Providing research results to study participants: support versus practice of researchers presenting at the American Society of Hematology annual meeting

Rigby, Heather; Fernandez, Conrad V.

doi:10.1182/blood-2005-02-0556

Cited by 59 publications

(56 citation statements)

References 12 publications

(17 reference statements)

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“…1,2 This suggestion has moved the controversial issue of disclosure of individual research results to the forefront of cancer research, not only for GWAS but for the entire spectrum of cancer research studies. Currently, many issues remain unclear, including the conditions that warrant disclosure of individual versus aggregate research results, how to handle findings unrelated to the original research, who should make these decisions, and who should be responsible for communicating findings to the research subject.…”

Section: Setting the Stagementioning

confidence: 99%

“…Available from: http://grants.nih.gov/grants/gwas/gwas__ data__ sharing__ plan.pdf. 2 The above scenario, although currently rare, is likely to increase in frequency as researchers worldwide generate data and gain access to a growing resource of large specimen banks and linked databases containing genotypic and phenotypic profiles in diseased and healthy populations (e.g., dbGAP, caBIG, PharmGkb). 3 Access to this information, coupled with the expansion of efficient and reliable tools at lower costs, such as whole genome sequencing, will offer unparalleled potential to integrate vast amounts of information to understand etiology, progression, and treatment of cancer.…”

Section: Setting the Stagementioning

confidence: 99%

“…5 NBAC, NIH GWAS policy, and NHGRI recommend that the investigator, working with the IRB, have a management plan for the potential occurrence when individual research results would be disclosed. 2,5,13 The NIH GWAS policy suggests that the IRB have a management plan to address not only return of results generated by the primary investigator but also return of results generated by a secondary investigator who would be responsible to contact the primary investigator with a clinically relevant finding. 2 Individual to give the results to the research subject.…”

Section: Learning From Existing Recommendationsmentioning

confidence: 99%

“…2,5,13 The NIH GWAS policy suggests that the IRB have a management plan to address not only return of results generated by the primary investigator but also return of results generated by a secondary investigator who would be responsible to contact the primary investigator with a clinically relevant finding. 2 Individual to give the results to the research subject. Nearly every group indicated that a medical professional trained in genetic counseling should give the results (e.g., medical geneticist, genetic counselor, medical professional trained in genetic counseling) ( Table 3).…”

Section: Learning From Existing Recommendationsmentioning

confidence: 99%

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Disclosure of Research Results from Cancer Genomic Studies: State of the Science

Dressler

2009

Clinical Cancer Research

107

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Although the cancer research community has supported a ''nondisclosure'' position about the return of individual results to research subjects, new technologies, such as genome wide association studies, will reveal clinically relevant findings, some of which cannot be ignored. What recommendations exist that can guide researchers and Institutional Review Boards (IRBs) about this issue? This article summarizes the relevant public documents about the disclosure of individual research results to inform policy development. Four stakeholder groups were selected to make this comparison: federal, professional, advisory, and advocacy groups. Regardless of a group's position on disclosure, there was consensus that if research results were to be disclosed under any condition, the results must be analytically and clinically validated and that the researcher should not make this decision alone, but in conjunction with the IRB. There was no consensus, however, on the specific determinants for disclosure or what constitutes clinical validity. Although sufficient agreement exists to begin developing general guidelines about the process for disclosure of individual research results, the actual determinants with which to guide this decision remain challenging. An alternate framework that addresses the threshold of uncertainty a stakeholder is willing to accept, the positive predictive value of the research finding, and the magnitude of harm of returning results may be more effective to guide decision making. These assessments, along with what is considered useful information, requires the involvement of the research subject community to inform decision-making and move the policy process forward. Setting the StageThe recent NIH Policy for GWAS suggests that the researcher and her/his IRB or designated institutional official are expected to devise a plan to address the possibility of revealing clinically relevant information identified through the course of genomic research.1,2 This suggestion has moved the controversial issue of disclosure of individual research results to the forefront of cancer research, not only for GWAS but for the entire spectrum of cancer research studies. Currently, many issues remain unclear, including the conditions that warrant disclosure of individual versus aggregate research results, how to handle findings unrelated to the original research, who should make these decisions, and who should be responsible for communicating findings to the research subject. Researchers and IRBs need guidance to help address these issues and develop responsible, consistent policies to protect the rights and welfare of research subjects, and to engender the public's trust in the research enterprise. For more than a decade, many professional, federal, advisory, and advocacy groups have presented guidelines or recommendations to address issues of disclosure of individual research results. What can we learn from these efforts? The purpose of this article is to review and comment on results from a systematic analysis ...

