RESEARCH ETHICS

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RESEARCH ETHICS

• Lorinda Schultz
• Member, Human Research Ethics Committee
• Research Ethics Advisor
• Faculty of Health
• The University of Newcastle

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Outline

• Why ethics?
• History
• Australian background (NHMRC/National Statement
  etc.
• University of Newcastle requirements
• How to write a successful application

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Lessons..?

• 'U' professors to be trained in research ethics
• By Rachel Kruer, Daily Staff Reporter 1/10/05
• http//media.www.michigandaily.com/media/storage/p
  aper851/news/2005/01/10/News/u.Professors.To.Be.Tr
  ained.In.Research.Ethics-1427768.shtml

• For 950, Engineering alum Tony Cabanero said he
  allowed clinical researchers conducting a study
  at the University Hospital to insert a syringe in
  each of his cheeks, one of them injecting a
  pain-inducing saline solvent. Meanwhile, the IVs
  in each of his arms carried an experimental
  medicine, of which Cabanero does not now remember
  the name, into his bloodstream. This procedure
  was repeated several times with varying doses of
  the solvent and the drug to investigate the
  drugs ability to inhibit pain, he said. Cabanero
  added that the doctor conducting the research
  told him that he would experience discomfort 30
  percent as intense as the worst pain imaginable.
  He scanned the highlighted portions of the
  paperwork and listened to the doctors
  reassurances that he had conducted this
  experiment multiple times and that nothing
  disastrous had ever occurred to the human
  participants in his previous trials.I really
  didnt care what they were doing I just signed
  and wanted the money, Cabanero said.

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In the beginning.

• Jenner did not get ethical approval for his
  inoculation research.yet it led to the
  eradication of smallpox.ongoing debate about
  risks of research and benefits and harms
  balancedo you think Jenners research was
  justified?

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The 20thC.

• Mass horrific human experimentation by German and
  Japanese (in Unit 731) doctors and scientists on
  concentration camp victims during WW2.led to

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.First ethical guidelines for conduct of research

• 1947 The Nuremberg Code (10 principles)
• Voluntary informed consent
• Likelihood of some good resulting
• Based on prior research (animal models)
• Avoidance of physical or psychological injury or
  harm
• Benefits should outweigh risks
• Proper experience of researcher
• Right to withdraw consent
• Research must stop if harm is resulting
• (no specific mention of children, unconscious
  people, or others who may not be competent to
  give consent)

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1964 Declaration of Helsinki

• World Medical Assembly revised 1975, 1989, 2000
• Therapeutic vs non-therapeutic research
• Adequacy of research design
• Protection from risk/harm
• Led to establishment of ethics committees to
  oversee research
• Trend towards requirement that research not be
  published without ethics approval
• Many countries adopted principles of both
  Nuremburg and Helsinki in their own legislation
• 1966 - First university course in research ethics
  (human experimentation)
• (Henry K. Beecher, Yale University)

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Continuation of unethical research.

• Tuskeegee Syphillis study (Alabama, 1932-1972,
  n400)
• http//www.cnn.com/US/9704/08/tuskegee/
• Willowbrook hepatitis study (New York,
  1950s-1970s)

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• Unfortunate experiment (National Womens
  Hospital, New Zealand, 1959-1987, n948 (Group 1,
  817 treated, 1.5 invasive cancer Group 2, 131
  untreated, 22 invasive cancer, 6 died)
• Nuclear radiation experimentation in Australia
  1950s-1970s Australia's radiation safety
  authority has confirmed that the bodies of
  thousands of children and adults were used in
  scientific nuclear tests without parental
  consent.
• http//news.bbc.co.uk/2/hi/asia-pacific/1380766.st
  m
• Stanley Milgrams Obedience to Authority Study
  (1963)

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In Australia

• National Health and Medical Research Council
  (NHMRC)
• National Statement on Ethical Conduct in Human
  Research (2007)
• http//www.nhmrc.gov.au/publications/synopses/e72s
  yn.htm
• There is also a document on that site What is
  new in the National Statement

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Who needs to apply for human research ethics
clearance?

