Presentation on theme: "IWK Research Ethics - Workshop Series Session #1 Why do we need Research Ethics Approval? October 21, 2013 Bev White, Manager, Research Ethics Research."— Presentation transcript:
1 IWK Research Ethics - Workshop Series Session #1 Why do we need Research Ethics Approval? October 21, 2013Bev White, Manager, Research EthicsResearch Services, IWK Health Centre
2 Objectives Research Ethics Review – why do we have it? Mandate/Role of the REBGuidance documentsTCPS2, Division 5, ICH-GCP, PHIA, etc…Specific Issues of InterestScholarly reviewPrivacyTraineesBadly written protocols/consent documentsSecondary use of dataResources to navigate the REBQuestions
3 Research Ethics Review Nuremberg Code (1947)Universal Declaration of Human rights (1948)Tuskegee, Willowbrook (1932/72, 1960/70)Declaration of Helsinki (1964) – modified x 5MRC/Canada Council Guidelines (1978)Health Canada – ICH-GCP (1997)TriCouncil Policy Statement – 2(CIHR, NSERC, SSHRC) (1998, 2010, 2013?)
4 Why? Social responsibility Integrity of research Because we shouldSocial responsibilityIntegrity of research“The right thing to do”Because we mustLegislated requirementsGuidance documents
5 Research Ethics Guidance Documents and Regulations TCPS-2Applies to all human researchDivision 5Health Canada legislationICH-Good Clinical PracticesAdopted by Health Canada - Applies to Clinical TrialsBest Practices for Health Research Involving Children and AdolescentsPersonal Health Information Act - PHIAUS Regulations - Office of Human Research Protections - OHRPCFR 45, Part 46 - Department of Health and Human Services, Protection of Human subjectsCFR 21, FDA – Protections of Human Subjects, IRB(REB), Drugs & Devices
6 TCPS2The TCPS2 describes principles, standards and procedures for governing research involving humans.The TCPS2 applies to all research involving human or human tissues affiliated with, and undertaken by members of, research institutions administering funds awarded by any of the three federal granting agencies (CIHR, NSERC and SSHRC).It includes new chapters:Multi-Jurisdictional Studies, (Ch. 8),First Nations, Inuit & Métis Research (Ch. 9)Qualitative Research (Ch. 10)
7 TCPS2Addresses the interdependent duties shared by researchers, institutions and REBsArticulates and updates ethical norms - encourages continued reflection on complex ethical issues.Seeks to avoid imposing one disciplinary perspectiveHarmonize the ethics review process
8 TCPS2 Recognizes need for research Basic desire for new knowledge Advance knowledge for the benefit of subjectsBenefits particular groups and society
9 Respect for Justice and Inclusiveness. Balancing Harms and Benefits. Original 7 principles that form the basis for respect for human dignityRespect for Justice and Inclusiveness.Balancing Harms and Benefits.Minimizing HarmMaximizing BenefitRequirement for Free and Informed Consent.Respect for Vulnerable Persons.Respect for Privacy and Confidentiality.
10 Core Principle Respect for Persons (Human Dignity) Fully informed consentVoluntary participationParticipant anonymityData confidentialitySpecial treatment of vulnerable populationsThird party consentTreat subjects as autonomous beingsRespect the right to privacyProtect subjects with limited autonomy
11 Core Principle Concern for Welfare – Do Good (Beneficence) Study designSubject screening and exclusionRisk assessmentBenefits to subjectBenefits to societyBenefits should outweigh risksMinimize HarmMaximize BenefitsRisk/Benefit
12 Core Principle Justice – Be Fair Distribute benefits and risks equitablyAvoid exploitation of vulnerable populationsLink risks to benefitsAllow all groups access to benefits of researchSelect subjects equitably
13 Mandate REB structure and function dictated by the Tri-Council Policy Statement on Ethical Conduct for Research Involving HumansExplicit instructions regarding all aspectsAll organizations and institutions receiving funding from the Tri-Agencies (CIHR, NSERC, SSHRC) must comply with TCPS2
14 TCPS2 Section1 Article A1.1All research that involves living human subjects requires review and approval by an REB “…before research is started”Research is defined as “systematic investigation to establish facts, principles or generalizable knowledge”includes both quantitative and qualitative methodologies :surveys,questionnaires,interviews,human sampling (tissues),human testing (physiological / psychological),human observation (behavioral investigations)clinical investigations
15 Scope of research needing review Whether the research is funded or notWhether the subjects are from inside or outside the universityWhether subjects are paid or notWhether the research is inside or outside of CanadaWhether the research is conducted inside or outside the universityWhether the research is conducted by staff or studentsWhether the research is conducted in person or remotely
