Informed consent in biomedical research –A review of its importance and current global guidelines

Abstract

INTRODUCTION Informed consent is an essential step in the ethical conduct and regulation of research and it has been a keystone in preparing guidelines for conducting research and ethical oversight of research. It is the process by which a patientparticipant consents to participate in a research project after obtaining detailed information about the likely procedures risks and benefits.OBJECTIVES The article aims to trace the evolution of guidelines for obtaining informed consent knowledge of which is required in the conduct of biomedical and health sciences research by researchers with varied background and experiences. It also highlights the challenges in obtaining a valid informed consent.MATERIALS AND METHODS The following electronic databases were searched through October 152017 1 PubMed MEDLINE 2 Cochrane Database of Systematic Reviews 3 Science Direct and 4 ISI Web of Science. Two separate searches were performed. The first search used the following search parameters MeSH terms Informed consent AND MeSHTerms Codes of ethics OR Bioethical issues AND MeSH terms Challenges and the second Used MeSH terms Informed consent AND MeSH terms Ethical committees.RESULTS Articles were initially screened based on the titles and abstracts. The accepted articles were reviewed for study design. All references cited in the accepted articles werereviewed to identify additional papers not identified in the database searches. Disagreement regarding inclusion or exclusion of the retrieved papers was resolved by discussion producing the final set of articles used in this review.CONCLUSION Informed consent is much more than a signed form. In spite of obtaining informed individual consent it is most likely that the participants patients may not be fully aware of their rights and in this regard the role of investigator is crucial.nbsp