scholarly journals Return of individual research results from genomic research: A systematic review of stakeholder perspectives

PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0258646
Author(s):  
Danya F. Vears ◽  
Joel T. Minion ◽  
Stephanie J. Roberts ◽  
James Cummings ◽  
Mavis Machirori ◽  
...  
Keyword(s):  
Empirical Studies ◽  
Genomic Research ◽  
Empirical Literature ◽  
Research Results ◽  
Research Participants ◽  
Stakeholder Perspectives ◽  
Overwhelming Evidence ◽  
The Usa ◽  
Psychological Harm ◽  
Individual Research Results

Despite the plethora of empirical studies conducted to date, debate continues about whether and to what extent results should be returned to participants of genomic research. We aimed to systematically review the empirical literature exploring stakeholders’ perspectives on return of individual research results (IRR) from genomic research. We examined preferences for receiving or willingness to return IRR, and experiences with either receiving or returning them. The systematic searches were conducted across five major databases in August 2018 and repeated in April 2020, and included studies reporting findings from primary research regardless of method (quantitative, qualitative, mixed). Articles that related to the clinical setting were excluded. Our search identified 221 articles that met our search criteria. This included 118 quantitative, 69 qualitative and 34 mixed methods studies. These articles included a total number of 118,874 stakeholders with research participants (85,270/72%) and members of the general public (40,967/35%) being the largest groups represented. The articles spanned at least 22 different countries with most (144/65%) being from the USA. Most (76%) discussed clinical research projects, rather than biobanks. More than half (58%) gauged views that were hypothetical. We found overwhelming evidence of high interest in return of IRR from potential and actual genomic research participants. There is also a general willingness to provide such results by researchers and health professionals, although they tend to adopt a more cautious stance. While all results are desired to some degree, those that have the potential to change clinical management are generally prioritized by all stakeholders. Professional stakeholders appear more willing to return results that are reliable and clinically relevant than those that are less reliable and lack clinical relevance. The lack of evidence for significant enduring psychological harm and the clear benefits to some research participants suggest that researchers should be returning actionable IRRs to participants.

scholarly journals Automatic Placement of Genomic Research Results in Medical Records: Do Researchers Have a Duty? Should Participants Have a Choice?

2015 ◽  
Vol 43 (4) ◽  
pp. 827-842
Author(s):  
Anya E.R. Prince ◽  
John M. Conley ◽  
Arlene M. Davis ◽  
Gabriel Lázaro-Muñoz ◽  
R. Jean Cadigan
Keyword(s):  
Medical Record ◽  
Medical Records ◽  
Genomic Research ◽  
Research Results ◽  
Research Participants ◽  
Difficult Question ◽  
Automatic Placement ◽  
Study Participants ◽  
Research Studies

The growing practice of returning individual results to research participants has revealed a variety of interpretations of the multiple and sometimes conflicting duties that researchers may owe to participants. One particularly difficult question is the nature and extent of a researcher’s duty to facilitate a participant’s follow-up clinical care by placing research results in the participant’s medical record. The question is especially difficult in the context of genomic research. Some recent genomic research studies — enrolling patients as participants — boldly address the question with protocols dictating that researchers place research results directly into study participants’ existing medical records, without participant consent. Such privileging of researcher judgment over participant choice may be motivated by a desire to discharge a duty that researchers perceive themselves as owing to participants. However, the underlying ethical, professional, legal, and regulatory duties that would compel or justify this action have not been fully explored.

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.

P4-080: DISCLOSURE OF INDIVIDUAL RESEARCH RESULTS TO COGNITIVELY NORMAL RESEARCH PARTICIPANTS

2014 ◽  
Vol 10 ◽  
pp. P812-P812 ◽  
Author(s):  
Jonathan Gooblar ◽  
Catherine M. Roe ◽  
Natalie J. Selsor ◽  
Matthew Gabel ◽  
John Morris
Keyword(s):  
Cognitively Normal ◽  
Research Results ◽  
Research Participants ◽  
Individual Research Results

scholarly journals Participant Satisfaction With a Preference-Setting Tool for the Return of Individual Research Results in Pediatric Genomic Research

2015 ◽  
Vol 10 (4) ◽  
pp. 414-426 ◽  
Author(s):  
Ingrid A. Holm ◽  
Brittany R. Iles ◽  
Sonja I. Ziniel ◽  
Phoebe L. Bacon ◽  
Sarah K. Savage ◽  
...  
Keyword(s):  
Genomic Research ◽  
Research Results ◽  
Participant Satisfaction ◽  
Individual Research Results

scholarly journals Practices and Attitudes toward Returning Genomic Research Results to Low-Resource Research Participants

