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Knowledge, attitude, and practices regarding informed consent for research purposes among postgraduate resident doctors

Noopur Vyas, Pradeep Jadhav, Rohit Sane.


Abstract

Background: Informed consent is an ethical and legal requirement for research involving human participants. Postgraduate (PG) residents are budding doctors who are in their interim phase of education and are engaged in thesis/research work, which mandates adequate knowledge of informed consent and regulatory guidelines. There exists paucity of data in literature on the informed consent process with regard to PG residents; therefore, this study was conducted to assess the knowledge, attitude, and practices (KAP) of informed consent among PG residents.

Aims and Objectives: The aim of the study was to assess the level of knowledge and attitude about the informed consent process and assess practices adopted by PG residents for research purposes.

Materials and Methods: It was a cross-sectional, observational and questionnaire-based study conducted from January 2018 to March 2018 at a tertiary care teaching hospital, Navi Mumbai. The study included PG residents of either sex pursuing specialty MD/MS courses. A validated KAP questionnaire was used to assess KAP of the informed consent process. Responses from the eligible participants were obtained and analyzed.

Results: A total of 100 PG residents participated; 39% of males and 61% of females. Overall, the knowledge score was high and attitude toward informed consent was average. However, 34% participants felt that witness is not necessary, 20% felt that once the patient participates, they should not be allowed to withdraw and few felt that on voluntary withdrawal, participants are not liable for further standard care and compensation. In practice, few participants failed to explain consent in the local language and neglected to take the signature of an impartial witness.

Conclusions: Overall, the KAP of informed consent among PG residents were adequate. Structured continuing medical education/workshops are necessary to advance informed consent practices.

Key words: Informed Consent; Postgraduate; Residents






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