Australian National University Human Research Ethics Committee

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Australian National University Human Research
Ethics Committee

• Training
• for members of
• Local Ethics Sub-Committees

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• This is an shortened presentation made by
• Prof Lawrence Cram
• Deputy Vice-Chancellor (Research)

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• The National Health Medical Council Act 1992
  establishes the Australian Health Ethics
  Committee (AHEC).
• The NHMRC must adopt the guidelines of AHEC in
  respect of medical research involving humans.

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• With the blessing of the ARC, AVCC, and learned
  academies, the NHMRC requires that all
  organizations that receive NHMRC funding must
  establish a Human Research Ethics Committee
  (HREC) and subject all research involving humans
  to ethical review by that committee.

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• The work of HRECs and researchers working on
  human subjects is shaped by the National
  Statement on Ethical Conduct in Research
  involving Humans (1999) http//www.anu.edu.au/ro/e
  thics/human.php
• The primary purpose of the statement is the
  protection of the welfare and the rights of
  participants in research.

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Principles of Ethical Conduct

• Integrity (NS 1.1)
• Respect (NS 1.2)
• Beneficence (NS 1.3)
• Justice (NS 1.5)

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Research Integrity

• Commitment to the search for knowledge
• Follow recognised principles of research conduct
• Honest and ethical conduct of research and
  dissemination of results

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Respect for persons

• Regard to the welfare, rights, beliefs,
  perceptions, customs, cultural heritage of people
  
• Respect for people as individuals and as
  collectives

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Respect points to consider

• Does the research respect the inherent dignity of
  all the participants?
• Are the welfare, rights, beliefs, perceptions,
  customs and cultural heritage of all participants
  respected in the research design?
• Where the research involves a collectivity or
  collectivities as participants, how are those
  components respected at the level of the
  collectivity?
• Does the research involve participants who are
  competent to decide for themselves?
• Does the research involve participants whose
  capacity for making informed choices is impaired
  or who otherwise have diminished autonomy?

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Beneficence in research design

• Researchers have an obligation to minimise the
  risk of harm or discomfort to participants
• Dignity and well-being of participants takes
  precedence over the expected benefits of the
  pursuit of knowledge

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Beneficence points to consider

• What risks of harm arise in the proposed
  research?
• What is the magnitude of each of these risks?
• What is the probability of each of these risks?
• Has the researcher minimised these risks, either
  in the design or conduct of the research, to a
  satisfactory extent?
• Have all reasonable efforts been made to minimize
  each aspect of the risks involved in the research
  project?

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Justice

• Within a population, there must be a fair
  distribution of the benefits and burdens of
  participation in research, and, for any research
  participant, a balance of burdens and benefits.

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Justice requires that Researchers

• Avoid imposing on particular groups, who are
  likely to be subject to over-researching
• Design research so that the selection,
  recruitment, exclusion and inclusion of research
  participants is fair
• Not discriminate in the selection and recruitment
  of actual and future participants by including or
  excluding them on the grounds of race, age, sex,
  disability, or religious or spiritual beliefs
  except where the exclusion or inclusion of
  particular groups is essential to the purpose of
  the research

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Justice points to consider

• What is the justification for selecting certain
  people for recruitment and excluding others?
• Are these justifications based on the design of
  the research?
• Are potentially vulnerable people to be
  approached for recruitment? Why? How are these
  potential participants to be protected against
  exploitation?
• Is the recruitment process conducted in such a
  way that the privacy of potential participants is
  respected, and their right to refuse to
  participate acknowledged?

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Justice (2)

• Do recruitment methods, such as advertising,
  ensure that potential participants are given a
  clear account of the purpose of the researchers
  approach?
• Are the participants representative of the
  population intended to benefit from the research?

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MAJOR ISSUES for HRECs

• Merit of the research
• Recruitment
• Consent
• Privacy

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1. Merit of the research

• Poor research on human subjects is unethical
  (weak beneficence, poor respect)
• It is sometimes argued that HRECs have no role in
  evaluating the research methods or objectives.
  This argument is wrong. An HREC should not clear
  a protocol involving poor research.
• HREC members should however appreciate that
  different research communities approach research
  in different ways
• HRECs should normally not second-guess research
  methods that have been successful in peer review

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2. Recruitment of research subjects

• Justice respect imply that participants must
  not be coerced.
• Privacy of individuals must be respected.
• Normally, people or collectives invited to
  participate should know how they have been
  selected for the invitation.
• Particular issues when a superior body
  identifies participants

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2. Consent of participants (A)

