Infonetica Research Ethics Open Day Research ethics and

Infonetica Research Ethics Open Day Research ethics and its implications for assessing research quality Dr Birgit Whtiman, Head of Research Governance University of Bristol, UK

Plan for this session • Global research ethics and integrity developments • Requirements of the ‘Concordat to support research integrity’ in the UK and its implications for assessing research quality • Introduction to the approach taken by the University of Bristol in relation to the implementation of the Concordat

Research integrity global context • Singapore statement: 340 individual, 51 countries http: //www. singaporestatement. org/statement. html • European Code of Conduct for Research Integrity http: //www. esf. org/fileadmin/Public_documents/Publications/Code_Conduct_Research. Integrity. pd • Montreal Statement on Research Integrity http: //www. researchintegrity. org/Statements/Montreal%20 Statement%20 English. pdf • Rio de Janeiro June 2015

Singapore Statement Research institutions should create and sustain environments that • encourage integrity through education • clear policies • reasonable standards for advancement while fostering work environments that support research integrity

Singapore Statement • • • Integrity / trustworthiness Adherence to regulations Appropriate research methods Accurate records Share data and findings openly Authorship / Acknowledgement Peer review Conflict of interest Reporting / Responding to irresponsible practice

European Code of Conduct Principles of integrity in scientific & scholarly research: • honesty in communication; • reliability in performing research; • objectivity; impartiality and independence; • openness and accessibility; • duty of care; • fairness in providing references, giving credit; • responsibility for the scientists and researchers of the future.

Montreal Statement • “collaborations present special challenges”: • substantial differences in regulatory and legal systems • organisational and funding structures • research cultures • approaches to training

Concordat to support research integrity 1. Maintaining the highest standards of rigour / integrity 2. Ensuring research conducted according to appropriate ethical, legal and professional frameworks 3. Supporting a research environment underpinned by a culture of integrity, based on good governance 4. Using transparent, robust and fair processes in relation to allegations of research misconduct 5. Working together to strengthen integrity of research by regular and open review http: //www. universitiesuk. ac. uk/highereducation/Documents/2012/The. Concordat. To. Support. Research. Integrity. pdf

Concordat expectations • Applies to all fields of research • Complements existing frameworks • Commitment to the principles set out in the concordat should demonstrate to government, business, international partners and the wider public that they can continue to have confidence in the [quality] of the research

Research is conducted according to appropriate ethical, legal and professional frameworks, obligations and standards • Research is subject to appropriate consideration of ethical issues • Research must comply with ethical, legal and professional frameworks, obligations and standards • Clear policies on ethical approval must be available to all researchers • Access to advice, guidance and training • Streamlining of requirements for review

Positive culture of research integrity • Commitment to supporting a research environment that is underpinned by a culture of integrity • based on good governance, best practice and support for the development of researchers.

Transparent, robust and fair processes to deal with allegations of research misconduct • Research that falls short of the standards of ethics, research and scholarship required to ensure integrity of research: • Fabrication • Falsification • Plagiarism • Failure to meet ethical, legal and professional obligations: • Improper dealing with allegations of misconduct

Working together to strengthen the integrity of research and to reviewing progress regularly and openly. • Committed to the ongoing development of a culture that supports and nurtures research integrity • Mechanisms that provide assurances and ensure appropriate investigation and action in the case of suspected misconduct. • Annual statement to governing body

University of Bristol • 25 academic schools are arranged into six faculties • Number of staff: 5, 700 • No of undergraduate students: 13, 500 • No of postgraduate students: 5, 500

Implementing the Concordat • Uo. B has undertaken a comprehensive review and mapping exercise to take stock • An action plan has been developed • A Task and Finish Group was set-up with input from Faculty Management, HR, Staff Development, Doctoral Training Centre, Finance, H+S

Building on the existing QA framework Phase 1 Support, set-up and conduct for high risk studies falling under: UK Clinical Trial Regulation EU device regulations NHS Research Governance framework 2 Ensuring compliance with the HT Act 3 Support the University’s ethics infrastructure

Implementing the Concordat • Mapping exercise to gather evidence for compliance • Self-assessment against the UKRIO tool • Self-assessment against the Af. RE Policies and Procedures QA tool

Key elements of the QA framework • Senior Management support • Dedicated Research Governance Team • Web-based supported ethics infrastructure Risk management processes • Policies and Guidance • Training for staff and students • Annual audit and monitoring programme • Benchmarking

University of Bristol Ethics Structure University Council University Senate University Ethics of Research Committee Arts Engineering Med Vet Med Dent Science Social Science & Law

Auditable system • Online ethics tool • Support from a dedicated Research Ethics Co-ordinator

Self-assessment: Ethics standards 1=not met, 2= partially met, 3=almost met, 4=fully met / exceeded UKRIO / Af. RE 1: Principles of Research Ethics 1. Autonomy 2. Beneficence 3. Non-malfeasance 4. Confidentiality 5. Integrity Evidence Action

