Informing Study Participants of Research Results: An Ethical Imperative

2003 ◽  
Vol 25 (3) ◽  
pp. 12 ◽  
Author(s):  
Conrad V. Fernandez ◽  
Eric Kodish ◽  
Charles Weijer
Keyword(s):  
Ethical Imperative ◽  
Research Results ◽  
Study 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.

Return of Research Results to Study Participants

JAMA ◽  
2018 ◽  
Vol 320 (5) ◽  
pp. 435 ◽  
Author(s):  
Charlene A. Wong ◽  
Adrian F. Hernandez ◽  
Robert M. Califf
Keyword(s):  
Research Results ◽  
Return Of Research Results ◽  
Study Participants

scholarly journals One thing leads to another: the cascade of obligations when researchers report genetic research results to study participants

2012 ◽  
Vol 20 (8) ◽  
pp. 837-843 ◽  
Author(s):  
Fiona Alice Miller ◽  
Robin Zoe Hayeems ◽  
Li Li ◽  
Jessica Peace Bytautas
Keyword(s):  
Genetic Research ◽  
Research Results ◽  
Study Participants

scholarly journals Description of Motor and Functional Fitness of 4th-5th Grade Boys of a Rural Underfilled School

2019 ◽  
Vol 19 (3) ◽  
pp. 123-129 ◽  
Author(s):  
A. O. Tolstoi
Keyword(s):  
Research Methods ◽  
Mathematical Statistics ◽  
General Level ◽  
Functional Fitness ◽  
Research Results ◽  
School Year ◽  
Motor Fitness ◽  
Motor Tests ◽  
Study Participants ◽  
5Th Grade

The study purpose was to determine the dynamics of motor and functional fitness of 4th-5th grade boys of a rural underfilled school during the school year. Materials and methods. The study participants were boys of 4th grade (n = 9) and 5th grade (n = 5). During parent-teacher meetings, the children and their parents were informed about all the features of the study and gave their consent to participate in the experiment. The study used the following research methods: analysis of scientific and methodological literature, pedagogical testing, and methods of mathematical statistics for processing research results. Results. On average, the 4th grade boys’ results are 10.8 times better in push-ups (p < 0.05); 5.3 times better in pull-ups (p < 0.05); 15.3 s better in bent-arm hang (p < 0.05). By the results of other motor tests, the differences between average values are statistically non-significant (p > 0.05). Conclusions. The general level of the pupils’ functional and motor fitness is sufficient. There are statistically significant differences between the 4th and 5th grade boys in push-ups, pull-ups, bent-arm hang, Stange test, Serkin test (p < 0.05). By the results of other tests, the differences between average values are statistically non-significant (p > 0.05).

scholarly journals At the Research-Clinical Interface

2020 ◽  
Vol 15 (8) ◽  
pp. 1181-1189 ◽  
Author(s):  
Kathleen M. West ◽  
Erika Blacksher ◽  
Kerri L. Cavanaugh ◽  
Stephanie M. Fullerton ◽  
Ebele M. Umeukeje ◽  
...  
Keyword(s):  
Genetic Research ◽  
Clinical Implications ◽  
Clinical Validity ◽  
Research Results ◽  
Individual Research Results ◽  
Study Participants ◽  
Participant Perspectives ◽  
Apolipoprotein L1 ◽  
Analytic Validity

Whether individual results of genetic research studies ought to be disclosed to study participants has been debated in recent decades. Previously, the prevailing expert view discouraged the return of individual research results to participants because of the potential lack of analytic validity, questionable clinical validity and medical actionability, and questions about whether it is the role of research to provide participants with their data. With additional knowledge of participant perspectives and shifting views about the benefits of research and respect for participants, current expert consensus is moving toward support of returning such results. Significant ethical controversies remain, and there are many practical questions left to address, including appropriate procedures for returning results and the potential burden to clinicians when patients seek guidance about the clinical implications of research results. In this review, we describe current views regarding the return of genetic research results, including controversies and practical challenges, and consider the application of these issues to research on apolipoprotein L1 (APOL1), a gene recently associated with health disparities in kidney disease. Although this case is unique, it illustrates the complexities involved in returning results and highlights remaining questions.

