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Four reasons why too many informed consents to clinical research are invalid: a critical analysis of current practices.


ABSTRACT:

Objective

Informed consent (IC) is a central ethical and legal requirement for clinical research that aims to protect the autonomy of participants. To enable an autonomous decision and valid consent, adequate understanding must be ensured. However, a considerable proportion of participants do not understand the relevant aspects about participation in research, for example, approximately 45% could not name at least one risk. As such, the inadequate understanding of IC has been known for several decades, and it still constitutes a severe problem for the ethical conduct of research. Through delineating the most pressing deficits of current IC procedures that lead to insufficient understanding, we aim to encourage the discussion among stakeholders, for example, clinical researchers, an

SUBMITTER: Wisgalla A 

PROVIDER: S-EPMC8900041 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature