A study to assess the completeness of informed consent documents for biomedical research on human participants submitted to the institutional ethics committee of a tertiary care hospital

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dc.contributor.authorAnandabaskar, Nishanthien_US
dc.contributor.authorVimal, Mourouguessineen_US
dc.contributor.authorDongre, Amol Rambhauen_US
dc.contributor.authorKagne, Rajendrakumar Nivaratiraoen_US
dc.date.accessioned2020-04-23T08:00:04Z
dc.date.available2020-04-23T08:00:04Z
dc.date.issued2020-01
dc.description.abstractBackground: Informed consent is an essential pre-requisite for research on human participants. However, many studies have shown that informed consent documents (ICDs) are incomplete and lack many of the essential elements. The objective of the study was to assess the completeness of ICDs submitted to an institutional ethics committee (IEC) against the Indian Council of Medical Research (ICMR) ethical guidelines for biomedical research on human participants.Methods: This is a retrospective cross-sectional study. The ICDs submitted to the IEC during the period from January 2015 to December 2017 were reviewed for completeness, with the help of a checklist which is based ICMR ethical guidelines for biomedical research on human participants 2006.Results: A total of 212 ICDs were reviewed during the study period. More than 50% of the ICDs have clearly explained many of the essential elements like nature and purpose of the study (62.3%), voluntary participation (98.6%), procedures (68.9%), risks (71.2%), benefits (92.9%), alternative treatments (60.7%), maintaining confidentiality (99.1%), no loss of benefits on withdrawal from the study (87.8%) and contact details of principal investigator (99.5%). However, the other essential elements of the ICD are either not mentioned or not clearly explained.Conclusions: This study has shown that although majority of the ICDs submitted for review by the IEC have mentioned many of the essential elements, some of the elements like contact details of Chairman of IEC, future use of sample, compensation for trial related injury and provision of counseling for consent of genetics testing have not been stated.en_US
dc.identifier.affiliationsDepartment of Pharmacology, Sri Manakula Vinayagar Medical College and Hospital, Puducherry, Indiaen_US
dc.identifier.affiliationsDepartment of Pathology, Sri Manakula Vinayagar Medical College and Hospital, Puducherry, Indiaen_US
dc.identifier.affiliationsDepartment of Community Medicine, Sri Manakula Vinayagar Medical College and Hospital, Puducherry, Indiaen_US
dc.identifier.affiliationsDepartment of Forensic Medicine, Sri Manakula Vinayagar Medical College and Hospital, Puducherry, Indiaen_US
dc.identifier.citationAnandabaskar Nishanthi, Vimal Mourouguessine, Dongre Amol Rambhau, Kagne Rajendrakumar Nivaratirao. A study to assess the completeness of informed consent documents for biomedical research on human participants submitted to the institutional ethics committee of a tertiary care hospital. International Journal of Basic & Clinical Pharmacology. 2020 Jan; 9(1): 138-145en_US
dc.identifier.issn2319-2003
dc.identifier.issn2279-0780
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/200493
dc.languageenen_US
dc.publisherMedip Academyen_US
dc.relation.issuenumber1en_US
dc.relation.volume9en_US
dc.source.urihttps://dx.doi.org/10.18203/2319-2003.ijbcp20195776en_US
dc.subjectInformed consent formen_US
dc.subjectInstitutional review boarden_US
dc.subjectParticipant information sheeten_US
dc.subjectResearch proposalen_US
dc.titleA study to assess the completeness of informed consent documents for biomedical research on human participants submitted to the institutional ethics committee of a tertiary care hospitalen_US
dc.typeJournal Articleen_US
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