Doctoral Schools

Research Integrity: Position yourself for success!

Research Integrity Event organized by Ghent University, Ghent University Hospital and Janssen Pharmaceutica

Cluster

Research & Valorization

Target Group

Doctoral and postdoctoral researchers, professors, scientific staff and technical staff involved in life sciences research.

  • Voor artsen: accreditering bij RIZIV is aangevraagd.

Programme

  • 8:45        Registration

Abstract: Participants will gain a basic understanding of approaches to combining data from different experiments to identify the prevalence and impact of reporting of risks of bias in animal studies; discuss heterogeneity of findings in the context of the so called replication crisis; and hear of future applications of these tools in the context or research improvement activities.

Abstract: Responsible Conduct of Research seems an obvious feature of science but is it so in practice? What are the main features of RCR in Life Sciences and how do we deal with these at Ghent University? This presentation offers the broad perspective from policy over initiatives to specific guidance.

Abstract: Every researcher, including those involved in clinical research, should adhere to the general principles of scientific integrity as outlined in the document ‘Code of Ethics for Scientific Research in Belgium’, published by Belspo and the Academies of Medicine and Science in 2009. Moreover specific regulations are in place for health care workers and their interaction with pharmaceutical and medical devices companies: these are outlined in a code of conduct by MDEON (https://www.mdeon.be/en/), and the recently published Belgian law on transparency (sunshine act).
On a European level, the Alliance for Biomedical Research in Europe, a consortium of 27 leading European Medical Societies representing more than 400.000 researchers and health professionals, have published a code of conduct for specific activities, including organisation of congresses, publications and clinical practice guidelines, continuous medical educations and continuous professional development (https://www.biomedeurope.org/code-of-conduct.html).     

Abstract: Pharmaceutical industry depends on robust data and scientific rigor as key drivers for decision making, patent strength and time-to-market, which in turn will determine knowledge gain and availability of new treatments to patients. To optimize sourcing of projects with the best possible expertise and maximize the potential of innovative approaches, pharmaceutical industry moved to a business model of increased external collaborations over the last couple of years. While this embraces open innovation and strengthens preclinical drug discovery programs with expert input from academia, it also increases risks related to decentralized outsourcing of activities. Risk mitigation starts with awareness of key risk factors and knowledge of helpful solutions. Here I will discuss some useful quality principles for academic groups, not only if they want to be an attractive partner for pharmaceutical industry, but also if they wish to ensure generation of robust and reliable data in general.

Abstract: The integrity of scientific data generated either internally or resulting from external collaborations is pivotal for drug development. Substantial evidence has accumulated that robustness, rigor and validity of research data can be problematic, which may impact on conclusions made regarding predictability of preclinical models and/or quality of drug targets for evaluation in clinical proof-of-concept studies. Higher failure rates due to non-reliable scientific data increase the risks and costs associated with Research and Development (R&D) and may hamper the successful translation of innovation to novel treatments for patients.  This presentation will share how Janssen deals with these challenges through the DDI (Discovery Data Integrity) program.  Given the importance of external collaborations to our pipeline we will briefly talk about the steps we are taking to try and ensure quality at all levels both internally and externally.

 

  • 12:30-13:30    Lunch

 

  • 13:45-16:15    Workshops

(1)    Creating a data management plan (or how to get started with RDM)
This is an introductory workshop for researchers without much prior knowledge of RDM basics or data management planning
Trainers: Dr. Myriam Mertens, Ghent University, & Dr. Nele Pauwels, Ghent University (Hospital)
Abstract: Scientific research, including in the life sciences, is increasingly data-driven. With increasing data volumes and complexity, research data management (RDM) becomes an essential part of good research practice. Research data not only constitute the evidence on which scientific claims are based, but often also have great value beyond the original study for which they are collected. RDM encompasses all activities to ensure that research data are reliable, secure, sustainable and reusable, and starts with good planning. This workshop will introduce participants to some key RDM topics and the basics of data management planning. It will include some activities, and participants will have a chance to create a data management plan (DMP) for their research project using an online tool.
Practicalities: participants should bring a laptop or other device with acces to the eduroam network and a web browser

(2)    Race to Market: Building an Efficient Discovery Engine
Trainer: Dr. Anja Gilis, Janssen
Abstract: Are you confident in the quality of your data? Every day, hundreds of scientists are generating, analyzing and managing data that form the basis to discover and develop new drugs that patients are waiting for. Laboratory data are the building blocks of the scientific work and data quality is critical to crucial business decisions and long term success. Janssen invites you to an in-depth look into potential quality risks and inefficiencies in research and explore measures to improve processes in drug discovery. Real life examples will be used to stimulate interactive discussions on challenges and potential solutions. Big Pharma, Biotech startup or University lab: your reputation, intellectual property protection and decision making all depend on high quality data.  


(3)    Hands-on Electronic Data Capture
Trainer: Mr. Joachim Geeraert, Ghent University Hospital
Abstract: An electronic data capture (EDC) is a computerized system designed for the collection of clinical data in electronic format to streamline data collection. The EDC assists in the design, development and quality assurance of Case Report Forms and surveys to collect data that meets the highest standards.
During the workshop it is shown how a current web-based EDC solution allows to setup the datamanagement of a clinical experiment/clinical trial.
In addition, we will explore how an EDC system can help improve the quality and integrity of your data collection through best practices for data management, user roles, an audit trail, validated fields, a data resolution workflow, the use of ontologies and the application of data quality rules.
Practicalities: participants should bring their own laptop with access to the eduroam network in order to use the online EDC system for the workshop; participants should also bring a charger and power outlet if required

(4)    Playing the cards right – ethics and integrity in research
Trainer: Ms. Stefanie Van der Burght, Ghent University
Abstract: Researchers come across all kinds of questions and dilemma’s while doing research, not the least related to ethics and integrity. It’s not the ‘not knowing’, it’s the ‘not knowing where to look or go’ that causes most problems.
This workshop helps you recognize these situations, using real-life examples in Life Sciences and gives you hands-on advice about tools and tricks to deal with them. With dilemma’s, cards and lively discussions, we deal with issues such as:
• “How do you feel granting co-authorship with a limited contribution”
• “Would you perform peer-review of a scientific paper from a researcher who is also a close friend?”
• “Would you tell if you found a mistake in one of your published papers?”
• “How do you feel about submitting your grant proposal knowing upfront that it promises more than you will be able to deliver?”
• “Would you rewrite your research questions if a sponsor of your research asks you to?”
And many more…
Are you ready to play the game?
Disclaimer: This workshop shows great overlap with the integrity workshop given at the DS Introduction Day and the DS Transferable skills training ‘Fostering Responsible Conduct of Research’. In case you already attended one of these courses, best pick another session.

(5)    Good Ethics Practice
Trainers: Prof.em. dr. R. Rubens, Dhr. Christophe Demeestere and Mevr. Muriel Fouquet
Abstract: Just like GLP (Good Laboratory Practice) and GCP (Good Clinical Practice) a good Ethics Practice is necessary when a project is submitted. Based upon experience gathered in the Ethics Committee of UGent/UZGent we will inform the participants considering the practicalities of a good Ethics submission. We will inform the participants concerning the documents and ICF necessity.

Venue

Het Pand, Onderbergen 1, 9000 Gent

How to get there?  https://www.ugent.be/het-pand/en/contact

Registration

Please follow this link: https://webappsx.ugent.be/eventManager/events/integrityforsuccess

Language

English

Evaluation methods and criteria (doctoral training programme)

PhD researchers who attend the entire day, can include this as a transferable skills seminar (cluster Research and Valorization) in their curriculum

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