2021 ◽  
pp. 1-12
Author(s):  
Megan B. Raymond ◽  
Kayla E. Cooper ◽  
Lisa S. Parker ◽  
Vence L. Bonham
Keyword(s):  
Low Income ◽  
Clinical Care ◽  
Genomic Research ◽  
Research Results ◽  
Low Resource ◽  
Research Participants ◽  
Research Programs ◽  
Ancillary Care ◽  
Genomic Results ◽  
Resource Research

<b><i>Introduction:</i></b> Many research programs are challenged to accommodate low-resource research participants’ (LRRP) ancillary care needs when returning genomic research results. We define LRRP as those who are low income, uninsured, underinsured, or facing barriers to act upon the results returned. This study evaluates current policies and practices surrounding return of results (RoR) to LRRP, as well as the attitudes of investigators toward providing ancillary care to LRRP. <b><i>Methods:</i></b> A semi-structured interview study was conducted with representatives of 35 genomic research programs nationwide. Eligible programs were returning, or planning to return, medically actionable genomic results to participants. <b><i>Results:</i></b> Three content categories emerged from this study, including: (1) RoR structures, (2) barriers to RoR to LRRP, and (3) solutions to meet community and LRRP needs. Three major structures of RoR emerged: (1) RoR Embedded in Clinical Care, (2) RoR Independent of Clinical Care, and (3) Reliance on Clinical Partnerships to Facilitate RoR. Inadequacy of program resources to address the needs of LRRP was commonly considered a significant obstacle. The attitudes and views of informants regarding responsibility to provide ancillary care for LRRP receiving genomic results were highly varied. Some informants believed that genomic sequencing and testing was not a priority for LRRP because of other pressing issues in their lives, such as housing and food insecurity. Research programs differ regarding whether clinical and social support for LRRP is considered within the purview of the research team. Some programs instituted accommodations for LRRP, including social work referral and insurance enrollment assistance. <b><i>Conclusion:</i></b> Support to access downstream treatment is not readily available for LRRP in many genomic research programs. Development of best practices and policies for managing RoR to LRRP is needed.

scholarly journals Views on genomic research result delivery methods and informed consent: a review

2021 ◽  
Author(s):  
Danya F Vears ◽  
Joel T Minion ◽  
Stephanie J Roberts ◽  
James Cummings ◽  
Mavis Machirori ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Result ◽  
Genomic Research ◽  
Return Of Results ◽  
Empirical Literature ◽  
Delivery Methods ◽  
Web Based ◽  
Face To Face ◽  
The Public ◽  
Stakeholder Perspectives

There has been little discussion of the way genomic research results should be returned and how to obtain informed consent for this. We systematically searched the empirical literature, identifying 63 articles exploring stakeholder perspectives on processes for obtaining informed consent about return of results and/or result delivery. Participants, patients and members of the public generally felt they should choose which results are returned to them and how, ranging from direct (face-to-face, telephone) to indirect (letters, emails, web-based delivery) communication. Professionals identified inadequacies in result delivery processes in the research context. Our findings have important implications for ensuring participants are supported in deciding which results they wish to receive or, if no choice is offered, preparing them for potential research outcomes.

scholarly journals The Responsibility to Recontact Research Participants after Reinterpretation of Genetic and Genomic Research Results

2019 ◽  
Vol 104 (4) ◽  
pp. 578-595 ◽  
Author(s):  
Yvonne Bombard ◽  
Kyle B. Brothers ◽  
Sara Fitzgerald-Butt ◽  
Nanibaa’ A. Garrison ◽  
Leila Jamal ◽  
...  
Keyword(s):  
Genomic Research ◽  
Research Results ◽  
Research Participants

scholarly journals Aid measureres from unemployed perspective (in the light of the research results)

Management ◽  
2015 ◽  
Vol 19 (1) ◽  
pp. 73-88
Author(s):  
Janina Stankiewicz ◽  
Hanna Bortnowska
Keyword(s):  
Empirical Studies ◽  
Economic Downturn ◽  
Negative Consequences ◽  
Negative Effects ◽  
Research Results ◽  
The Usa ◽  
The Government

Summary The negative consequences of the economic downturn started in 2008 in the USA affected many countries, including - Poland. In many organizations, it was necessary to carry out the redundancies, and these ones, if they were implemented in an unethical way, usually intensified dysfunctional processes within the companies. The paper presents examples of outplacement activities which can be taken by the government and by employers to limit these negative effects and to reduce the extent of unemployment. It also shows the results of empirical studies carried out among workers of the Lubusz region, who were made redundant in 2008-2014. There were indicated, e.g. the activities, which benefited the respondents and those ones, which they would like to use, but did not have such an option.

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