Self-assessment: Ethics standards 1=not met, 2= partially met, 3=almost met, 4=fully met / exceeded UKRIO / Af. RE 2: Principles of governance arrangements Independence a. Do reviewing committees include members from a wide range of disciplines? b. Do committees have members from outside the Faculty or academic unit covered by the committee? c. Do the constitutions of RECs grant freedom to make ethical judgments, while being consistent with accountability? d. Do committees include ‘lay’ or external members e. (if faculty/ departmental committees in place) Is there an over-arching strategic committee that functions as the appeals committee f. Are arrangements for appeal in place? Evidence Action

Self-assessment: Ethics standards 1=not met, 2= partially met, 3=almost met, 4=fully met / exceeded UKRIO / Af. RE Evidence 2: Principles of governance arrangements Competence a. Does the UREC have a clear process in place to ensure that ethical opinions are reached timely and consistently? b. Does the UREC have a standard form that asks all the questions that a competent REC in that Faculty of Academic Unit needs to have answers for? c. Does the university demonstrate that it has a commitment to competent ethical review by recognising UREC members for their contribution to the University by citizenship recognition or allocated hours in the working week? ONLINE ETHICS TOOL Action

Self-assessment: Ethics standards 1=not met, 2= partially met, 3=almost met, 4=fully met / exceeded UKRIO / Af. RE Domain 2: Principles of governance arrangements Facilitation: The Ethics review infrastructure must be clear a. How is the independence and integrity of committee decisions maintained? b. What is the mechanism for appeal? c. What procedure deals with complaints that an applicant had been treated unfairly or discourteously. d. How are RECs linked to the Research Governance structures? e. How is compliance with ethical requirements monitored? How is non-compliance addressed? f. Job descriptions or TOR for Research Ethics Evidence Action

Self-assessment: Ethics standards 1=not met, 2= partially met, 3=almost met, 4=fully met / exceeded UKRIO / Af. RE 2: Principles of governance arrangements Openness, Transparency and Accountability a. How are the ethics policies and processes of review made available to the public? b. How is individual intellectual property safeguarded? c. Is the policy and process regularly reviewed? d. How is confidentiality about any disputes or appeals maintained? Evidence Action

Self-assessment: Ethics standards 1=not met, 2= partially met, 3=almost met, 4=fully met / exceeded UKRIO / Af. RE 3: Policies, Procedures and Guidelines / SOPs Policy Does the institution have a robust ethics policy Standard Operating Procedure The institution has a framework to meet compliance obligations. The SOP or guidance framework should cover the following: a. The role of a Research Ethics Committee b. The constitution of a Research Ethics Committee c. Applications d. Fast tracking Ethical Review e. Devolved Review Evidence Action

Self-assessment: Ethics standards 1=not met, 2= partially met, 3=almost met, 4=fully met / exceeded UKRIO / Af. RE 4: Training and development Training provision What arrangements are in place for a. Training of ethics committee members b. Training of other academic staff in the institution Evidence Action

Policies and Guidance • Student and Staff Handbooks • The Data Protection Act Guidance • Staff induction • Anti-Corruption and Bribery Policy • Policies & procedures that • Conflict of Interest Regulations govern good research & • Code of Practice HT Act guide the investigation and • Policy on working with animals reporting of potential misconduct. Part of the T+C • Research Degree Programmes Code of Practice of employment: • Postgraduate Research (PGR) Students Regulations and Code of v Research Governance and Integrity Policy Practice for Research Degrees v Ethics of Research Policy and Procedure v Regulations on Research Misconduct • PGR Tool Kit under development v Policy on Public Interest Disclosure • STa. R online tool to ensure PGR training needs are recorded / met. • Planned Supervisor and Ho. S training

Regular training • Staff Development Courses • DTC course elements • Access to Af. RE and NIHR Good Clinical Practice (GCP) training • MRC e-learning • Ethics Seminars • School, research team, MSc, Ph. D specific training.

Mandatory Training • Mandatory Data protection e-learning • Mandatory Health & Safety training • Mandatory Diversity in the Workplace training • Up to 5 compulsorily training modules have to be completed before a researcher is able to obtain a Home Office licence.

Audit and monitoring • Monitoring programme for 10% of active studies via a Service Level Agreement • Annual reporting round for University Research Ethics Committees • Annual internal audits • Inspections by regulatory bodies

Development of a QA framework Phase 4 Integrated approach to enhance a positive culture of research integrity by harnessing and harmonising the University’s research integrity infrastructure driven by the Task & Finish Group + In collaboration with the Russell Group WG and other stakeholders

Plan • Global research ethics and integrity developments • Requirements of the ‘Concordat to support research integrity’ in the UK’ and its implications for assessing research quality • Introduction to the approach taken by the University of Bristol in relation to the implementation of the Concordat

Summary • Uo. B is committed to high standards of research integrity, made visible to the public in line with the requirements of the Concordat. • An integrated approach between key areas, with input from multi-professional teams, is essential for creating a positive culture of research integrity (for students & staff) internally & externally. • Awareness of evidence base and cultural / ethical environment • Global interest in the approach the UK has taken, to establish if this will enhance research integrity

Thank you Birgit. Whitman@bristol. ac. uk