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.

A Survey of Researchers[rquo] Practice in Returning Research Results To Research Participants. Oral Abstracts Presented at ASH Annual Meeting 2003.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3130-3130
Author(s):  
Heather B. Rigby ◽  
Conrad V. Fernandez
Keyword(s):  
Research Ethics ◽  
Annual Meeting ◽  
International Research ◽  
The United States ◽  
Research Community ◽  
Return Of Results ◽  
Research Results ◽  
Research Participants ◽  
Return Of Research Results ◽  
Study Participants

Abstract Background: Offering research results to study participants is increasingly considered an ethical obligation founded on the principle of respect for persons. This practice acknowledges the importance of the participant’s contribution in the study and, in some instances, enables the participant to benefit directly from the health information derived from the research. Recent studies have established that there is growing support for this practice among investigators and study participants in highly selected populations. The frequency and means of this practice is unknown in the broader national and international research community. Methods: We pilot-tested a questionnaire, which we designed for this study. It had a high content validity. The questionnaire was designed to document the frequency with which researchers offer return of results to research participants, the means by which researchers offer results, the role of Research Ethics Boards (REBs) in the return of research results, and the demographics of the study participants. We classified all 887 abstracts presented at the American Society of Hematology Annual Meeting in December 2003 according to study type. Only those abstracts involving human subjects were included. Of the 478 eligible abstracts, email addresses for 472 (98.7%) first or senior authors were found using public web sites. The investigators were sent the 4–5 minute survey by email. Two reminders were sent to non-respondents. Responses were downloaded to a secure server and analyzed by descriptive and Chi squared techniques. Results: Interim results were obtained 11 days after initiating the survey. Complete responses were received from 84 of the 471 (18%) investigators. Most responders were physicians (n=68; 81%) and almost half (n=40; 47%) received Research Ethics Board (REB) approval for their study in the United States. Only 23 (27%) investigators had a formal plan for the return of results to study participants. No clear preference for any one means of returning research results was indicated. The majority (n=18; 78%) indicated that they would provide the participant with a choice of whether or not to receive research results and most (n=14; 61%) indicated that they would provide an overall summary of results rather than an overall summary plus individual level results. Reasons for not returning research results included: did not consider it (n=25), contact difficulties (n=22), and participant difficulty in understanding results (n=19). Cost and concern for the patient regarding adverse effects of receiving results were infrequently cited. Only 2 (2%) of investigators reported that their REB mandated the offer of return of research results to all participants. 55 researchers (66%) supported or strongly supported the return of results to participants, 27 (32%) were neutral, and only 2 (2%) opposed or strongly opposed this practice. Updated data and further analyses will be reported at the annual meeting. Conclusion: Investigators in the international research community infrequently offer to return results to research participants, and REBs rarely mandate this practice. Our study reaffirms the findings of other studies that indicate a high level of support for this practice among researchers. Further work is needed to assess participant needs and concerns, and how to bridge the gap between the expressed attitudes of researchers and actual practice.

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 dissemination of study results: perspectives of individuals with cystic fibrosis

2019 ◽  
Vol 15 (3-4) ◽  
pp. 1-14
Author(s):  
Emily Christofides ◽  
Karla Stroud ◽  
Diana Elizabeth Tullis ◽  
Kieran C. O’Doherty
Keyword(s):  
Cystic Fibrosis ◽  
Research Ethics ◽  
Research Results ◽  
Research Participants ◽  
Study Results ◽  
Research Findings ◽  
The Impact ◽  
To Receive ◽  
Accessible Format

The practice of communicating research findings to participants has been identified as important in the research ethics literature, but little research has examined empirically how this occurs and what research participants’ views are in this regard. We interviewed 21 adults with cystic fibrosis who had previously participated in research and 2 research coordinators at a cystic fibrosis clinic. We aimed to better understand research participants’ views on receiving research results, types of findings they are interested in, how they would like to receive this information, and the impact this might have on future participation. Participants reported that they do not generally recall receiving study findings, though many reported that they would like to receive them. While some participants were not interested in receiving results, all participants felt that these results should be provided when desired by participants and believed that receiving study findings would support future participation. Participants felt that an accessible format, such as a lay summary, would be most helpful. This study supports calls to make study findings available to participants, though the format in which they are provided requires consideration. Participants rarely recalled receiving findings despite the clinic in which this study was conducted returning them regularly. Therefore, questions pertaining to the provision of study findings must focus less on whether to share the findings and more on how to share them with participants most effectively. The logistics of providing study findings may be challenging in some cases, but participant support for the practice highlights its importance.

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 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 Characterizing health researcher barriers to sharing results with study participants

2019 ◽  
Vol 3 (6) ◽  
pp. 295-301 ◽  
Author(s):  
Pearl A. McElfish ◽  
Christopher R. Long ◽  
Laura P. James ◽  
Aaron J. Scott ◽  
Elizabeth Flood-Grady ◽  
...  
Keyword(s):  
Scientific Publication ◽  
Return Of Results ◽  
Policy And Practice ◽  
Research Dissemination ◽  
Promotion And Tenure ◽  
Funding Agencies ◽  
Study Results ◽  
Study Participants ◽  
Dissemination Of Results ◽  
To Receive

AbstractIntroduction:Research participants want to receive results from studies in which they participate. However, health researchers rarely share the results of their studies beyond scientific publication. Little is known about the barriers researchers face in returning study results to participants.Methods:Using a mixed-methods design, health researchers (N = 414) from more than 40 US universities were asked about barriers to providing results to participants. Respondents were recruited from universities with Clinical and Translational Science Award programs and Prevention Research Centers.Results:Respondents reported the percent of their research where they experienced each of the four barriers to disseminating results to participants: logistical/methodological, financial, systems, and regulatory. A fifth barrier, investigator capacity, emerged from data analysis. Training for research faculty and staff, promotion and tenure incentives, and funding agencies supporting dissemination of results to participants were solutions offered to overcoming barriers.Conclusions:Study findings add to literature on research dissemination by documenting health researchers’ perceived barriers to sharing study results with participants. Implications for policy and practice suggest that additional resources and training could help reduce dissemination barriers and increase the return of results to participants.

