1. NUI, Galway, Research Ethics Committee, Training Day Oct 2005
How to apply to the NUI, Galway
Research Ethics Committee
Dr Molly Byrne, School of Psychology
15th October, 2010

2. NUI, Galway, Research Ethics Committee, Training Day Oct 2005
Session overview
How the REC works
How to complete the application form
Common issues that arise
Questions and answers

3. Declaration of Helsinki 1964
NUI, Galway, Research Ethics Committee, Training Day Oct 2005
Declaration 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 Works
Provides a Service via the Office of the Vice-President for Research
To assist in the ethical review of research
Complimentary support to the Declaration of Helsinki and International Good Practice
Reviews all staff and post-grad research
Website 4

5. NUI, Galway, Research Ethics Committee, Training Day Oct 2005
Terms of Reference
Advocate and encourage ethical standards of practice in research
Protect research participants from unnecessary harm and preserve their rights
Through its functions, provide reassurance to the public that best practice is being applied 5

6. Committee composition
Law
Social Science (2)
Professional Care and Treatment of People (3 – inc 1 mental health)
Mental Health
Ethics Training
Lay Members (2)
Sciences (2)
Post Grad Representative
Committee Secretary

7. Application Procedure
Complete Application form and checklist
Application Procedure
Submission to REC Secretary at least 3 weeks before next REC meeting
All details of
Application Form
Informed Consent procedures
Participant information leaflets
Questionnaires
Protocol
Other details as appropriate
PDF format, Processed by REC Secretary
Application for ethical approval distributed to REC members at least 2 weeks before REC meeting

8. Dates for REC meetings
Deadline for submission: 5pm Tuesday, October 26th 2010 
Research Ethics Committee Meeting: 10.30am, Wednesday, November 17th 2010
Deadline for submission: 5pm Tuesday January 4th 2011
Research Ethics Committee Meeting: 1.30pm Wednesday, January 26th 2011

9. Possible Decisions Deferral Approval Approval Declined
Provisional Approval

10. Important considerations
Scientific design and conduct
Recruitment and protection of research participants
Consent
Confidentiality

11. Scientific Design and Conduct of the Study
NUI, Galway, Research Ethics Committee, Training Day Oct 2005
Scientific Design and Conduct of the Study
Is the information complete to allow investigation of ethical questions in the study?
Suitability of the protocol and the data collection forms
Justification of predictable risks and inconveniences V’s anticipated benefits for participants/ volunteers and the concerned community
Criteria for prematurely withdrawing participants/ volunteers from the research
Criteria for suspending/terminating research
Adequacy of provisions for monitoring and auditing the conduct of the research, including data safety
Adequacy of the site including support staff, available facilities and emergency procedures where applicable
The manner in which the results will be reported and published 11

12. Recruitment of Research Participants
NUI, Galway, Research Ethics Committee, Training Day Oct 2005
Recruitment of Research Participants
Characteristics of population and justification for selection
Method by which initial contact and recruitment made and appropriateness
Method by which full information conveyed and consent obtained
Inclusion and exclusion criteria 12

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 2005
Care and Protection of Research Participants
The safety of any intervention used
Suitability of the investigator (qualifications/experience)
Queries and complaints procedure
If applicable, plans to withdraw standard therapies/ justification
If applicable, adequacy of support during and after
Procedure for participants early withdrawal
If appropriate procedure for informing GP 14

15. Care and Protection of Research Participants
NUI, Galway, Research Ethics Committee, Training Day Oct 2005
Care and Protection of Research Participants
A description of any financial costs to participant
The rewards and compensations (if any) for participants and justification 15

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 2005
Care and Protection of Research Participants
A description of any financial costs to participant
The rewards and compensations (if any) for participants and justification
Provisions for compensation/treatment in the case of injury/disability/death
Insurance and indemnity arrangements covering liability of investigator
Description of payments to researcher to conduct study 17

18. Protection of Research Participant Confidentiality
NUI, Galway, Research Ethics Committee, Training Day Oct 2005
Protection of Research Participant Confidentiality
Who will have access to personal data?
Measures taken to ensure confidentiality and security of personal data
Extent to which the info will be anonymised
How samples/data will be obtained and the purpose for which they will be used
How long will samples/data be kept (standard is 5 years) 18

19. Informed Consent Process
NUI, Galway, Research Ethics Committee, Training Day Oct 2005
Informed Consent Process
Full description of process
Adequacy, completeness and understandability of written and oral info given
Content and wording of participant info sheet
Content and wording of informed consent form and provisions for those incapable of giving consent personally
Justification for including individuals who cannot consent and full account for arrangements in obtaining consent
Assurances that participants/volunteers will receive info that becomes available during the course of the research 19

20. How to complete the application form
NUI, Galway, Research Ethics Committee, Training Day Oct 2005
How to complete the application form
Section by section…..
Applicant details
Study details
Recruitment of participants
Consent
Details of interventions
Risks and ethical problems
Indemnity
Confidentiality

21. Section 1: Applicant details
NUI, Galway, Research Ethics Committee, Training Day Oct 2005
Section 1: Applicant details
Title, identical to one used on funding applications
All investigators listed
Signed by principle investigator and Head of School/Supervisor
Include 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 2005
Section 2: Study details
Qs 7&8: Aims, objectives and background written so they’re understandable to a reader without specialist knowledge
Q 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 2005
Section 3: Recruiting participants
Clear description of process of recruitment
‘Non-competent’ or vulnerable participants
Only when necessary, must justify
Care to protect
Incentives to participate?
Should not be so strong that they compromise real choice about whether to participate
‘Course credit’ system within psychology
Inclusion/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: Consent
Ideally,
Clearly worded participant information sheet to keep
Plenty of time to decide (at least 24 hours)
Separate form for written consent
Not 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 2005
Participant information sheet
Appendix 1 to REC Guidance Notes
Must 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/theory
Risks and benefits
Confidentiality assured
Participation is voluntary
Contact for researcher for added questions
Carry out your own review of some Participant Information Sheets

27. Section 5: Details of Interventions
NUI, Galway, Research Ethics Committee, Training Day Oct 2005
Section 5: Details of Interventions
Indicate any intervention being used (even if it’s a survey)
Mostly focuses on medical/physical intervention 27

28. Section 6: Risks and Ethical Problems
NUI, Galway, Research Ethics Committee, Training Day Oct 2005
Section 6: Risks and Ethical Problems
Careful and realistic consideration of potential risks, side affects, adverse effects, physical or psychological discomfort to participants, likelihood of occurrence, steps taken to deal with risk 28

29. What do you think?
What are the risks involved in the following studies:
Interviewing children about their body image
Conducting a controlled trial of a new therapeutic programme for autism
Reviewing medical records to document frequency of reporting of mental health problems within the University medical centre
Conducting 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: Indemnity
NUI Galway Professional Indemnity will cover the majority of studies
View University Indemnity Policy to ascertain if your study is covered in full 31

32. Section 8: Confidentiality
NUI, Galway, Research Ethics Committee, Training Day Oct 2005
Section 8: Confidentiality
Means ensuring that information is accessible only to those authorized to have access to it
Precautions in the public use of audio, video, visual materials if confidentiality and anonymity guaranteed
Medical records - study relevant material only
Main investigator responsibility for others to observe confidentiality also 32

33. Common issues that arise
NUI, Galway, Research Ethics Committee, Training Day Oct 2005
Common issues that arise
Unclear, not enough information
Quality 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 research
Generally 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 assent
Assent 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 2005
What next?
Consult website and support materials
Think 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 time
Talk with your supervisor/colleagues 37