Presentation on theme: "NUI, Galway, Research Ethics Committee, Training Day Oct 2005"— Presentation transcript:
1 NUI, Galway, Research Ethics Committee, Training Day Oct 2005 How to apply to the NUI, GalwayResearch Ethics CommitteeDr Molly Byrne, School of Psychology15th October, 2010
2 NUI, Galway, Research Ethics Committee, Training Day Oct 2005 Session overviewHow the REC worksHow to complete the application formCommon issues that ariseQuestions and answers
3 Declaration of Helsinki 1964 NUI, Galway, Research Ethics Committee, Training Day Oct 2005Declaration of Helsinki 1964“Research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.The participants must be volunteers and informed participants in the research project”.3
4 NUI, Galway, Research Ethics Committee, Training Day Oct 2005 How REC WorksProvides a Service via the Office of the Vice-President for ResearchTo assist in the ethical review of researchComplimentary support to the Declaration of Helsinki and International Good PracticeReviews all staff and post-grad researchWebsite4
5 NUI, Galway, Research Ethics Committee, Training Day Oct 2005 Terms of ReferenceAdvocate and encourage ethical standards of practice in researchProtect research participants from unnecessary harm and preserve their rightsThrough its functions, provide reassurance to the public that best practice is being applied5
6 Committee composition LawSocial Science (2)Professional Care and Treatment of People (3 – inc 1 mental health)Mental HealthEthics TrainingLay Members (2)Sciences (2)Post Grad RepresentativeCommittee Secretary
7 Application Procedure Complete Application form and checklistApplication ProcedureSubmission to REC Secretary at least 3 weeks before next REC meetingAll details ofApplication FormInformed Consent proceduresParticipant information leafletsQuestionnairesProtocolOther details as appropriatePDF format, Processed by REC SecretaryApplication for ethical approval distributed to REC members at least 2 weeks before REC meeting
8 Dates for REC meetingsDeadline for submission: 5pm Tuesday, October 26th 2010 Research Ethics Committee Meeting: 10.30am, Wednesday, November 17th 2010Deadline for submission: 5pm Tuesday January 4th 2011Research Ethics Committee Meeting: 1.30pm Wednesday, January 26th 2011
9 Possible Decisions Deferral Approval Approval Declined Provisional Approval
10 Important considerations Scientific design and conductRecruitment and protection of research participantsConsentConfidentiality
11 Scientific Design and Conduct of the Study NUI, Galway, Research Ethics Committee, Training Day Oct 2005Scientific Design and Conduct of the StudyIs the information complete to allow investigation of ethical questions in the study?Suitability of the protocol and the data collection formsJustification of predictable risks and inconveniences V’s anticipated benefits for participants/ volunteers and the concerned communityCriteria for prematurely withdrawing participants/ volunteers from the researchCriteria for suspending/terminating researchAdequacy of provisions for monitoring and auditing the conduct of the research, including data safetyAdequacy of the site including support staff, available facilities and emergency procedures where applicableThe manner in which the results will be reported and published11
12 Recruitment of Research Participants NUI, Galway, Research Ethics Committee, Training Day Oct 2005Recruitment of Research ParticipantsCharacteristics of population and justification for selectionMethod by which initial contact and recruitment made and appropriatenessMethod by which full information conveyed and consent obtainedInclusion and exclusion criteria12
13 What do you think?You hear about a study in which the researchers want to know more about the experience of people recently diagnosed with diabetes. In the study, general practitioners will ask patients whether they would like to take part in the study at the end of the consultation in which they have been diagnosed with diabetes.
14 Care and Protection of Research Participants NUI, Galway, Research Ethics Committee, Training Day Oct 2005Care and Protection of Research ParticipantsThe safety of any intervention usedSuitability of the investigator (qualifications/experience)Queries and complaints procedureIf applicable, plans to withdraw standard therapies/ justificationIf applicable, adequacy of support during and afterProcedure for participants early withdrawalIf appropriate procedure for informing GP14
15 Care and Protection of Research Participants NUI, Galway, Research Ethics Committee, Training Day Oct 2005Care and Protection of Research ParticipantsA description of any financial costs to participantThe rewards and compensations (if any) for participants and justification15
16 What do you think?You hear about a study in which the researchers want to interview young, single mothers about their experiences of taking part in paid employment and childcare. The researchers put up signs in local community centres saying that participants will be paid €100 if they take part.
17 Care and Protection of Research Participants NUI, Galway, Research Ethics Committee, Training Day Oct 2005Care and Protection of Research ParticipantsA description of any financial costs to participantThe rewards and compensations (if any) for participants and justificationProvisions for compensation/treatment in the case of injury/disability/deathInsurance and indemnity arrangements covering liability of investigatorDescription of payments to researcher to conduct study17
18 Protection of Research Participant Confidentiality NUI, Galway, Research Ethics Committee, Training Day Oct 2005Protection of Research Participant ConfidentialityWho will have access to personal data?Measures taken to ensure confidentiality and security of personal dataExtent to which the info will be anonymisedHow samples/data will be obtained and the purpose for which they will be usedHow long will samples/data be kept (standard is 5 years)18
19 Informed Consent Process NUI, Galway, Research Ethics Committee, Training Day Oct 2005Informed Consent ProcessFull description of processAdequacy, completeness and understandability of written and oral info givenContent and wording of participant info sheetContent and wording of informed consent form and provisions for those incapable of giving consent personallyJustification for including individuals who cannot consent and full account for arrangements in obtaining consentAssurances that participants/volunteers will receive info that becomes available during the course of the research19
20 How to complete the application form NUI, Galway, Research Ethics Committee, Training Day Oct 2005How to complete the application formSection by section…..Applicant detailsStudy detailsRecruitment of participantsConsentDetails of interventionsRisks and ethical problemsIndemnityConfidentiality
21 Section 1: Applicant details NUI, Galway, Research Ethics Committee, Training Day Oct 2005Section 1: Applicant detailsTitle, identical to one used on funding applicationsAll investigators listedSigned by principle investigator and Head of School/SupervisorInclude CV for the Principle Investigator (and for the supervisor if he/she is not the principle investigator)
22 Section 2: Study details NUI, Galway, Research Ethics Committee, Training Day Oct 2005Section 2: Study detailsQs 7&8: Aims, objectives and background written so they’re understandable to a reader without specialist knowledgeQ 9. Summary of detailed protocol must be appended to application. Summary detailed and specific enough for REC members to know in broad terms what you’re planning to do.Q 10. List all possible risks, however minor.
