Work

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

Year: 2017

Type: article

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.

Source: Journal of Clinical and Translational Science

DOI: 10.1017/cts.2016.21

Authors: Rhonda G. Kost, Stephen M. Poppel, Barry S. Coller

Institution: Rockefeller University

Language: English

Topic: Ethics in Clinical Research

Subfield: Public Health, Environmental and Occupational Health

Field: Medicine

Domain: Health Sciences

Open Access status: gold

Estimated APC paid: $3,200

Funders: National Institutes of Health, Clinical and Translational Science Institute, Boston University, National Center for Advancing Translational Sciences