Explaining Next Generation Sequencing (NGS) Studies to Research Volunteers in Plain Language

Human Genomics Core Working Group Center for Clinical and Translational Science, Rockefeller University This brochure is intended for investigators who design and conduct research involving Next Generation Sequencing (NGS). The goal is to provide both context and language to aid investigators in explaining research involving NGS to research volunteers. The IRB‐approved Informed Consent Form (ICF) for a given study captures the required elements to be conveyed about a specific research study. However, research participants come from a broad range of backgrounds which presents various challenges to obtaining truly informed consent. Barriers to comprehension include limited medical literacy, limited scientific understanding, limited research literacy, and therapeutic misconception. Investigators may need additional information and strategies to overcome these challenges. The content below reflects a consensus of a Working Group of the Rockefeller Center for Clinical and Translational Science consisting of IRB members, professionals specializing in human subject protections and research conduct, faculty, genetic counselors, and IRB and CCTS leadership. In addition to the content below, the Working Group composed a participant tri‐fold pamphlet by modifying an existing excellent pamphlet developed by the New England Research Subject Advocacy Group and contributing partners (http://catalyst.harvard.edut/services/rsa; http://catalyst.harvard.edu/regulatory/language.pdf) that you may want to provide to prospective participants. It includes a series of suggested questions that the participant may ask you as the investigator. This document is designed to assist you in developing the answers that fit your study and convey complex information clearly. Studies by Appelbaum et al. (Genet Med. 2014 May;16(5):367‐73), Jamal et al. (Am J Med Genet A. 2013 May;161A(5):935‐50), and Yu et al. (Am J Hum Genet. 2014 Jul 3;95(1):77‐84) provide information on the views of genetic professionals on what information should be included in obtaining consent and what information should be shared with participants. A video designed to educate potential participants is available in YouTube (https://www.youtube.com/watch?v=IXamRS85hXU).