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An Audit of Protocol Deviations Submitted to an Institutional Ethics Committee of a Tertiary Care Hospital.

ABSTRACT: Protocol deviations (PDs) may jeopardize safety, rights, and welfare of subjects and data integrity. There is scarce literature and no guidelines for Institutional Ethics Committees (IECs) to process PD reports. The PD reports submitted to IECs from Jan 2011 to August 2014 were analyzed retrospectively. Types of studies reporting PDs, category and type of PDs, PD rate per participant, time of reporting PD since its occurrence and corrective actions stated by principal investigator (PI) for major deviations were noted. Out of 447 PDs from 73/1387 total studies received during study period, 402 were from 126 pharma studies. Investigator initiated studies and dissertations reported negligible PDs. Median number of PDs was 4 per protocol. Out of 447 PDs, 304 were related to study procedure, 87, 47 and 9 were from safety, informed consent document (ICD) and eligibility category respectively. The most common reason for PDs was incomplete ICD (22/47). Maximum study procedure related PDs were due to patient visiting outside window period (126/304). Thirty five of 87 PDs were due to missed safety assessment. The overall PD reporting rate per participant was 0.08. In 90% of reports, date of occurrence of PD was not specified. The median delay for reporting PDs after occurrence was 94 days. PDs classified as Major were 73% (323/447). The most common corrective actions stated by PI were participant counseling (85/323) and caution in future (70/323). The study findings emphasize the need for GCP training at regular interval of study team members. IEC have to be vigilant and visit sites frequently, take initiative and formulate guidelines regarding PD reporting.

SUBMITTER: Jalgaonkar SV

PROVIDER: S-EPMC4703381 | biostudies-other | 2016

REPOSITORIES: biostudies-other

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Project description:Purpose To estimate the burden of infectious diseases and the seasonality of mosquito-borne diseases seen at The Indus Hospital, Karachi (TIH). Methodology We performed a retrospective data analysis of all infectious diseases (ID) cases, retrieved from medical records over a five-year period starting from 1 January 2012 till 31 December 2016 at The Indus Hospital (TIH), which is a 150-bed, charity-based, tertiary-care health facility. The collected data has been categorized into three groups: (A) public health-related diseases, including community and environmental IDs, i.e., mosquito-borne diseases such as malaria and dengue, respiratory tract infections, diarrheal diseases, typhoid, and hepatitis; (B) systemic infection related IDs that target individual anatomical or physiological systems such as the respiratory tract, urinary tract, skin and soft tissue, and the cardiac system, and lastly, those IDs which are (C) programmatically managed at TIH, namely cases from the tuberculosis (TB), human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), and malaria clinics, and the rabies prevention center. As the study is an audit, ethical approval was waived by the institutional review board (IRB). Result Overall data from 71,815 patients were assessed. In the public health group (A), the main bulk of diseases were due to malaria, tuberculosis, respiratory tract infections (upper and lower), and diarrheal diseases in both males and females in descending order; there was preponderance of malaria, respiratory tract infections, and diarrheal diseases in males, and of tuberculosis among females. Among the systemic diseases group (B), urinary tract infections (UTIs) had a disproportionately high incidence, followed by skin and soft tissue infections, while bone and joint infections and diabetic foot had equal incidence. In the programmatic group (C), the highest number of cases seen was dog bites followed by drug-sensitive TB. Overall, the six most common infections were malaria, cases of dog bites, tuberculosis, respiratory tract infections, diarrheal diseases, and hepatitis C. More women than men had TB; diarrheal disease and respiratory tract infections were more common in children. UTIs were the most common systemic infections among both men and women. Conclusion There is a great need to have an effective surveillance mechanism of preventable diseases at the national level. Our study highlights the diversity of cases that should direct medical curriculum development, post-graduate training, and health services improvement.