‘Who is going to put their life on the line for a dollar? That’s crazy’: community perspectives of financial compensation in clinical research

2021 ◽  
pp. medethics-2020-106715
Author(s):  
Amie Devlin ◽  
Kirsten Brownstein ◽  
Jennifer Goodwin ◽  
Emily Gibeau ◽  
Mariana Pardes ◽  
...  
Keyword(s):  
Clinical Research ◽  
Low Income ◽  
Research Participation ◽  
Semistructured Interview ◽  
Financial Compensation ◽  
Black African ◽  
Research Participants ◽  
Study Results ◽  
Study Participants ◽  
Available Information

BackgroundFinancial compensation of research participants has been standard practice for centuries, however, there is an ongoing debate among researchers and ethicists regarding the ethical nature of this practice. While these debates develop ethical arguments and theories, they fail to incorporate input from those most affected by financial compensation: potential research participants.MethodsTo identify attitudes surrounding clinical research, participants of a long-standing cohort completed a one-time interview. Open-ended questions stimulated a participant-driven discussion surrounding medical research. Following a grounded theory methodology, 58 semistructured interview transcripts were coded, focusing on attitudes surrounding financial compensation of research participants.ResultsOf the interviews coded, the majority of participants identified as Black/African American (n=44) and were women (n=40). Five major themes emerged. In support of financial compensation, participants felt that study participants should be compensated for time, effort and risk. However, participants were concerned that compensation may differentially impact low-income populations and entice them to hide potentially harmful side effects. Participants also mentioned that financial compensation may invalidate study results if participants knowingly provide false information to subvert inclusion/exclusion criteria.ConclusionThe emergence of both positive and negative themes reiterates the complicated issue of providing financial compensation for study participation. While compensation as a motivator for research participation raises ethical concerns, participants discussed weighing the benefits with the risks in order to make an informed decision. To avoid paternalistic behaviours, research staff must allow potential research participants to review the available information and make the decision that best reflects their wishes.

scholarly journals Return of Results from Research Using Newborn Screening Dried Blood Samples

2015 ◽  
Vol 43 (3) ◽  
pp. 559-568
Author(s):  
Michelle Huckaby Lewis ◽  
Aaron J. Goldenberg
Keyword(s):  
Newborn Screening ◽  
Clinical Relevance ◽  
Return Of Results ◽  
Genomic Sequencing ◽  
Ongoing Debate ◽  
Blood Samples ◽  
Research Results ◽  
Screening Programs ◽  
Research Participants ◽  
The Impact

Whether research results should be returned to participants has been an ongoing debate in the research and bioethics communities for years. The debate has become more complicated as advances in technology permit the discovery through genomic sequencing of a growing number of findings that may or may not have clinical relevance for research participants. As part of the larger conversation regarding whether and under what circumstances research results should be returned to participants, research conducted using residual newborn screening dried blood samples (DBS) deserves special consideration due to the nature of newborn screening, the recent controversy regarding the retention and use of DBS, and the impact of this controversy on state newborn screening programs.

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 Preferences for Updates on General Research Results: A Survey of Participants in Genomic Research from Two Institutions

2021 ◽  
Vol 11 (5) ◽  
pp. 399
Author(s):  
Casey Overby Taylor ◽  
Natalie Flaks Manov ◽  
Katherine D. Crew ◽  
Chunhua Weng ◽  
John J. Connolly ◽  
...  
Keyword(s):  
Research Result ◽  
Hierarchical Cluster ◽  
Genomic Research ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Four Dimensions ◽  
Research Participants ◽  
Research Activities ◽  
Study Results ◽  
Set Up

There is a need for multimodal strategies to keep research participants informed about study results. Our aim was to characterize preferences of genomic research participants from two institutions along four dimensions of general research result updates: content, timing, mechanism, and frequency. Methods: We conducted a web-based cross-sectional survey that was administered from 25 June 2018 to 5 December 2018. Results: 397 participants completed the survey, most of whom (96%) expressed a desire to receive research updates. Preferences with high endorsement included: update content (brief descriptions of major findings, descriptions of purpose and goals, and educational material); update timing (when the research is completed, when findings are reviewed, when findings are published, and when the study status changes); update mechanism (email with updates, and email newsletter); and update frequency (every three months). Hierarchical cluster analyses based on the four update preferences identified four profiles of participants with similar preference patterns. Very few participants in the largest profile were comfortable with budgeting less money for research activities so that researchers have money to set up services to send research result updates to study participants. Conclusion: Future studies may benefit from exploring preferences for research result updates, as we have in our study. In addition, this work provides evidence of a need for funders to incentivize researchers to communicate results to participants.

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