16 Scope of research needing review Whether the research is to be published, or notWhether the research is collected from subjects or from records not in the public domain (e.g. database research)Whether the research is observational, experimental, correlational or descriptiveWhether or not a similar project has been approved elsewhereWhether the research is a pilot study or a fully developed studyWhether it is basic or applied researchWhether the research is for teaching or training or for the acquisition of new knowledge
17 What doesn’t need ethics review? Research using publicly available informationArchival or literature-based studiesResearch about ‘public figures’ using published information or third-party interviewsObservation of public eventsQuality Assurance (Q/A) studiesProgram evaluations for direct local applicationPerformance reviews (educational purposes)
18 Secondary Use of DataTCPS2: “Use in research of data contained in records collected for a purpose other than the research itself” – e.g. Health Records“If identifying information is involved, [full] REB approval shall be sought”Justification for use of identifying informationProtection of privacy and minimization of harmsIndividuals have not objected to secondary useIf no identifying information, still need REB review and approvalGenerally will be expedited
19 Role of the REB TCPS2 – Chapter 6 - Governance of the REB Independent AuthorityREB mandate is to review and then approve, reject, propose modifications or halt proposed or ongoing research involving humans at the institution.Institution may not override decisions
20 Research Ethics Board Membership (minimum 5) 2 members with broad expertise in scientific methods1 member knowledgeable in ethics1 member knowledgeable in law1 member from community
21 Institutional Accountability Each local REB must review research in multi-center researchThere must be local (international site) and institutional (home institution of investigator) review for international researchGrant awards DO NOT EQUAL REB approval (you may not begin recruitment, data collection until you have written REB approval
22 Not the Role of the REB NOT to obstruct the conduct of research NOT to rewrite badly constructed consentsNOT to revise badly written protocolsNOT to require idiosyncratic changes to protocols or consentsNOT to nit-pick protocols
23 Common Ethical issues in research… Disclosure of illegal activitiesDisclosure of child / adult abuseDisclosure of previously unknown diagnoses (mental or physical)Significant physical discomfort / harmSignificant emotional / psychological distress
24 REB Review - Initial Full Review Delegated Review – Minimal Risk Primary and secondary reviewerAll REB members read submissionFace-to-face discussionWritten recommendationsMajor & minor revisionsAppeals process, if impassePrimary and secondary reviewer assignedOther REB members read submission, only if moved to full reviewWritten recommendationsMajor & minor revisionsAppeals process, if impasse
25 REB Review - OngoingAll ongoing research requires annual review (proportionate to risk)Review of consent processSafety monitoring committeeReview of study documentsReview of adverse eventsReview of patient chartsRandom audit
26 Practical IssuesAllow time to prepare REB submissionREB requires review of project by supervisorSubmission deadlinesIWK – 1st Tuesday of the month – REB meets on the 3rd Tuesday of the month (no meeting Jan & Aug)CDHA – Every Friday – 6 days prior to the meeting, REB meets every MondayDelegated review (minimal risk) projects can be submitted at any time at the IWK.
27 Practical Issues Follow the instructions on the website Add a cover letter if there are special circumstances that the REB needs to be aware ofProvide point by point responses to all itemsRevisions - Highlight changes in relevant documents; Consents, etc.Revisions - Remember to change version dateConsider your submission package to be the first step in your conversation with the REB
28 Practical issues - Continuing Review Annual review will require summary of progress to date, unanticipated problems, recruitment.If a change is needed for any reason during the conduct of the project – an amendment to REB must be submitted. Include revised consent documents (or related materials) with changes highlighted.The REB and Research Services are here to help you
29 Protecting Research Participants Ensure all research is conducted ethicallyBased upon ethical principlesRespect for individualsMinimize risk/maximize benefitJustice and Inclusiveness (Be fair)“Aim is to prevent unintentional use of a human being solely as a means toward even a legitimate end”.
30 Protecting Investigators & the Institution Be aware of and vigilant for issues which may compromise participant safetyAssist investigators in developing research which meets relevant regulationsEducate investigators in issues of research ethics
31 Scholarly Review Has been a sore point “Bad science cannot be good ethics”TCPS2: “The REB shall satisfy itself that the design of a research project that poses more than minimal risk is capable of addressing the questions asked in the research”“Avoid duplicating previous professional peer-review assessment unless there is a good and defined reason for doing so”.