• Human research is research which is conducted
  with or about people, or their data or tissue
  (p.3 National Statement on Ethical Conduct in
  Human Research)
• Any staff member or research student wishing to
  conduct any research involving
• Human participants
• Human tissue
• Personal records, or unpublished human research
  must obtain ethics approval before the research
  commences
• More specific definitions and guidelines on what
  constitutes human research on p7-8 of National
  Statement
• Institutions that receive Australian Govt
  research funding must have a Human Research
  Ethics Committee (HREC) to review and approve
  human research before it commences.
• Research must comply with National Statement on
  Ethical Conduct in Human Research

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Types of human participation in research

• As research subjects
• (on whom experiments, including testing of new
  drugs, are conducted)
• As persons whose body organs or tissues are
  obtained and/or retained for research
• Eg, blood, saliva, urine, biopsy specimens
• As research participants from whom information is
  obtained
• Eg, through observation, interviews, focus
  groups, questionnaires, telephone surveys,
  psychological or other types of testing
• As people who might be identified in official
  documents
• Eg, employment records, student records, police
  records, court documents, medical records.
• As people whose information (identified or
  de-identified) is part of an existing,
  unpublished source
• Eg, a researcher wishing to use all, or part of,
  an unpublished data-base obtained by another
  researcher for a different research project

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The new National Statement

• Is organised around four values
• Respect for human beings
• Research merit and integrity
• Justice
• Beneficence
• More specific guidance for specific types of
  research research involving specific kinds of
  participants

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The new National Statement

• Is composed of 5 sections
• Values and principles of ethical conduct
• Themes in research ethics risk, benefit and
  consent
• Ethical considerations specific to research
  methods or fields
• Ethical considerations specific to participants
• Process of research governance specific to
  participants

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The new National Statement

• New
• 2.1 Risk
• 3.1 Qualitative methods
• 3.2 Databanks
• 3.6 Human stem cells
• 4.1 Woman who are pregnant and the human foetus
• 4.6 People who may be involved in illegal
  activities
• 4.8 People in other countries
• 5.1 Institutional responsibilities

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The new National Statement

• Ethical conduct is more than simply doing the
  right thing. It involves acting in the right
  spirit, out of an abiding respect and concern for
  ones fellow creatures. The National Statement in
  ethical conduct in human research is therefore
  oriented to something more fundamental than
  ethical dos and donts - namely, an ethos
  that should permeate the way those engaged in
  human research approach all that they do in their
  research.

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• Research students have a responsibility to
• consult with their supervisor,
• read the National Statement,
• read the guidelines for preparing ethics
  applications on Uni or Hunter Health ethics
  websites, and
• work closely with their supervisor(s) in
  preparing an ethics application

• If still unsure, should contact Faculty Research
  Ethics advisors
• Ms. Lorinda Schultz
• School of Nursing Midwifery
• RW2-53, Richardson Wing
• Tel [phone]
• Email lorinda.schultz_at_newcastle.edu.au
• Dr Helen Warren-Forward
• School of Health Sciences
• HA25, Hunter Building
• Tel [phone]
• E-mail helen.warrenforward_at_newcastle.edu.au

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Making an application to the Uni or Hunter New
England Health Research Ethics Committee

• Uni
• Start from Human Research Ethics website
• http//www.newcastle.edu.au/research/human/index
  .html
• Application Procedures page
• Notes for Researchers tips and guidelines
  read first!
• Participant Information Statements and Consent
  Forms
• Application forms (with inbuilt guidelines)

• HNEHREC for research in the following categories
• Staff, clients or patients of HNEH will be
  recruited as participants in the research and/or
• Records held by HNEH will be accessed and/or
• Human tissue samples held by HNEH will be
  accessed.
• http//www1.hnehealth.nsw.gov.au/ethics/researchet
  hics.htm
• If staff or student of Uni, must then register
  approval from HNEHREC with Uni committee
  (registration process on Uni ethics website

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Staff or students of the University using
facilities of the HNEH for their research

• The University HREC will be the lead committee
  and take primary responsibility for reviewing
  and, where appropriate, approving the research
  if
• The involvement of HNEH is restricted to
  University staff or students accessing
  facilities, services or equipment in HNEH, and no
  patients, clients or staff of HNEH will be
  participants in the research. 
• Examples of such research might be the use of
  medical imaging or pathology services.
• Must register Uni approval with HNEH

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What to avoid doing.