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.

scholarly journals Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants

2010 ◽  
Vol 3 (6) ◽  
pp. 574-580 ◽  
Author(s):  
Richard R. Fabsitz ◽  
Amy McGuire ◽  
Richard R. Sharp ◽  
Mona Puggal ◽  
Laura M. Beskow ◽  
...  
Keyword(s):  
Genetic Research ◽  
Research Results ◽  
Practical Guidelines ◽  
Study Participants

Providing research results to study participants: support versus practice of researchers presenting at the American Society of Hematology annual meeting

Blood ◽  
2005 ◽  
Vol 106 (4) ◽  
pp. 1199-1202 ◽  
Author(s):  
Heather Rigby ◽  
Conrad V. Fernandez
Keyword(s):  
Annual Meeting ◽  
International Research ◽  
Research Results ◽  
Individual Level ◽  
Institutional Review ◽  
Community Evaluation ◽  
American Society ◽  
High Level ◽  
Study Type ◽  
Study Participants

AbstractOffering to provide research results to study participants is gaining increasing support based, in part, on the principle of respect for persons. The frequency and means of this practice is unknown in national and international research communities. All investigators who presented oral abstracts involving human research at the American Society of Hematology Annual Meeting (December 2003) were surveyed. Responses were received from 197 (42%) of 472 eligible investigators. Nonrespondents did not differ in study type or country of origin. Only 30% (n = 48) of those who completed the survey had a formal plan for the return of research results; 40% of these would return both a summary plus individual level results. Of the respondents, 69% (n = 109) supported or strongly supported the practice; only 3% opposed the practice. The most commonly cited reasons for not returning results were: did not consider it (38%), anticipated contact difficulties (32%), and participant difficulty understanding results (26%). Only 11 (7%) indicated that their institutional review board (IRB) mandates the offer to provide results to all participants; this did not vary significantly by country. Given the high level of support in the international research community, evaluation of well-planned interventions for offering to provide research results to participants should be a priority.

How do Hispanics/Latinos Perceive and Value the Return of Research Results?

2022 ◽  
pp. 154041532110708
Author(s):  
Juan R. Canedo ◽  
Victoria Villalta-Gil ◽  
Carlos G. Grijalva ◽  
David Schlundt ◽  
Rebecca N. Jerome ◽  
...  
Keyword(s):  
Perceived Value ◽  
Specific Information ◽  
Cross Sectional ◽  
Research Results ◽  
Risk Of Disease ◽  
Return Of Research Results ◽  
Higher Educational Attainment ◽  
Types Of Information ◽  
Research Initiatives ◽  
Study Participants

Introduction: Interest in the return of research results has been increasing; however, little is known about how Hispanics/Latinos perceive and value receiving results. This study examined differences among Hispanics/Latinos by education and income in the experience and expectations about the return of research results, perceived value of specific types of information, and the least and most valuable specific information. Method: Retrospective observational design using a cross-sectional national survey sample of Hispanics/Latinos (n = 327). Results: Higher educational attainment was positively associated with the expectation to receive research results, likelihood to participate in research if given study findings, and likelihood to trust researchers if given results. Higher income was positively associated with the perceived value of getting results. Respondents with higher education specifically perceived greater value in information about how lifestyle and genetics affect their risk of disease, how genetics affect how they respond to medications, their ancestry, available clinical trials near them, and how to connect with other study participants. Respondents with higher income perceived greater value in information about how genetics affect their risk of disease and how they respond to medications. Conclusion: The findings offer important insights for planning research initiatives and for developing culturally targeted educational materials for Hispanics/Latinos.

scholarly journals 3409 The Power of Phenotypic Extremes in Detecting Novel Genetic Modifiers of Hemophilia

