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Development of a tiered and binned genetic counseling model for informed consent in the era of multiplex testing for cancer susceptibility.

ABSTRACT: Multiplex genetic testing, including both moderate- and high-penetrance genes for cancer susceptibility, is associated with greater uncertainty than traditional testing, presenting challenges to informed consent and genetic counseling. We sought to develop a new model for informed consent and genetic counseling for four ongoing studies.Drawing from professional guidelines, literature, conceptual frameworks, and clinical experience, a multidisciplinary group developed a tiered-binned genetic counseling approach proposed to facilitate informed consent and improve outcomes of cancer susceptibility multiplex testing.In this model, tier 1 "indispensable" information is presented to all patients. More specific tier 2 information is provided to support variable informational needs among diverse patient populations. Clinically relevant information is "binned" into groups to minimize information overload, support informed decision making, and facilitate adaptive responses to testing. Seven essential elements of informed consent are provided to address the unique limitations, risks, and uncertainties of multiplex testing.A tiered-binned model for informed consent and genetic counseling has the potential to address the challenges of multiplex testing for cancer susceptibility and to support informed decision making and adaptive responses to testing. Future prospective studies including patient-reported outcomes are needed to inform how to best incorporate multiplex testing for cancer susceptibility into clinical practice.Genet Med 17 6, 485-492.

SUBMITTER: Bradbury AR

PROVIDER: S-EPMC4983405 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Development of a tiered and binned genetic counseling model for informed consent in the era of multiplex testing for cancer susceptibility.

Bradbury Angela R AR Patrick-Miller Linda L Long Jessica J Powers Jacquelyn J Stopfer Jill J Forman Andrea A Rybak Christina C Mattie Kristin K Brandt Amanda A Chambers Rachelle R Chung Wendy K WK Churpek Jane J Daly Mary B MB Digiovanni Laura L Farengo-Clark Dana D Fetzer Dominique D Ganschow Pamela P Grana Generosa G Gulden Cassandra C Hall Michael M Kohler Lynne L Maxwell Kara K Merrill Shana S Montgomery Susan S Mueller Rebecca R Nielsen Sarah S Olopade Olufunmilayo O Rainey Kimberly K Seelaus Christina C Nathanson Katherine L KL Nathanson Katherine L KL Domchek Susan M SM

Genetics in medicine : official journal of the American College of Medical Genetics 20141009 6

<h4>Purpose</h4>Multiplex genetic testing, including both moderate- and high-penetrance genes for cancer susceptibility, is associated with greater uncertainty than traditional testing, presenting challenges to informed consent and genetic counseling. We sought to develop a new model for informed consent and genetic counseling for four ongoing studies.<h4>Methods</h4>Drawing from professional guidelines, literature, conceptual frameworks, and clinical experience, a multidisciplinary group develo ...[more]

PMID: 25297947

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Project description:Research involving human participants requires their consent, and it is common practice to capture consent information on paper and store those hard copies, presenting issues such as long-term storage requirements, inefficient retrieval of consent forms for reference or future use, and the potential for transcription errors when transcribing captured informed consent. There have been calls to move to electronic capture of the consent provided by research participants (e-consent) as a way of addressing these issues. A tiered framework for e-consent was designed using the freely available features in the inbuilt REDCap e-consent module. We implemented 'branching logic', 'wet signature' and 'auto-archiver' features to the main informed consent and withdrawal of consent documents. The branching logic feature streamlines the consent process by making follow-up information available depending on participant response, the 'wet signature' feature enables a timestamped electronic signature to be appended to the e-consent documents and the 'auto-archiver' allows for PDF copies of the e-consent documents to be stored in the database. When designing the content layout, we provided example participant information text which can be modified as required. Emphasis was placed on the flow of information to optimise participant understanding and this was achieved by merging the consent and participant information into one document where the consent questions were asked immediately after the corresponding participant information. In addition, we have provided example text for a generic human genomic research study, which can be easily edited and modified according to specific requirements. Building informed consent protocols and forms without prior experience can be daunting, so we have provided researchers with a REDCap template that can be directly incorporated into REDCap databases. It prompts researchers about the types of consent they can request for genomics studies and assists them with suggestions for the language they might use for participant information and consent questions. The use of this tiered e-consent module can ensure the accurate and efficient electronic capture and storage of the consents given by participants in a format that can be easily queried and can thus facilitate ethical and effective onward sharing of data and samples whilst upholding individual participant preferences.

Dataset Information

Development of a tiered and binned genetic counseling model for informed consent in the era of multiplex testing for cancer susceptibility.

Publications

Development of a tiered and binned genetic counseling model for informed consent in the era of multiplex testing for cancer susceptibility.

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