Quality and Research Integrity. The experience at the University of - PowerPoint PPT Presentation

Quality and Research Integrity. The experience at the University of Barcelona Dr . Carmen Navarro Quality Research Service Agency for Quality Assurance University of Barcelona 1

Schedule • Is it time to be concerned about scientific reliability? • Lessons learned from quality assurance • Our experience at the University of Barcelona • Quality in research: simply “good science?” • Closing remarks 2

Is it time to be concerned about Scientific reliability? 3

Accurate Reproducible Scientific results Traceable 4

“The idea that the same experiments always get the same results, no matter who performs them, is one of the cornerstones of science’s claim to objective truth. If a systematic campaign of replication does not lead to the same results, then either the original research is flawed (as the replicators claim) or the replications are (as many of the original researchers on priming contend). Either way, something is awry”. Trouble at the lab. Unreliable research. The Economist, Oct. 19th 2013 5

Raise standards for preclinical cancer research NATURE; 29 March 2012; v 483; 581. C. Glenn Begley and Lee M. Ellis . “The scientific community assumes that the claims in a preclinical study can be taken at face value — that although there might be some errors in detail, the main message of the paper can be relied on and the data will, for the most part, stand the test of time. Unfortunately, this is not always the case. Although the issue of irreproducible data has been discussed between scientists for decades, it has recently received greater attention (as the costs of drug development have increased along with the number of late-stage clinical-trial failures and the demand for more effective therapies”. 6

Amgen in Thousand • Oaks, California, tried to confirm published findings. Fifty-three papers were deemed 'landmark' studies Scientific findings were confirmed in only 6 (11%) cases. Even knowing the limitations of preclinical research, this was a shocking result. Kindly given by Dr. Rebecca Davies Raise standards for preclinical • cancer research NATURE; 29 March 2012; v 483; 581. C. Glenn Begley and Lee M. Ellis 7

C Zimmer, New York Times, April 16, 2012 *Source: Journal of Medical Ethics Number of retractions from scientific journals, 2000-2009* Slide provided by J Bolling, SQA, April 2013 3 Kindly given by Dr . Rebecca Davies 8

• PhD students are the future scientists • We have work to do! 9

Lessons Learned from Quality Assurance 10

Quality Assurance Systems • Essential when the risk of being wrong could be fatal for human safety. • Generally associated with translational science and technology transfer. • Much higher incidence in sectors subjected to regulation. 11

Reliability Integrity Quality Excellence in Traceability Assurance Research Systems 12

Our experience at the University of Barcelona 13

The University of Barcelona (UB) – UB is the biggest public institution of higher education in Catalonia and one of the biggest in Spain. – It occupies a competitive position at national, European and worldwide levels in the most important ranking tables designed on a range of variables within different geographical areas. 14

The UB in the city of Barcelona Diagonal Campus Gateway to Knowledge Mundet Campus Bellvitge Health Medicine Campus – Clinic Sciences Campus Hospital Humanities Campus 15 15

Some general figures 24 Faculties 63,000 and University students schools 5,500 teaching and research staff 74 bachelor’s 144 master’s 2,200 administrative 48 doctoral programs and services staff 16

UB in Research and Technology Transfer 301 752 Doctoral research theses groups submitted 24 research institutes and centers 892 active research projects 5180 scientific publications Figures corresponding to 2016 17

Agency for Quality Assurance In 2007 the UB created the Agency for • Quality Assurance. Its main objective is to give support to • government bodies, centers, institutes, departments, administrative units and other university entities in all the processes of planning, evaluation and quality improvement at the University. 18

Rectorate Steering Committee Agency Director Organization Quality Quality And Research Academic Quality Service Service Service 19

The present mission of QRS To provide support in all the processes of implementation, formal acknowledgement and maintenance of quality systems implemented in research groups and structures to support research at UB. 20

Our certifications/accreditations ISO 9001 Certification • » Scientific and Technological Centers (CCiTUB) » Center of Research in Metabolism (CEREMET) » Service of Development of Medicines (SDM) » Center of Production and Validation of Advanced Therapies (CREATIO) ISO 17025 Accreditation • Environmental Radiology Laboratory (LRA) GLP Certification • » Enteric Viruses Group (GVE) » Unit of Experimental Toxicology and Ecotoxicology (UTOX) 21

• The implementation of quality systems in research groups has given an added value to their results. But… • How can we extend these benefits to all kind of research? 22

Quality in research: simply “good science”? 23

QUALITY TIME IT MAY NOT BE SEXY, BUT QUALITY ASSURANCE IS BECOMING A CRUCIAL PART OF LAB LIFE. Nature article.pdf 456 | NATURE | VOL 529 | 28 JANUARY 2016 24

Kindly given by Dr. Rebecca Davies Document Control Continuous SOPs Equipment Improvement Forms and Calibration Learning from Records Preventive mistakes; Maintenance Adjusting protocols Repair Sound Research Method Science Control of Validation error QC CAPA, RCA Personnel Control of data Training Integrity Consistency Security Competency Traceability 25

Code of Good Research Practices http://diposit.ub.edu/dspace/bitstream/2445/28544/1/codibonespractiques_eng.pdf 26 26

Objectives and scope The Code of good research practices establishes guidelines on how to carry out research activities. Its objectives are to: • improve the quality of research in all fields; • set up mechanisms for ensuring honesty, responsibility and rigour in research; • ensure that researchers-in-training acquire good scientific practices. This document is applicable to all the members of the UB Group who carry out research activities of any kind. 27

Competence Planning and and Leadership follow up of supervision of and projects: researchers in organization protocols for Honesty, training of research responsability, research teams rigour and conflicts of Procedures interest and methods Code of Good Practices in Research with Facilities and experimental equipment Research research animals Obtaining, register, Diffusion of Security, Research storage, results, health and with human custody and authorship conservation of environment beings intellectual materials and property results 28

• The created document, that was initially designed for assuring the quality of the results of research, finally included also some guidelines about integrity in research 29 29

Quality and integrity… Two sides of the same coin? Quality Integrity 30 30

Closing remarks 31

To think about… Do PhD students need to be taught about quality • assurance? Can be a Code for Good Research Practice a good • tool for enhancing awareness of researchers towards quality? 32

Facing the future Introducing quality assurance aspects in Doctoral • education. Defining the main elements of quality systems • that contribute to produce “good science” Providing tools easy to use • Quality is a tool, not an objective in itself • “Concentrate on science, not on compliance” 33

We have the responsibility for training a new generation of scientists committed to reliability, integrity and traceability in science , and so improving the trust in science that society deserves. 34

Thank you! Quality Research Service University of Barcelona Edifici Florensa, c/Adolf Florensa 8, 08028 Barcelona, Spain cnavarroaragay@ub.edu Mireia Garcia Santiago Mata Carme Navarro Oriol Bernad Rosa Vilanova Miquel de los Cobos Albert Pérez http://www.ub.edu/agenciaqualitat/recerca/en/functions.html 35