D8.1 Policy for integrating the six agendas (ethics, gender equality, public engagement, governance, scientific education and open access) of responsible research and innovation (PDF / 1MB)
The goal of this policy document is to define the agendas of Responsible Research and Innovation (RRI) and ways of implementation within MICROB-PREDICT. Governance, ethics, gender equality, public engagement, open access and scientific education as the agendas of RRI are defined here offering measures for implementation.
D8.2 Information and Informed Consent template for participation of human beings for using biological samples of human origin in research and for the use of personal data in research (PDF / 577 KB)
This document provides a template for the use of human biological samples and personal data in biomedical research. It could be used as a guidance or can be adapted to support the templates of each research institution involved.
D8.3 Public engagement strategy to design MICROB-PREDICT along with the need of patients (PDF / 1 MB)
The goal of this policy document is to provide a framework of public engagement in research in MICROB-PREDICT, and to review the best approaches to patient involvement, as well as its benefits and costs. We summarize the Responsible Research and Innovation approach, define what public engagement entails, the different actors, tools and methodologies and give recommendations.
D8.4 Codes of conduct applicable and research integrity policy including publications in journals (PDF / 1 MB)
This document analyzes the current codes of good conduct published by each member of the MICROB-PREDICT project, discusses what is included, any references to national or international guidelines, how easily accessible the relevant information is from the home page and the general usefulness of the document for the members of the institutions themselves and the public. At the end, there are 10 recommendations of useful points that each code of conduct should include.
D8.5 Model describing typical treatment paths in decompensated cirrhosis (PDF / 1 MB)
In order to estimate how new tests that enable physicians to distinguish between patients that are low vs. high risk, and patients that respond vs. do not respond to treatments, we develop a benchmark model where the patient can be in one of four states: Cirrhosis, Decompensation, and Acute Chronic Liver Failure and Death. The model includes information about the probability of going from one state to another, as well as the costs and quality of life in patients in each state. Knowing that a patient is high risk and/or a good candidate to respond to certain treatments, it is possible to avoid or delay progression to more severe states. These models will be used to calculate costs and benefits of the different interventions compared to the standard treatment when the data for the effectiveness of the tests becomes available at a later stage in the project.
D8.6 Implementation of an economic evaluation model in a software package (PDF / 448 MB)
This deliverable describes the implementation of an app that implements an economic evaluation – calculations of costs and benefits – of a diagnostic test for response to Albumin treatment for patients with liver cirrhosis and shows how to use the model and the software to conduct an economic evaluation.
D8.7 Checklist for participants to assure informed consent / other mechanisms for those unable to give a written consent (PDF / 320 KB)
The document includes a proposal of checklist for participants and for researchers in biomedical research focused on participant information and the consent process to ensure that the project complies with the ethical and legal standards applicable. It is designed to assure the free, informed and voluntary consent of participants including those unable to consent and who need a legal representative.