introduction to research ethics in university college cork dr kieran doran, solicitor senior...

INTRODUCTION TO RESEARCH ETHICSINTRODUCTION TO RESEARCH ETHICSIN UNIVERSITY COLLEGE CORK IN UNIVERSITY COLLEGE CORK

Dr Kieran Doran, SolicitorDr Kieran Doran, SolicitorSenior Healthcare Ethics LecturerSenior Healthcare Ethics LecturerSchool of Occupational Therapy School of Occupational Therapy

University College CorkUniversity College Cork

INTRODUCTION TO RESEARCH ETHICSINTRODUCTION TO RESEARCH ETHICSIN UNIVERSITY COLLEGE CORKIN UNIVERSITY COLLEGE CORK

What is Research Ethics Governance?What is Research Ethics Governance?

Research Ethics Governance is a systematic tool used by many Research Ethics Governance is a systematic tool used by many Institutions that undertake research.Institutions that undertake research.

Where proposed research may engage potentially ethically sensitive Where proposed research may engage potentially ethically sensitive issues, for example, involvement of human subjects in research, it is issues, for example, involvement of human subjects in research, it is important to provide institutional safeguards to promote best important to provide institutional safeguards to promote best practice. practice.

All Universities in Ireland have systems in place that promote and All Universities in Ireland have systems in place that promote and regulate ethical practice in research. regulate ethical practice in research.


Why is Research Ethics Governance important?Why is Research Ethics Governance important?

AA robust and suitable model of Research Ethics robust and suitable model of Research Ethics Governance confers the following benefits on a Governance confers the following benefits on a University: University:

It helps in fulfilling institutional and individual It helps in fulfilling institutional and individual responsibilities under the Law;responsibilities under the Law;It promotes public confidence and trust in the research It promotes public confidence and trust in the research activity of the University;activity of the University;It helps to fulfil institutional and individual responsibilities It helps to fulfil institutional and individual responsibilities to behave in an ethical and equitable manner toward to behave in an ethical and equitable manner toward research participants, employees and funding bodies;research participants, employees and funding bodies;


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


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


Principles of Ethical ResearchPrinciples of Ethical Research

UCC is committed to promoting consistent ethical behaviour as an integral part 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 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 human participants in research are entitled to be dealt with in an ethical manner. manner.

UCC is also committed to promoting respect for the dignity of individual UCC is also committed to promoting respect for the dignity of individual participants. UCC requires without exception that its researchers performing participants. UCC requires without exception that its researchers performing clinical Research working with human participants are fully familiar with and clinical Research working with human participants are fully familiar with and observe the World Medical Association Declaration of Helsinki 1964 “Ethical observe the World Medical Association Declaration of Helsinki 1964 “Ethical Principles for Medical Research Involving Human Subjects”Principles for Medical Research Involving Human Subjects”


World Medical Association World Medical Association Declaration of Helsinki 1964 Declaration of Helsinki 1964 ““Ethical Principles for Medical Research Ethical Principles for Medical Research Involving Human Subjects”Involving Human Subjects”

These Guidelines are used in regard to Medical Research These Guidelines are used in regard to Medical Research in respect of identifiable human material or identifiable in respect of identifiable human material or identifiable data. In all medical research these Guidelines state that the data. In all medical research these Guidelines state that the well being of the human subject takes precedence over that well being of the human subject takes precedence over that of science or society. of science or society.


World Medical Association World Medical Association

Declaration of Helsinki 1964 Declaration of Helsinki 1964

““Ethical Principles for Medical Research Ethical Principles for Medical Research

Involving Human Subjects”Involving Human Subjects”

It states that the primary purpose of medical research It states that the primary purpose of medical research

involving human subjects is to improve both diagnostic and involving human subjects is to improve both diagnostic and

therapeutic procedures and the understanding of disease. therapeutic procedures and the understanding of disease.



Medical Research is subject to ethical standards that Medical Research is subject to ethical standards that promote respect for all human subjects and protect their promote respect for all human subjects and protect their health and rights. Some research groups are vulnerable health and rights. Some research groups are vulnerable and need protection, particularly those who are and need protection, particularly those who are economically and medically disadvantaged.economically and medically disadvantaged.


