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Informed Consent is fundamental and required element for Human Research Participants. Informed consent must clearly outline participation requirements, risks and benefits, and communicate that no coercion was used during participant recruitment; these elements ensure that recruited participants’ rights are protected throughout the course of the study. During the recruitment process potential participants are contacted and presented with a study relevant to them specifically. Once the participant has received the study information they can choose to participate in the study by providing their consent or they can decline participation. Any research study involving participants’ DNA and medical record data requires consent.
See: The Belmont Report
- Brothers KB, Lynch JA, Aufox SA, Connolly JJ, Gelb BD, Holm IA, Sanderson SC, McCormick JB, Williams JL, Wolf WA, Antommaria AH, Clayton EW. Practical Guidance on Informed Consent for Pediatric Participants in a Biorepository. Mayo Clin Proc. 2014 Nov;89(11):1471-80. PMC4254313.
- Garrison NA, Sathe NA, Antommaria AH, Holm IA, Sanderson SC, Smith ME, McPheeters ML, Clayton EW. A Systematic Literature Review of Individuals’ Perspectives on Broad Consent and Data Sharing in the United States. Genet Med. 2015 Nov 19.
- Brothers KB, Holm IA, Childerhose JE, Antommaria AH, Bernhardt BA, Clayton EW, Gelb BD, Joffe S, Lynch JA, McCormick JB, McCullough LB, Parsons DW, Sundaresan AS, Wolf WA, Yu JH, Wilfond BS; Pediatrics Workgroup of the Clinical Sequencing Exploratory Research (CSER) Consortium; Pediatrics Workgroup of the Clinical Sequencing Exploratory Research CSER Consortium. When Participants in Genomic Research Grow Up: Contact and Consent at the Age of Majority. J Pediatr. 2016 Jan;168:226-231.
- Consent for Returning Pharmacogenomics Results (Lead: Maureen Smith)