Informed consent for next-generation nucleotide sequencing studies: Aiding communication between participants and investigators
UMass Center for Clinical and Translational Science
Translational Medical Research
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.
UMCCTS funding, Translational research, design and analysis, genetic counseling, patient-centered research
DOI of Published Version
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 of clinical and translational science
Kost RG, Poppel SM, Coller BS. (2017). Informed consent for next-generation nucleotide sequencing studies: Aiding communication between participants and investigators. UMass Center for Clinical and Translational Science Supported Publications. https://doi.org/10.1017/cts.2016.21. Retrieved from https://escholarship.umassmed.edu/umccts_pubs/222