scholarly journals Return of Results to Patients: A Gesture of Respect and Responsibility

2021 ◽  
Author(s):  
Mark A. Lewis
Keyword(s):  
Return Of Results

scholarly journals ‘CTRL’: an online, Dynamic Consent and participant engagement platform working towards solving the complexities of consent in genomic research

2021 ◽  
Author(s):  
Matilda A. Haas ◽  
Harriet Teare ◽  
Megan Prictor ◽  
Gabi Ceregra ◽  
Miranda E. Vidgen ◽  
...  
Keyword(s):  
Large Scale ◽  
Genomic Medicine ◽  
International Standards ◽  
Security And Privacy ◽  
Genomic Research ◽  
Return Of Results ◽  
Future Research ◽  
Design And Development ◽  
Participant Engagement ◽  
Dynamic Consent

AbstractThe complexities of the informed consent process for participating in research in genomic medicine are well-documented. Inspired by the potential for Dynamic Consent to increase participant choice and autonomy in decision-making, as well as the opportunities for ongoing participant engagement it affords, we wanted to trial Dynamic Consent and to do so developed our own web-based application (web app) called CTRL (control). This paper documents the design and development of CTRL, for use in the Australian Genomics study: a health services research project building evidence to inform the integration of genomic medicine into mainstream healthcare. Australian Genomics brought together a multi-disciplinary team to develop CTRL. The design and development process considered user experience; security and privacy; the application of international standards in data sharing; IT, operational and ethical issues. The CTRL tool is now being offered to participants in the study, who can use CTRL to keep personal and contact details up to date; make consent choices (including indicate preferences for return of results and future research use of biological samples, genomic and health data); follow their progress through the study; complete surveys, contact the researchers and access study news and information. While there are remaining challenges to implementing Dynamic Consent in genomic research, this study demonstrates the feasibility of building such a tool, and its ongoing use will provide evidence about the value of Dynamic Consent in large-scale genomic research 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 Pediatric Cancer Genetics Research and an Evolving Preventive Ethics Approach for Return of Results after Death of the Subject

2015 ◽  
Vol 43 (3) ◽  
pp. 529-537
Author(s):  
Sarah Scollon ◽  
Katie Bergstrom ◽  
Laurence B. McCullough ◽  
Amy L. McGuire ◽  
Stephanie Gutierrez ◽  
...  
Keyword(s):  
Cancer Genetics ◽  
Recurrence Risk ◽  
Genomic Research ◽  
Return Of Results ◽  
Genetics Research ◽  
Personal Significance ◽  
Pediatric Diseases ◽  
Increased Risk ◽  
Preventive Ethics ◽  
Risk Of Cancer

In the pediatric clinical setting, the parent/guardian will almost always be the authorized representative and designated recipient of clinical and research results, making the issue of to whom results should be returned in the pediatric setting less complex than in adult settings. It is also clear that, in genomic research related to pediatric diseases such as cancer, results may be of considerable clinical, ethical, and personal significance for parents in a number of ways, including a genomic explanation of the origin of their child’s cancer, implications for the genetic testing and medical care of other siblings and of the parents themselves, and reproductive planning with regard to the recurrence risk for future children to have an increased risk of cancer. However, what remains unclear is which results should be disclosed, and under what circumstances, to parents of deceased children.

Pediatric research ‘personalized’? International perspectives on the return of results

2013 ◽  
Vol 10 (1) ◽  
pp. 89-95 ◽  
Author(s):  
Bartha Maria Knoppers ◽  
Amélie Rioux ◽  
Ma’n H Zawati
Keyword(s):  
Pediatric Research ◽  
Return Of Results ◽  
International Perspectives

scholarly journals Psychiatric genetics researchers' views on offering return of results to individual participants

2018 ◽  
Vol 180 (8) ◽  
pp. 589-600 ◽  
Author(s):  
Kristin M. Kostick ◽  
Cody Brannan ◽  
Stacey Pereira ◽  
Gabriel Lázaro‐Muñoz
Keyword(s):  
Return Of Results ◽  
Psychiatric Genetics

scholarly journals Ethical, Legal, and Social Issues Related to the Inclusion of Individuals With Intellectual Disabilities in Electronic Health Record Research: Scoping Review (Preprint)

2019 ◽  
Author(s):  
Melissa Raspa ◽  
Rebecca Moultrie ◽  
Laura Wagner ◽  
Anne Edwards ◽  
Sara Andrews ◽  
...  
Keyword(s):  
Informed Consent ◽  
Intellectual Disabilities ◽  
Vulnerable Populations ◽  
Scoping Review ◽  
Social Issues ◽  
Genetic Research ◽  
Return Of Results ◽  
Privacy And Security ◽  
Electronic Health ◽  
Individuals With Intellectual Disabilities

