010 white paper on managing Incidental Findings in the adrenal glands, kidneys, liver, and pancreas. The Renal Subcommittee, consisting of six abdominal radiologists and one urologist, developed this algorithm. The recommendations draw from published evidence and expert opinion and were finalized by informal iterative consensus. Each flowchart within the algorithm describes imaging features that identify when there is a need for additional imaging, surveillance, or referral for management. Our goal is to improve quality of care by providing guidance for managing Incidentally detected renal masses.
Pari V Pandharipande - One of the best experts on this subject based on the ideXlab platform.
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navigating uncertainty in the management of Incidental Findings
Journal of The American College of Radiology, 2019Co-Authors: Stella K Kang, Lincoln L Berland, William W Mayosmith, Alec J Megibow, Jenny K Hoang, Brian R Herts, Pari V PandharipandeAbstract:Abstract The lack of prospective outcomes studies for many types of Incidental Findings limits our understanding of both their natural history and the potential efficacy of treatment. To support decision making for the management of Incidental Findings, major sources of uncertainty in management pathways can be mapped and analyzed using mathematical models. This process yields important insights into how uncertainty influences the best treatment decision. Here, we consider a classification scheme, grounded in decision science, which exposes various levels and types of uncertainty in the management of Incidental Findings and addresses (1) disease-related risks, which are considered in context of a patient’s competing causes of mortality; (2) potential degrees of intervention; (3) strength of evidence; and (4) patients’ treatment-related preferences. Herein we describe how categorizing uncertainty by the sources, issues, and locus can build a framework from which to improve the management of Incidental Findings. Accurate and comprehensive handling of uncertainty will improve the quality of related decision making and will help guide future research priorities.
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management of Incidental liver lesions on ct a white paper of the acr Incidental Findings committee
Journal of The American College of Radiology, 2017Co-Authors: Richard M Gore, Lincoln L Berland, Elliot K Fishman, Perry J Pickhardt, Koenraad J Mortele, Jeanne M Horowitz, Claus J Fimmel, Mark S Talamonti, Pari V PandharipandeAbstract:The ACR Committee on Incidental Findings presents recommendations for managing liver lesions that are Incidentally detected on CT. These recommendations represent an update from the liver component of the ACR 2010 white paper on managing Incidental Findings in the pancreas, adrenal glands, kidneys, and liver. The Liver Subcommittee-which included five abdominal radiologists, one hepatologist, and one hepatobiliary surgeon-developed this algorithm. The recommendations draw from published evidence and expert opinion and were finalized by informal iterative consensus. Algorithm branches categorize liver lesions on the basis of patient characteristics and imaging features. They terminate with an assessment of benignity or a specific follow-up recommendation. The algorithm addresses most, but not all, pathologies and clinical scenarios. The goal is to improve the quality of care by providing guidance on how to manage Incidentally detected liver lesions.
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management of Incidental adrenal masses a white paper of the acr Incidental Findings committee
Journal of The American College of Radiology, 2017Co-Authors: William W Mayosmith, Lincoln L Berland, Julie H Song, Giles L Boland, Isaac R Francis, Gary M Israel, Peter J Mazzaglia, Pari V PandharipandeAbstract:The ACR Incidental Findings Committee presents recommendations for managing adrenal masses that are Incidentally detected on CT or MRI. These recommendations represent an update to the adrenal component of the JACR 2010 white paper on managing Incidental Findings in the adrenal glands, kidneys, liver, and pancreas. The Adrenal Subcommittee, constituted by abdominal radiologists and an endocrine surgeon, developed this algorithm. The algorithm draws from published evidence coupled with expert subspecialist opinion and was finalized by a process of iterative consensus. Algorithm branches categorize Incidental adrenal masses on the basis of patient characteristics and imaging features. For each specified combination, the algorithm concludes with characterization of benignity or indolence (sufficient to discontinue follow-up) and/or a subsequent management recommendation. The algorithm addresses many, but not all, possible pathologies and clinical scenarios. Our goal is to improve the quality of patient care by providing guidance on how to manage Incidentally detected adrenal masses.
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management of Incidental pancreatic cysts a white paper of the acr Incidental Findings committee
Journal of The American College of Radiology, 2017Co-Authors: Alec J Megibow, Lincoln L Berland, Mark E Baker, Desiree E Morgan, Ihab R Kamel, Dushyant V Sahani, Elliot Newman, William R Brugge, Pari V PandharipandeAbstract:Abstract The ACR Incidental Findings Committee (IFC) presents recommendations for managing pancreatic cysts that are Incidentally detected on CT or MRI. These recommendations represent an update from the pancreatic component of the JACR 2010 white paper on managing Incidental Findings in the adrenal glands, kidneys, liver, and pancreas. The Pancreas Subcommittee—which included abdominal radiologists, a gastroenterologist, and a pancreatic surgeon—developed this algorithm. The recommendations draw from published evidence and expert opinion, and were finalized by informal iterative consensus. Algorithm branches successively categorize pancreatic cysts based on patient characteristics and imaging features. They terminate with an ascertainment of benignity and/or indolence (sufficient to discontinue follow-up), or a management recommendation. The algorithm addresses most, but not all, pathologies and clinical scenarios. Our goal is to improve quality of care by providing guidance on how to manage Incidentally detected pancreatic cysts.
