1. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Dr Kieran Doran, Solicitor
Senior Healthcare Ethics Lecturer
School of Occupational Therapy
University College Cork

2. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
What is Research Ethics Governance?
Research Ethics Governance is a systematic tool used by many
Institutions that undertake research.
Where proposed research may engage potentially ethically sensitive
issues, for example, involvement of human subjects in research, it is
important to provide institutional safeguards to promote best
practice.
All Universities in Ireland have systems in place that promote and
regulate ethical practice in research.

3. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Why is Research Ethics Governance important?
A robust and suitable model of Research Ethics
Governance confers the following benefits on a
University:
It helps in fulfilling institutional and individual responsibilities under the Law;
It promotes public confidence and trust in the research activity of the University;
It helps to fulfil institutional and individual responsibilities to behave in an ethical and equitable manner toward research participants, employees and funding bodies;

4. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Why is Research Ethics Governance important?
It helps in protecting the interests of all parties involved in research, namely research participants/donors, investigators, funding bodies and the host institution;
It makes research proposals more attractive to funding bodies, as very often local ethical review is a prerequisite to the release of funds;
It helps in fulfilling obligations to indemnity insurers;
It may be an explicit requirement for publication of research;
It promotes efficiency and clarity in research protocols;

5. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Why is Research Ethics Governance important?
It reduces any propensity toward development of a blame culture within the institution. If a Committee endorses a research proposal then, in so far as the protocol is properly followed, the institution must accept corporate responsibility for the conduct of the research; and
It may provide specific guidance with regard to, inter alia, Informed Consent, Confidentiality, Data Protection Policies, and protection of vulnerable groups where these do not already exist by statute or by international norms.

6. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Principles of Ethical Research
UCC is committed to promoting consistent ethical behaviour as an integral part
of its research culture. UCC is particularly committed to the principle that all
human participants in research are entitled to be dealt with in an ethical
manner.
UCC is also committed to promoting respect for the dignity of individual
participants. UCC requires without exception that its researchers performing
clinical Research working with human participants are fully familiar with and
observe the World Medical Association Declaration of Helsinki 1964 “Ethical
Principles for Medical Research Involving Human Subjects”

7. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
World Medical Association
Declaration of Helsinki 1964
“Ethical Principles for Medical Research
Involving Human Subjects”
These Guidelines are used in regard to Medical Research
in respect of identifiable human material or identifiable
data. In all medical research these Guidelines state that the
well being of the human subject takes precedence over that
of science or society.

8. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
World Medical Association
Declaration of Helsinki 1964
“Ethical Principles for Medical Research
Involving Human Subjects”
It states that the primary purpose of medical research
involving human subjects is to improve both diagnostic and
therapeutic procedures and the understanding of disease.

9. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
World Medical Association
Declaration of Helsinki 1964
“Ethical Principles for Medical Research
Involving Human Subjects”
Medical Research is subject to ethical standards that
promote respect for all human subjects and protect their
health and rights. Some research groups are vulnerable
and need protection, particularly those who are
economically and medically disadvantaged.

10. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
World Medical Association
Declaration of Helsinki 1964
“Ethical Principles for Medical Research
Involving Human Subjects”
Special attention has to be given to those who cannot give
or refuse consent for themselves, or who may consent
under duress, or those who may benefit personally from the
research.

11. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
World Medical Association
Declaration of Helsinki 1964
“Ethical Principles for Medical Research
Involving Human Subjects”
Basic Principles of Medical Research:
The protection of the life, health, privacy and dignity of the human subject;
It has to be based on and conform to generally accepted principles as well as on a thorough knowledge of the relevant clinical and medical literature;
Appropriate caution has to be taken in regard to research which may affect the environment, and animals used for research must be respected at all times.

12. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Basic Principles of Medical Research:
The experimental procedure involving human subjects be clearly stated in an experimental protocol. The protocol has to be independently vetted without any undue influence;
The research protocol should at all times contain a statement of the ethical considerations being applied and that these considerations are being adhered to by the researchers;
Medical research conducted on human subjects should only be carried out by scientifically competent individuals under proper medical supervision;
Medical Research involving human subjects should be preceded by an appropriate assessment of the predictable risks and burdens to the human subjects.

13. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Basic Principles of Medical Research:
Physicians should not engage in clinical research involving human subjects unless they are confident that the risks involved in the research have been adequately assessed and satisfactorily managed;
Medical research involving human subjects should only be conducted if the potential improvements to health/welfare exceed the inherent risks and burdens to the subject. This is particularly the case with healthy human subjects;
Any human subject involved in medical research must be volunteers who are fully informed and from whom a full Informed Consent has been received in writing;
The privacy and confidentiality of any human subject in medical research must be respected at all times;

14. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Basic Principles of Medical Research:
Both authors and publishers of medical research have ethical obligations. In the publication of the results investigators are obliged to preserve the accuracy of the results;
Sources of funding, affiliations and all other possible conflicts of interest should be declared publicly by those involved in medical research.

15. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Additional Basic Principles of Medical Research:
A Physician may combine medical research with medical care only to the extent that the research is justified by its potential prophylactic, diagnostic or therapeutic value and where research is combined with medical care, additional standards apply to protect the research subjects;
The benefits, risk, burdens and effectiveness of a new method should be tested in conjunction with the best current prophylactic, diagnostic and therapeutic standards;
The refusal of a patient to participate in a clinical study must never interfere with the physician-patient relationship.

16. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Privacy and Confidentiality
Researchers have a responsibility to safeguard the privacy
and the personal information of the participants in the
research project. The most useful and important research
involves the use of highly sensitive personal data.
The misuse or inadequate protection of such sensitive
personal data violates their rights and may have legal consequences
for the University under the Data Protection Acts and the
Freedom of Information Acts

17. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Who has responsibility for Ethics in Research?
It is the responsibility of all researchers to adhere to all
legal requirements associated with their research. It is also
their responsibility to adhere to the principles of good
research practice and other ethical requirements.
All researchers are ought to ensure that all relevant
guidelines and regulations are followed, and that they abide
by any directions from the relevant Committee or UREB.

18. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Who has responsibility for Ethics in Research?
Once a research protocol has been authorised by a Committee, the
researcher must adhere to the approved methodology. Any proposed
deviation from the protocol must be resubmitted to the relevant
Committee for reappraisal.
Additionally, restrictions or stipulations may be placed on
researchers by statutory bodies, funding bodies, professional
organisations and in the case of medical researchers, by hospital and
health authorities. It is the responsibility of the researcher to bring any
such factors to the attention of the Committee as part of the review
process.

19. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Who has responsibility for Ethics in Research?
It is important to note that research projects that are
conducted by students, either undergraduate or
postgraduate, may also require approval from an
appropriate research ethics committee.
Supervisors of such projects have a responsibility to ensure
compliance by their students.

20. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Progress Reports in Research
The approving Committee may require the researcher to submit
Progress Reports at periodic intervals. If an adverse incident should
occur, this must be reported in appropriate detail to the Committee
immediately.
An adverse incident is, in general, an event occurring in the course of a
study which has a significant and unfavourable effect on the welfare of
any participants. The reporting requirements for adverse events which
occur in clinical trials must be strictly observed.

21. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Overview of Research Ethics in UCC
Three (3) Research Ethics Committees in
UCC:
Clinical Research Ethics Committee of the Cork Teaching Hospitals (CREC);
Animal Experimentation Ethics Committee (AEEC); and
Social Research Ethics Committee (SREC).

22. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Overview of Research Ethics in UCC
Clinical Research Ethics Committee of
Cork Teaching Hospitals (CREC)
This Committee deals with clinical research
involving human participants, their identifiable
data or tissue.

23. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Overview of Research Ethics in UCC
Clinical Research Ethics Committee of
Cork Teaching Hospitals (CREC)
The Committee can grant or refuse permission on ethical
grounds for research projects involving the following:
Clinical Trials (of Treatments or Diagnostic Processes);
Epidemiological or Other Studies involving the collection of Personal Healthcare related data;
Behavioural studies of persons in a Healthcare setting; and
Studies on tissue and tissue extracts obtained in a Healthcare environment.

24. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Overview of Research Ethics in UCC
Clinical Research Ethics Committee of
Cork Teaching Hospitals (CREC)
This Committee is recognised by the Department
of Health and Children as a nationally competent
Ethics Committee for Clinical Trials under
SI 190/2004 European Communities (Clinical Trials on
Medicinal Products for Human Use) Regulations.

25. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Overview of Research Ethics in UCC
Clinical Research Ethics Committee of
Cork Teaching Hospitals (CREC)
The Committee also assesses Clinical Trial Protocols submitted to it by
Researchers who are not staff members either of UCC or of the
Hospitals affiliated to UCC for teaching. The Committee may also
reserve the right, as a matter of institutional authority, to modify
research validated by an external research ethics committee on the
basis of local competence to deliver.

26. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Overview of Research Ethics in UCC
Animal Experimentation Ethics Committee (AEEC)
This Committee deals with proposals to use Animals in research. Its
approval is required for Animal experiments carried out by UCC Staff.
This approval is in addition to the legal requirement for a licence
granted by the Minister for Health and Children prior to conducting
animal experiments. The Committee is guided by both the Cruelty to
Animals Act 1876 and the European Communities (Amendment of
Cruelty to Animals Act 1876) Regulations 2002.

27. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Overview of Research Ethics in UCC
Social Research Ethics Committee (SREC)
The Committee has responsibility for ethical oversight of non-clinical
research involving human participants.
Here the research may include direct or indirect interaction with human
participants for the purpose of data collection using research methods
such as questionnaires, interviews, observations, as well as focus
groups. It is an interdisciplinary Committee and its remit includes, but
is not limited to research concerning Sociology, Psychology,
Economics, Politics, Marketing, Social Work, Law and Epidemiology

28. INTRODUCTION TO RESEARCH ETHICS IN UNIVERSITY COLLEGE CORK
Thank You!
Dr Kieran Doran, Solicitor
Senior Healthcare Ethics Lecturer
School of Occupational Therapy
UCC
(021)