• Applications that/are
• Confusing/unclear
• Dont address important relevant ethical issues
  eg. privacy
• Written without reference to National Statement
  and Guidelines
• Omit questions
• Provide superficial responses or insufficient
  information
• Poorly written participant information letters

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Getting through

• Explain WHAT you want to do clearly, logically,
  briefly and simply
• Explain WHY in the same way. Having clear
  objectives and research questions is essential
• Explain the PROCESS of what you intend to do in
  detail
• Show HOW you are going to address the key issues
  of
• Balancing benefits and harms
• Protection of participants from harm/risk
• Recruitment
• Consent
• Rights
• Consult REA

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• Showing you have actually read and applied the
  principles of the national statement to your
  research decisions and processes is an incredible
  help.
• Also read the guidelines on Uni ethics website

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Benefits/Harms Risk

• Carefully consider potential risks to individuals
• Small probability of risk does not equal not
  significant
• Could be a whole range of potential harm/risks
  ranging from physical to psychological, and
  includes loss of privacy
• Have to take into account participant
  vulnerability

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Uni process now governed by level of risk

• Level of review potential risk to participants
• L1 no appreciable risk expedited review
• L2 low manageable risk expedited review panel
• L3 potential for significant risk full HREC
  review (NEAF)

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Participants rights..Recruitment Consent

• Fully informed ongoing consent
• Un-coerced without inducement (time to consider)
• Consider power relationships
• Conflict of interest

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Participants Rights

• Refuse
• Withdraw (real, not lip service eg. what cues are
  you going to be paying attention to)
• To be treated with dignity, respect and
  sensitivity
• Privacy
• Complain
• Be involved
• Access findings

• to anonymity and confidentiality
• to protection from embarrassment, discomfort,
  pain, and from (lasting) harm
• assurance that research will be stopped if
  evidence of harm becomes apparent
• assurance that the wellbeing of the person takes
  precedence over the researchers need to know

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• We do not act rightly because we have virtue or
  excellence, but rather we have those because we
  have acted rightly.
• Aristotle.

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Decisions Jan-June 2007

• Categories
• Approved
• Conditional Approval
• Deferred
• Decision Pending

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Common reasons for conditional approval and
deferments
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Challenging ethical issues in qualitative
research.

• Type of research, eg. Phenomenology, Grounded
  Theory, Ethnography or Action determines what
  researcher will do, and how data will be analysed
  etc. and each has its unique challenges, but
  there are some common ethical issues relating to
  all qualitative methods, arising from its
  messyness
• Those issues are consent, participant distress,
  exploitation, misrepresentation identification
• Is informed consent ever truly informed? If the
  researcher doesnt know where the research will
  lead, how can the participant ever give informed
  consent?
• Relationship of researcher to participants both
  before, during and after research process, is not
  distant.this can create challenges of research
  becoming therapy or power imbalances in the
  researcher/participant relationship.dual
  relationship of researcher as clinician and
  researcher.need to establish and maintain
  healthy researcher roles and boundaries
• Recruitment, often not at a distance.eg.
  techniques like snowballing, purposive
  sampling,maximum variation sampling, theoretical
  sampling etc. creates ethical challenges

• Use of interviews, individual or focus group and
  participant observation, creates dilemmas for
  both anonymity and confidentiality
• Disclosures/observation of illegal or dangerous
  activity, creating dilemma for confidentiality
• Exploration of highly charged and distressing
  personal experiences, such as child abuse,
  experiences of war etc.how will participant
  distress be a) recognised and b) responded to?
• With small numbers of participants, will
  participant disclosures, be identifiable?
• Participants have the right to view and amend
  transcripts of taped interviews, and view
  videotapes and withdraw segments if they
  wish.(reducing the risk of misrepresentation)
• Care needs to be taken with storage of data,
  where linking information is held etc.

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Example

• You work in an aged care facility and want to
  recruit some of your current clients and fellow
  staff for a research project to assess their
  experiences with and views on the quality of care
  being delivered to them. This includes accessing
  participants medical records for the purpose of
  identifying demographic and diagnostic
  information as well as the occurrence and
  handling of adverse events.
• What are some of the ethical issues inherent in
  this and how will you address them?

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Example

• As you proceed with data collection, during
  interviews with staff, some new and junior staff
  reveal to you instances of interactions with two
  senior staff members in particular that indicate
  that those other staff members have been bullying
  them, and also that they have been rough and
  forceful in their interactions with some
  patients. They are able to related details of
  instances that would meet the criteria for
  assault, battery and elder abuse. During the
  interview, these participants become very upset
  about this, saying they dont know what to do,
  that they know of other people who have resigned
  because of this, that they are on the verge of
  resigning, and there is nothing they can do about
  it because the staff members concerned are very
  senior and very close to management.
• What are some of the ethical issues inherent in
  this and how will you address them?

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References

• Burns, N. and Grove, S.K. (1995) Understanding
  Nursing Research, Philadelphia W.B. Saunders
  (Chapter 10)
• Coney, S. (1988) The Unfortunate Experiment,
  Auckland Penguin Books.
• National Health and Medical Research Council
  (2007) National Statement on Ethical Conduct in
  Research Involving Humans, Canberra, Commonwealth
  of Australia.