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NHS Research Ethics ApprovalNHS Research Ethics Approval…………the processthe process
Dr Sheila A SimpsonDr Sheila A Simpson
27 May 200827 May 2008
ETHICSETHICS
••The process of determining what is right and wrong The process of determining what is right and wrong
•• Personal code of conduct based on respect for one's Personal code of conduct based on respect for one's self, others, and your surroundingsself, others, and your surroundings
•• The study of human values and moral conduct The study of human values and moral conduct
•• The philosophy or code pertaining to what is ideal in The philosophy or code pertaining to what is ideal in human character and conducthuman character and conduct
Ethics Ethics …………..or how to behave properly..or how to behave properly
Ethics in MedicineEthics in Medicine
•• Respect for autonomyRespect for autonomyIncluding protection of those with diminished autonomyIncluding protection of those with diminished autonomy
•• BeneficenceBeneficence
•• Non MalificenceNon Malificence
•• JusticeJusticefairness, equity, distributing the benefits and burdens fairness, equity, distributing the benefits and burdens of healthcare in societyof healthcare in society
God and doctor we adore God and doctor we adore on the brink of danger, not before.on the brink of danger, not before.
The danger past, all is requited;The danger past, all is requited;God is forgotten, the doctor slightedGod is forgotten, the doctor slighted
BUTBUT…………………………
There is a foreseeable contribution to human good that justifiesThere is a foreseeable contribution to human good that justifiesclinical researchclinical research
BUTBUT
•• It is unethical for clinical research NOT be be open and accountIt is unethical for clinical research NOT be be open and accountableable
•• It is unethical NOT to disseminate resultsIt is unethical NOT to disseminate results
•• Registration of trials/clinical research is necessary:Registration of trials/clinical research is necessary:
* prevents duplication of effort* prevents duplication of effort* and ensures both positive and negative results are* and ensures both positive and negative results are made publicmade public
•• Hippocrates Hippocrates –– 500BC: Medical oath outlining physicians 500BC: Medical oath outlining physicians dutiesduties
•• 1628 1628 –– Sir William Harvey: Described the circulationSir William Harvey: Described the circulation
•• 1672 1672 –– Sir Robert Sir Robert TalborTalbor: Secrecy and deception in : Secrecy and deception in medicinemedicine
•• 1798 1798 –– Dr Edward Jenner: Dr Edward Jenner: Experimentation using cowpox to protect against small Experimentation using cowpox to protect against small poxpox
•• 1930s/1940s 1930s/1940s –– Nazi experimentation: POWs Nazi experimentation: POWs –– exposed to exposed to cold water to see how long they would survivecold water to see how long they would survive
•• 1947 1947 –– Nuremburg code: Set of principles for human Nuremburg code: Set of principles for human experimentationexperimentation
•• 1964 1964 –– The Helsinki Declaration: Code of practice for The Helsinki Declaration: Code of practice for physicians involved in medical researchphysicians involved in medical research
•• 1967 1967 –– Dr Maurice Pappworth: Ethics and clinical Dr Maurice Pappworth: Ethics and clinical medicine, an analysis of questionable medical research medicine, an analysis of questionable medical research ––informed consentinformed consent
Research Ethics Committees Research Ethics Committees ……a historya history
•• First established in NHS in mid 1960First established in NHS in mid 1960’’ss…………on a voluntary basison a voluntary basis
•• LRECsLRECs first organised by dept of health guidance in 1991 (England) first organised by dept of health guidance in 1991 (England) 1992 (Scotland)1992 (Scotland)
•• MREC system created in 1997MREC system created in 1997
•• Further regulations issued in 2002 which gave explicit statutorFurther regulations issued in 2002 which gave explicit statutory y duties to duties to RECREC’’ss.
