Offering participants results of a clinical trial: sharing results of a negative study

Partridge, Ann H.; Wong, Julia S.; Knudsen, Katherine; Gelman, Rebecca; Sampson, E.; Gadd, Michele A.; Bishop, Karyn L.; Harris, Jay R.; Winer, Eric P.

doi:10.1016/s0140-6736(05)71085-0

Cited by 90 publications

(59 citation statements)

References 4 publications

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“…[4] Recently, several NCI-funded cooperative groups have approved the concept of offering results to study participants and have considered guidelines for sharing results [8,9]. However, no routine mechanism is in place at present to share study results and there are only limited data available regarding how to share results or how patients react to the information [10][11][12][13][14].…”

Section: Introductionmentioning

confidence: 99%

The impact of sharing results of a randomized breast cancer clinical trial with study participants

Partridge

Wolff

Marcom

et al. 2008

Breast Cancer Res Treat

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Section: Introductionmentioning

confidence: 99%

The impact of sharing results of a randomized breast cancer clinical trial with study participants

Partridge

Wolff

Marcom

et al. 2008

Breast Cancer Res Treat

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“…First, researchers seek to protect research subjects from potentially harmful consequences of receiving preliminary or unconfirmed research results, including false reassurances or unnecessary scares. 4,5 Second, clinician-researchers seek to distinguish and keep separate the professional role of scientist from the fiduciary role of clinician. Third, federal law restricts the use of information, including research results, in treatment decisions unless the test is done in a CLIA-approved laboratory 6 (Clinical Laboratory Improvement Amendments).…”

Section: Arguments For and Against Disclosurementioning

confidence: 99%

“…The National Action Plan on Breast Cancer (NAPBC) 9 , a group composed of breast cancer patient advocates, National Cancer Institute (NCI) representatives, scientists, and others, supports the routine disclosure of genetic research results to participants, whereas both the National Bioethics Advisory Commission (NBAC) 5 and Office of Human Research Protections (OHRP), formerly Office of Protection of Research Risks (OPPR), only support disclosure of genetic research results in rare circumstances. 4 NAPBC asserts however, that providing research results that do not meet CLIA and other validity requirements (i.e., analytic and clinical validity) increases risks and may cause ''erroneous conclusions to be made that could result in physical, psychosocial or economic harms.''…”

Section: Learning From Existing Recommendationsmentioning

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%

“…In addition to clinical and scientific validity, NBAC requires that ''a course of action is available to ameliorate or treat the health concern''. 5 NBAC's position reflects the current perspective of OHRP/OPPR, NHLBI, and much of the clinical cancer research community that, in addition to clinical validation of the result, an intervention needs to be available to warrant disclosure. This position, common among many professional and regulatory groups, is not shared by some advocacy groups, or ASHG (9), especially in noncancer related contexts (e.g., Huntington's Disease, Alzheimer's disease), which support a right to know regardless of the availability of an intervention.…”

Section: 13mentioning

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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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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Offering participants results of a clinical trial: sharing results of a negative study

Cited by 90 publications

References 4 publications

The impact of sharing results of a randomized breast cancer clinical trial with study participants

The impact of sharing results of a randomized breast cancer clinical trial with study participants

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

Communicating Clinical Trial Results to Research Participants

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