Data sharing: A viable resource for future

Clinical trials and research studies are being conducted worldwide at a rampant pace leading to generation of large amount of data. However, to reap the benefits of the data generated it is important that this data is shared with the general public without which it can be deemed useless. Despite its importance being known to us, data sharing does not come without its share of problems and it is not as easy to execute as it sounds on-paper. Over the past few years, multiple coveted organizations around the world involved in research activities have come up with their respective guidelines and initiatives to make sure the sharing of research data is smooth and ethical. Developing countries like India have made a few strides in the right direction with some initiatives in-place, but there still seems a long way to go before unanimous data sharing can be a reality. The stakeholders may have to face certain possible repercussions due to data sharing but there is no doubt that if done in the right way, it can lead to universal development

Exploiting the potential of intranet for managing drug spectrum a web base publication in a Tertiary Care Hospital in Mumbai

Objective: The study surveyed the availability of the intranet in campus and also the knowledge related to drug spectrum an intranet publication. Materials and Methods: Institutional ethics committee permission was obtained. Verbal consent was taken from the faculty and resident doctors of departments where all the facilities were available. Universal sampling method was used for recruitment. Pre-validated questionnaires were given to approximately 100 faculty and 500 resident doctors in the year 2012-2013. The questionnaire contained 15 items. Content analysis was done. The study questionnaire focused on a survey to obtain participants feedback on the use of the intranet and to evaluate the use of intranet as a source of knowledge. It also dealt on the relevance of the drug spectrum in the context of their subject. The responses were taken after giving the participants sufficient time. Data was entered into an Excel 2003 spread sheet and analyzed by using descriptive statistics. Results: The total number of respondents who participated in our study was 134 including faculty and residents from various departments. A total of 117 (89.66%) respondents stated that their departments have access to the internet. Departments having access to intranet was 103 (76.29%). 67 (49.62%) respondents have accessed. 67 (49.62%) did not have the time to visit intranet site whereas 67 (49.62%) have not accessed intranet. 89 (65.92%) respondents were not aware of the drug spectrum. 101 (74.81%) respondents felt that drug spectrum is a useful activity on intranet. 45 (33.33%) knew about the intranet periodical drug spectrum, but most of the respondents (33.33%) explained the meaning of the word drug spectrum according to their understanding, but never knew about the online intranet journal drug spectrum. Conclusion: The study found that the intranet is available in the campus, but it is not being utilized. The awareness and knowledge regarding drug spectrum is lacking, but the participants had a lot of suggestions. Thus, intranet has immense utility, and to make drug spectrum more readable suggestions of the respondents needs to be incorporated which in turn can benefit the medical fraternity as a whole

Knowledge, attitude, and practices toward ayurvedic medicine use among allopathic resident doctors: A cross-sectional study at a tertiary care hospital in India

Context: Ayurveda is most commonly practiced form of complementary and alternative medicine (CAM) in India. There are very few studies showing the knowledge, attitude, and practices (KAP) of allopathic doctors about Ayurvedic drugs and its use. Aims: The study was initiated to assess KAP toward Ayurvedic medicine use among allopathic resident doctors. Settings and Design: Cross-sectional and prospective study. Materials and Methods: After obtaining permission from the Institutional Ethics Committee, allopathic resident doctors from clinical departments were approached personally. They were given pre-formed validated questionnaire to assess KAP toward Ayurvedic medicine use. Statistical Analysis Used: Descriptive statistics. Results: Allopathic residents had little knowledge about basic concepts of Ayurveda, that is, ′panchakarma′ and ′tridosha′. Majority residents (99%) had no opportunity to learn basics of Ayurveda, but 67% residents prescribed Ayurvedic medicines to patients. However, many residents (76%) mentioned that cross practice should not be allowed due to lack of knowledge. One resident knew that cross-practice was not allowed by law. The commonly prescribed proprietary Ayurvedic medicines were Liv-52 (39%), Shatavari (13%), Cystone (12%) and common ailments for which these medicines prescribed were liver disorders (34%), arthritis (18%), cough and cold (13%), kidney stones (11%), and piles (10%). Nearly 76% residents felt incorporation of Ayurveda with modern medicine would attract more patients and at the same time most residents (92%) agreed that Ayurvedic medicines need scientific testing before use. Though 50% of the residents agreed for voluntary training in Ayurveda, 80% denied compulsory training. Nearly 63% residents recommended Ayurveda among all CAMs. Most of residents heard of Ayurveda from their colleagues. Conclusions: This study reveals that allopathic resident doctors had little knowledge about Ayurveda and Ayurvedic medicine use but engaged in prescription of Ayurvedic medicines. So some interventions should be taken to increase the knowledge and awareness of allopathic resident doctors about Ayurvedic medicine use