Research Ethics Committees Research Ethics Committees ……a historya history
•• 2000 2000 –– COREC establishedCOREC established•• 2001 2001 –– Governance arrangements for Research Ethics Governance arrangements for Research Ethics
CommitteesCommittees•• 2001 2001 –– European Union Clinical Trials DirectiveEuropean Union Clinical Trials Directive•• 2004 2004 -- UK regulationsUK regulations
–– The medicines for human use (clinical trials) regulationsThe medicines for human use (clinical trials) regulations
EU Clinical Trials DirectiveEU Clinical Trials Directive
•• Harmonise clinical trial procedures in EuropeHarmonise clinical trial procedures in Europe•• Share information across member statesShare information across member states•• Good practice legally bindingGood practice legally binding•• 60 day time limit for opinion; 35 day time limit for 60 day time limit for opinion; 35 day time limit for
amendmentsamendments•• One single opinion per countryOne single opinion per country
•• APPLIES TO ALL RESEARCHAPPLIES TO ALL RESEARCH
•• Pathologist ordered the removal of organs from dead Pathologist ordered the removal of organs from dead infants bodiesinfants bodies
•• No consent from relatives was obtainedNo consent from relatives was obtained
•• 2000 pots containing body parts of 850 infants were 2000 pots containing body parts of 850 infants were found in a cellarfound in a cellar
Salisbury Trust: Salisbury Trust: •• Patients consented to the use of surplus skin in Patients consented to the use of surplus skin in ‘‘all forms all forms
of medical researchof medical research’’
•• Some of the skin was soldSome of the skin was sold
•• Salisbury Trust received Salisbury Trust received ££17, 000 per year from the 17, 000 per year from the Defence Evaluation & Research Agency (DERA)Defence Evaluation & Research Agency (DERA)
•• Human Tissue Act 2004Human Tissue Act 2004
•• Mental Capacity Act 2005Mental Capacity Act 2005
Research Ethics Committees Research Ethics Committees ……a historya history
Implications Of EU DirectiveImplications Of EU Directive
•• March 2004 March 2004 –– Central Office of Research Ethics Central Office of Research Ethics Committees (COREC)Committees (COREC)
–– One national Research Ethics Application FormOne national Research Ethics Application Form
–– 11stst issue of Standard Operating Procedures for issue of Standard Operating Procedures for Research Ethics CommitteesResearch Ethics Committees
–– Introduction of central allocation system (CAS) for Introduction of central allocation system (CAS) for booking multi site applicationsbooking multi site applications
–– Introduction of national Research Ethics Data BaseIntroduction of national Research Ethics Data Base
•• 2005 Warner Report2005 Warner Report
•• 2007 2007 -- National Research Ethics ServiceNational Research Ethics Service
Name change from CORECName change from COREC
•• 2008 2008 –– IIntegrated ntegrated RResearch esearch AApplication pplication SSystem formystem form
–– Information requirements for a range of permissions Information requirements for a range of permissions and approvals into a single integrated application and approvals into a single integrated application systemsystem
Research Ethics Committees Research Ethics Committees ……a historya history
www.myreseachproject.org.ukwww.myreseachproject.org.uk
IRASIRAS
•• Not mandatory until June Not mandatory until June
•• Streamlines the application process if you are applying Streamlines the application process if you are applying to different bodies such as MHRA/ARSACto different bodies such as MHRA/ARSAC
•• Form sieve should tailor the form to your proposalForm sieve should tailor the form to your proposal
Research Ethics Committees Research Ethics Committees ……a historya history
"No man is an island, entire of itself; everyNo man is an island, entire of itself; everyman is a piece of the continent, a part of theman is a piece of the continent, a part of themain. If a clod be washed away by the sea,main. If a clod be washed away by the sea,Europe is the less, as well as if a promontoryEurope is the less, as well as if a promontorywere, as well as if a manor of thy friend's orwere, as well as if a manor of thy friend's orof thine own were: any man's death diminishesof thine own were: any man's death diminishesme, because I am involved in mankind, and me, because I am involved in mankind, and therefore never send to know for whom the bells therefore never send to know for whom the bells tolls; it tolls for theetolls; it tolls for thee."
John DonneJohn Donne (1572 (1572 -- 1631)1631)
Ethical Approval RequiredEthical Approval Required
•• Patients and users of the NHSPatients and users of the NHS•• Relatives and carers of NHS patientsRelatives and carers of NHS patients•• NHS staff as subjectsNHS staff as subjects
•• Access to data, organs and other bodily material both past Access to data, organs and other bodily material both past & present& present
•• Recently deceased in NHS premisesRecently deceased in NHS premises
•• Use or access to NHS premisesUse or access to NHS premises•• Any clinical drug trialsAny clinical drug trials
Is Ethical Approval RequiredIs Ethical Approval RequiredResearch, Audit or Service Evaluation (1 of 2)Research, Audit or Service Evaluation (1 of 2)
(from COREC, ethics consultation e-group)
SERVICE SERVICE EVALUATIONEVALUATION
CLINICAL AUDITCLINICAL AUDITRESEARCHRESEARCH
Designed & conducted to Designed & conducted to define current caredefine current care
Designed & conducted to Designed & conducted to provide new knowledge provide new knowledge to provide best careto provide best care
Designed & conducted Designed & conducted to generate new to generate new knowledgeknowledge
Measures current service Measures current service without reference to a without reference to a standardstandard
Measures against a Measures against a standardstandard
““What standard does this What standard does this service achieve?service achieve?””
