The Return of Results of Deceased Research Participants

2011 ◽  
Vol 39 (4) ◽  
pp. 621-630 ◽  
Author(s):  
Anne Marie Tassé
Keyword(s):  
Population Studies ◽  
Genetic Research ◽  
Family Members ◽  
Research Participant ◽  
Return Of Results ◽  
Research Results ◽  
Research Participants ◽  
Related Family ◽  
Ethical And Legal Issues

Until the mid-20th century, biomedical research centered on the study of specific diseases, concerned with short periods of time and small groups of living research participants. However, the growth of longitudinal population studies and long-term biobanking now forces the research community to examine the possibility of the death of their research participants.The death of a research participant raises numerous ethical and legal issues, including the return of deceased individuals’ research results to related family members. As with the return of individual research results for living research participants, the question of the obligation to return a deceased person’s research results to family members has yet to be settled. This question is particularly acute in the context of genetic research since the research results from one individual may have health implications for all biological relatives.

scholarly journals Solutions for Unexpected Challenges Encountered when Integrating Research Genomics Results into the EHR

ACI Open ◽  
2020 ◽  
Vol 04 (02) ◽  
pp. e132-e135
Author(s):  
Luke V. Rasmussen ◽  
Christin Hoell ◽  
Maureen E. Smith ◽  
Rex Chisholm ◽  
Justin Starren ◽  
...  
Keyword(s):  
Genetic Research ◽  
Lessons Learned ◽  
Return Of Results ◽  
Patient Portal ◽  
Test Results ◽  
Research Results ◽  
Genetic Test Results ◽  
Future Return ◽  
New Research ◽  
Genetic Results

Abstract Background While there have been published reports detailing technical challenges of incorporating genetic test results into the electronic health record (EHR) with proposed solutions, less has been published about unanticipated sociotechnological or practical communication challenges involved in this process. Objectives This study was aimed to describe unanticipated issues that arose returning genetic research results through the EHR as part of the National Human Genome Research Institute (NHGRI)-funded electronic Medical Records and Genomics (eMERGE) 3 consortium, and provide lessons learned for future implementations Methods We sequenced 3,000 participants on a 109-gene panel and returned genetic results initially in person and/or by letter, with a later release directly into the EHR and patient portal. Results When results were returned through the EHR, multiple participants expressed confusion and contacted the health system, resulting in our institution temporarily freezing our return of research results. Discussion We determined the likely causes of this issue to be (1) the delay between enrollment and results return, (2) inability to personalize mass e-mail messages announcing new research test results in the EHR, (3) limited space for description of test results in the EHR, and (4) the requirement to list an ordering physician for research results in the EHR. For future return of results, we propose sending preparatory e-mails to participants, including screenshots of how they can expect to see their results presented in the EHR portal. Conclusion We hope our lessons learned can provide helpful guidance to other sites implementing research genetic results into the EHR and can encourage EHR developers to incorporate greater flexibility in the future.

scholarly journals Return of Genetic Research Results to Participants and Families: IRB Perspectives and Roles

2015 ◽  
Vol 43 (3) ◽  
pp. 502-513 ◽  
Author(s):  
Laura M. Beskow ◽  
P. Pearl O'Rourke
Keyword(s):  
Genetic Information ◽  
Genetic Research ◽  
Family Members ◽  
Research Process ◽  
Secondary Users ◽  
Consent Forms ◽  
Research Results ◽  
Considerable Debate ◽  
The Subject ◽  
Genetic Results

Whether or not to offer individual genetic results to research participants has been the subject of considerable debate, yet consensus regarding what, when, and how to return remains elusive. Despite this lack of clarity, the discussion has moved to the offer of research results to family members of participants, including when the participant is deceased. Given the familial implications of genetic information, this extension is perhaps logical. But it raises concerns throughout the research process, including, for example, questions about disclosures and choices on consent forms, procedures for identifying and contacting family members, and how any such obligations might apply to secondary users of biospecimens and data.

scholarly journals Assessing research participant preferences for receiving study results

2019 ◽  
Vol 4 (3) ◽  
pp. 243-249
Author(s):  
Sarah Cook ◽  
Stephanie Mayers ◽  
Kathryn Goggins ◽  
David Schlundt ◽  
Kemberlee Bonnet ◽  
...  
Keyword(s):  
Focus Groups ◽  
Information Needs ◽  
College Education ◽  
Research Participant ◽  
Stakeholder Group ◽  
Survey Study ◽  
Research Results ◽  
Research Participants ◽  
Study Results ◽  
To Receive

