Operations Director, CTRU

Slides:



Advertisements
Similar presentations
NIGB Legal requirements for use of personal data in research OnCore UK / NRES Training workshop Ethical Principles relating to consent for use of samples.
Advertisements

NATIONAL INFORMATION GOVERNANCE BOARD
Chapter 6 Negotiating access and research ethics
An Introduction to the Ethics Review Procedure Lindsay Unwin: Research & Innovation Services, UREC Secretary.
Research and the Data Protection and Freedom of Information Acts.
HOT TOPICS ARCHIVING OR HOW NOT TO DUMP YOUR RUBBISH!
Unit 4- Assignment 3 P5, P6, M2 BTEC Business Level 3.
Confidentiality & Records Management. What is Information Governance? What is Records Management?
Obtaining Informed Consent: 1. Elements Of Informed Consent 2. Essential Information For Prospective Participants 3. Obligation for investigators.
An Introduction to the Ethics Review Procedure for New Ethics Reviewers Lindsay Cooper, Research & Innovation Services 11 March 2010.
Research Ethics-Integrity-Governance. University Initiative:The Catalyst? ‘02 Good Research Practice Standards & Procedure to Investigate Potential Research.
Challenge Questions How good is our operational management?
Duncan Woodhouse – Assistant Registrar for Information Security, Risk Management and Business Continuity Helen Wollerton – Administrative Officer (Legal.
Data Protection Recruitment Process
Ethics in Business Research
DATA PROTECTION AND PATIENT CONFIDENTIALITY IN RESEARCH Nic Drew Data Protection Manager University Hospital of Wales   
CLINICAL RESEARCH AND THE NHS. Research and clinical governance Translational research using samples and data Qualitative research Multidisciplinary nature.
International Research & Research Involving Children K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development.
D-1 McGraw-Hill/Irwin ©2005 by the McGraw-Hill Companies, Inc. All rights reserved. Module D Internal, Governmental, and Fraud Audits “I predict that audit.
Introducing Research Ethics: Policy and Procedure
Guidelines for data preparation - ESRC Datasets Policy Louise Corti ESDS/UKDA Social Science Data Archives for Social Historians: creating, depositing.
Confidentiality and Security Issues in ART & MTCT Clinical Monitoring Systems Meade Morgan and Xen Santas Informatics Team Surveillance and Infrastructure.
ESRC Datasets Policy and Qualitative Data Preparation Gill Backhouse Senior Acquisitions and Liaison Officer Qualidata.
OCR Nationals Level 3 Unit 3.  To understand how the Data Protection Act 1998 relates to the data you will be collecting, storing and processing  To.
The Global Health Network Marijke Geldenhuys 19 September 2014 Adhering to the GCP Principles.. what does that even mean?
Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro NHS R&D Overview How to avoid the common pitfalls? Thomas Fairman Research Liaison Manager.
Privacy and Confidentiality. Definitions n Privacy - having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally,
FleetBoston Financial HIPAA Privacy Compliance Agnes Bundy Scanlan Managing Director and Chief Privacy Officer FleetBoston Financial.
Business Project Nicos Rodosthenous PhD 28/10/ /10/20141Dr Nicos Rodosthenous.
APEC Engineers Workshop Legal Considerations - Central Register Sept 2015 Angela Frawley, General Counsel.
Data Protection and research Rachael Maguire Records Manager.
VETERANS HEALTH ADMINISTRATION SLIDE 0 New Requirements for VA ORD Investigators: Implementation of Data Management and Access Plans.
APEC Privacy Framework “The lack of consumer trust and confidence in the privacy and security of online transactions and information networks is one element.
Responsible Transparency MCC’s Experience with Microdata Protection and Dissemination Authors: Stephanie Burch, Heather Hanson, Jack Molyneaux, Jennifer.
Data protection—training materials [Name and details of speaker]
AssessPlanDo Review QuestionYesNo? Do I know what I want to evaluate and why? Consider drivers and audience Do I already know the answer to my evaluation.
The research ethics review process Hazel Abbott, Chair University Research Ethics Committee.
Ethical, legal and social aspects of public health genomics Mark Taylor, School of Law, University of Sheffield 7 th November 2014.
Evaluation Planning Checklist (1 of 2) Planning Checklist Planning is a crucial part of the evaluation process. The following checklist (based on the original.
Ethics Training Niall O’Loughlin Policy & Information Officer, RES
Accountability & Structured Privacy Management
REFLECT: Recovery Following Intensive Care Treatment
Chapter 6 Negotiating access and research ethics
Frameworks for Sensitive Data in the Research Lifecycle
Chapter Four: Writing Strategies and Ethical Considerations
Chapter 6 Negotiating access and research ethics
Information Sharing for Integrated care A 5 Step Blueprint
Research and the Data Protection and Freedom of Information Acts
Within Trial Decisions: Unblinding and Termination
General Data Protection Regulation
General Data Protection Regulations Preparing for the upcoming changes in data protection law David Jones & Angharad Williams.
Information Security Seminar
Incentive Marketing Association And the GDPR
Research Ethics Matthew Billington
GENERAL DATA PROTECTION REGULATION (GDPR)
Refuah Community Health Collaborative (RCHC) PPS
Section 3: Sweep implementation
Chapter 6 Negotiating access and research ethics
Research Ethics and Integrity Officer
G.D.P.R General Data Protection Regulations
Patient information: Research study taking place today
Recording Clinical Data
How we use Your Health Records
In Argentina Ana Palmero Legal and Research Ethics Advisor
Recording Clinical Data
Recording Clinical Data
Chapter 6 Negotiating access and research ethics
Data Protection What can I do? GDPR Principles General Data Protection
General Data Protection Regulation (GDPR)
Contracting Considerations in Research & Innovation
Presentation transcript:

