How to apply to the NUI, Galway

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How to apply to the NUI, Galway Research Ethics
Committee Dr Anne Byrne, School of Political
Science and Sociology Dr Molly Byrne, School of
Psychology 25th February, 2009
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Are you conducting research with human subjects?
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What are the ethical issues for researchers?
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DO NO HARM (nonmaleficience) and DO GOOD
(beneficience).
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NO DECEPTION
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INFORMED CONSENT
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ANONYMITY and CONFIDENTIALITY
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How do you manage these concerns in making an
application to REC?
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Regulatory and ethical obligations to protect
research participants apply, for example, to
research that uses Data from varied research
methods including surveys, interviews, and
observation Private information, such as
medical, family, or employment information, or
residual administrative records including
earnings, and treatment histories that can be
readily identified with individuals, even if the
information was not specifically collected for
the study in question Tissue specimens,
obtained for routine medical care that would have
been discarded if not used for research, or DNA
samples, where samples can be linked to a living
individual.
Human Subject Research
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The objective of the NUI Galway Research Ethics
Committee is to safeguard the health, welfare and
rights of human participants and researchers (in
the case of hazardous materials) in research
studies and to afford dignity to the handling and
treatment of biological materials, taking into
account the scientific procedures and concerns of
the local community. For any research proposal to
gain ethical approval it must be necessary and of
a design that minimises predictable risk to both
the research participant and the
researcher.Therefore, you may require Ethical
Approval if you wish to carry out research within
NUI Galway for any area that involves humans or
their tissues, biological materials or hazardous
substances
safeguarding the health, welfare and rights of
human participants and researchers

• For Ethical Approval to be given there is a
  requirement that the research requiring approval
  should not commence before such approval is
  granted. 

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Session overview

• How the REC works (AB)
• How to complete the application form (MB AB)
• Common issues that arise (MB)
• Questions and answers

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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.

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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
• Operating procedures
• Website http//www.nuigalway.ie/research/vp_resear
  ch/ethics.html

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Terms of Reference

• Advocate and encourage ethical standards of
  practice in research
• Protect subjects of research from unnecessary
  harm
• Preserve the subjects rights
• Through its functions, provide reassurance to the
  public that best practice is being applied

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X 2 (Full Alternate)
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Primary Task

• The primary task of the Research Ethics
  Committee is to review research proposals and
  their supporting documentation, with special
  attention being given to the informed consent
  process, documentation and the suitability and
  feasability of the protocol. Research Ethics
  Committees need to take into account prior
  scientific reviews, if any, and any requirements
  of applicable laws and regulations
• Research Ethics Committees are responsible for
  following the progress of all studies (for which
  a positive decision has been reached) from the
  time the research commences through to its
  termination
• Standard Operating Procedures NUIG REC

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Elements of Review

• Scientific Design and Conduct of the Study
  (Protocol)
• Recruitment of Research Participants/Volunteers
• Care and Protection of Research
  Participants/Volunteers
• Protection of Research Participant/Volunteer
  Confidentiality
• Informed Consent Process
• Community Considerations

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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 Vs 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 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

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Recruitment of Research Participants / Volunteers

• 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

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Care and Protection of Research Participants /
Volunteers

• 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

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Care and Protection of Research Participants /
Volunteers

• 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

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Protection of Research Participant / Volunteer
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
• Data Protection Act (1988, 2003) obligations

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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

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Community Considerations

• Impact and relevance of the research on the local
  community and the concerned communities from
  which participants/volunteers are drawn
• If appropriate process to consult with the
  concerned communities during the course of
  designing the research study
• If appropriate community consultation during the
  research
• Way results will be available to research
  participants and the concerned communities

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Complete Application form and checklist
Application Procedure

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

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Possible Decisions
Approval Declined
Provisional Approval
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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

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Section 1 Applicant details

• Title, identical to one used on funding
  applications
• All investigators listed
• Signed by principal investigator and Head of
  School/Supervisor

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Section 2 Study details

• Qs 78 Aims, objectives and background written
  so theyre understandable to a reader without
  specialist knowledge
• Q 9. Summary of detailed study plan appended to
  application. Summary detailed and specific enough
  for REC members to know in broad terms what
  youre planning to do.
• Q 10. List all possible risks, however minor.
  Complete Risk Assessment (Annex 3) form for each
  risk.

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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

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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

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Informed consent contd

• 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

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Section 5 Details of Interventions

• Info sheet to GP if drug/invasive procedure
  involved
• Medical devices subject to similar regulations as
  drugs
• Blood/tissue samples - retained or destroyed on
  completion of the study?
• Ionising/non-ionising radiation?

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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
• If there is an identifiable risk - See Risk
  Assessment Form

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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

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Section 8 Confidentiality

• Data Protection Act
• 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

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Writing a Participant Information Sheet

• Purpose of study, nature of procedures, risks and
  benefits
• Participant can decline/free to withdraw without
  explanation or penalty
• Availability or non-availability of compensation
  for injury
• An invitation to ask for more information

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Over to you....

• Review examples of Participant Information Sheets
• Are they good or bad in your view?
• What do they do well and do poorly
• Write your own!

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Common issues that arise

• Unclear, not enough information
• Quality of research (only when risk...)
• Incomplete application form (use n/a)
• Children in research consent, assent, proxy
  consent
• Anonymity and confidentiality
• Searching medical records (Agent to practice)
• Retention and storage of data (5 year rule)

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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
• Send queries to Anne and Molly
• Talk with your supervisor/colleagues

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RESEARCH ETHICS COMMITTEE Submission Deadlines
and Meetings Timetable Planning Ahead

• Deadline for submission 5pm Tuesday, January
  6th, 2009
• Research Ethics Committee Meeting 1.30pm
  Wednesday, January 28th 2009
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• Deadline for submission 5pm Monday, March 2nd
  2009
• Research Ethics Committee Meeting 10.30am
  Tuesday, March 24th 2009
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• Deadline for submission 5pm Tuesday, May 5th
  2009 
• Research Ethics Committee Meeting 10.30am
  Wednesday, May 27th 2009
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• Deadline for submission 5pm Monday, June 15th
  2009 
• Research Ethics Committee Meeting 1.30pm
  Tuesday, July 7th 2008
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• Deadline for submission 5pm Tuesday, Sept 1st
  2009
• Research Ethics Committee Meeting 1.30pm
  Wednesday, September 23rd 2009
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• Deadline for submission 5pm Monday, November 2nd
  2009 
• Research Ethics Committee Meeting 10.30am,
  Tuesday, November 24th 2009

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Procedures for monitoring ongoing research

• Reporting requirements
• Up to REC to decide
• Minimum Annual Report
• Follow-up Review
• Study Termination