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

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

Jan 27, 2024 147 likes •504 views

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

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Quality and Research Integrity. The experience at the University

  • f Barcelona

Dr . Carmen Navarro Quality Research Service Agency for Quality Assurance University of Barcelona

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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
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Is it time to be concerned about Scientific reliability?

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Scientific results

Accurate Reproducible Traceable

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“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

  • bjective truth. If a systematic campaign
  • f 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

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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

  • f

irreproducible data has been discussed between scientists for decades, it has recently received greater attention (as the costs

  • f

drug development have increased along with the number of late-stage clinical-trial failures and the demand for more effective therapies”.

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  • Amgen in Thousand

Oaks, California, tried to confirm published findings. Fifty-three papers were deemed 'landmark' studies Scientific findings were confirmed in

  • nly 6 (11%) cases.

Even knowing the limitations of preclinical research, this was a shocking result.

  • Raise standards for preclinical

cancer research NATURE; 29 March 2012; v 483; 581.

  • C. Glenn Begley and Lee M.

Ellis Kindly given by Dr. Rebecca Davies

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C Zimmer, New York Times, April 16, 2012

*Source: Journal of Medical Ethics

Number of retractions from scientific journals, 2000-2009* 3

Slide provided by J Bolling, SQA, April 2013 Kindly given by Dr . Rebecca Davies

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  • PhD students are the future

scientists

  • We have work to do!
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Lessons Learned from Quality Assurance

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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.

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Excellence in Research Quality Assurance Systems Reliability Integrity Traceability

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Our experience at the University of Barcelona

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The University of Barcelona (UB)

– UB is the biggest public institution

  • f higher education in Catalonia and
  • ne 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

  • f variables within different

geographical areas.

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The UB in the city of Barcelona

Mundet Campus Humanities Campus Diagonal Campus Gateway to Knowledge Bellvitge Health Sciences Campus Medicine Campus – Clinic Hospital

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Some general figures

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

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UB in Research and Technology Transfer

Figures corresponding to 2016

752 Doctoral theses submitted 892 active research projects 301 research groups 24 research institutes and centers 5180 scientific publications

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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

  • ther university entities in all the

processes of planning, evaluation and quality improvement at the University.

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

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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.

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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)

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  • 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?

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Quality in research: simply “good science”?

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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

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Document Control

SOPs Forms and Records Equipment

Calibration Preventive Maintenance Repair

Research Method Validation QC Personnel Training Consistency Competency Control of data Integrity Security Traceability

Control of error

CAPA, RCA Continuous Improvement

Learning from mistakes; Adjusting protocols

Sound Science

Kindly given by Dr. Rebecca Davies

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Code of Good Research Practices

http://diposit.ub.edu/dspace/bitstream/2445/28544/1/codibonespractiques_eng.pdf

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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.

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Code of Good Practices in Research

Honesty, responsability, rigour and conflicts of interest Leadership and

  • rganization
  • f research

teams Planning and follow up of projects: protocols for research Competence and supervision of researchers in training Procedures and methods Facilities and equipment Obtaining, register, storage, custody and conservation of materials and results Diffusion of results, authorship intellectual property Security, health and environment Research with human beings Research with experimental research animals

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  • 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

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Quality and integrity… Two sides of the same coin?

Integrity Quality

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Closing remarks

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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?

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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”

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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.

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Quality Research Service University of Barcelona

Edifici Florensa, c/Adolf Florensa 8, 08028 Barcelona, Spain cnavarroaragay@ub.edu

Thank you!

http://www.ub.edu/agenciaqualitat/recerca/en/functions.html Mireia Garcia Santiago Mata Carme Navarro Oriol Bernad Rosa Vilanova Miquel de los Cobos Albert Pérez