How to apply to the NUI, Galway Research Ethics Committee

Dr Molly Byrne, School of Psychology 15th October, 2010

Session overview

1. How the REC works 2. How to complete the application form 3. Common issues that arise4. Questions and answers

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”.

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 http://www.nuigalway.ie/research/vp_research/ethics.html

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

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

Complete Application form and checklist

Application for ethical approval distributed to REC members at least 2

weeks before REC meeting

All details of•Application Form•Informed Consent procedures•Participant information leaflets•Questionnaires•Protocol•Other details as appropriatePDF format, Processed by REC Secretary

Submission to REC Secretary at least 3 weeks before next REC meeting

App

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Pro

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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 2011Research Ethics Committee Meeting: 1.30pm Wednesday, January 26th 2011

Dates for REC meetings

Possible Decisions

DeferralApproval

Approval Declined

Provisional Approval

Important considerations

• Scientific design and conduct• Recruitment and protection of research

participants• Consent• Confidentiality

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

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

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.

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

Care and Protection of Research Participants

• A description of any financial costs to participant • The rewards and compensations (if any) for

participants and justification

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.

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

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)

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

How to complete the application form

Section by section…..1. Applicant details2. Study details3. Recruitment of participants4. Consent5. Details of interventions6. Risks and ethical problems7. Indemnity8. Confidentiality

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)

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.

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

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.

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

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

Section 5: Details of Interventions

• Indicate any intervention being used (even if it’s a survey)

• Mostly focuses on medical/physical intervention

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

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

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.

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

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

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)

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

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.

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).

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