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 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 Improving Information and Communications Technology (ICT) Knowledge and Skills to Develop Health Research Capacity in Kenya

2019 ◽  
Vol 11 (3) ◽  
Author(s):  
Aliza Monroe-Wise ◽  
John Kinuthia ◽  
Sherrilynne Fuller ◽  
Matthew Dunbar ◽  
David Masuda ◽  
...  
Keyword(s):  
Data Management ◽  
Low Income ◽  
Clinical Care ◽  
Research Capacity ◽  
Information And Communications Technology ◽  
Learning Program ◽  
Knowledge And Skills ◽  
Low Resource Settings ◽  
Low Resource ◽  
Ict Tools

ObjectivesInformation and communication technology (ICT) tools are increasingly important for clinical care, research, data management, international collaborations, and dissemination. Many technologies would be particularly useful for healthcare workers in resource-limited settings; however, these individuals are the least likely to utilize ICT tools, in part because they lack knowledge and skills necessary to use them. Our program aimed to train researchers in low-resource settings on using ICT tools.MethodsWe conducted a tiered, blended learning program for researchers in Kenya on three areas of ICT: geographic information systems, data management, and communication tools. Tiers included didactic online courses for 100-300 students for each topic, skills workshops for 30 students, and mentored projects for 10. Concurrently, a training of trainers course comprised of an online course and a skills workshop to ensure sustainable ongoing training.ResultsCourse ratings were high, particularly when participants engaged in hands-on skill building activities. Teaching that incorporated local examples was most valuable. Discussion boards were sometimes distracting, depending on multiple factors. Mentored projects were most useful when there were clear expectations, pre-existing projects or data, and clear timelines.DiscussionTraining in the use of ICT tools is essential to improve their use among researchers in low-income settings. However, very few training courses have been described. Our students demonstrated acquisition of new skills and felt these skills to be valuable in their workplaces.ConclusionsFurther and ongoing training in ICT skills should be considered in other low-resource settings, and could use our program as a foundational model.

Pragmatic Clinical Trial-Collateral Findings: Recognizing the Needs of Low-Resource Research Participants

2020 ◽  
Vol 20 (1) ◽  
pp. 19-21
Author(s):  
Courtney A. Stewart ◽  
Kayla E. Cooper ◽  
Megan B. Raymond ◽  
Faith E. Fletcher ◽  
Vence L. Bonham
Keyword(s):  
Clinical Trial ◽  
Pragmatic Clinical Trial ◽  
Low Resource ◽  
Research Participants ◽  
Collateral Findings ◽  
Resource Research

Attitudes of Researchers to the Return of Incidental and Targeted Genomic Findings Obtained in a Research Setting to Participants

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2069-2069
Author(s):  
Conrad V Fernandez ◽  
Denise Avard ◽  
Bartha Knoppers ◽  
Colleen O'Connell ◽  
David Malkin ◽  
...  
Keyword(s):  
Genetic Counselling ◽  
Incidental Findings ◽  
Clinical Utility ◽  
Genomic Research ◽  
Data Set ◽  
Research Results ◽  
Ethics Review ◽  
Institutional Ethics ◽  
Wide Range ◽  
Genomic Results

Abstract Abstract 2069 Background: The use of genomic research has exploded in recent years. Various guidelines recommend disclosure of significant, clinically validated findings to participants. Continued debate in this area has led to calls for stakeholder involvement to inform policy. In particular, the attitudes of genomics researchers are salient yet relatively unexplored with respect to how the sharing of both targeted and incidental findings should be accomplished. Methods: All 107 researchers affiliated with two large-scale Genome Canada projects [Canadian Pediatric Cancer Genome Consortium (CPCGC) and the Finding of Rare Genes Canada Consortium (FORGE)] were surveyed using a mailed, validated 32-item questionnaire that had been pilot tested with genomics researchers. The survey was designed to cover a wide range of topics including attitudes of researchers to the return of incidental and targeted research results, the need for genetic counselling, responsibilities to participants over time, to child participants and to siblings of participants, and institutional ethics review. Two reminders were sent to non-respondents. Data were analyzed with descriptive statistics. Results: 74/107 (69%) responded. Most were between 41–55 yr of age (n=40, 54%) and had their most senior training inNorth America (n=67, 91%). The majority were experienced researchers (n=58, 78%) and felt comfortable in discussing genomic results with participants (n= 66, 89%). Respondents did not feel a strong responsibility to look for meaningful incidental results in the genomic data set they created (n=27, 37%). However, once potentially significant results were identified, researchers indicated that participants had a strong or very strong right to receive analytically validated genomic results irrespective of whether these results were incidental findings (n= 50, 68%) or primary targets of the research (n= 64, 87%). Most indicated that results with clinical utility that were actionable should be offered to participants (n=54, 73%) although some indicated that research results should not be returned under any circumstances (n=6, 8%). The majority felt that a research result should be confirmed in a clinical lab prior to return to participants (n=51, 69%). Most indicated that genetic counselling should be provided either almost always or frequently prior to genomic research participation (n=48, 64%). Respondents indicated that siblings of genomic research participants had a strong or very strong right to be informed of results (n=46, 62%), and this was especially true if an intervention to ameliorate the identified condition is feasible (n=56, 76%). A minority of researchers felt personal responsibility to ensure genomic research results obtained on a child of potential clinical utility were eventually communicated to him/her when the child became an adult (n=10, 14%). A slim majority felt the parents or health care provider should be responsible (n=38, 51%). Some researchers reported encountering incidental findings of clinical utility (n=25, 34%) and had offered them to participants. However, the minority reported that their institutional ethics review boards either always (n=10, 14%) or sometimes (n=24, 32%) required an offer of results. Only 16 (22%) indicated that their ethics board had a detailed process on how to do so. Conclusions: Researchers in general support the offer of return of targeted and incidental genomic research results to participants. A minority strongly oppose such action. There is typically a high degree of support for the offer of genomic research findings to siblings, especially if actionable. Given the new developments in genomics and resulting incidental findings, researchers describe little specific guidance about the process that should be followed in returning results to participants. Greater policy guidance would be of assistance in providing a consistent approach to the offer of incidental or targeted genomic research results. Acknowledgments: Funded by Genome Canada and the Canadian Institutes of Health Research. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Considerations for Returning Research Results to Culturally Diverse Participants and Families of Decedents

