The community representative plays a very important role in an institutional review board (IRB) but there is sparse data about their understanding of their role in an IRB. This study was conducted to assess perceptions of community members serving on IRBs of one region in India. A validated questionnaire (Cohen's kappa coefficient of 0.84) was administered to community members of IRBs in a prospective cross-sectional study. The questions related to demography, perceptions of their role in the IRB, experiences while serving on the IRBs, difficulties faced by them, and suggestions to improve their contributions. Of the 56 IRBs contacted, all 15 of the public institutions shared details of their community members, while only 26 of the 41 IRBs of private institutions responded. When questioned about why they joined the IRB, one third of the respondents said either that there was "no specific reason" for joining or that they accepted the invitation to serve on the insistence of other members of the IRBs or the head of their institution. All except one felt that community members were needed for optimal functioning. Six participants said that they did not review informed consent documents (ICD), and 10 were unaware that their presence was vital for quorum to be met. Twenty-eight said they participated actively in meetings and did not feel intimidated by the presence of clinicians. Twelve reported difficulties in understanding medical terminologies in ICDs. Although the majority of participants were aware about their role in an IRB, some did not review important documents such as ICDs. Restricted participation by private hospital IRBs was a striking observation in our study. There is a need to define eligibility criteria and develop targeted training modules for community members to ensure their effective contribution to effective oversight of clinical research.
The cornerstone for an effective biomedical waste (BMW) management is appropriate waste segregation. Improper waste segregation practices can have an adverse impact on public health and increase the cost of treatment. Deficiencies in waste segregation practices can be corrected by continuous monitoring and education. Manpower for monitoring waste segregation in a large teaching hospital is scanty. We utilized the undergraduate medical students as monitors and studied the impact on waste segregation practices. A prospective observational study was carried out from August 2004 to January 2005. For monitoring waste segregation, the different areas of the hospital were divided amongst the II M.B.B.S students. They were provided with an observation sheet wherein the status of waste segregation and overall hygiene was recorded on a scale of 1-5. The impact of this programme was then analysed over the study period. The results indicated that a statistically significant improvement in waste segregation practices occurred in all areas. Thus, a large hospital with a medical college can identify students or a similar group for monitoring waste segregation or other aspects of biomedical waste management. This will improve their understanding of good practice in BMW management in future.
Objective:In view of dearth of information in national and international guidelines on payment practices in research, the present study was done to find out payments for participation allowed by 3 Ethics committees (ECs) and reasons for payment.Method:This was a retrospective observational study which analysed research proposals reviewed by 2 institutional and 1 non-institutional ECs over a period of 2 years. The permission of ECs was obtained and confidentiality of data was maintained.Results:Of the 73 studies requiring payment, 89.04% were interventional and 10.96% observational. Reimbursement of travel expenses (60%) was the major reason for payment followed by inconvenience due to participation, loss of wages and time spent. The queries raised by EC in more than 50 % of studies were related to informing patients about the payment in the informed consent document. The investigators complied with the EC requirements regarding payment (15/21) and the remaining provided explanations. The median amount of payment in pharmaceutical sponsored studies was higher compared to investigator initiated studies. Higher payments were approved by ECs on case to case basis in a few studies. The ECs did not have any policy/ standard operating procedure for payment practices.Conclusion:The present study first of its kind in India, demonstrated that quantum of payment was not uniform for pharmaceutical sponsored and investigator initiated studies and payments were not considered for majority of observational studies. Travel reimbursement was the most common reason for payment. There is a need to develop guidelines for determining appropriate payment/incentives to participants for specific types of research related activities.
Blastocystis hominis has become unique and an interesting pathogenic parasite and has been reported to contribute to irritable bowel syndrome. The parasite is highly pleomorphic and its diagnostic yield increases when more than one laboratory technique is used. Blastocystis hominis responds to metronidazole and trimethoprim-sulfamethoxazole (TMP-SMX). The prevalence of Blastocystis hominis in patients having irritable bowel syndrome is reported to be 43% in the present study. Blastocystis hominis was seen in 25%, 30%, 18.5% and 43% samples using wet mount, trichrome staining, formol ether sedimentation technique and culture in modified Jones' medium respectively. Vacuolar forms were the predominant forms. 87.34% patients did not show Blastocystis hominis in stool samples after treatment whereas 12.65% showed the presence of parasite. Hence, it becomes mandatory to examine stool specimen of patients having irritable bowel syndrome for early diagnosis and treatment of these patients will reduce morbidity.
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