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EsPRit: ethics committee proposals for Long Term Medical Data Registries in rapidly evolving research fields - a future-proof best practice approach.

ABSTRACT: Long-term data collection is a challenging task in the domain of medical research. Many effects in medicine require long periods of time to become traceable e.g. the development of secondary malignancies based on a given radiotherapeutic treatment of the primary disease. Nevertheless, long-term studies often suffer from an initial lack of available information, thus disallowing a standardized approach for their approval by the ethics committee. This is due to several factors, such as the lack of existing case report forms or an explorative research approach in which data elements may change over time. In connection with current medical research and the ongoing digitalization in medicine, Long Term Medical Data Registries (MDR-LT) have become an important means of collecting and analyzing study data. As with any clinical study, ethical aspects must be taken into account when setting up such registries. This work addresses the problem of creating a valid, high-quality ethics committee proposal for medical registries by suggesting groups of tasks (building blocks), information sources and appropriate methods for collecting and analyzing the information, as well as a process model to compile an ethics committee proposal (EsPRit).To derive the building blocks and associated methods software and requirements engineering approaches were utilized. Furthermore, a process-oriented approach was chosen, as information required in the creating process of ethics committee proposals remain unknown in the beginning of planning an MDR-LT. Here, we derived the needed steps from medical product certification. This was done as the medical product certification itself also communicates a process-oriented approach rather than merely focusing on content. A proposal was created for validation and inspection of applicability by using the proposed building blocks. The proposed best practice was tested and refined within SEMPER (Secondary Malignoma - Prospective Evaluation of the Radiotherapeutics dose distribution as the cause for induction) as a case study.The proposed building blocks cover the topics of "Context Analysis", "Requirements Analysis", "Requirements Validation", "Electronic Case Report (eCRF) Design" and "Overall Concept Creation". Additional methods are attached with regards to each topic. The goals of each block can be met by applying those methods. The proposed methods are proven methods as applied in e.g. existing Medical Data Registry projects, as well as in software or requirements engineering.Several building blocks and attached methods could be identified in the creation of a generic ethics committee proposal. Hence, an Ethics Committee can make informed decisions on the suggested study via said blocks, using the suggested methods such as "Defining Clinical Questions" within the Context Analysis. The study creators have to confirm that they adhere to the proposed procedure within the ethic proposal statement. Additional existing Medical Data Registry projects can be compared to EsPRit for conformity to the proposed procedure. This allows for the identification of gaps, which can lead to amendments requested by the ethics committee.

SUBMITTER: Oberbichler S

PROVIDER: S-EPMC5648439 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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EsPRit: ethics committee proposals for Long Term Medical Data Registries in rapidly evolving research fields - a future-proof best practice approach.

Oberbichler S S Hackl W O WO Hörbst A A

BMC medical informatics and decision making 20171018 1

<h4>Background</h4>Long-term data collection is a challenging task in the domain of medical research. Many effects in medicine require long periods of time to become traceable e.g. the development of secondary malignancies based on a given radiotherapeutic treatment of the primary disease. Nevertheless, long-term studies often suffer from an initial lack of available information, thus disallowing a standardized approach for their approval by the ethics committee. This is due to several factors, ...[more]

PMID: 29047394

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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:The informed-consent process should be one of meaningful information exchange between researchers and study participants. One of the responsibilities of research ethics committees is to oversee appropriate informed consent. The committee must consider various matters before deciding whether the process is appropriate, including the adequacy and completeness of the written information provided to study participants, and the process of obtaining informed consent. This study aimed to identify, quantitatively and qualitatively, consent-related issues in different types of malaria proposals submitted to the Faculty of Tropical Medicine, Ethics Committee.This study reviewed proposal documentation submitted to two panels of the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, from 2011 to 2015. The documentation included proposals, notifications to researchers of review outcomes and ethical issues of concern to committee members. Each element of the informed-consent process was identified and analyzed by study classification, design, and specimen use, including whether the study involved a vulnerable population. Summative content analysis was used to analyze patterns of common issues raised in reviews.Of the 112 proposals reviewed, 63 required an informed consent process. All researchers proposed communicating with their study participants; however, about two-thirds needed to improve their explanations of study procedures (study activities and specimen/data-collection process) to participants. About 40% of the proposals attracted comments on informed-consent process elements--risk and discomfort, vulnerable status, and compensation. Studies that planned to collect or use new/linked specimens raised more issues around informed consent than studies using linked data/records. Studies that involved vulnerable populations raised more issues than those that did not. The committee usually asked researchers to clarify, elaborate, revise, or paraphrase the consent process elements that were considered to involve inadequate information exchange between researcher and study participant.This study aimed to describe lessons for malaria researchers about common informed-consent process issues in different types of malaria proposals. The information and analysis of informed-consent elements should assist the preparation of malaria-research proposals.

Project description:IntroductionPatient registries, 'organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time', are potentially valuable sources of data for supporting regulatory decision-making, especially for products to treat rare diseases. Nevertheless, patient registries are greatly underused in regulatory assessments. Reasons include heterogeneity in registry design and in the data collected, even across registries for the same disease, as well as unreliable data quality and data sharing impediments. The Patient Registries Initiative was established by the European Medicines Agency in 2015 to support registries in collecting data suitable to contribute to regulatory assessments, especially post-authorisation safety and effectiveness studies.MethodsWe conducted a qualitative synthesis of the published observations and recommendations from an initiative-led multi-stakeholder consultation and four disease-specific patient registry workshops. We identified the primary factors facilitating the use of registry data in regulatory assessments. We generated proposals on operational measures needed from stakeholders including registry holders, patients, healthcare professionals, regulators, marketing authorisation applicants and holders, and health technology assessment bodies for implementing these.ResultsTen factors were identified as facilitating registry use for supporting regulatory assessments of medicinal products. Proposals on operational measures needed for implementation were categorised according to three themes: (1) nature of the data collected and registry quality assurance processes; (2) registry governance, informed consent, data protection and sharing; and (3) stakeholder communication and planning of benefit-risk assessments.ConclusionsThese are the first explicit proposals, from a regulatory perspective, on operational methods for increasing the use of patient registries in medicines regulation. They apply to registry holders, patients, regulators, marketing authorisation holders/applicants and healthcare stakeholders broadly, and their implementation would greatly facilitate the use of these valuable data sources in regulatory decision-making.

Project description:BackgroundApproval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form.MethodsWe obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important.ResultsTwenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important.ConclusionThe number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent.

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EsPRit: ethics committee proposals for Long Term Medical Data Registries in rapidly evolving research fields - a future-proof best practice approach.

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EsPRit: ethics committee proposals for Long Term Medical Data Registries in rapidly evolving research fields - a future-proof best practice approach.

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