23 Section 3: Recruiting participants NUI, Galway, Research Ethics Committee, Training Day Oct 2005Section 3: Recruiting participantsClear description of process of recruitment‘Non-competent’ or vulnerable participantsOnly when necessary, must justifyCare to protectIncentives to participate?Should not be so strong that they compromise real choice about whether to participate‘Course credit’ system within psychologyInclusion/exclusion criteria – should not unnecessarily exclude people/groups
24 What do you think?You are conducting a study of post-primary school children to find out more about their exercise behaviour. In your REC application form you indicate that you will exclude all children for whom English is not their first language.
25 NUI, Galway, Research Ethics Committee, Training Day Oct 2005 Section 4: ConsentIdeally,Clearly worded participant information sheet to keepPlenty of time to decide (at least 24 hours)Separate form for written consentNot always possible....Time may be limited, e.g. Recruiting participants opportunistically as they attend hospital‘Opt out’ and assumed consent sometimes necessary, e.g. Sexual health study, no initial consent to contact
26 Participant information sheet NUI, Galway, Research Ethics Committee, Training Day Oct 2005Participant information sheetAppendix 1 to REC Guidance NotesMust use simple, non-technical terms, understood by lay person (PILOT IT!)Participants want to know about what will happen to them, more than about science/theoryRisks and benefitsConfidentiality assuredParticipation is voluntaryContact for researcher for added questionsCarry out your own review of some Participant Information Sheets
27 Section 5: Details of Interventions NUI, Galway, Research Ethics Committee, Training Day Oct 2005Section 5: Details of InterventionsIndicate any intervention being used (even if it’s a survey)Mostly focuses on medical/physical intervention27
28 Section 6: Risks and Ethical Problems NUI, Galway, Research Ethics Committee, Training Day Oct 2005Section 6: Risks and Ethical ProblemsCareful and realistic consideration of potential risks, side affects, adverse effects, physical or psychological discomfort to participants, likelihood of occurrence, steps taken to deal with risk28
29 What do you think?What are the risks involved in the following studies:Interviewing children about their body imageConducting a controlled trial of a new therapeutic programme for autismReviewing medical records to document frequency of reporting of mental health problems within the University medical centreConducting an interview study with ex-prisoners about rehabilitation
30 Risks to the researcher Addressed by developing a safety protocol for the researcher.Includes items like:The researcher will inform her supervisor specifically when and where interviews will be conducted and will inform her on return from each interview.The researcher will carry a mobile phone at all times.All interviews will be conducted during daylight hours.The researcher will be dressed appropriately for the interviews.Interviews will be conducted in open areas where possible, and near domestic housing and/or populated areas.The researcher will not carry any money or valuables with her when conducting interviews.
31 NUI, Galway, Research Ethics Committee, Training Day Oct 2005 Section 7: IndemnityNUI Galway Professional Indemnity will cover the majority of studiesView University Indemnity Policy to ascertain if your study is covered in full31
32 Section 8: Confidentiality NUI, Galway, Research Ethics Committee, Training Day Oct 2005Section 8: ConfidentialityMeans ensuring that information is accessible only to those authorized to have access to itPrecautions in the public use of audio, video, visual materials if confidentiality and anonymity guaranteedMedical records - study relevant material onlyMain investigator responsibility for others to observe confidentiality also32
33 Common issues that arise NUI, Galway, Research Ethics Committee, Training Day Oct 2005Common issues that ariseUnclear, not enough informationQuality of research (especially when risk...)Incomplete application form (use n/a)Searching medical records (Agent to practice)Retention and storage of data (5 year rule)
34 Children and researchGenerally speaking, the primary ethical challenge regarding risk is to ensure protection of individual children while making sure research improves the situation of children as a group (Kopelman, 2000).‘Vulnerability perspective’ versus ‘competence and empowerment’ perspective
35 Consent and assentAssent is defined as ‘a child’s affirmative agreement to participate in research’ (HHS, 2005, p. 1).A child’s assent needs to be complemented by a decision of a ‘legally recognised surrogate decision-maker’ (Baylis et al, 1999)Based on assumption that children or adolescents are not yet fully competent to make such decisions, especially not decisions that might involve some risk of harm.
36 Developing age appropriate materials Researcher needs to be familiar with the needs and characteristics of children of different age groups, and especially of the particular population to be included in the research (Broome etal, 2003; Holaday et al, 2007).Recommended to involve children themselves in the development of informed consent material (Ford et al, 2007).
37 What next? Consult website and support materials NUI, Galway, Research Ethics Committee, Training Day Oct 2005What next?Consult website and support materialsThink through step by step what needs to be done for complete application to be submitted on time, so that you can commence your investigative work on timeTalk with your supervisor/colleagues37