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EHS Ethics Briefing Session January 13 th 2015. Slide 2 EHS Ethics Briefing Session. Dr. Barry Coughlan Assistant Director of Clinical Psychology Department of Psychology; Chair EHS REC; Faculty of Education & Health Sciences University of Limerick Limerick, Ireland. Tuesday January 13 th 2014. Slide 3 Session Overview Welcome, Introduction & EHS REC overview. EHS Ethics Form & Guidance Document. Vulnerable Populations. Common problems & pitfalls when submitting to EHSREC. HSE Ethics Applications. Questions & answer session. Slide 4 Structure of EHS REC Committee Membership: Physical Education & Sport Sciences x2 Psychology x2 Graduate Entry Medical School x3 Education & Professional Studies x2 Nursing & Midwifery x2 Clinical Therapies x2 Statistical Consultant x1 External member x2 Administrator x1 Slide 5 EHS Research Ethics Committee reviews all applications & agree outcome. Administrator assigns EHSREC number and sends documents to EHS Committee Members for review ApprovedMinor Revisions Return revised application with cover letter indicating changes made. ApprovedMinor Revisions Chairs Action (project already has EHSREC approval) Major Revision requiring full resubmission Submit Ethics Application by deadlines indicated on web Send electronic copies to ehsresearchethics@ul.ie Send paper copies to EHSREC administrator E1003 Slide 6 AY 12/13 Statistics. Slide 7 AY 12/13 Outcomes. Slide 8 What Issues Should Ethics Committees Consider? Respect for persons: Regard for the welfare, rights, beliefs, perceptions and customs, both individual and collective, of individuals involved in research. Privacy & Confidentiality: The need for research should be weighed against infringements of privacy and steps must be taken to ensure that individuals are protected from any harm that might be caused as the result of access to their personal information. Validity of Research Proposals: The merit of a study is itself an ethical issue. The essential features of ethically justified research involving human participants are that the research offers a means of developing information, not otherwise obtainable, that the design of the research is sound, that the investigators & other research personnel are qualified & capable & that the methods to be used should be appropriate to the objectives of the research & the field of study. Slide 9 What Issues Should Ethics Committees Consider? Risks: Researchers should maximise the potential benefits to the participants and minimise the potential risks of harm. If there are any risks resulting from participation in the research, then there must be benefits, either to the subject, or to humanity or society in general. Researchers must ensure that predictable injury, either through acts of commission or omission will be prevented. Justice: Justice: Justice imposes duties to neither neglect nor discriminate against individuals or groups who may benefit from advances in research, to avoid imposing on a particular group an unfair burden of participation in research and to design research so that the selection and recruitment of research participants/volunteers Slide 10 Some Important Points to Consider Informed consent. Clear & detailed information, within the application Role of the PI. Importance of timely submission! Is EHS REC the correct committee for my study? (HSE or others?). Ensuring applications are complete, reviewed & signed. Issue of indemnity. Quality. Slide 11 http://www.ul.ie/ehs/research-ethics Slide 12 Slide 13 Slide 14 Slide 15 Slide 16 Guidance Document All you need to know about the application process Slide 17 Slide 18 Slide 19 EHSREC Application Form Slide 20 Slide 21 Slide 22 Slide 23 Slide 24 Slide 25 Slide 26 Slide 27 Slide 28 Slide 29 Slide 30 Slide 31 Vulnerable Populations & Complex Learning Needs Slide 32 Ethically Sound Research Involves values and judgements that bring together the academic; the professional; the personal and are coded as: TrustTruthfulnessHonestyIntegrityRespect Impartiality and fairness AccuracyOpenness Reflexive awareness (Drake & Heath, 2011) Slide 33 Major Ethical Principles Informed consent. Minimisation of potential harm/deprivation of benefit. Confidentiality & protection of privacy. Slide 34 Informed Consent Refers to disclosure by the researcher, before the study, of what will happen during the study and of any other information that might affect the persons decision about whether or not to enter the study. It involves: Adequate information Freedom of choice Competence Slide 35 Informed Consent Difficulties arise when the persons understanding of the issues is limited. Children or adults who are not fully competent to make their own decisions. Intellectual disability and other clinical populations (as an example) Slide 36 Important Issues Sensitivity & clinical skills are required by the researcher. How information is given? Level of readability Comprehensibility of the study description. What information is given? Avoid technical language To whom is information given? Processing time? Slide 37 Practical Issues Appropriate data gathering strategies (assistive technologies for example) Interview duration Interview Setting. Rapport & trust. Questioning style. Importance of Facilitated Communication Slide 38 Other Issues Participants legal status/standing. Consent versus Assent. Individual capacity. Codes of Professional Practice/Standards/ Best Practice Guidelines will guide us. Slide 39 Common Problems & Pitfalls Slide 40 Common Errors! Incomplete applications Incorrect details given . Additional information not included (appendices) Formatting problems Lack of clarity within information provided actual application or associated documents. Poor linkage between study title, study aims & methodology. Overall QUALITY! Slide 41 HSE & Other Applications Slide 42 http://www.hse.ie/eng/service s/list/3/hospitals/ulh/staff/car eertrain/Research/ResearchEth ics/ Slide 43