2015 ◽  
Vol 43 (3) ◽  
pp. 569-575
Author(s):  
Nanibaa' A. Garrison
Keyword(s):  
Culturally Diverse ◽  
Genomic Medicine ◽  
Research Participant ◽  
Genomic Research ◽  
Special Focus ◽  
Ethical Considerations ◽  
Research Results ◽  
Diverse Backgrounds ◽  
Considerable Debate ◽  
Genomic Results

As genomic medicine advances and immense amounts of data are generated that may potentially affect human health, there is increasing concern around which of these results matter to participants. There has been considerable debate on which research results to return to participants and when those results should be returned. To date, however, the debates around the return of genomic results have not focused on how those results should be returned, especially when the results come from minority and/or culturally diverse participants. This commentary explores cultural and ethical considerations, and shares insight from my own Navajo background, around returning genomic research results to participants and potentially to families of culturally diverse backgrounds, with a special focus on considerations when the research participant is deceased, and raises points for further discussion.

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 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 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.

scholarly journals Challenges to Bringing Personalized Medicine to a Low-Resource Setting in Peru

2021 ◽  
Vol 18 (4) ◽  
pp. 1470
Author(s):  
Nelly Solis ◽  
Elizabeth Zavaleta ◽  
Patrik Wernhoff ◽  
Constantino Dominguez-Barrera ◽  
Mev Dominguez-Valentin
Keyword(s):  
Low Income ◽  
Age Of Onset ◽  
Genomic Research ◽  
Mortality And Morbidity ◽  
Screening Programs ◽  
Low Resource ◽  
Effective Interventions ◽  
Resource Limited ◽  
Resource Setting ◽  
Low Resource Setting

We provide an overview of the challenges that low-resource setting cities are facing, including a lack of global implementation of cancer screening programs, accurate data and statistics that may aid the health authorities and guide future public health activities, as well as reorient strategies, interventions and budgets to promote lifestyles that help prevent disease. Current cancer care does not fully reflect ethnic, cultural, environmental and resource differences. Herein, we described a snapshot of the cancer mortality and morbidity from a hospital that cares a rural and low-income population from Peru, called Chimbote (316,966 inhabitants) and showed the limitation of access to oncological care and genetic services. The city is located in the region of Ancash, which is a department of Northern Peru. Of note, we identified a greater proportion of cancer cases than previously described, with a young age of onset and differential profile of the most frequent cancers. With the emergence of increasingly effective interventions, it becomes paramount that populations living in resource-limited settings have access to cancer services and participate in genetics and genomic research.

scholarly journals Scoping review protocol: bladder cancer in Nigeria: what are the gaps in clinical care and research?

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e041894
Author(s):  
Joyce Kibaru ◽  
Pinky Kotecha ◽  
Abdulkarim Muhammad Iya ◽  
Beth Russell ◽  
Muzzammil Abdullahi ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Scoping Review ◽  
Low Income ◽  
Clinical Care ◽  
Grey Literature ◽  
Case Series ◽  
Cochrane Library ◽  
Future Research ◽  
Scoping Reviews ◽  
Local Risk

IntroductionBladder cancer (BC) is the 10th common cancer worldwide and ranks seventh in Nigeria. This scoping review aims to identify the gaps in clinical care and research of BC in Nigeria as part of the development of a larger national research programme aiming to improve outcomes and care of BC.Methods and analysisThis review will be conducted according to Arksey and O’Malley scoping review methodology framework. The following electronic databases will be searched: Medline (using the PubMed interface), Ovid Gateway (Embase and Ovid), Cochrane library and Open Grey literature. Two independent reviewers will screen titles and abstracts and subsequently screen full-text studies for inclusion, any lack of consensus will be discussed with a third reviewer. Any study providing insight into the epidemiology or treatment pathway of BC (RCTs, observations, case series, policy paper) will be included. A data chart will be used to extract relevant data from the included studies. Results will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews. A consultation process will be carried out with a multidisciplinary team of Nigerian healthcare professionals, patients and scientists.Ethics and disseminationThe results will be disseminated through peer-reviewed publications. By highlighting the key gaps in the literature, this review can provide direction for future research and clinical guidelines in Nigeria (and other low-income and middle-income countries), where BC is more prevalent due to local risk factors and healthcare settings.

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