RESUMO
BACKGROUND:: observational research is increasingly important in clinical decision-making. Opt-out consent has been proposed as a more practical way to obtain participants' consent for such research. The authors evaluated patients' views on opt-out consent for observational research by identifying perceived benefits and barriers. METHODS:: following a systematic literature review of research on participants' perspectives on opt-out consent, a focus group interview was conducted with oncological patients and their family members. RESULTS:: the review identified 13 articles detailing perspectives on opt-out consent. Perceived advantages included benefitting medicine and future generations. These findings were confirmed in the focus group. The main reported barriers to opt-out consent are concerns regarding privacy and the sharing of data with third parties. Participants also demonstrated concerns on insufficient education on opt-out consent. CONCLUSION:: participants demonstrated willingness to participate in observational studies utilising opt-out consent. Special focus should be placed on outlining existing safeguards in research.