• Full information must be conveyed at
  participants level of comprehension
• Purpose
• Methods
• Demands on time, etc
• Risks
• Inconveniences discomforts
• Intended outcomes of research (including the form
  of any publication)
• Potential impact (Positive or negative) on
  participant
• Participants make an informed and voluntary choice

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3. Consent of participants (B)

• Consent to participate is always required (with
  listed exceptions)
• Where consent is required, each participants
  consent must be clearly established
• Assurance of right to withdraw at any time
  without giving reasons
• An explanation of what will happen to the data if
  a participant withdraws

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3. Consent of participants (C)

• Researchers often argue against written evidence
  of the establishment of consent
• In some cases this may be accepted e.g. with
  illiterate participants or in particular cultural
  settings. This increases the risk of the
  research.
• Protocols must list the points that will be made
  to participants in order to obtain informed
  consent (HRECs believe that some researchers may
  tend to cut corners especially with large
  samples and/or difficult communications

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3. Consent of participants (D)

• Waiver of consent from participants in some
  circumstances (e.g.)
• de-identified data in epidemiological research,
• observational research in public places,
• anonymous surveys

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Are inducements for participation ok?

• Proportionality principle
• HREC does not approve the use of raffles,
  seeing them as inherently unfair. Raffles induce
  but do not compensate individuals (except the
  winner).
• Rewards/incentives are appropriate if the
  amount/style to the effort involved and are
  offered to all.

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Research involving deception of participants

• As a general principle, deception of, concealment
  of the purposes of a study from, or covert
  observation of, identifiable participants are not
  considered ethical because they are contrary to
  the principle of respect for persons in that free
  and fully informed consent cannot be given

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4. Privacy (A)

• Privacy Act 1988 creates Information Privacy
  Principles dealing with collection of information
• Privacy principles cover
• storage of data,
• access to data,
• ensuring accuracy of data

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4. Privacy (B)

• Critical distinction between anonymity and
  confidentiality
• Need for clarity in regards to promises of
  confidentiality (who does know, what can be
  protected)
• Identified/de-identified data (HREC approval
  needed even for de-identified data)

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What the LESC should review

• Work done at Honours level other than theses or
  sub-theses normally do not need to be reviewed,
  nor do Undergraduate projects below Honours level
  (not research)
• However, each member should be alert to any
  undergraduate or honours education activity that
  potentially includes any high-risk category

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Definition of High-Risk

• Protocols including any of the following
  research topics are classified as Category A
  (high-risk) and must be sent directly to the
  Human Research Ethics Committee for its
  consideration

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High-risk involving the following participants

• Children and young people (minors under the age
  of 18)
• Aboriginal or Torres Strait Islander peoples
• Clients of a service provider, including health
  service providers
• Prison inmates
• People with an intellectual or mental impairment
• People highly dependent on medical care

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• Hospital in-patients
• Clinical clients
• Cadavers/body organs or tissue
• Members of socially disadvantaged groups
• People in dependent or unequal relationships
• Refugees, temporary protection visa holders, or
  others in similarly sensitive situations

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High-risk topics which include

• Illegal activities of any kind
• Aboriginal or Torres Strait Islander projects
• Deception of participants
• Concealment or covert observation
• Fieldwork in potentially dangerous locations
• Fieldwork in politically sensitive areas
• Mental health research, such as suicide and
  depression
• Medical research in general

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High-risk research procedures which include

• Covert observation
• Examination of medical, educational, personnel or
  other confidential records
• Physical experimentation
• Administration of physical substances such as
  drugs, alcohol and food
• Physical examination, including measurements such
  as blood pressure or temperature
• Collection of body tissues or fluid samples
• Surgical procedures

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Definition of Minimal-Risk

• Also known as Category B protocols
• Minimal risk research occurs when the
  probability of harm or discomfort anticipated in
  the research are not greater in and of themselves
  that those ordinarily encountered in daily life
  (NS, p64)

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Minimal-risk research which targets any of the
following

• Healthy members of the community
• University students
• Employees of a specific company/organisation
• Members of a specific community group, club or
  association
• People not in a dependent relationship or in a
  situation where coercion is possible

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Minimal-risk research procedures which include

• Anonymous questionnaires (i.e. where identities
  cannot be traced in any way)
• Coded (potentially identifiable)
  questionnaires/surveys
• Identifiable surveys or questionnaires
• Examination of student work, journals, etc
• Overt observation
• Interviews (structured or unstructured), whether
  in person or by telephone
• Questions by email
• Web-based surveys