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Section: Setting the Stagementioning

confidence: 99%

Section: Setting the Stagementioning

confidence: 99%

Section: Learning From Existing Recommendationsmentioning

confidence: 99%

Section: Learning From Existing Recommendationsmentioning

confidence: 99%

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Disclosure of Research Results from Cancer Genomic Studies: State of the Science

Dressler

2009

Clinical Cancer Research

107

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“…Despite the attention given to this issue, to our knowledge, few data have been collected regarding the prevalence of returning research results, although some studies suggest that the practice is uncommon (Partridge et al, 2004;Rigby and Fernandez, 2005;Shalowitz and Miller, 2008). To provide insight on the practices of genetic and genomic researchers regarding disclosure of research results to participants, we conducted an online survey of authors of genetics and genomics articles published in 2006 and 2007.…”

mentioning

confidence: 99%

Researcher Practices on Returning Genetic Research Results

Heaney

Tindall

Lucas

et al. 2010

Genetic Testing and Molecular Biomarkers

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Background/Aims: As genetic and genomic research proliferates, debate has ensued about returning results to participants. In addition to consideration of the benefits and harms to participants, researchers must also consider the logistical and financial feasibility of returning research results. However, little data exist of actual researcher practices. Methods: We conducted an online survey of 446 corresponding authors of genetic/genomic studies conducted in the United States and published in 2006-2007 to assess the frequency with which they considered, offered to, or actually returned research results, what factors influenced these decisions, and the method of communicating results. Results: The response rate was 24% (105/446). Fifty-four percent of respondents considered the issue of returning research results to participants, 28% offered to return individual research results, and 24% actually returned individual research results. Of those who considered the issue of returning research results during the study planning phase, the most common factors considered were whether research results were deemed clinically useful (18%) and respect for participants (13%). Researchers who had a medical degree and conducted studies on children were significantly more likely to offer to return or actually return individual results compared to those with a Ph.D. only. Conclusions: We speculate that issues associated with clinical validity and respect for participants dominated concerns of time and expense given the prominent and continuing ethical debates surrounding genetics and genomics research. The substantial number of researchers who did not consider returning research results suggests that researchers and institutional review boards need to devote more attention to a topic about which research participants are interested.

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Communicating Clinical Trial Results to Research Participants

Dorsey

Beck²,

Adams³

et al. 2008

Arch Neurol

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Background: Communicating clinical trial results to research participants is seldom accomplished in a timely or an effective manner. Objective: To evaluate the effectiveness of a plan to communicate results in an industry-sponsored randomized controlled trial for Huntington disease. Design, Setting, and Participants: Postal survey to research participants at 28 of 41 research sites (including 217 of 316 participants) in Canada and the United States. Intervention: We communicated trial results by means of (1) a media release from the investigators within a day after a sponsor-issued press release; (2) a subsequent telephone call from the site staff to the participants; and (3) a conference call for research participants 2 weeks after the results were released. Main Outcome Measures: Source and timing for learning study results and satisfaction with their communication. Results: Of the 217 study participants surveyed, 114 (52.5%) responded. Most (73.1%) first learned the study results from their site's telephone call, and 46.3% learned the results within 1 day of the sponsor's press release. Participants reported high or complete satisfaction with the site telephone call (89.3%) and conference call (82.1%) but relatively low satisfaction with the sponsor's press release (50.0%). Most respondents reported good understanding of the risks and benefits of the experimental treatment and the next steps for their participation. Conclusion: Surveyed research participants learned of the clinical trial results soon after public release and highly valued the personalized and accurate communication efforts by the study investigators.

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Providing research results to study participants: support versus practice of researchers presenting at the American Society of Hematology annual meeting

Cited by 59 publications

References 12 publications

Disclosure of Research Results from Cancer Genomic Studies: State of the Science

Disclosure of Research Results from Cancer Genomic Studies: State of the Science

Researcher Practices on Returning Genetic Research Results

Communicating Clinical Trial Results to Research Participants

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