School of Natural Sciences ethics application process. Dr. Jane Stout Chairperson of the SNS Research Ethics Committee October 2015
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1 School of Natural Sciences ethics application process Dr. Jane Stout Chairperson of the SNS Research Ethics Committee October 2015
2 Why have a School Ethics Committee? TCD policy: all research to be conducted in ethical manner Many research funding bodies (incl. European Commission) require statements on the ethical review process of the host institutions Increasingly, journals are only accepting papers if the research has received formal ethical review
3 Ethics in TCD All research in TCD should be conducted in line with the TCD Policy on Good Research Practice, which includes ethical principles. All research should follow the guiding ethical principles of: 1. respect for the individual subject or population 2. beneficence and the absence of maleficence (research should have the maximum benefit with minimal harm) 3. justice (all research subjects and populations should be treated fairly and equally) AL_Good%20Research%20Practice%20policy_COU NCIL%20APPROVEDandminutedgg.pdf
4 European code of conduct for research integrity 8 basic principles that underpin research integrity Honesty Reliability Objectivity Impartiality and independence Open communication Duty of care Fairness Responsibility for future science generations
5 Ethics in TCD TCD has two levels of Research Ethics Committee (RECs); Level 1 for low risk research and Level 2 for medium to high risk research. The School of Natural Sciences REC is a Level 1 (low risk) committee and was set up in TCD s Level 2 RECs include: Animal Research Ethics Committee FEMS Ethics Committee Faculty of Arts Humanities and Social Sciences Ethics Committee Faculty of Health Sciences Ethics Committee St James's Hospital / Tallaght Hospital, Research Ethics Committee (JREC)
6 School of Natural Science Research Ethics Committee Jane Stout (Chair) Emma Siddall Sean McClenaghan (Geology) Steve Waldren (Botany) Susan Murphy (Geography)? (Zoology) Gaia Narciso (Economics)
7 Who needs to complete an ethics application Ethical approval is needed for all research conducted in the School This applies to all staff, postgraduate and undergraduate students and volunteers/interns Failure to submit is form of research misconduct and Junior/Senior Dean may become involved
8 Application process Completed SNS REC application forms should be ed to Jane Stout and Emma Siddall The deadline for submission is the 15 th of each month The application will be read by two members of the REC. The outcome of the review is: Approval Approval with changes Rejection We aim to give you a response by the 1 st of the following month
9 SNS Ethics webpage
10 Application process All researchers must complete: Section 1: Applicant Details Section 2: Initial Research Ethics Checklist Section 5: Declaration
11 Section 1: Applicant details
12 Section 2: Initial Research Ethics Checklist Does your research project fall clearly under any of the following categories? 1. Quality assurance study (e.g. assessment of teaching practice) 2. Audits of standard practice (not involving identifiable records) 3. Research on publically available information, documents or data If you answer YES to one or more of the questions in section 2 your research doesn t need ethical approval and can proceed once the REC has received signed copy of the ethics application form. YES NO If you answered NO to all questions in section 2, then proceed to section 3
13 Section 3: Checklist for School REC suitability 1. Surveys asking questions of a sensitive or private nature 2. Questionnaires or observational studies involving children or vulnerable adults. 3. Research where there is a risk of a participant feeling undue pressure to participate by virtue of his/her relationship with the researcher (e.g. student/supervisor; patient/clinician). 4. Projects involving a justifiable degree of deception. 5. Analysis of archival irrevocably anonymised human tissue samples for which consent for research was not originally given, and was not acquired in the course of clinical treatment. (Archived samples taken for a previous research study must always get new ethical approval). 6. Research involving invasive procedures (other than those listed above). 7. Research involving vulnerable persons.
14 Section 3: Checklist for School REC suitability 8. Research where identifiable information obtained may have legal, economic or social consequences for research subjects. 9. Research that may identify illegal activity on the part of the participant. 10. Projects where each subject is paid (over and above token gestures). 11. Research that may potentially endanger the subjects, and/or researchers, and/or 3rd parties, and/or the environment. 12. Research involving the collection of human tissue. 13. Research that may have a direct military role. 14. Potentially harmful research involving humans conducted outside Ireland. 15. Research involving psychological intervention.
