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Impact of Next Generation Sequencing on the Organization and Funding of Returning Research Results: Survey of Canadian Research Ethics Boards Members.

ABSTRACT: Research Ethics Boards (REBs) are expected to evaluate protocols planning the use of Next Generation Sequencing technologies (NGS), assuring that any genomic finding will be properly managed. As Canadian REBs play a central role in the disclosure of such results, we deemed it important to examine the views and experience of REB members on the return of aggregated research results, individual research results (IRRs) and incidental findings (IFs) in current genomic research. With this intent, we carried out a web-based survey, which showed that 59.7% of respondents viewed the change from traditional sequencing to NGS as more than a technical substitution, and that 77% of respondents agreed on the importance of returning aggregated research results, the most compelling reasons being the recognition of participants' contribution and increasing the awareness of scientific progress. As for IRRs specifically, 50% of respondents were in favour of conveying such information, even when they only indicated the probability that a condition may develop. Current regulations and risk to participants were considered equally important, and much more than financial costs, when considering the return of IRRs and IFs. Respondents indicated that the financial aspect of offering genetic counseling was the least important matter when assessing it as a requisite. Granting agencies were named as mainly responsible for funding, while the organizing and returning of IRRs and IFs belonged to researchers. However, views in these matters differ according to respondents' experience. Our results draw attention to the need for improved guidance when considering the organizational and financial aspects of returning genetic research results, so as to better fulfill the ethical and moral principles that are to guide such undertakings.

SUBMITTER: Jaitovich Groisman I

PROVIDER: S-EPMC4868059 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Impact of Next Generation Sequencing on the Organization and Funding of Returning Research Results: Survey of Canadian Research Ethics Boards Members.

Jaitovich Groisman Iris I Godard Beatrice B

PloS one 20160511 5

Research Ethics Boards (REBs) are expected to evaluate protocols planning the use of Next Generation Sequencing technologies (NGS), assuring that any genomic finding will be properly managed. As Canadian REBs play a central role in the disclosure of such results, we deemed it important to examine the views and experience of REB members on the return of aggregated research results, individual research results (IRRs) and incidental findings (IFs) in current genomic research. With this intent, we c ...[more]

PMID: 27167380

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Project description:ObjectivesThe Plutocratic Proposal is a novel method of funding early phase clinical trials where a single donor funds the entire trial and in so doing secures a place on it. The aim of this study was to identify and explore concerns that may be raised by UK research ethics committees (RECs) when reviewing clinical trials funded in this way.DesignEmpirical ethics combining ethical analysis and qualitative data from three focus groups held online using Frith's symbiotic approach. Data were analysed using inductive thematic approach informed by the study aims and ethical analysis.Participants22 participants were recruited: 8 research patient public involvement group members, 7 REC chairs and 7 clinical researchers. All were based in the UK.ResultsWith one exception, participants thought the Plutocratic Proposal may be 'all things considered' acceptable, providing their concerns were met, primary of which was upholding scientific integrity. Other concerns discussed related to the acceptability of the donor securing a place on the trial including: whether this was an unfair distribution of benefits, disclosing the identity of the donor as the funder, protecting the donor from exploitation and funding a single study with multiple donors on the same terms. Some misgivings fell outside the usual REC purview: detrimental impact of donors of bad character, establishing the trustworthiness of the matching agency and its processes and optimising research funding and resources. Despite their concerns, participants recognised that because the donor funds the whole trial, others would also potentially benefit from participating.ConclusionsWe identified concerns about the Plutocratic Proposal. UK RECs may be open to approving studies if these can be addressed. Existing governance processes will do some of this work, but additional REC guidance, particularly in relation to donors securing a place on the trial, may be necessary to help RECs navigate ethical concerns consistently.

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Project description:Background: Genomic and biobanking research has increased in Africa over the past few years. This has raised pertinent ethical, legal, and societal concerns for stakeholders such as sample or data ownership, commercialization, and benefit sharing. There is limited awareness of the concept of benefit sharing by stakeholders in sub-Saharan Africa. Objective: This study aimed to explore the perceptions of researchers and research ethics committee members on benefit sharing in international collaborative genomic and biobanking research. Methods: Qualitative in-depth interviews were conducted with 15 researchers and 19 research ethics committee members. A thematic approach was used to interpret the results. Results: Six themes emerged from the data and these included perceptions on the benefits of genomic and biobanking research; discussion of benefit sharing with participants during the informed consent process; legal implications of benefit sharing and the role of material transfer agreements; equity and fairness in sharing the benefits of genomic research; perceived barriers to fair benefit sharing; and recommendations for fostering fair and equitable benefit sharing in genomic and biobanking research. Most respondents clearly understood the various forms of benefits of genomic and biobanking research and opined that such benefits should be fairly and equitably shared with low and middle-income country researchers and their institutions, and research communities. The perceived barriers to the fair benefit sharing unfavorable include power disparities, weak research regulatory frameworks, and lack of scientific integrity. Conclusion: Overall, respondents believed that the distribution of the advantages of genomic and biobanking research in North-South collaborative research was not equitable nor fair, and that the playing field was not leveled. Therefore, we advocate the following for fair and equitable benefit sharing: Building the capacities and empowering research scientists in developing nations; strengthening regulatory frameworks and extending the purview of the research ethics committee in the development and implementation of material transfer agreements; and meaningfully involving local research communities in benefit sharing negotiations.

Dataset Information

Impact of Next Generation Sequencing on the Organization and Funding of Returning Research Results: Survey of Canadian Research Ethics Boards Members.

Publications

Impact of Next Generation Sequencing on the Organization and Funding of Returning Research Results: Survey of Canadian Research Ethics Boards Members.

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