Human Research Ethics and Obtaining Ethics Approval

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Human Research Ethics and Obtaining Ethics
Approval

• Division EASS Autumn School
• Janet Bryan

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Why we need to consider research ethics and
obtain ethics approval

• UniSA Research Services
• It is important that research involving human
  participants is conducted in a way that protects
  all people involved in the research the
  researcher, the participants of the research, and
  the University

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Useful resources for preparing your ethics
application

• UniSA policy
• http//www.unisa.edu.au/policies/policies/resrch/
  res02.asp
• University Human Research Ethics webpage
• http//www.unisa.edu.au/res/ethics/human.asp
• National Statement on Ethical Conduct in Human
  Research (NHMRC, 2007)
• http//www.nhmrc.gov.au/publications/synopses/e35
  syn.htm
• Australian Code for the Responsible Conduct of
  Research
• http//www.nhmrc.gov.au/publications/synopses/r39
  syn.htm

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Principles and Themes of Ethical Research
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Principles of ethical conduct in research

• Research merit and integrity research is
  valuable and is conducted with integrity
• Justice provides a fair distribution of
  benefits and burdens of research
• Beneficence minimise risk to participants
• Respect regard for the welfare, rights,
  beliefs, perceptions, customs and cultural
  heritage of participants

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Themes in research Risk and benefit

• Potential benefits of research should justify any
  risks.
• Identifying risk Does the research lead to harm
  (physical, psychological, social, economic or
  legal), discomfort or inconvenience?
• Gauging risk What kind, severity and likelihood
  of harm, discomfort or inconvenience? Judgements
  should be made on available evidence.  
• Minimising risk design the research aims and
  methods to minimise risk.
• Managing risk include procedures for dealing
  with risk and for monitoring it during the course
  of the research.

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Themes in research Consent

• Informed Consent
• The provision of information about purpose,
  methods, demands, risks, inconveniences,
  discomforts, and possible outcomes so that an
  informed voluntary choice can be made
• Those not participating should be able to do so
  without consequence
• Consideration of the capacity to make a voluntary
  choice

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Obtaining Ethics Approval
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What requires ethics approval?

• Any research involving contact with human
  participants
• Clinical research
• Research involving data collected by interviews,
  questionnaires, focus groups, observation
• Action research projects
• Use of human tissue
• Access to medical or other records which are not
  publicly available, which identify individuals
  and which contain personal information

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How to obtain ethics approval

• UniSA has 2 levels of ethics committees, the
  University Human Research Ethics Committee (HREC)
  and Divisional ethics committees (DEASS HREC)

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DEASS HREC

• DEASS HREC website
• http//www.unisa.edu.au/easacademicservices/commit
  tees/ethics/
• Assesses the majority of Honours and Masters by
  Coursework student application
• Submission made any time but check meeting times
• Note the recess from 7th-25th July. Deadline
  before recess is Tues 10th June
• Submission via email to
• lianne.quin_at_unisa.edu.au

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University HREC

• UniSA Ethics committee website
• http//www.unisa.edu.au/res/ethics/human.asp
• Note meeting and submission dates
• The information and forms required to submit an
  ethics application are the same for both Div and
  Uni committees

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Preparing an ethics application

• Use the following
• The Guidelines for Preparing Ethics Protocols is
  very useful as it takes you through the
  completion of an ethics application step-by-step
• The Ethics Protocol Proforma which contains the
  coversheet, checklist and proforma.

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Ethics coversheet

• Records contact details of the researcher (you),
  the title of your project and supervisors
  signature
• Note that supervisors are responsible for signing
  to say that they have read the application and
  they think it is completed in accordance with
  UniSAs protocol guidelines

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Ethics checklist

• Identifies any issues that need to be approved by
  the University HREC rather than the Divisional
  Ethics Committee. Covers things like
• The nature of the sample
• Risks to participants and researchers
• Variations to the consent procedures the type of
  methodology used
• Whether other organisations will be involved
• Reporting procedures
• Payment of participants.
• If you answer yes to any of these questions it
  will most likely need to be approved by to
  University HREC

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Ethics proforma

• Write in plain English
• Answer the questions!
• Remember the ethics committee is assessing your
  project with regard to the principles and themes
  for ethical research
• Number your responses in line with the numbering
  on the proforma
• If multiple ethics approvals required, dont use
  another organisations proforma

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Section 1. Research Aims

• 1.1 Aims of research, what you project is aiming
  to do
• 1.2 The need for and value of the research
  Research involving humans must be valuable and
  the value should outweigh risks.

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Section 2. Research Methodology

• 2.1 Research questions and hypotheses
• 2.2 Outline design and methods. Committee needs
  to ensure your methods will produce valid
  results. Include all copies of research tools
• 2.3 Indicate whether your project is part of a
  larger one

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Section 3. Research participants

• Participants must be volunteers, free to choose
  without consequence, must be fully informed,
• Student participants must not be subjected to
  academic, personal or financial pressure.
• UniSA procedures on gaining approval to access
  research participants
• www.unisa.edu.au/res/ethics/human.aspaccess

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Research participants

• 3.1 Who will be approached/recruited. How many?
  The number of participants should be justifed
• 3.2 Selection and exclusion criteria. These need
  to be justified to ensure equality of
  participation
• 3.3 How will participants be recruited? Provide
  copies of advertisements, flyers etc.

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Research participants

• 3.4 How you will provide detailed information
  about your study to participants? The information
  Sheet provides all information required for
  participants to make informed consent. Refer to
  guidelines for Information Sheet
• 3.5 How you will obtain consent. Usually by
  requesting a consent form be signed, use Consent
  Form template.
• Signing signifies participants know whats
  expected, what potential risks are, that they are
  free to withdraw without prejudice.
• Return of anonymous questionnaire also signifies
  consent.

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Research participants

• 3.6 Acknowledge any unequal power relationship
  with you as a researcher and detail how you will
  reduce the obligation to take part.
• 3.7 How will participants confidentiality be
  preserved? Separate identifying information from
  data as soon as possible
• 3.8 Identify any potential risks and detail how
  these will be minimised.

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Research participants

• 3.9 Indicate how any safety implications for the
  researcher will be addressed.
• 3.10 Detail and justify any reimbursement for
  participation. Can be reimbursed for costs of
  travel, parking and other expenses incurred due
  to participation.

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Section 4. Recording, reporting, storage and
access to data and results

• 4.1 Describe how data will be recorded. Need
  explicit consent to audio or video record
  (include on consent form)
• 4.2 Describe how, where and in what form data
  will be stored. Data must be securely stored for
  7 years
• 4.3 Specify who will have access to the data.
  Data must not be used and disseminated in any way
  not agreed upon by participants.

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Section 5. Ownership of research

• 5.1 Detail who will own the data. Students
  normally own the data they collect.
• Authorship may be shared, must reflect the
  proportion of work undertaken.