Is Coercion Involved in the Decision-Making of Medical Students Participating in Research?: A Cross-Sectional Study

10.1353/asb.2016.0002Asian Bioethics Review8120-3

Impact of the COVID pandemic on functioning of the institutional ethics committee: A comparison study

Purpose and Aim: In COVID 19 pandemic, it was essential to document the functioning of the institutional ethics committee (IEC), how the organization adapted and faced challenges posed, thus forming the rationale behind this particular audit. The objectives were to assess the impact of the pandemic on the structure, review process, outcomes, and administration of IEC and to compare the same during its functioning in the prepandemic stage. Subject and Methods: The study was conducted as a retrospective audit. After exemption from ethics review, the data were collected from the IEC office situated in KEM Hospital and were segregated into four domains: structure, review process, outcomes, and administration. The data were analyzed using descriptive statistics. Mann–Whitney U-test was used to compare the turnover time for approval of projects between the two study periods at 5% level of significance. SPSS software version 22 was used to analyze the data. Results: Constitution changed , more protocols pertaining to COVID 19 studies were reviewed, meetings frequency doubled, and Standard Operating Procedures was amended to incorporate the changes faced during pandemic. Significant decrease in turnover time was noticed with respect to submission to query letter and study completion. There were more protocol deviations. Financial burden and expenditure decreased due to less paperwork and meetings being held online. Conclusion: The ethics committee infrastructure and functioning had to undergo a paradigm shift to adapt to the various changes and overcome the various hurdles occurring during the COVID-19 pandemic

A study to assess completeness of project application forms submitted to Institutional Ethics Committees (IEC) of a tertiary care hospital

Objectives: To review Ethics Committee (EC) application forms and to find out similarities and differences in content of five ECs forms in India. Materials and Methods: The completeness of EC application forms was assessed on the following themes: title, study team, sponsor responsibility, scientific aspects, patient safety, regulatory permissions, Informed consent process from 2008-2009. Application forms (available online) of 5 ECs were studied and compared. Results: A total of 445 application forms were analyzed, 382 were academic, 63 were sponsored. The common deficiencies in academic studies were inappropriate titles (25.13%), lack of budget details (90%). More than 95% studies had not mentioned the method of recruitment. The issue of vulnerability was not marked in more than 50% of studies. Compensation for participation/injury was poorly stated in academic (99%) studies. Among industry sponsored studies, 98% were compliant with regulatory permissions and 41% were CTRI registered. The information pertaining to Informed Consent was mentioned in all forms. Comparative analysis of application forms of 5 ECs showed that the requirements for submission were similar except 1-2 ECs asked for additional information like percentage of time allotted by investigator for studies, GCP training of study team, certification by investigator regarding accuracy of local versions of Informed consent. Conclusion: Our study recommends that increased awareness and vigilance by investigators of academic studies regarding submission of applications to EC will increase efficiency and speed of review process. A common application form for all ECs across India would be an important step to achieve uniformity in functioning of ethics committees

Payment for participation in clinical research: Review of proposals submitted to the ethics committees

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