““Does this service reach a Does this service reach a predetermined standard?predetermined standard?
Qualitative research Qualitative research --explores themes explores themes following established following established methodologymethodology
Designed to answer the Designed to answer the question:question:
Designed to answer the Designed to answer the question:question:
Quantitative research Quantitative research --hypothesis basedhypothesis based
Is Ethical Approval RequiredIs Ethical Approval RequiredResearch, Audit or Service Evaluation (2 of 2Research, Audit or Service Evaluation (2 of 2)
(from COREC, ethics consultation e-group)
Does not involve Does not involve allocation to treatment allocation to treatment groups: the HCP and groups: the HCP and patients choose treatmentpatients choose treatment
Does not involve Does not involve allocation to treatment allocation to treatment groups: the HCP and groups: the HCP and patients choose treatmentpatients choose treatment
May involve allocation to May involve allocation to treatment groups NOT treatment groups NOT chosen by HCP or patientchosen by HCP or patient
No ethical review No ethical review requiredrequired
No ethical review No ethical review requiredrequired
Ethical review requiredEthical review required
SERVICE SERVICE EVALUATIONEVALUATION
CLINICAL AUDITCLINICAL AUDITRESEARCHRESEARCH
Involves no more than Involves no more than administration of simple administration of simple interview, questionnaire interview, questionnaire or record analysisor record analysis
Involves no more than Involves no more than administration of administration of questionnaire or record questionnaire or record analysisanalysis
May involve additional May involve additional therapies, samples or therapies, samples or investigationsinvestigations
DoesnDoesn’’t involve a new t involve a new treatmenttreatment
DoesnDoesn’’t involve a new t involve a new treatmenttreatment
May involve a new May involve a new treatmenttreatment
•• Case 1Case 1–– A researcher wants to look at the effects of waiting A researcher wants to look at the effects of waiting
lists on patientlists on patient’’s states of mind. This would involve s states of mind. This would involve interviews with patients. They also want to see if a interviews with patients. They also want to see if a particular marker for stress is elevated in the blood. particular marker for stress is elevated in the blood.
–– Are there any the ethical issues? Are there any the ethical issues?
–– Would he need approval from an NHS ethics Would he need approval from an NHS ethics committee?committee?
Case 2Case 2
-- A nurse would like to look at the effect of the A nurse would like to look at the effect of the new discharge policy on the department new discharge policy on the department compared to the old. The nurse would also like compared to the old. The nurse would also like to get the view points of NHS staff within the to get the view points of NHS staff within the department.department.
-- Are there any the ethical issues? Are there any the ethical issues?
-- Would approval be required from an NHS Would approval be required from an NHS ethics committee?ethics committee?
The CommitteeThe Committee
•• Expert membersExpert members–– Clinical and nonClinical and non--clinical research clinical research –– Qualitative or other research methods applicable to Qualitative or other research methods applicable to
health services, social science & social carehealth services, social science & social care–– Clinical practice including:Clinical practice including:
Hospital and community staffHospital and community staffGeneral practiceGeneral practice
–– Statistics relevant to researchStatistics relevant to research–– PharmacyPharmacy
•• Lay members (one third of the committee)Lay members (one third of the committee)
The CommitteeThe Committee
•• There should be a sufficiently broad range of There should be a sufficiently broad range of experience and expertise, so that the scientific, experience and expertise, so that the scientific, clinical and methodological aspects of a research clinical and methodological aspects of a research proposal can be reconciled with the welfare of proposal can be reconciled with the welfare of research participants, and with broader ethical research participants, and with broader ethical implications.implications.