2019 ◽  
Vol 3 (s1) ◽  
pp. 23-24
Author(s):  
Ohad Shimshon Bentur ◽  
Barry S. Coller
Keyword(s):  
Informed Consent ◽  
Genetic Information ◽  
Genetic Modifier ◽  
Genetic Research ◽  
Informed Consent Process ◽  
Consent Process ◽  
Genetic Modifiers ◽  
Research Results ◽  
Study Participants ◽  
Actionable Variants

OBJECTIVES/SPECIFIC AIMS: 1. To identify novel genetic modifiers that result in a mild bleeding phenotype in patients with FVIII <1%. 2. To examine the feasibility of a practice model that incorporates the principles and methods for both obtaining consent for NGS and returning individual research results from the sources described above. METHODS/STUDY POPULATION: 1. We plan a 3-step approach for identifying novel genetic modifiers of hemophilia: a. Obtain samples from individuals with an extremely mild bleeding phenotype: The study will be narrowed to patients with confirmed FVIII <1%, a null mutation in the gene for FVIII, and a mild bleeding phenotype according to a detailed bleeding history. b. Identify variants that modify phenotype: Whole exome sequencing will be performed, followed by a focused analysis of genes known or suspected to be involved in thrombosis and hemostasis and prediction of variant impact using algorithms that account for conservation and deleteriousness of all variants. c. Verify the impact of novel variants in independent samples: In silico (analyze genetic databases for suspected variants), in vivo (assess bleeding in animal models of hemophilia after introducing presumed modifier variants). 2. We will employ a model for obtaining informed consent and communicating individual genetic research results and results with potential clinical impact to research participants: a. The informed consent process will be performed after potential participants read a pamphlet entitled “Genetic Research at The Rockefeller University Hospital and Center for Clinical and Translational Science.” The pamphlet includes 16 questions that the potential participants are urged to ask the investigator, including, “What will you look for in my genetic information?”, “Will I receive results from this study?”. Potential participants will also be informed of the meaning of clinically actionable variants, either pathogenic variants related to phenotype or secondary (“incidental”) findings (i.e. variants unrelated to phenotype, the knowledge of which could lead to actions that may improve health). Participants who do not want to receive information about potentially actionable variants will be excluded from the study to avoid a situation where the investigator has clinically important information that cannot be shared with the participant. b. Genetic testing will be performed in a CLIA-certified lab to allow investigators to share the results with the study participants. c. Results will be reported to study participants according to a standard operating procedure (SOP) that classifies the report of variants according to the relation to phenotype and the pathogenic potential. d. Participant satisfaction with the informed consent process and the return of results will be assessed by a questionnaire for obtaining participants’ perceptions of their research experience, based on a standard set of validated research participation experiences measures (Kost RG et al, J Clin Transl Sci. 2018;2:31). RESULTS/ANTICIPATED RESULTS: Samples from individuals with severe null mutation hemophilia and a mild bleeding phenotype will be enriched in genetic modifier variants. After completing participation, participants will express satisfaction with the informed consent process and the results of the return of genetic information. DISCUSSION/SIGNIFICANCE OF IMPACT: Genetic risk assessment to predict bleeding risk has the potential to provide hemophilia patients with tailored therapy, allowing for very early initiation of treatment (prophylactic thrice weekly IV administration of FVIII) in patients with a high bleeding risk and deferring this costly and burdensome treatment in patients who are expected to be mild bleeders. Genetic modifier variants of hemophilia may be found to predict thrombosis in non-hemophiliac patients and profoundly impact the treatment of venous thrombosis. A structured process for obtaining consent for NGS and return of genetic results to study participants can protect them from uncertain genetic information. Moreover, this process will prevent a situation in which investigators have knowledge about clinically actionable variants but they are not allowed to report them to the participants or do not have a process for doing so. Sharing individual research results and results with clinical significance with participants of studies that involve whole exome sequencing can promote transparency and engagement of participants throughout the research enterprise.

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