scholarly journals Return of individual research results and incidental findings in the clinical trials cooperative group setting

2012 ◽  
Vol 14 (4) ◽  
pp. 411-416 ◽  
Author(s):  
Michael Ferriere ◽  
Brian Van Ness
Keyword(s):  
Clinical Trials ◽  
Incidental Findings ◽  
Cooperative Group ◽  
Group Setting ◽  
Research Results ◽  
Individual Research Results

scholarly journals An implementation framework for the feedback of individual research results and incidental findings in research

2014 ◽  
Vol 15 (1) ◽  
Author(s):  
Adrian Thorogood ◽  
Yann Joly ◽  
Bartha Maria Knoppers ◽  
Tommy Nilsson ◽  
Peter Metrakos ◽  
...  
Keyword(s):  
Incidental Findings ◽  
Implementation Framework ◽  
Research Results ◽  
Individual Research Results

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.

scholarly journals Implementing a Geriatric Assessment in Cooperative Group Clinical Cancer Trials: CALGB 360401

2011 ◽  
Vol 29 (10) ◽  
pp. 1290-1296 ◽  
Author(s):  
Arti Hurria ◽  
Constance T. Cirrincione ◽  
Hyman B. Muss ◽  
Alice B. Kornblith ◽  
William Barry ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Geriatric Assessment ◽  
Health Care Professionals ◽  
Assessment Tool ◽  
Healthcare Providers ◽  
Psychological State ◽  
Cooperative Group ◽  
Group Setting ◽  
Assessment Measures ◽  
Cancer Trials

Purpose Factors captured in a geriatric assessment can predict morbidity and mortality in older adults, but are not routinely measured in cancer clinical trials. This study evaluated the implementation of a geriatric assessment tool in the cooperative group setting. Patients and Methods Patients age ≥ 65 with cancer, who enrolled on cooperative group cancer trials, were eligible to enroll on Cancer and Leukemia Group B (CALGB) 360401. They completed a geriatric assessment tool before initiation of protocol therapy, consisting of valid and reliable geriatric assessment measures which are primarily self-administered and require minimal resources and time by healthcare providers. The assessment measures functional status, comorbidity, cognitive function, psychological state, social support, and nutritional status. The protocol specified criteria for incorporation of the tool in future cooperative group trials was based on the time to completion and percent of patients who could complete their portion without assistance. Patient satisfaction with the tool was captured. Results Of the 93 patients who enrolled in this study, five (5%) met criteria for cognitive impairment and three did not complete the cognitive screen, leaving 85 assessable patients (median age, 72 years). The median time to complete the geriatric assessment tool was 22 minutes, 87% of patients (n = 74) completed their portion without assistance, 92% (n = 78) were satisfied with the questionnaire length, 95% (n = 81) reported no difficult questions, and 96% (n = 82) reported no upsetting questions. One hundred percent of health care professionals completed their portion. Conclusion This brief, primarily self-administered geriatric assessment tool met the protocol specified criteria for inclusion in future cooperative group clinical trials.

scholarly journals Preferences regarding Return of Genomic Results to Relatives of Research Participants, Including after Participant Death: Empirical Results from a Cancer Biobank

2015 ◽  
Vol 43 (3) ◽  
pp. 464-475 ◽  
Author(s):  
Carmen Radecki Breitkopf ◽  
Gloria M. Petersen ◽  
Susan M. Wolf ◽  
Kari G. Chaffee ◽  
Marguerite E. Robinson ◽  
...  
Keyword(s):  
Incidental Findings ◽  
Genetic Research ◽  
Research Participant ◽  
Potential Health ◽  
Research Results ◽  
Health Significance ◽  
Genomic Results ◽  
Individual Research Results ◽  
The Individual ◽  
Archive Data

Biobank data and samples frequently endure beyond the life of the individual who provided the sample; this is particularly true for biorepositories that archive data and samples from cancer patients. Those data and samples may be used for research, including after the death of the individual. When the research produces genetic research results (a term used here to include incidental findings and individual research results) that have potential health or reproductive importance for the individual who provided the sample, the results may also have importance for blood relatives. This raises the question of whether the research results should be shared with relatives, at their request or at the initiative of the researchers. The issues are complex even when the research participant is alive, but are particularly challenging after the death of the individual whose data and sample are archived, as the individual may not have been asked their preferences about sharing with family, including after death. Even if the individual’s preferences on sharing have been elicited, investigators and biobank directors may be concerned about withholding genetic research results from relatives that are of potential health significance.

scholarly journals Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations

2015 ◽  
Vol 43 (3) ◽  
pp. 440-463 ◽  
Author(s):  
Susan M. Wolf ◽  
Rebecca Branum ◽  
Barbara A. Koenig ◽  
Gloria M. Petersen ◽  
Susan A. Berry ◽  
...  
Keyword(s):  
Incidental Findings ◽  
Genomic Research ◽  
Research Results ◽  
Health Implications ◽  
Multiple Contexts ◽  
Important Health ◽  
Reproductive Concerns ◽  
Genomic Results ◽  
Individual Research Results ◽  
Genetic Results

The debate about how to manage individual research results and incidental findings in genetic and genomic research has focused primarily on what information, if any, to offer back to research participants. However, increasing controversy surrounds the question of whether researchers have any responsibility to offer a participant’s results (defined here to include both individual research results and incidental findings) to the participant’s relatives, including after the participant’s death. This question arises in multiple contexts, including when researchers discover a result with potentially important health implications for genetic relatives, when a participant’s relatives ask a researcher whether any research results about the participant have implications for their own health or reproductive planning, when a participant’s relative asks whether any of the participant’s results have implications for a child’s health, and when the participant is deceased and the participant’s relatives seek information about the participant’s genetic results in order to address their own health or reproductive concerns.

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