BACKGROUND Data from electronic health records (EHRs) are increasingly used in the field of genetic research to further precision medicine initiatives. However, many of these efforts exclude individuals with intellectual disabilities, which often stem from genetic conditions. To include this important subpopulation in EHR research, important ethical, legal, and social issues should be considered. OBJECTIVE The goal of this study was to review prior research to better understand what ethical, legal, and social issues may need further investigation when considering the research use of EHRs for individuals with genetic conditions that may result in intellectual disability. This information will be valuable in developing methods and best practices for involving this group in research given they are considered a vulnerable population that may need special research protections. METHODS We conducted a scoping review to examine issues related to the use of EHRs for research purposes and those more broadly associated with genetic research. The initial search yielded a total of 460 unique citations. We used an evaluative coding process to determine relevancy for inclusion. RESULTS This approach resulted in 59 articles in the following areas: informed consent, privacy and security, return of results, and vulnerable populations. The review included several models of garnering informed consent in EHR or genetic research, including tiered or categorical, blanket or general, open, and opt-out models. Second, studies reported on patients’ concerns regarding the privacy and security of EHR or genetic data, such as who has access, type of data use in research, identifiability, and risks associated with privacy breach. The literature on return of research results using biospecimens examined the dissension in the field, particularly when sharing individualized genetic results. Finally, work involving vulnerable populations highlighted special considerations when conducting EHR or genetic research. CONCLUSIONS The results frame important questions for researchers to consider when designing EHR studies, which include individuals with intellectual disabilities, including appropriate safeguards and protections.

scholarly journals Pueblos originários y educación: De la colonialidad a las experiências decoloniales en Brasil y Chile

2020 ◽  
Vol 28 ◽  
pp. 163
Author(s):  
Juan Guillermo Mansilla ◽  
José Rubens Lima Jardilino
Keyword(s):  
Latin America ◽  
Indigenous Peoples ◽  
Latin American ◽  
Indigenous Education ◽  
Theoretical Perspective ◽  
Return Of Results ◽  
Documentary Analysis ◽  
Abstract Knowledge ◽  
History Of ◽  
Written Sources

This article on the education of indigenous peoples in Latin America is a synthesis of an approximation of studies on the history of Education of indigenous peoples (schooling), taking Brazil and Chile as a case study. It represents an effort of reflection of two researchers of the History of Latin American Education Society (SHELA), who have been studying Indigenous Education or Indigenous School Education in Chile and Brazil, from the theoretical perspective of “coloniality and decoloniality” of indigenous peoples in Latin America. The research is based on a comprehensive-interpretative paradigm, whose method is linked to the type of qualitative historiographic descriptive research considering primary and secondary written sources, complemented with visual data (photographs). The documentary analysis was made from material based on primary written sources, secondary and unobtrusive personal documents. The study included three distinct phases in the process of producing results: 1) a critical review of the data of our previous research, in addition to the bibliographic review of research results regarding the presence of the school in other indigenous cultures of the Americas; 2) capturing and processing of new data; and 3) validation and return of results with the research participants. Content analysis was carried out in order to reveal nuclei of central abstract knowledge, endowed with meaning and significance from the perspective of the producers of the discourse, as well as knowledge expressed concretely in the texts, including their latent contents.

Return of Results Policies for Genomic Research: Current Practices & The Hearts in Rhythm Organization Approach

2021 ◽  
Author(s):  
Drake A. Comber ◽  
Brianna Davies ◽  
Jason D. Roberts ◽  
Rafik Tadros ◽  
Martin S. Green ◽  
...  
Keyword(s):  
Genomic Research ◽  
Return Of Results ◽  
Current Practices

scholarly journals Molecular Neuropathology in Practice: Clinical Profiling and Integrative Analysis of Molecular Alterations in Glioblastoma

2019 ◽  
Vol 6 ◽  
pp. 237428951984835 ◽  
Author(s):  
MacLean P. Nasrallah ◽  
Zev A. Binder ◽  
Derek A. Oldridge ◽  
Jianhua Zhao ◽  
David B. Lieberman ◽  
...  
Keyword(s):  
Patient Care ◽  
Dna Methyltransferase ◽  
Improve Patient Care ◽  
Return Of Results ◽  
Molecular Testing ◽  
Methylguanine Dna Methyltransferase ◽  
Molecular Alterations ◽  
Molecular Abnormalities ◽  
Tissue Handling ◽  
Testing Algorithm

Molecular profiling of glioblastoma has revealed complex cytogenetic, epigenetic, and molecular abnormalities that are necessary for diagnosis, prognosis, and treatment. Our neuro-oncology group has developed a data-driven, institutional consensus guideline for efficient and optimal workup of glioblastomas based on our routine performance of molecular testing. We describe our institution’s testing algorithm, assay development, and genetic findings in glioblastoma, to illustrate current practices and challenges in neuropathology related to molecular and genetic testing. We have found that coordination of test requisition, tissue handling, and incorporation of results into the final pathologic diagnosis by the neuropathologist improve patient care. Here, we present analysis of O6-methylguanine-DNA-methyltransferase promoter methylation and next-generation sequencing results of 189 patients, obtained utilizing our internal processes led by the neuropathology team. Our institutional pathway for neuropathologist-driven molecular testing has streamlined the management of glioblastoma samples for efficient return of results for incorporation of genomic data into the pathological diagnosis and optimal patient care.

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