Operations Director, CTRU Practical steps to protect participant trust when releasing data from clinical trials Gillian Booth Operations Director, CTRU University of Leeds

A bit like a tightrope walk – balancing the risks and benefits As with most areas of clinical research this is about considering any risks, how likely they are to occur and their impact if they do occur and what mitigation can be put in place As early as possible (trial set up) think about future proofing use of data for further research e.g. consent, contractual terms clear for ownership and future use / exploitation of IP The following slides describe the CTRU approach

What is the Purpose? Is the evidence of scientific integrity satisfactory? Is there potential for the data to be misused? Where will the data be held and who will take legal responsibility? Through asking questions such as: The purpose of the research, what data is required and what it will be used for Who is requesting the data and where are they employed Where is the data being sent and where will it be stored? Evidence of scientific integrity: - Is this bone fide research and is the researcher a bone fide researcher? Data variables sufficient to allow the research project to achieve it’s goals Funding in place Ethical approval / peer review needed and if so, in place? Exacting the same standards to which we would be expected to work

Do you have Permission? What is the legal basis for the data release? What are the governance procedures? Are there any other restrictions?

Medical Confidentiality Comply with the Law Protection of Rights and Wellbeing of the Individual EU Clinical Trials Directive NHS Act 2006 Consent Data collected under a duty of medical confidentiality. You must be clear on the legal basis for the transfer (either appropriate consent to release the data for the purpose Or Section 251 approval) Consent is needed even where data is anonymized Best to consider this up front and include in the original consent form. Will require tracking throughout the lifetime of the trial (incase the consent position changes) and also after the trial (this is a key feature of the new DPR) Medical Confidentiality

Implement Governance Processes Will the data release affect the scientific integrity of the trial? During trial – requests are considered by the Independent Trial Steering Committee After trial – processes for approval differ across organisations e.g.: Independent Data Release Committee Independent Trial Committee (e.g. TSC) Chief Investigator, CTU and Sponsor Note - Some funders have specific requirements regarding the governance process for release of data for secondary research purposes e.g. MRC this needs to be considered for individual trials if the unit policy does not standardly comply

Other Restrictions Who owns the IP? Are there specific contractual considerations or restrictions? What is the ‘value’ of the dataset? (Research sensitivity and commercial sensitivity)

Protecting the Participant’s Identity Is the data identifiable? Will the data be combined with other datasets and how does this affect the chance of re-identification? Where is the data being sent? What are the security arrangements? In the UK the 1998 DPA applies – there are different legal considerations across the world. Essentially the risk is ‘identification of a individual participant’ – all measures should be put in place to minimise the risk to an acceptable level. In the UK where data is identifiable it is covered by the DPA1998. This places specific restrictions on use of the data including where it can be sent i.e. abroad. Where is it being sent – if outside of EEA must be anonymized unless certain protections in place through contracts Who (organization) will take legal responsibility for the data once transferred including security Security Who (organization) will take legal responsibility for the data once transferred including security. Examples include: Only contract with legal entity Contractual restrictions not to try reidentify or contact the participants Only use for agreed purposes and destroy when project complete Storage under password protected / restricted access systems Not to transfer over the web or email e.g. use SFTS