15 Section 3 question 11 Research that may potentially endanger the subjects, and/or researchers, and/or 3rd parties, and/or the environment. Please answer NO to this category if you have official approval from an outside body or if work will be designed specifically to minimize the chances of potentially endangering people and/or the environment.
16 Section 3 If you have answered YES to any questions in section 3, then the application is deemed to be of moderate or high risk and should be submitted to an appropriate Level 2 Ethics Committee. Such as the FEMS REC or the Animal REC If you have answered NO to all questions in section 3 then please complete Section 4 and 5.
17 Section 4 - Potential ethical issues Are there ethical issues or problems which may arise with the proposed study, and what steps will be taken to address these? Are there potentially adverse outcomes to the environment (e.g. destruction of individuals, populations, habitats, physical structures)? Will the environment be altered by the experiment (e.g. through alteration of biological, geological or chemical systems)?
18 Section 4 - Ethical considerations to reduce risk and impact Where potential risks to participants or the environment may be present, explain any steps that will be taken to mitigate against and minimize these and any additional support services that might be used should the need arise. For studies involving human participants outline the information and informed consent forms. Mention the presence of a translator if necessary. Questions will be designed to gather the data needed but reduce the chances of discussion of other confidential information.
19 Section 4 Data storage Provide an explanation of any measures that will be put in place to preserve confidentiality and anonymity of human participants, including an explicit explanation of secure data storage and disposal plans. Provide details of where data will be stored at the end of the project. TCD s Policy on Good Research Practice states that in general data should be stored for 10 years after the completion of the project. In the case of personal data, and in accordance with the Data Protection Acts 1988 and 2003, once the data retention period has expired, the data must be destroyed either through deletion of electronic data or the shredding of hard copy data.
20 Section 4 - Published ethical guidelines to be followed Identify professional code(s) of practice and/or ethical guidelines relevant to the research, such as: TCD Policy on Good Research Practice American Association for Public Opinion Research Code of Professional Ethics and Practice UK Academy of Social Sciences Ethical Principles OECD Code of Conduct The Respect Code of Practice Amateur Entomologists Society code of conduct
21 Forms for studies involving humans For studies involving human participants both a Participant Information Form and an Informed Consent Form need to be included with the Ethics application. Both these forms need to be presented to each participant before the study commences.
22 Participant Information Form This should be written in clear non-technical English and aimed at the potential subjects in the project, not at the REC Recommended wording for certain sections is provided in italics Please feel free to delete sections that are not relevant to your research
23 Informed Consent Form Participants must read or have read to them the information form, before being asked to sign the consent form. If the participant is unable to read the forms themselves, a witness may read them the information and sign the consent form on their behalf. The form must be co-signed by the researcher. An original of the form should be kept by the research, one should be given to the participant, and another sent to any associated sponsor
24 Section 5 - Declaration Signature of supervisor in the case of students All student applications should be reviewed and approved by the project supervisor prior to submission.
25 Reports If the project runs for more than one year, an annual report needs to be completed and returned to the REC each year. Once the research is completed an end of project report must be returned to the REC.
26 Annual Report Is the study continuing? If YES, please provide the anticipated date of completion. Have there been any modifications to the study for which Ethical approval was granted? If YES, please provide details (only give details that are relevant to ethical approval) Have there been any adverse outcomes associated with the conduct of the research? If YES, please provide details. State that all data are being stored in accordance with TCD s data storage policy, the FOI Act and requirements of the Data Protection Commissioner.
27 End of project report Are the results of the study published? If YES, where (give details of thesis, paper, report etc.) Were there any modifications to the study for which Ethical approval was granted? If YES, please provide details (only give details that are relevant to ethical approval) Were there any adverse outcomes associated with the conduct of the research? If YES, please provide details. State that all data are being stored in accordance with TCD s data storage policy, the FOI Act and requirements of the Data Protection Commissioner.
28 Summary Download forms from h/ethics/ Complete, sign and to REC Don t forget information & consent forms if study involves humans Revise as necessary Complete annual/end of project reports What is Ethics in Research & Why is it Important? by David B. Resnik
29 Thank You
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