What is GDPR?
GDPR is the General Data Protection Regulation.
Does GDPR affect me?
If you collect, use or store personal data, digital, manual, handwritten or any type of record, then GDPR affects you.
What is Personal Data?
Personal data relates to any information relating to a living individual, whether it relates to his or her private, professional or public life. It can be anything from a name, photo, email address, bank details, health records and medical information, posts on social media, even a computer IP address.
Can I access Personal Date belonging to an individual or patient?
Yes, if you have a patient’s or individuals’ explicit consent for you to access their information. If you do not have this, then no, you can’t.
I’m a student, can I use patient data for research?
Yes, if you have the patient’s explicit consent for you to access their health information for your research. If you do not have this, then no, you can’t.
Explicit consent means what, exactly?
It means did you ask the patient’s permission to access their data / health records? Did you explain to the patient who you are and why you want to use their information? Did the patient agree to this? Is there a record of the patient agreeing to this? You need to be able to say “yes” to all these questions. If there’s a “no” then you not have explicit consent and you are not allowed to access the patient’s information.
Ethics approval was already granted for this research. I’m a student and I am just joining this research project. Do I have any responsibilities?
Yes. You need to see that approval was granted, you need to know the parameters of the approval, and you need to discuss everything with your supervisor. Your supervisor will be sent a letter by us for forwarding to the original ethics committee that gave approval which states your name and who you are.
I’m a student in the School of Medicine therefore, I am a member of the clinical team.
No, you’re not. You are student and have no more right to access a person’s private health information than someone walking in off the street. You are not bound by any professional code of conduct and ethics as you are not a practitioner. You need to have explicit consent from patients before accessing their medical data for research purposes.
What is anonymisation of data?
"Anonymisation" of data means processing it with the aim of irreversibly preventing the identification of the individual to whom it relates. Data can be considered effectively and sufficiently anonymised if it does not relate to an identified or identifiable natural person or where it has been rendered anonymous in such a manner that the data subject is not or no longer identifiable.
What is pseudonymisation of data?
"Pseudonymisation" of data means replacing any identifying characteristics of data with a pseudonym, or, in other words, a value which does not allow the data subject to be directly identified.
Do I need to get Garda Vetting for my research?
If the participants (or controls) belong to any of the following vulnerable groups you will require Garda Vetting (other groups might also be included in this category depending on the nature and context of the research):
• Children under 18 years of age;
• University Students;
• People who have language difficulty as English is not their first language;
• People who have a recognised or diagnosed intellectual or mental impairment (dementia, mental illness etc);
• People suffering from a physical impairment, whether as a result of injury, illness or age;
• People with a physical disability;
• Older people;
• People confined to institutions (prisoners, residents in 24 hour nursing facilities);
• Persons in unequal relationships with the researcher (teacher/student; therapist/client; employer/employee).
What issues should be addressed in your information leaflet for participants (please note that the items listed below are also the headings to be used in your information sheet and are addressed to the participant)?
a) Introductory Statement:
Researcher’s name & descriptor (Professor, Dr, Mr., Ms.)
Name of Researchers School
The topic and title of the research
b) ‘What is the research about?’ &,
c) ‘Why am I, as the researcher, undertaking this research?’
d) ‘Why have you been invited to be a participant?’
e) ‘How will your data be used?’
f) ‘What will happen if you decide to take part in this research study?’
g) ‘How will your privacy be protected?’
h) ‘What are the benefits of taking part in this research study?’
i) ‘What are the risks of taking part in this research study?’
j) ‘Can you change your mind at any stage and withdraw from the research study?’
k) ‘How will you find out what happens with this research?’