World Medical Association World Medical Association

Declaration of Helsinki 1964 Declaration of Helsinki 1964

““Ethical Principles for Medical Research Ethical Principles for Medical Research

Involving Human Subjects”Involving Human Subjects”

Special attention has to be given to those who cannot give Special attention has to be given to those who cannot give

or refuse consent for themselves, or who may consent or refuse consent for themselves, or who may consent

under duress, or those who may benefit personally from the under duress, or those who may benefit personally from the

research. research.



Basic Principles of Medical Research:Basic Principles of Medical Research:

The protection of the life, health, privacy and dignity of the human subject;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 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;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 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 the environment, and animals used for research must be respected at all times. times.



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



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



Both authors and publishers of medical research Both authors and publishers of medical research have ethical obligations. In the publication of the have ethical obligations. In the publication of the results investigators are obliged to preserve the results investigators are obliged to preserve the accuracy of the results;accuracy of the results;Sources of funding, affiliations and all other Sources of funding, affiliations and all other possible conflicts of interest should be declared possible conflicts of interest should be declared publicly by those involved in medical research. publicly by those involved in medical research.


Additional Basic Principles of Medical Research:Additional Basic Principles of Medical Research:

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


Privacy and ConfidentialityPrivacy and Confidentiality

Researchers have a responsibility to safeguard the privacy Researchers have a responsibility to safeguard the privacy and the personal information of the participants in the and the personal information of the participants in the research project. The most useful and important research research project. The most useful and important research involves the use of highly sensitive personal data. involves the use of highly sensitive personal data.

The misuse or inadequate protection of such sensitive The misuse or inadequate protection of such sensitive personal data violates their rights and may have legal consequences personal data violates their rights and may have legal consequences for the University under the Data Protection Acts 1988-2003 and the for the University under the Data Protection Acts 1988-2003 and the Freedom of Information Acts 1997-2003 Freedom of Information Acts 1997-2003


Who has responsibility for Ethics in Research?Who has responsibility for Ethics in Research?

It is the responsibility of all researchers to adhere to all It is the responsibility of all researchers to adhere to all legal requirements associated with their research. It is also legal requirements associated with their research. It is also their responsibility to adhere to the principles of good their responsibility to adhere to the principles of good research practice and other ethical requirements. research practice and other ethical requirements.

All researchers are ought to ensure that all relevant All researchers are ought to ensure that all relevant guidelines and regulations are followed, and that they abideguidelines and regulations are followed, and that they abideby any directions from the relevant Committee or UREB. by any directions from the relevant Committee or UREB.



Once a research protocol has been authorised by a Committee, the Once a research protocol has been authorised by a Committee, the researcher must adhere to the approved methodology. Any proposed researcher must adhere to the approved methodology. Any proposed deviation from the protocol must be resubmitted to the relevant deviation from the protocol must be resubmitted to the relevant Committee for reappraisal.Committee for reappraisal.

Additionally, restrictions or stipulations may be placed on Additionally, restrictions or stipulations may be placed on researchers by statutory bodies, funding bodies, professional researchers by statutory bodies, funding bodies, professional organisations and in the case of medical researchers, by hospital and organisations and in the case of medical researchers, by hospital and health authorities. It is the responsibility of the researcher to bring anyhealth authorities. It is the responsibility of the researcher to bring anysuch factors to the attention of the Committee as part of the review such factors to the attention of the Committee as part of the review process. process.



It is important to note that research projects that are It is important to note that research projects that are

conducted by students, either undergraduate or conducted by students, either undergraduate or

postgraduate, may also require approval from an postgraduate, may also require approval from an

appropriate research ethics committee. appropriate research ethics committee.

Supervisors of such projects have a responsibility to ensureSupervisors of such projects have a responsibility to ensure

compliance by their students. compliance by their students.


Progress Reports in ResearchProgress Reports in Research

The approving Committee may require the researcher to submit The approving Committee may require the researcher to submit Progress Reports at periodic intervals. If an adverse incident should Progress Reports at periodic intervals. If an adverse incident should occur, this must be reported in appropriate detail to the Committee occur, this must be reported in appropriate detail to the Committee immediately.immediately.

An adverse incident is, in general, an event occurring in the course of a 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 study which has a significant and unfavourable effect on the welfare of any participants. The reporting requirements for adverse events which any participants. The reporting requirements for adverse events which occur in clinical trials must be strictly observed. occur in clinical trials must be strictly observed.