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management of the Incidental renal mass on ct a white paper of the acr Incidental Findings committee
Journal of The American College of Radiology, 2017Co-Authors: Brian R Herts, Lincoln L Berland, Stuart G Silverman, Gary M Israel, Nicole Hindman, Robert G Uzzo, Robert P Hartman, Deborah A Baumgarten, Pari V PandharipandeAbstract:The ACR Incidental Findings Committee (IFC) presents recommendations for renal masses that are Incidentally detected on CT. These recommendations represent an update from the renal component of the JACR 2010 white paper on managing Incidental Findings in the adrenal glands, kidneys, liver, and pancreas. The Renal Subcommittee, consisting of six abdominal radiologists and one urologist, developed this algorithm. The recommendations draw from published evidence and expert opinion and were finalized by informal iterative consensus. Each flowchart within the algorithm describes imaging features that identify when there is a need for additional imaging, surveillance, or referral for management. Our goal is to improve quality of care by providing guidance for managing Incidentally detected renal masses.
Mildred K Cho - One of the best experts on this subject based on the ideXlab platform.
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managing Incidental Findings and research results in genomic research involving biobanks and archived data sets
Genetics in Medicine, 2012Co-Authors: Susan M. Wolf, Brian G Van Ness, Mildred K Cho, Robert C Green, Frances P Lawrenz, Jeffrey P Kahn, Brittney N Crock, Laura M Beskow, Michael F Christman, Ralph HallAbstract:Managing Incidental Findings and research results in genomic research involving biobanks and archived data sets
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managing Incidental Findings in human subjects research analysis and recommendations
Social Science Research Network, 2008Co-Authors: Susan M. Wolf, Mildred K Cho, Frances P Lawrenz, Charles A Nelson, Jeffrey P Kahn, Ellen Wright Clayton, Joel G Fletcher, Michael K Georgieff, Dale E HammerschmidtAbstract:Tremendous debate surrounds the question of whether researchers owe back to human subjects information about Incidental Findings of potential clinical and reproductive importance to the individual. Historically, law, ethics, and practice have drawn a bright line between the duties of clinicians and the duties of researchers, imposing on researchers no duty to return information of clinical importance. Indeed, bioethics and health law are built on a dichotomy between clinical care (the domain of the doctor-patient relationship) and research (the domain of the researcher-subject relationship). Yet the debate over whether researchers have any duty to return Incidental Findings (and the related debate over whether they have a duty to return individual research results) challenges that fundamental dichotomy. This article offers analysis and recommendations from a two-year project funded by the National Institutes of Health (NIH) and led by Susan M. Wolf (Principal Investigator) to determine how to manage Incidental Findings (IFs) in human subjects research, focusing on genetic and genomic research, with comparison to imaging research. This is the first national project funded by NIH on this issue. IFs are defined as Findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. IFs are frequently discovered in conducting research and can hold life-and-death importance (as when researchers stumble upon a genetic variant predicting life-threatening response to a commonly used anesthetic). The article argues that researchers have an obligation to address the possibility of discovering IFs and articulate how IFs will be managed. This information should be reflected in the researcher’s protocol and communications with the IRB, as well as in consent forms and communications with research participants. The article recommends a pathway for researchers to follow in addressing IFs. It categorizes IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. This is the first comprehensive analysis and major set of recommendations on how to handle Incidental Findings in human subjects research including genomic research. It is the centerpiece of a symposium issue including sixteen articles from a multidisciplinary group of top scholars on this pressing issue.
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managing Incidental Findings in human subjects research analysis and recommendations
Journal of Law Medicine & Ethics, 2008Co-Authors: Susan M. Wolf, Mildred K Cho, Frances P Lawrenz, Charles A Nelson, Jeffrey P Kahn, Ellen Wright Clayton, Joel G Fletcher, Michael K Georgieff, Dale E Hammerschmidt, Kathy HudsonAbstract: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?
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practical approaches to Incidental Findings in brain imaging research
Neurology, 2008Co-Authors: Judy Illes, Matthew P. Kirschen, Gary H. Glover, Emmeline Edwards, Peter A Bandettini, Mildred K Cho, Paul J Ford, Jennifer Kulynych, Ruth MacklinAbstract:A decade of empirical work in brain imaging, genomics, and other areas of research has yielded new knowledge about the frequency of Incidental Findings, investigator responsibility, and risks and benefits of disclosure. Straightforward guidance for handling such Findings of possible clinical significance, however, has been elusive. In early work focusing on imaging studies of the brain, we suggested that investigators and institutional review boards must anticipate and articulate plans for handling Incidental Findings. Here we provide a detailed analysis of different approaches to the problem and evaluate their merits in the context of the goals and setting of the research and the involvement of neurologists, radiologists, and other physicians. Protecting subject welfare and privacy, as well as ensuring scientific integrity, are the highest priorities in making choices about how to handle Incidental Findings. Forethought and clarity will enable these goals without overburdening research conducted within or outside the medical setting.
