October 21, 2021
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Course Description

The Health Research Regulations (HRR) came into effect 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 engaged in the conduct research have the responsibility to ensure compliance with GDPR and the HRRs. Employees of research organisations such as data protection officers, managers, researchers, healthcare providers and principal investigators should understand their obligations and the interplay between the two pieces of law. Failure to comply can carry the potential of fines, reprimands 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.

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
  • Dealing with a breach
  • Making an application to the Health Research Consent Declaration Committee
  • Review of HRCDC decisions and clarifications
  • Transferring research data outside the EU; Brexit
  • Proposed amendments to HRR- retrospective chart review, pre-screening
  • Key risks and risk management
  • Future and secondary use of data; Bio-banks
  • Audit
  • Genetic research

Who Should Attend?

This course would be relevant to Data Protection Officers, researchers, data processors data controllers or responsible for the implementation and follow-through of your organisation’s Data Protection and Researchers, Research Ethics Committee Members.


On completion of this one-day training course, you will receive your CMG MasterClass Certificate of Attendance in Health Research Regulations. Please note certificates are issued at the close of the training course to participants on completion of the course. You will also receive a full Health Research Regulations course pack to refer back to at any time in the future. Please check directly with your association or awarding body to see how many points they will award.


An ‘Early Bird’ discounted rate of €425 is currently available. This training course normal rate is €525. Places are limited and are allocated on a first come first served basis. The course cost includes all course documentation, Subject Access Request, FOI & the Right of Access and certificates.


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