RESUMEN
Background: 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.
RESUMEN
Background: Acute poisoning is a medical emergency and a global public health problem. The poisoning pattern varies across countries and even between different regions within a country. The aim of this was to explore the demographic, etiological, and clinical characteristics of acute poisoning cases admitted to a tertiary care hospital in Puducherry, South India.Methods: This was a retrospective hospital record based study of acute poisoning cases admitted to our hospital during the period from January 2015 to December 2017. The patients’ demographic, etiological and clinical characteristics were analyzed.Results: Of the total of 275 cases of acute poisoning, majority of them were in the age group of 21- 30 years (32%) and were females (58.5%). Most of the cases were suicidal in nature (75.3%). Majority of the patients consumed a single poisonous agent (92.7%) and the route of poisoning was oral in all of them. Majority of the patients (56.7%) reached the hospital within 2 hours of exposure to the poison with median duration of hospital stay of 2 days, and mortality of 2.9%. Majority of the suicidal poisonings were associated with abuse of insecticides (39.4%), rodenticides (19.7%) and plant seeds (14.4%); whereas the accidental poisonings were mostly due to household agents (79.1%).Conclusions: Our study shows that the majority of the poisoning cases occurred with a single poisonous agent consumed orally, for suicidal purposes in young age group and women. Pesticides and plant seeds were commonly abused for committing suicides and household agents dominated the list of causes for accidental poisoning.