Jonathan S Berg - One of the best experts on this subject based on the ideXlab platform.
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Incidental Findings with Genomic Testing: Implications for Genetic Counseling Practice
Current Genetic Medicine Reports, 2015Co-Authors: Myra I. Roche, Jonathan S BergAbstract:This paper summarizes the current controversies surrounding the identification and disclosure of “Incidental” or “secondary” Findings from genomic sequencing and the implications for genetic counseling practice. The rapid expansion of clinical sequencing has influenced the ascertainment and return of Incidental Findings, while empiric data to inform best practices are still being generated. Using the North Carolina Clinical Genomic Evaluation by Next Generation Exome Sequencing (NCGENES) research project as an example, we discuss the implications of different models of consent and their impact on patient decisions.
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processes and preliminary outputs for identification of actionable genes as Incidental Findings in genomic sequence data in the clinical sequencing exploratory research consortium
Genetics in Medicine, 2013Co-Authors: Jonathan S Berg, Eliezer M Van Allen, Nikhil Wagle, Laura M Amendola, Christine M Eng, Stacy W GrayAbstract:As genomic and exomic testing expands in both the research and clinical arenas, determining whether, how, and which Incidental Findings to return to the ordering clinician and patient becomes increasingly important. Although opinion is varied on what should be returned to consenting patients or research participants, most experts agree that return of medically actionable results should be considered. There is insufficient evidence to fully inform evidence-based clinical practice guidelines regarding return of results from genome-scale sequencing, and thus generation of such evidence is imperative, given the rapidity with which genome-scale diagnostic tests are being incorporated into clinical care. We present an overview of the approaches to Incidental Findings by members of the Clinical Sequencing Exploratory Research network, funded by the National Human Genome Research Institute, to generate discussion of these approaches by the clinical genomics community. We also report specific lists of "medically actionable" genes that have been generated by a subset of investigators in order to explore what types of Findings have been included or excluded in various contexts. A discussion of the general principles regarding reporting of novel variants, challenging cases (genes for which consensus was difficult to achieve across Clinical Sequencing Exploratory Research network sites), solicitation of preferences from participants regarding return of Incidental Findings, and the timing and context of return of Incidental Findings are provided.Genet Med 15 11, 860-867.Genetics in Medicine (2013); 15 11, 860-867. doi:10.1038/gim.2013.133.
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acmg recommendations for reporting of Incidental Findings in clinical exome and genome sequencing
Genetics in Medicine, 2013Co-Authors: Jonathan S Berg, Amy L Mcguire, Robert C Green, Wayne W Grody, Sarah S Kalia, Bruce R Korf, Christa Lese Martin, Robert L Nussbaum, Julianne M OdanielAbstract:In clinical exome and genome sequencing, there is a potential for the recognition and reporting of Incidental or secondary Findings unrelated to the indication for ordering the sequencing but of medical value for patient care. The American College of Medical Genetics and Genomics (ACMG) recently published a policy statement on clinical sequencing that emphasized the importance of alerting the patient to the possibility of such results in pretest patient discussions, clinical testing, and reporting of results. The ACMG appointed a Working Group on Incidental Findings in Clinical Exome and Genome Sequencing to make recommendations about responsible management of Incidental Findings when patients undergo exome or genome sequencing. This Working Group conducted a year-long consensus process, including an open forum at the 2012 Annual Meeting and review by outside experts, and produced recommendations that have been approved by the ACMG Board. Specific and detailed recommendations, and the background and rationale for these recommendations, are described herein. The ACMG recommends that laboratories performing clinical sequencing seek and report mutations of the specified classes or types in the genes listed here. This evaluation and reporting should be performed for all clinical germline (constitutional) exome and genome sequencing, including the "normal" of tumor-normal subtractive analyses in all subjects, irrespective of age but excluding fetal samples. We recognize that there are insufficient data on penetrance and clinical utility to fully support these recommendations, and we encourage the creation of an ongoing process for updating these recommendations at least annually as further data are collected.
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description and pilot results from a novel method for evaluating return of Incidental Findings from next generation sequencing technologies
Genetics in Medicine, 2013Co-Authors: Katrina A B Goddard, Jonathan S Berg, Evelyn P Whitlock, Marc S Williams, Elizabeth M Webber, Jennifer Webster, Jennifer S Lin, Kasmintan A Schrader, Doug Camposoutcalt, Kenneth OffitAbstract:Description and pilot results from a novel method for evaluating return of Incidental Findings from next-generation sequencing technologies
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exploring concordance and discordance for return of Incidental Findings from clinical sequencing
Genetics in Medicine, 2012Co-Authors: Robert C Green, Jonathan S Berg, Gerard T Berry, Leslie G Biesecker, David Dimmock, James P Evans, Wayne W Grody, Madhuri Hegde, Sarah S Kalia, Bruce R KorfAbstract:Exploring concordance and discordance for return of Incidental Findings from clinical sequencing