Project description:OBJECTIVE:The general purpose for ethics consultations is to deliberate on issues on medical and scientific research and act towards the safeguard of the patient's rights and dignity. With the implementation of European Union (EU) Regulation 536/2014 on clinical trials and cost and time-optimization, the nature of consultations and the bodies they are carried out might be to some extent affected. Accordingly, we sought to gain an updated perspective on the current role and current practices of ethics consultations nationwide in both clinical and research settings. METHODS:The study was carried forth by a three-step mixed-method approach: i) review of policies/regulations for ethics committee (EC) nationwide; ii) a structured survey on ethics consultation activity completed by each EC during 2016; iii) incorporated into the third part, a qualitative assessment with a selected sample of 8 key-informants for a semi-structured interview, discussing EC history, the ethics consultation function, and the professional experience of consultants. RESULTS:Review of the policies/regulations promoted by ECs showed that 72,6% (n = 69) of all the ECs (N = 95) being actually capable of providing ethics consultation service by policy. 71 ECs (74.7%) responded to the survey on ethics consultation requests; among them, 48 (67.6%) provided ethics consultations of which 23 (23/48) actually received requests for this service in the year 2016. Many ECs did not have a structured database in place to provide precise figures of requests received in the last year nor of their contents. CONCLUSION:To date, ethics consultation in clinical and research practice is largely underappreciated and not well understood by users. The consultants themselves lack a comprehensive vision of work carried out in their field, and bioethics training programs to keep them updated. Despite clinical ethics consultation services should not necessarily be mandatory, following the recent EU Regulation on clinical trials, institutional ethics consultation bodies should be re-evaluated.

Project description:Study publication bias and outcome reporting bias have been recognised as two threats to the validity of systematic reviews. The purpose of this research was to estimate the proportion of missing participant outcome data from randomised controlled trials (RCTs) due to lack of publication of whole studies and due to outcome data missing within study publications.Data were extracted from protocols of clinical research projects submitted to the research ethics committee of the University of Freiburg (Germany) between 2000 and 2002 and associated fully published articles. The total amount of published and unpublished outcome data from all trial participants was calculated for each trial and the overall proportion of missing data from both unpublished and published trials computed. Full and partially reported outcome data was also taken into consideration. The impact of funding source on missingness was also considered at the trial level. From 308 parallel group trials in the study cohort, 167 were published and 141 were unpublished. Overall, 260,563 participants contributed to a total of 2,618,116 participant outcome data across all trials. About half (47%) of the participant outcome data from the 308 trials was reported in full but at least 81% were partially reported. Of the 19% of participant data that were missing, 4% was attributable to missing data from published trials and 15% from unpublished trials. Commercially funded trials had a higher probability of publication (relative risk 1.20, 95% confidence interval 0.86, 1.67; p = 0.27) but were less likely to fully report all outcomes than non-commercially funded trials (relative risk 0.64, 95% confidence interval 0.30, 1.38; p = 0.26).Missing participant outcome data from both published and unpublished trials is frequent. Clinical trial registration including outcome information not only identifies that clinical trials exist but the systematic examination and monitoring of trial information within a registry can help detect selective reporting of entire studies and of outcome data within studies and possibly prevent it.

Project description:IntroductionA Clinical Ethics Committee (CEC) is a multi-professional service whose aim is to support healthcare professionals (HPs) and healthcare organisations to deal with the ethical issues of clinical practice.Although CEC are quite common worldwide, their successful implementation in a hospital setting presents many challenges.EVAluating a Clinical Ethics Committee implementation process (EvaCEC) will evaluate the implementation of a CEC in a comprehensive cancer centre in Northern Italy 16 months after its establishment.Methods and analysisEvaCEC is a mixed-method study with a retrospective quantitative analysis and a prospective qualitative evaluation by a range of data collection tools to enable the triangulation of data sources and analysis. Quantitative data related to the amount of CEC activities will be collected using the CEC's internal databases. Data on the level of knowledge, use and perception of the CEC will be collected through a survey with closed-ended questions disseminated among all the HPs employed at the healthcare centre. Data will be analysed with descriptive statistics.The Normalisation Process Theory (NPT) will be used for the qualitative evaluation to determine whether and how the CEC can be successfully integrated into clinical practice. We will perform one-to-one semistructured interviews and a second online survey with different groups of stakeholders who had different roles in the implementation process of the CEC. Based on NPT concepts, the interviews and the survey will assess the acceptability of the CEC within the local context and needs and expectations to further develop the service.Ethics and disseminationThe protocol has been approved by the local ethics committee. The project is co-chaired by a PhD candidate and by a healthcare researcher with a doctorate in bioethics and expertise in research. Findings will be disseminated widely through peer-reviewed publications, conferences and workshops.Trial registration numberNCT05466292.

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An Audit of Protocol Deviations Submitted to an Institutional Ethics Committee of a Tertiary Care Hospital.

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