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GDPR and The Health Research Regulations

  • 5 CPD Hours Apex Building, Blackthorn Road Sandyford Business District D18 (map)

Understand the role of GDPR when applied to healthcare research, learn how to conduct an assessment and how to ensure compliance 

The Health Research Regulations (HRR) 2018 were signed into law in August 2018. In addition to GDPR and the Data Protection Act 2018 the HRR have a significant impact on how healthcare research is conducted. 

Organisations that conduct research have the responsibility to ensure compliance with these laws. It is essential that employees and officers of research organisations such as data protection officers, managers, researchers and principle investigators understand their obligations. Failure to comply can carry the potential of heavy fines and civil litigation. 

This one-day course will provide delegates with clear processes to follow when conducting health research to ensure compliance with the relevant law and guidelines. It will also provide guidance on constructing a GDPR compliant Data Impact Assessment for research purposes. It will clarify roles within research organisations and will identify the key risks in processing health data and how to manage them. Recent developments, clarifications and decisions from the Health Research Consent Declaration Committee along with proposed amendments to the Regulation will also be examined. All delegates will receive a full course pack to refer back to, and will leave with 5 structured CPD hours.  

Course Content

  • Health Research Regulation, Data Protection Act 2018, GDPR and their impact on Health Research

  • The roles of the data processor, data controller and DPO

  • The principles of GDPR

  • Knowing the difference between identifiable, pseudonymised or anonymous data

  • The lawful basis for processing data – Article 6 and 9

  • Conducting a research data risk assessment

  • The methodologies of DPIA

  • Producing a GDPR compliant DPIA

  • The rights of the subject and how to inform them

  • Requirements of the Health Research Regulation

  • Consent

  • What constitutes a GDPR compliant consent

  • Information principles

  • Capacity Issues and consent

  • Making an application to the Health Research Consent Declaration Committee

  • Review of HRCDC decisions and clarifications

  • Transferring research data outside if the EU

  • Proposed amendments to HRR- retrospective chart review, pre-screening

  • Key risks and risk management

  • Future and secondary use of data; Bio-banks

  • Audit

Who Should Attend?

This course would be relevant to data protection officers, researchers, data processors, data controllers or those responsible for the implementation of your organisation’s data protection.

Certification

On completion of this one-day training course, you will receive your CMG MasterClass Certificate as well as your CPD Certificate containing 5 Structured CPD Hours. Please note certificates are issued at the close of the training course to participants who complete the full five hours.

Cost

This training course costs €425 EARLY-BIRD Rate (Normal rate €465). The price includes course documentation and training pack, teas and coffee, snacks, biscuits, fruit on arrival. Lunch is a light fare containing freshly cut sandwiches, wraps, a selection of teas and coffee. Alternatively, you can avail of the local food stores and coffee shops within a one-minute radius of the training centre for hot food or alternative lunch options.