Overview of Research Ethics in UCCOverview of Research Ethics in UCC

Three (3) Research Ethics Committees inThree (3) Research Ethics Committees inUCC:UCC:1.1. Clinical Research Ethics Committee of the Clinical Research Ethics Committee of the

Cork Teaching Hospitals (CREC);Cork Teaching Hospitals (CREC);2.2. Animal Experimentation Ethics Committee Animal Experimentation Ethics Committee

(AEEC); and(AEEC); and3.3. Social Research Ethics Committee (SREC).Social Research Ethics Committee (SREC).



Clinical Research Ethics Committee of Clinical Research Ethics Committee of Cork Teaching Hospitals (CREC)Cork Teaching Hospitals (CREC)

This Committee deals with clinical research This Committee deals with clinical research involving human participants, their identifiable involving human participants, their identifiable data or tissue. data or tissue.




The Committee can grant or refuse permission on ethical The Committee can grant or refuse permission on ethical grounds for research projects involving the following: grounds for research projects involving the following:

Clinical Trials (of Treatments or Diagnostic Processes);Clinical Trials (of Treatments or Diagnostic Processes);Epidemiological or Other Studies involving the collection of Personal Epidemiological or Other Studies involving the collection of Personal Healthcare related data;Healthcare related data;Behavioural studies of persons in a Healthcare setting; andBehavioural studies of persons in a Healthcare setting; andStudies on tissue and tissue extracts obtained in a Healthcare Studies on tissue and tissue extracts obtained in a Healthcare environment. environment.




This Committee is recognised by the Department This Committee is recognised by the Department of Health and Children as a nationally competent of Health and Children as a nationally competent Ethics Committee for Clinical Trials under Ethics Committee for Clinical Trials under SI 190/2004 European Communities (Clinical Trials on SI 190/2004 European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations.Medicinal Products for Human Use) Regulations.




The Committee also assesses Clinical Trial Protocols submitted to it by The Committee also assesses Clinical Trial Protocols submitted to it by Researchers who are not staff members either of UCC or of the Researchers who are not staff members either of UCC or of the Hospitals affiliated to UCC for teaching. The Committee may also Hospitals affiliated to UCC for teaching. The Committee may also reserve the right, as a matter of institutional authority, to modify reserve the right, as a matter of institutional authority, to modify research validated by an external research ethics committee on the research validated by an external research ethics committee on the basis of local competence to deliver. basis of local competence to deliver.



Animal Experimentation Ethics Committee (AEEC)Animal Experimentation Ethics Committee (AEEC)

This Committee deals with proposals to use Animals in research. Its This Committee deals with proposals to use Animals in research. Its approval is required for Animal experiments carried out by UCC Staff. approval is required for Animal experiments carried out by UCC Staff.

This approval is in addition to the legal requirement for a licence This approval is in addition to the legal requirement for a licence granted by the Minister for Health and Children prior to conducting granted by the Minister for Health and Children prior to conducting animal experiments. The Committee is guided by both the Cruelty to animal experiments. The Committee is guided by both the Cruelty to Animals Act 1876 and the European Communities (Amendment of Animals Act 1876 and the European Communities (Amendment of Cruelty to Animals Act 1876) Regulations 2002. Cruelty to Animals Act 1876) Regulations 2002.



Social Research Ethics Committee (SREC)Social Research Ethics Committee (SREC)

The Committee has responsibility for ethical oversight of non-clinical The Committee has responsibility for ethical oversight of non-clinical research involving human participants. research involving human participants.

Here the research may include direct or indirect interaction with human Here the research may include direct or indirect interaction with human participants for the purpose of data collection using research methods participants for the purpose of data collection using research methods such as questionnaires, interviews, observations, as well as focus such as questionnaires, interviews, observations, as well as focus groups. It is an interdisciplinary Committee and its remit includes, but groups. It is an interdisciplinary Committee and its remit includes, but is not limited to research concerning Sociology, Psychology, is not limited to research concerning Sociology, Psychology, Economics, Politics, Marketing, Social Work, Law and Epidemiology Economics, Politics, Marketing, Social Work, Law and Epidemiology


Thank You!Thank You!Dr Kieran Doran, SolicitorDr Kieran Doran, SolicitorSenior Healthcare Ethics LecturerSenior Healthcare Ethics LecturerSchool of Occupational Therapy School of Occupational Therapy UCCUCC(021) 4901513(021) [email protected] [email protected]

introduction to research ethics in university college cork dr kieran doran, solicitor senior...

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