AbstractIntroduction:Dissemination of results to research participants is largely missing from the practices of most researchers. Few resources exist that describe best practices for disseminating information to this important stakeholder group.Methods:Four focus groups were conducted with a diverse group of individuals. All participants were part of a Patient-Centered Outcomes Research Institute-funded survey study. Focus groups aimed to identify participants’ preferences about receiving research results and their reactions to three different dissemination platforms.Results:Four focus groups with 37 participants were conducted, including: (1) adults with one comorbidity, at least a college education, and high socioeconomic status (SES); (2) adults with one comorbidity, less than a college education, and lower SES; (3) adults with low health literacy and/or numeracy; and (4) Black or African American adults. Participants discussed their preferences for research results delivery and how each of the platforms met those preferences. This included information needs as they relate to content and scope, including a desire to receive both individual and aggregate results, and study summaries. Email, paper, and website were all popular avenues of presentation. Some desired a written summary, and others preferred videos or visual graphics. Importantly, participants emphasized the desire for having a choice in the timing, frequency, and types of results.Conclusion:Research participants prefer to receive research results, including study impact and key findings, disseminated to them in an engaging format that allows choice of when and how the information is presented. The results encourage new standards whereby research participants are considered a critical stakeholder group.

scholarly journals Recommendations for the Return of Research Results to Study Participants and Guardians: A Report From the Children's Oncology Group

2012 ◽  
Vol 30 (36) ◽  
pp. 4573-4579 ◽  
Author(s):  
Conrad V. Fernandez ◽  
Kathleen Ruccione ◽  
Robert J. Wells ◽  
Jay B. Long ◽  
Wendy Pelletier ◽  
...  
Keyword(s):  
Task Force ◽  
Return Of Results ◽  
Personal Contact ◽  
Oncology Group ◽  
Cooperative Research ◽  
Group Setting ◽  
Research Results ◽  
Research Participants ◽  
Study Results ◽  
Study Participants

Purpose The Children's Oncology Group (COG) strongly supports the widely recognized principle that research participants should be offered a summary of study results. The mechanism by which to do so in a cooperative research group setting has not been previously described. Methods On the basis of a review of the available empirical and theoretic literature and on iterative, multidisciplinary discussion, a COG Return of Results Task Force (RRTF) offered detailed recommendations for the return of results to research study participants. Results The RRTF established guidelines for the notification of research participants and/or their parents/guardians about the availability of research results, a mechanism for and timing of sharing results via registration on the COG public Web site, the scope of the research to be shared, the target audience, and a process for creating and vetting lay summaries of study results. The RRTF recognized the challenges in adequately conveying complex scientific results to audiences with varying levels of health literacy and recommended that particularly sensitive or complex results be returned using direct personal contact. The RRTF also recommended evaluation of the cost, effectiveness, and impact of sharing results. Conclusion These recommendations provide a framework for the offering and returning of results to participants. They can be used by individual investigators, multi-investigator research collaboratives, and large cooperative groups.

Return of Research Results: General Principles and International Perspectives

2011 ◽  
Vol 39 (4) ◽  
pp. 583-592 ◽  
Author(s):  
Emmanuelle Lévesque ◽  
Yann Joly ◽  
Jacques Simard
Keyword(s):  
Technological Progress ◽  
Genetic Research ◽  
Return Of Results ◽  
Ethical Guidelines ◽  
Research Results ◽  
Scholarly Publications ◽  
International Perspectives ◽  
Rapid Pace ◽  
Return Of Research Results ◽  
Ethical Norms

Five years ago, an article co-written by some of us (Joly and Simard) presented an emerging trend to disclose some individual genetic results to research participants within the international research community. At the time, ethical norms and scholarly publications on the return of results often did not distinguish between the return of research results in general and the return of unexpected results (also called incidental findings). Both technologies and research practices have evolved significantly. Today whole genome and exome sequencing are increasingly affordable and frequently used in genetic research. Because these techniques produce a vast amount of interpretable and non-interpretable data (i.e., data of unproven significance) about an individual, the issue of how to manage information generated by such technologies needs to be considered. However, the development of international ethical guidelines has not kept up with the rapid pace of technological progress. Indeed developments in genomic biobanking also challenge the duty to disclose research results.

Return of Results in Population Studies: How Do Participants Perceive Them?