(Governance arrangements for Research Ethics Committees 6.1)(Governance arrangements for Research Ethics Committees 6.1)
The Life cycle of an Ethics The Life cycle of an Ethics ApplicationApplication
Application FormApplication Form
Completion of NRES Form and documentationCompletion of NRES Form and documentation
Contact Ethics Office to register applicationContact Ethics Office to register application
Submit application (deadline)Submit application (deadline)
Decision letter IssuedDecision letter Issued
Committee MeetingCommittee Meeting
Committee meetingCommittee meeting
•• WELFAREWELFARE
Will the subject be protectedWill the subject be protected
–– Minimal riskMinimal risk
–– ConsentConsent
•• VALIDITY VALIDITY Can the proposal be justifiedCan the proposal be justified
–– Is the research question importantIs the research question important
–– Is the design of the study capable of answering the Is the design of the study capable of answering the questionquestion…….and with what confidence (power, .and with what confidence (power, quantitative studies)quantitative studies)
–– An invalid study at best wastes resources, at worst An invalid study at best wastes resources, at worst places subjects at riskplaces subjects at risk
(Professor John Sanders, Cambridge 2005(Professor John Sanders, Cambridge 2005)
Committee meetingCommittee meeting
…….cells will be harvested to investigate for the presence of cells will be harvested to investigate for the presence of polymorphisms in the MSH2 gene which may lead to the polymorphisms in the MSH2 gene which may lead to the identification of pathogenic mutations in somatic and /or germliidentification of pathogenic mutations in somatic and /or germline ne material. We will store the identity of the patient on our recormaterial. We will store the identity of the patient on our record base d base because we plan to contact them for fresh samples. because we plan to contact them for fresh samples.
We will not tell the patients the results of our investigations We will not tell the patients the results of our investigations but we can but we can send them a copy of our paper. send them a copy of our paper.
Committee MeetingCommittee Meeting
Three decisions can be awardedThree decisions can be awarded
•• ApprovedApproved
•• Provisional opinion, request for further Provisional opinion, request for further informationinformation
•• RejectedRejected
The Most Common Problems With ApplicationsThe Most Common Problems With Applications
••Participant anonymity Participant anonymity
••Site Specific Exemption (A6)Site Specific Exemption (A6)
••Indemnity (A35, A36)Indemnity (A35, A36)
••Not supplying further information, supporting documentationNot supplying further information, supporting documentation
Common Ethical Application IssuesCommon Ethical Application Issues
•• Participants confidentiality, anonymity in Participants confidentiality, anonymity in collected datacollected data
–– Codes are preferred to namesCodes are preferred to names
•• First approach to participants First approach to participants
–– should be by someone known to themshould be by someone known to them
The Six PrinciplesThe Six Principles (compatible with data protection Act, 2000)(compatible with data protection Act, 2000)
1. Any use or transfer of data should be scrutinised by guardian1. Any use or transfer of data should be scrutinised by guardian of of that datathat data
2. Do not identify patients if not necessary2. Do not identify patients if not necessary
3. Use minimum identifiable data3. Use minimum identifiable data
4. Access to such data should be on a need to know basis4. Access to such data should be on a need to know basis
5. All should be aware of their responsibilities5. All should be aware of their responsibilities
6. All such activity should be lawful6. All such activity should be lawful
What about the What about the creationcreation of information?of information?
•• The existence of a database needs to be registered to comply The existence of a database needs to be registered to comply with the lawwith the law
•• If the database concerns patient management ie the diabetic cliIf the database concerns patient management ie the diabetic clinicniclist with recall information, then no permission from the patienlist with recall information, then no permission from the patient is t is deemed necessarydeemed necessary
•• If the database concerns research, or if the clinical database If the database concerns research, or if the clinical database is to beis to beused for research, then patient consent must be soughtused for research, then patient consent must be sought
Use of Data:Use of Data:
In general, records created for one purpose should In general, records created for one purpose should not be used for another purpose without the not be used for another purpose without the patientpatient’’s consents consent
Who should seek the consent from the patient?Who should seek the consent from the patient?
•• The database manager (or responsible clinician) The database manager (or responsible clinician)
•• Not a researcher who does not know the patientNot a researcher who does not know the patient
••Accessing of patient records if not part of normal workAccessing of patient records if not part of normal work-- ensure appropriate permission soughtensure appropriate permission sought
••Research on certain group of participantsResearch on certain group of participants-- ensure still alive before sending the invitation letterensure still alive before sending the invitation letter
••Time to decide to participate in studyTime to decide to participate in study-- minimum of 24 hours, unless full explanationminimum of 24 hours, unless full explanation
Common Ethical Application IssuesCommon Ethical Application Issuescontcont
To summariseTo summarise
•• Why have Ethics Committees?Why have Ethics Committees?
* To protect all actual and potential research participants* To protect all actual and potential research participants
* * To protect researchersTo protect researchers
And finallyAnd finally………………....
Let us not forget the researcherLet us not forget the researcher
The Ethics Office: always there to help!The Ethics Office: always there to help!
