Research Integrity Dr. Hilary Tierney, SRESC with thanks to Dr. Carol Barrett MU Research Development Office research.ethics@mu.ie
Trust & Credibility The trust of the public, professional colleagues, those who commission and fund research and those being studied requires an effective system of ethical review, clear lines of responsibility and a manageable degree of independent overview. (Iphofen, 2011: p.5) Iphofen, R. (2011) Ethical Decision Making in Social Research: A Practical Guide, New York: Palgrave maynoothuniversity.ie
Research Ethics & Research integrity Policies Your responsibilities Responsibility Human Participants Best practice To you The Right to… To Participants Ethical approval maynoothuniversity.ie
Maynooth University Committees Biomedical and Social Research NUIM Ethics Life Sciences Ethics Ethics Sub Committee Sub Committee Committee Rolling & Monthly reviews – 3 tiers Interviews Surveys Data access Observation maynoothuniversity.ie
Sources & Resources MU Research Ethics Policy (2016) MU Research Integrity Policy (2016) Research Ethics page https://www.maynoothuniversity.ie/research/research- development-office/research-ethics Social Research Ethics Sub-committee page https://www.maynoothuniversity.ie/research/research- development-office/ethics/social-research-ethics-sub-committee- sresc maynoothuniversity.ie
Three Tiers of Approval All MU staff, PhD and M.Litt. students, are required to complete ethical review prior to data collection. • Tier 1 - rapid review of routine or non-contentious applications (2-3 weeks). Separate Form* • Tier 2 - expedited review of proposals that may have been approved elsewhere (as in collaborative studies) or have few contentious or non-standard aspects (3-4 weeks). • Tier 3 - standard review for proposals that require greater scrutiny (8+ weeks) • Specific criteria for each Tier maynoothuniversity.ie
Tier 1 appropriate for Research [SRESC] … • … conducted in an established third level educational setting, involving a researchers own normal/routine educational practices (Staff) • … .involving adults (with the exception of those identified as vulnerable ) where the topic is of a non-sensitive nature and data are collected in a manner that participants cannot be identified (i.e. subjects enjoy complete anonymity, no personal details taken or held). Surveys, and/or some observational studies. • … .. involving the collection or study of existing data, documents, and records if these sources are publicly available and participants originally consented to the use of their data for research purpose. maynoothuniversity.ie
Tier 2 appropriate for Research [SRESC] … • .. involving adults (excluding vulnerable adults) in non sensitive nature where the research subjects may be identified either directly or through a key/indicators linked to subjects. This includes surveys, interviews and/or observational studies. • … involving adults ( vulnerable* ) involving non-routine but standardised educational or psychological testing, in which the anonymity of participants is guaranteed. • In receipt of ethical approval from a recognised health-care centre or hospital. If no research is to be carried out at Maynooth University, applicants need only submit the hospital ethics application and approval letter. If projects include research elements at Maynooth University as well as a hospital, the Maynooth University form should be completed and submitted together with the hospital ethics application and approval letter. • A single renewal /extension or minor amendment of applications, with non- substantive modifications to previously approved Tier 3 applications involving non vulnerable humans. maynoothuniversity.ie
Tier 3 required for Research [SRESC] … .. • children (excluding proposals exempted from full review under the specific conditions described above) • pregnant women as subjects. • adults who may be deemed to be vulnerable in some way. Research addressing sensitive issues, broadly defined. • more than one phase/wave of data collection and/or involving high respondent burden. • induces affective arousal, physical stress or discomfort. • potential exposure to harm or risk greater than that encountered in normal life. • deception or withholding of information. • substantial revisions/renewals to previously approved Tier 3 applications (e.g. additional study groups, major additional observation strategies). maynoothuniversity.ie
The Biomedical and Life Sciences Research Ethics Sub-Committee [BSRESC] BSRESC reviews research projects that involve human participants, human derived material (e.g. blood and tissue samples), vertebrate animals and higher order invertebrate animals, genetically modified organisms (GMOs) and biohazardous materials, in order to ensure that the proposed research is ethically sound and does not present any risk of harm to research participants. • Research Ethics Criteria maynoothuniversity.ie
Legal obligations Data Protection Freedom of Information Check Laws in a Territory • EU data protection directive • Information technology rules (India) • The Privacy Law (Australia) • Personal data ordinance (Hong Kong) maynoothuniversity.ie
Data Protection Act, 1988. 2003 General Data Protection Regulation (GDPR) compliance by end May 2018 – review of policies in MU - changes will come • Collect personalised data for a SPECIFIC purpose only • Inform participants of how the data will be managed • Inform participants of the limits to confidentiality • Know what action to take if data is stolen • Know what kind of data falls outside of the Data Protection Act? https://www.maynoothuniversity.ie/data-protection/data-protection-policy maynoothuniversity.ie
Data Protection Advice Desktop • Sign and date & Lock it up • Remove from • Remove identifiers use a • Back up to hard camera, laptop, ‘key’ drive phone, recorder • Keep ‘key’ and data separate • Encrypt Mobile device Paper maynoothuniversity.ie
The rights of your participants • Welfare • Respect • Fully briefed • Minimise harm • Dignity • Manner of • Cultural consent • Privacy • Autonomy sensitivities Rights Protect Consent maynoothuniversity.ie
The Rights of Animals • Health Products • Replace animals • Individual Regulatory • Reduce number • Project Authority • Refine practices authorisations • Animal Welfare Body Regulation 3R’s Authorisation awb@nuim.ie maynoothuniversity.ie
The Best Rule of Thumb Consent Inform Risk Benefit maynoothuniversity.ie
Risk/Benefit Analysis What are the benefits of the research? Are the benefits to you To your participants To the wider community/society What are the risks associated with the research/outputs? Are there any risks to the participants To the wider community/society To you maynoothuniversity.ie
Risk/Benefit Analysis Assessing the risks Are you suitably trained to manage the subject matter/participants with whom you will be interacting If you are not formally trained have you relevant experience Have you access to suitable trained/experienced personnel for advice Have you a good working knowledge of other research practices for this piece of research Are you working in the right environment? Is it the safest environment for the participants? How do you protect the wider community, are there cultural sensitivities? maynoothuniversity.ie
Risk/Benefit Analysis Participant Selection Are you working with a vulnerable group and why? Is it because you have access? Conflict of interest What specific considerations do you have to include depending on the vulnerability? Mitigation against risk Detail potential routes to mitigate against each risk If you can’t mitigate against a particular risk to suitable level – what are the benefits, do they make it worth taking such a risk? If there are no benefits you have to question why? maynoothuniversity.ie
When do I need to get approval? Surveys Interviews Observation Animals Sampling maynoothuniversity.ie
MU Ethical Approval Submission Protocol (SRESC) 1. Tier (2/3) 10. Informed Consent (2 sections) 2. Title 11. Follow Up 3. Researcher Information (incl. 12. Data Management, Storage supervisor) and Retention (7 sections) 4. Previous Ethical Approval (if 13. Professional Code of Ethics applicable) 14. Declaration 5. Research Objectives (150 words) 6. Methodology (4 sections) Annexes 7. Participants (8 sections) Project Information Sheet(s) 8. Vulnerable Persons (3 sections) Consent Form(s) 9. Risk/Benefit Analysis (3 sections) Prior/other ethical approval Questionnaires Letters of Support if needed* maynoothuniversity.ie
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