Does the informed consent document in allied health research follow the national guidelines? A retrospective analysis of proposals submitted to an institutional ethics committee of a tertiary care hospital

Abstract

Background: Informed consent process forms an essential component of the research process. It protects participants' autonomy to decide whether or not to participate in the research freely. It is expected that the informed consent document (ICD) should explain the nature and content of the research to a participant in simple terminology and in the language that the participant understands. The researcher's responsibility is to obtain informed consent from every participant before his/her participation in the research. Objectives: The objective is to evaluate whether the informed consent process documents of research studies submitted for initial review by allied health branches of a tertiary care hospital follow the Indian Council of Medical Research (ICMR) guidelines and whether they relate to the protocol submitted for initial review. Study Design: This was a retrospective study. Methods: After institutional ethics committee (IEC) approval, all research studies submitted by allied health branches to the ethics committee of Seth GS Medical College and KEM Hospital, a tertiary care hospital in Mumbai, from November 1, 2018, to October 31, 2019, were reviewed. Thirty-five protocols were found to meet the inclusion criteria. The ICDs of these studies were evaluated for adherence to the ICMR 2017 guidelines. Ethics committee comments related to the ICDs were noted and analyzed. Results: 34 out of 35 research studies submitted had included all the ten mandatory points of the informed consent process, as per the Biomedical Health Research norms of the ICMR 2017. Seven protocols did not complete the review process and did not receive a letter of permission. IEC queries were mostly related to use of technical language, short forms of medical terms, improper mention of risks and discomforts, and sample size. Conclusion: This study concluded that the ICDs reviewed were complete in terms of sections recommended by the ICMR 2017 guidelines. However, there were certain lapses on the part of both the investigators and IEC, wherein the submitted ICDs did not convey the true nature of the study and the IEC did not correctly point out all these lapses at the time of the review.