Improving the trustworthiness, usefulness, and ethics of biomedical research through an innovative and comprehensive institutional initiative

The reproducibility crisis triggered worldwide initiatives to improve rigor, reproducibility, and transparency in biomedical research. There are many examples of scientists, journals, and funding agencies adopting responsible research practices. The QUEST (Quality-Ethics-Open Science-Translation) Center offers a unique opportunity to examine the role of institutions. The Berlin Institute of Health founded QUEST to increase the likelihood that research conducted at this large academic medical center would be trustworthy, useful for scientists and society, and ethical. QUEST researchers perform “science of science” studies to understand problems with standard practices and develop targeted solutions. The staff work with institutional leadership and local scientists to incentivize and support responsible practices in research, funding, and hiring. Some activities described in this paper focus on the institution, whereas others may benefit the national and international scientific community. The experiences, approaches, and recommendations of the QUEST Center will be informative for faculty leadership, administrators, and researchers interested in improving scientific practice.


To Have Practical Relevance, Scientific Claims Need to be Accurate

For all different stakeholders within the scientific community (researchers, reviewers, editors, policymakers, funding agencies, journalists, and the general public) it is important that scientific claims are as accurate as possible. However, there is increasing evidence questioning the robustness and accuracy of social and biomedical research outcomes. In this article, Rolf Zwaan and Anita Eerland have identified several prevalent threats to research accuracy. The authors discuss ways in which these threats can be removed or minimized. In addition, the authors suggest how different stakeholders can contribute to make science more accurate and thus more practically relevant.

PREPARE (Planning Research and Experimental Procedures on Animals: Recommendations for Excellence) Guidelines

As part of ongoing efforts to reduce waste and increase the reproducibility of animal research and testing, a group of experts led by the Secretary of Norecopa has produced a set of guidelines for planning animal experiments:
The PREPARE guidelines for planning animal experiments complement the ARRIVE guidelines and other guidance for reporting experiments. PREPARE focuses on a large number of factors which, although they are seldom reported in scientific papers, can dramatically influence the validity and outcome of studies on animals, as well as the health and safety of all those concerned. They cover stages of quality assurance, from the management of an animal facility to the individual procedures which form part of a research study.


PREPARE: guidelines for planning animal research and testing

The PREPARE (Planning Research and Experimental Procedures on Animals: Recommendations for Excellence) guidelines were published in 2017 to provide overarching guidance on how to plan animal experiments. This comprehensive set consists of 15 topics to cover literally all aspects of animal research. A detailed checklist is incredibly helpful and provides good guidance when planning animal experiments and working in animal facilities. Like this, they complement the ARRIVE guidelines and are considering broader aspects of this important part of research.

The PREPARE guidelines cover 15 topics, grouped in three main sections:

Formulation of the study
1. Literature searches
2. Legal issues
3. Ethical issues, harm-benefit assessment and humane endpoints
4. Experimental design and statistical analysis

Dialogue between scientists and the animal facility
5. Objectives and timescale, funding and division of labour
6. Facility evaluation
7. Education and training
8. Health risks, waste disposal and decontamination

Quality control of the components in the study
9. Test substances and procedures
10. Experimental animals
11. Quarantine and health monitoring
12. Housing and husbandry
13. Experimental procedures
14. Humane killing, release, reuse or rehoming
15. Necropsy

Ioannidis and Khoury, 2014 JAMA

In this viewpoint the assessing value in biomedical research is discussed based on research that is Productive, High-quality, Reproducible, Shareable and Translatable (PQRST). LINK

Guidelines by the European Science Foundation (ESF)

Intended to provide an europe-wide reference, this code addresses  the proper conduct and principled practice of systematic research in the medical, natural and social sciences and the humanities. It was established in 2010 by 31 research funding and performing organisations from 22 countries, together with All European Academies (ALLEA).

First document of a series released by different working groups as  a  basis for further  discussions. The ESF presents here the basic ideas for the need to capture information about the progress, productivity and quality of research and whether these systems are already in place or need to be established.

This document describes the complex field of assessing the impact of research. Pros and cons of different methodologies are discussed focusing on impact assessment in relation to public research funding.

The work of this group is the extension of a previous working group on this topic and completed the previous guidelines in respect to research output. e.g. publication, intellectual property, commercialisation…