Harmonising the human biobanking consent process: an Irish experience.

Autor:	O'Sullivan L; School of Medicine, University College Dublin, Dublin, D04 V1W8, Ireland.; Health Research Board-Trials Methodology Research Network, National University of Ireland Galway, Galway, H91 TK33, Ireland., Carroll TP; Alpha-1 Foundation Ireland, Royal College of Surgeons in Ireland, Education and Research Centre, Beaumont Hospital, Dublin, D09 YD60, Ireland., Clarke N; The Irish Longitudinal Study on Ageing (TILDA), Trinity College Dublin, Dublin, D02 R590, Ireland., Cooper S; Department of Gastroenterology, Hepatology and Nutrition, Children's Health Ireland at Crumlin, Dublin, D12 N512, Ireland., Cullen A; Conway Institute, University College Dublin, Dublin, D04 V1W8, Ireland., Gorman L; Department of Histopathology, St James's Hospital, Dublin, D08 W9RT, Ireland., McCann B; Public and Patient Partner and member, National Research Ethics Committee, 67-72 Lower Mount Street, Dublin, D02 H638, Ireland., Mee B; Department of Histopathology, St James's Hospital, Dublin, D08 W9RT, Ireland., Miller N; National University of Ireland, Galway, Galway, H91 TK33, Ireland., Murphy V; Cancer Trials Ireland, Innovation House, Glasnevin, Dublin, D11 KXN4, Ireland., Murray M; Irish Centre for Maternal and Child Health Research (INFANT), University College Cork, Cork, T12 YE02, Ireland., O'Leary J; Irish Centre for Maternal and Child Health Research (INFANT), University College Cork, Cork, T12 YE02, Ireland., O'Toole S; Department of Obstetrics and Gynaecology/Histopathology, Trinity College Dublin, Trinity St James's Cancer Institute, St James's Hospital, Dublin, D08 W9RT, Ireland., Snapes E; BioConsulting, Cork, Ireland., Bracken S; Formerly of Clinical Research Development Ireland, 28 Mount Street Lower, Dublin, D02 CX28, Ireland.
Jazyk:	angličtina
Zdroj:	HRB open research [HRB Open Res] 2022 Jan 13; Vol. 4, pp. 96. Date of Electronic Publication: 2022 Jan 13 (Print Publication: 2021).
DOI:	10.12688/hrbopenres.13384.3
Abstrakt:	Biobanks are repositories of human biological samples and data. They are an important component of clinical research in many disease areas and often represent the first step toward innovative treatments. For biobanks to operate, researchers need human participants to give their samples and associated health data. In Ireland, research participants must provide their freely given informed consent for their samples and data to be taken and used for research purposes. Biobank staff are responsible for communicating the relevant information to participants prior to obtaining their consent, and this communication process is supported by the Participant Information Leaflets and Informed Consent Form (PI/ICFs). PILs/ICFs should be concise, intelligible, and contain relevant information. While not a substitute for layperson and research staff discussions, PILs and ICFs ensure that a layperson has enough information to make an informed choice to participate or not. However, PILs/ICFs are often lengthy, contain technical language and can be complicated and onerous for a layperson to read. The introduction of the General Data Protection Regulation and the related Irish Health Research Regulation presented additional challenges to the Irish biobank community. In May 2019, the National Biobanking Working Group (NBWG) was established in Ireland. It consists of members from diverse research backgrounds located in universities, hospitals and research centres across Ireland and a public/patient partner. The NBWG aimed to develop a suite of resources for health research biobanks via robust and meaningful patient engagement, which are accessible, General Data Protection Regulation/Health Research Regulation-compliant and could be used nationally, including a PIL/ICF template. This open letter describes the process whereby this national biobank PIL/ICF template was produced. The development of this template included review by the Patient Voice in Cancer Research, led by Professor Amanda McCann at University College Dublin and the Health Research Data Protection Network. Competing Interests: No competing interests were disclosed. (Copyright: © 2022 O'Sullivan L et al.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu