Quality management and ethics in biomedical research

Translation of biomedical results requires highest possible quality standards in the conduction of research in order to ensure reproducible outcomes. To address and promote quality assurance in research NEURON sets out to inform and support the research community (academic and research institutions, researchers, multipliers) in the implementation of future pre-clinical and clinical research that is credible, contributory, communicable, and conforming.

NEURON is fully committed to the highest possible standards of quality assurance, including working to nationally and internationally recognized best practices:

In January 2019, European Brain Research Area project (EBRA) and NEURON organized a pilot workshop on “Quality assurance in Biomedical Research”.

In January 2021, a second workshop on ‘Neuroethics and quality assurance’ (link to Youtube video) welcomed Prof. Ulrich Dirnagl (Charité, QUEST, Berlin, Germany) and his talk: Your bench is closer to the patient bed than you think!; Prof. Daniel Strech (Charité, QUEST, Berlin, Germany) and his talk: How to safeguard the value of animal research.

© Dr. Bernd Roschitzki, University Zurich, Switzerland

Suggested reading:

Nuzzo, R. (2014). Scientific method: Statistical errors. Nature News 506, 150.
Ioannidis, J.P.A. (2005). Why Most Published Research Findings Are False. PLOS Medicine 2,
e124.

Landis, S.C., Amara, S.G., Asadullah, K., Austin, C.P., Blumenstein, R., Bradley, E.W., Crystal,
R.G., Darnell, R.B., Ferrante, R.J., Fillit, H., et al. (2012). A call for transparent reporting to
optimize the predictive value of preclinical research. Nature 490, 187–191.

Munafò, M.R., Nosek, B.A., Bishop, D.V.M., Button, K.S., Chambers, C.D., Percie du Sert, N.,
Simonsohn, U., Wagenmakers, E.-J., Ware, J.J., and Ioannidis, J.P.A. (2017). A manifesto for
reproducible science. Nature Human Behaviour 1, 0021.

Ethics

NEURON takes a specific responsibility on ethics in preclinical and clinical research and seeks to strengthen research integrity through the funding of only those projects that fulfil the legal and ethical international/EU (including ethical standards and guidelines in Horizon 2020) as well as national and institutional standards.
All proposed activities including those undertaken in countries outside the EU must comply with EU regulations (see Annex I of the fullproposal template).

In addition, ethical approval and/or a positive vote must be obtained from the relevant national or local ethics committee(s) prior to the start of respective studies. The obtainment of ethical clearance will be queried within the annual reports. All procedures involving human beings should conform to the Helsinki Declaration.

Ethics committees constitute a classical example of institutionalized reflection. These committees review the ethical aspects and implications of R&I plans and projects.

NEURON’s implementation of standards in the design of animal research and full implementation of the 3Rs reflects contemporary good practice for all research using animals, and reinforces that these standards are important for ethical reasons and to obtain the best possible scientific results. Research integrity and moral deliberation on scientific processes and outcomes are key requirements for both individuals and institutions. Defining a project should include considering the R&I’s possible intended and unintended impacts on society, the environment, and human and animal life.

Some tools that can be used are the following:

Tools

For the ethical self-assessment of a project or project proposal the EU guidelines can be downloaded here


The European Code of Conduct for Research Integrity offers a set of principles and priorities for self‐regulation of the research community.


Some examples of resources available for reflecting on existing ethical norms and anticipating impacts (including risk assessments) include using techno-moral vignettes, technology assessment methods, or future scenarios and foresight.


The POint of REgistration (PORE) is a HBP’s mechanism to register and identify these issues and keep track of how they are dealt with. Each registered issue is received by the Ethics Rapporteur Programme lead and reviewed by the Ethics Coordination team. The team decides how best to deal with the issue.


Capacity-enhancing exercises through workshops and other activities designed to facilitate the researcher awareness by facilitating the reflection beyond the minimum requirements of legal and ethical compliance. Some examples of Researcher Awareness work could be found here.

Ethical, Legal, and Social Aspects (ELSA) of Neuroscience

In order to investigate the ethical, philosophical, legal and socio-cultural aspects related to neuroscientific research that helps us to ensure that neuroscientific methods and findings are utilized in ways which are of the best possible benefit for our society ERA-NET NEURON launched in 2015 the Neuroethics Call for Proposals for “European Research Projects on Ethical, Legal, and Social Aspects (ELSA) of Neuroscience”. New editions of this calls were launched in 2017 and in 2020.