32 What is research ethics about? Applying the principles of ethics to a particular research contextThree main principles:Respect for Persons (Free & Informed)Concern for Welfare (Beneficence …“Do good”)Justice (Equality & Inclusiveness ….“Be fair”)
34 Informed Consent A process, not a piece of paper, BUT… TCPS2: “Researchers shall provide … full and frank disclosure of all information relevant to free and informed consent”“Must ensure that prospective subjects are given adequate opportunities to discuss and contemplate their participation”
35 Essential Elements Research study Provision of new “Comprehensible statement of purpose”“Comprehensive description of reasonably foreseeable harms and benefits”Free not to participateFree to withdrawCommercializationConflictsProvision of newinformation as availableContactsEthics contactConfidentialitySubject responsibilitiesStudy terminationCosts/paymentsAlternativesProvision of results
36 Consent TCPS2 - Waiver of consent if all the following met: No more than minimal risk,Waiver unlikely to affect rights of subject,Research cannot be practically carried out,Subjects will be provided with additional info, when possible, ANDConsent does not involve a therapeutic intervention.PHIA – Consent of the subject individuals is required unless a REB has determined that the consent is not required, or that it is impracticable to obtain consent.
37 Assent (Dissent) - children The discussion process with a Child taking part in research based on “Authorization” from their parent (or guardian)Involving participants in decision-making when they do not have the ability to provide informed consent.Respect children as personsHonour developing autonomyRespect parent’s roles in guiding moral developmentFlexibility is keySeeking assent may not always be appropriate. Dissent must be respected – if you ask, you must be prepared to respect a “NO” answer.
38 Assent (Dissent) - elements Provide appropriate informationInclude children in decision-makingIntegrate family decision-makingProcess over timeDetermine capacity to assentDocument assent processProcess may be verbal…signature not requiredPay attention to soliciting/respecting dissent
40 Supporting Documentation To do its job, REB needs all materials pertaining to the researchComplete protocolConsent documentsPosters/flyers/advertisementsBudgetCV’sEAS Form directed towards lay members of committee
41 Privacy Legislation Legislation governs the collection, handling, storage of personal information, including research records.PIPEDA - Personal Information Protection and Electronics Documents ActNova Scotia Hospitals ActPIIDPA - Nova Scotia Personal Information International Disclosure Protection ActPHIA - Nova Scotia Personal Health Information ActGuidance documentCIHR Best Practices for Protecting Privacy in Health Research (2005)PHIA Toolkit
42 Data Collection and Management AffectsWhat data you collect (minimum)How you handle it (storage, sending out)How long you keep itImpact on recruiting“Initial contact with individuals about a research project should be made by someone that individuals would expect to have relevant information about them”Future contact ask for permission
44 Ethics Review in Clinical Trials ICH-Good Clinical PracticesAdopted by Health CanadaApplies to Clinical TrialsDivision 5Health Canada legislation
45 Clinical Trial Application In September 2001 Health Canada Food and Drug Regulations (Part C, Division 5) were amended to require sponsor submission of a clinical trial application (CTA) for drug trials.
46 Clinical Trial Application Following receipt of a CTA by a study sponsor and Health Canada's internal review:'No objection letter' or'Not satisfactory notice' is issued by Health Canada.IWK REB withholds its REB approval pending receipt of a copy of the study's 'No objection letter'.Investigators are encouraged to initiate the CTA process early.Protocol amendments need to be submitted to Health Canada for approval.
47 Clinical Trial Application A similar Health Canada review and approval process exists for Natural Health Products and Medical Devices:Clinical trials involving natural health products. Under the Natural Health Products RegulationsWeb site:Clinical trials involving medical devices:
48 Research Ethics Cooperation Agreement – IWK, CDHA, Dal Dal Health Sciences REB accepts IWK or CDHA reviewIWK and CDHA do not accept Dal review, if patient relatedIWK and CDHA can not accept each other’s review, if patient related
49 Memorandum of Understanding IWK, CDHA Researchers who have dual appointments – the REB of record will forward copy of approval to the other institutionExpedited review – Advertisements and Use of ResourcesIndustry funded research - conducted at both institutions requires full Board review by both institutions.
50 REB Audit – Typical Results Research records taken out of Health CentreStudy documents misplacedHealth Canada requires originalsProtocol changes without REB approvalPersonnel changes without amendmentPersonal health information on laptops
51 Contacts Ken Jenkins, Manager – 473-8426 IWK Health Centre - REB guidelinesBev White –Joanne Street –Dalhousie Office of Research Ethics AdministrationCatherine Conner, Director –CDHA Research Ethics BoardKen Jenkins, Manager –