2020 ◽  
Author(s):  
Hélène Nobile ◽  
Pascal Borry ◽  
Jennifer Moldenhauer ◽  
Manuela M Bergmann
Keyword(s):  
Population Studies ◽  
Personal Information ◽  
Population Based ◽  
Return Of Results ◽  
Ethical Question ◽  
German Studies ◽  
Structured Interviews ◽  
Biobank Research ◽  
Public Health Epidemiology

Abstract As a cornerstone of public health, epidemiology has lately undergone substantial changes enabled by, among other factors, the use of biobank infrastructures. In biobank-related research, the return of results to participants constitutes an important and complex ethical question. In this study, we qualitatively investigated how individuals perceive the results returned following their participation in cohort studies with biobanks. In our semi-structured interviews with 31 participants of two such German studies, we observed that some participants overestimate the nature of the personal information they will receive from the study. Although this misestimation does not seem to jeopardize the validity of the consent provided at recruitment, it may still represent a threat for participants’ trust in research and thus their long-term commitment, crucial for such studies. We argue that such misestimation may have ethical consequences on the principles guiding the reflection on the return of results in biobank research, i.e. autonomy, beneficence, non-maleficence and reciprocity. We suggest that shifting from the idea of directly benefiting participants through the return of research results could help focusing on benefiting society as a whole, thereby increasing research trustworthiness of population-based studies using biobanks.

scholarly journals Statement of principles on the return of research results and incidental findings in paediatric research: a multi-site consultative process

Genome ◽  
2015 ◽  
Vol 58 (12) ◽  
pp. 541-548 ◽  
Author(s):  
Karine Sénécal ◽  
Vasiliki Rahimzadeh ◽  
Bartha M. Knoppers ◽  
Conrad V. Fernandez ◽  
Denise Avard ◽  
...  
Keyword(s):  
Incidental Findings ◽  
Ethical Issues ◽  
Grey Literature ◽  
Genetic Research ◽  
Return Of Results ◽  
Paediatric Research ◽  
Consultation Process ◽  
Research Results ◽  
Stakeholder Groups ◽  
Return Of Research Results

This paper proposes a set of recommendations for the return of research results and incidental findings in paediatrics. The Network of Applied Genetic Medicine of Quebec spearheaded the initiative to develop the Statement of Principles on the Return of Research Results and Incidental Findings, which was the result of a consultation process with clinical and research experts in the field. To formulate the Statement of Principles, the authors (i) reviewed empirical and grey literature on the return of research results and incidental findings in Europe and Canada, (ii) conducted a qualitative study of stakeholder groups, (iii) developed, and (iv) validated the recommendations through consultations with the stakeholder groups. The Statement of Principles provides a useful disclosure tool for deciding when, and under what circumstances to return research results and incidental findings. It addresses the issue of return of results in genetic research generally, and has also specific principles for various research contexts, including paediatric research. It delineates ethical issues unique to paediatric research, and provides a framework to guide research ethics committees as well as the research community in addressing these issues.

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 Research participants’ experiences with return of genetic research results and preferences for web‐based alternatives

2019 ◽  
Vol 7 (9) ◽  
Author(s):  
Jill B. Gaieski ◽  
Linda Patrick‐Miller ◽  
Brian L. Egleston ◽  
Kara N. Maxwell ◽  
Sarah Walser ◽  
...  
Keyword(s):  
Genetic Research ◽  
Web Based ◽  
Research Results ◽  
Research Participants

scholarly journals Canadian Research Ethics Board Leadership Attitudes to the Return of Genetic Research Results to Individuals and Their Families

2015 ◽  
Vol 43 (3) ◽  
pp. 514-522 ◽  
Author(s):  
Conrad V. Fernandez ◽  
P. Pearl O'Rourke ◽  
Laura M. Beskow
Keyword(s):  
Ethical Issues ◽  
Genetic Research ◽  
Research Participant ◽  
Genomic Research ◽  
Next Of Kin ◽  
Potential Health ◽  
Clinical Model ◽  
Research Results ◽  
Consensus Statements ◽  
Genetic Results

The return of individual genetic results to research participants has been widely discussed in the context of an explosion of genetic research utilizing an ever more rapid and inexpensive array of sequencing and bioinformatics platforms. To date, a number of consensus statements guide researchers as to the breadth and limits of their obligations for offering genomic research results to participants. Typically these recommendations are rooted in the result’s clinical validity, actionability, and potential health consequences, and are predicated on the informed consent of the participant. An emerging discussion is the challenging question of the degree to which researchers may additionally have responsibility for offering results to family members of the research participant. Some have argued that ethical obligations to relatives intensify as the significance and actionability of the result increase, while others claim that obligations to next of kin should follow the clinical model where the decision to share genetic results falls to the patient. A detailed reflection on the many ethical issues that arise in considering whether such a responsibility exists, and if so how to honor it, is presented in this issue of JLME by Wolf et al.

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