Title

Informed consent for next-generation nucleotide sequencing studies: Aiding communication between participants and investigators

UMMS Affiliation

UMass Center for Clinical and Translational Science

Publication Date

2017-04-01

Document Type

Article

Disciplines

Translational Medical Research

Abstract

INTRODUCTION: Obtaining informed consent from prospective participants for research studies that include next-generation nucleotide sequencing (NGS) presents significant challenges because of the need to explain all the potential implications of participating, including the possible return of "incidental" findings, in easy-to-understand language.

METHODS AND RESULTS: After reviewing the consent processes at other institutions, we decided to supplement the protocol-specific informed consent form with the following: (1) a short pamphlet for the prospective participant that includes a series of questions that she or he is encouraged to ask the investigator, and (2) a more detailed companion guide for investigators to help them develop simple-language answers to the questions. Both documents are available to use or modify.

CONCLUSIONS: We propose an approach to obtaining informed consent for NGS studies that encourages discussion of key issues without creating a complex, comprehensive document for participants; it also maximizes investigator flexibility. We also suggest mechanisms to return restricted information to participants.

Keywords

UMCCTS funding, Translational research, design and analysis, genetic counseling, patient-centered research

DOI of Published Version

10.1017/cts.2016.21

Source

Kost RG, Poppel SM, Coller BS. Informed consent for next-generation nucleotide sequencing studies: Aiding communication between participants and investigators. Version 2. J Clin Transl Sci. 2017 Apr;1(2):115-120. doi: 10.1017/cts.2016.21. Epub 2017 Feb 7. PMID: 28649453; PMCID: PMC5471895. Link to article on publisher's site

Journal/Book/Conference Title

Journal of clinical and translational science

Comments

The authors acknowledge the work of the New England Research Subject Advocacy Group, which was conducted with support from the UMass Center for Clinical and Translational Science and other centers that are part of the the National Center for Advancing Translational Sciences, National Institutes of Health.

Related Resources

Link to Article in PubMed

PubMed ID

28649453

Share

COinS