Ethics and Privacy in Intensive Care Research

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Ethics and Privacy in Intensive Care Research

• Dr Ian Seppelt
• Dept of Intensive Care Medicine
• Nepean Hospital, Sydney

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Ethics or research ethics?

• Beneficence
• Non-maleficence
• Autonomy
• Justice
• Distributive justice

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Lots of paperwork?

1. National Statement
2. Declaration of Helsinki
3. ICH Good Clinical Practice
4. NSW Privacy Act
5. NSW Human Tissue Act
6. NSW Guardianship Act

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Dealing With Ethics Committees!

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Know your enemy
X
friend

• In 2003 there were 226 Human Research Ethics
  Committees
• 51 (23) in NSW
• They approved 18,323 projects
• They rejected 232
• www.nhmrc.gov.au/issues/pdf/hrecarp.pdf
• Know the rules and give them what they expect!

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National Statement on Ethical Conduct in Research
Involving Humans

• 1998 draft revision Dec 2004
• http//www.nhmrc.gov.au/publications/pdf/e35.pdf

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1. Principles of Ethical Conduct

• 1.1 Respect for human beings, justice, research
  merit and integrity, and beneficence
• Research merit and integrity
• Justice in research
• Balancing benefits and risks in research
• Respect for human beings

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1. Principles of Ethical Conduct

• 1.2 Consent to participation in research
• General requirements for consent
• Consent to future use of data and tissue in
  research
• Refusing and withdrawing consent
• Qualification of consent requirements

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3. Ethical considerations specific to participants

• 3.4 Ethical considerations specific to research
  in people highly dependent on medical care

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Research merit and integrity

• 3.4.1 Research .. is justified where it is
  likely that the research will lead to improvement
  of those interventions and will not pose a risk
  to participants greater than that inherent in
  their condition and present treatment

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Justice

• 3.4.2 Because of their exposure to severe
  threats to their lives, the participation of
  people highly dependent on medical care may be
  essential to research that aims to improve
  interventions in those circumstances

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Balancing benefits and risks

• 3.4.5 The distinguishing features of intensive
  care research are the difficulty in communicating
  with patients . Wherever possible, consent to
  intensive care research, based on adequate
  information, should be sought from or on behalf
  of potential participants before admission to
  that research

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Balancing benefits and risks

• 3.4.8 The distinguishing feature of research
  involving unconscious people is that . it is
  impossible for them to be informed about the
  research or determine their wishes .

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Balancing benefits and risks

• 3.4.8 The distinguishing feature of research
  involving unconscious people is that . it is
  impossible for them to be informed about the
  research or determine their wishes . Anyone who
  is unconscious should normally be included only
  in minimally invasive observational research or
  research designed to investigate improvements to
  the treatment of that individuals condition

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Respect for human beings

• 3.4.9 When conformity to the general
  principles of consent is not feasible, and
  neither the individual nor the individuals
  representative can consider the proposal and give
  consent in advance, an HREC may approve a
  research project without prior consent if

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Respect for human beings

• 3.4.9 When conformity to the general
  principles of consent is not feasible, and
  neither the individual nor the individuals
  representative can consider the proposal and give
  consent in advance, an HREC may approve a
  research project without prior consent if
• (a) the research is based on valid scientific
  hypothese which support a reasonable possibility
  of benefit over standard care,
• (b) inclusion is not contrary to the interests
  of the patient and does not impose an unfair
  burden of participation

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Respect for human beings

• 3.4.9 When conformity to the general
  principles of consent is not feasible, and
  neither the individual nor the individuals
  representative can consider the proposal and give
  consent in advance, an HREC may approve a
  research project without prior consent if
• (c) the research is intended to be therapeutic
  for that patient and the research intervention
  poses no more of a risk than that which inherent
  in the patients condition
• (d) as soon as reasonably possible the patient
  and/or relatives will be informed of the
  patients inclusion in the research and of the
  option to withdraw from the research without any
  reduction in the quality of care.

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18th World Medical Assembly Declaration of
Helsinki (1948, revised 1996)

• Clinical research should
• Be conducted by scientifically qualified
  personnel
• Conform to generally accepted scientific
  principals
• Have formally approved protocols
• Have a balance between the research objectives
  and patient risk
• Ensure subjects their confidentiality and
  integrity

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18th World Medical Assembly Declaration of
Helsinki (1948, revised 1996)

• Clinical research should
• Only be performed if subjects have received
  comprehensive study information and the subjects
  freely give consent
• Cease if the hazards outweigh the potential
  benefits
• Ensure the subjects can abstain from or withdraw
  participation at any time
• Publish accurate results

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International Conference on Harmonisation Good
Clinical Practice 1997

• International ethical and scientific quality
  standard for designing, conducting, recording and
  reporting trials that involve the participation
  of human subjects

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International Conference on Harmonisation Good
Clinical Practice 1997

• Three tenets of GCP
• Patient protection (ethics)
• Credible data (science), and
• Control

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When does QA in healthcare require independent
ethical review?

• NHMRC 2003
• Nine questions.. If the answer to every question
  is no then ethical review is not required

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When does QA in healthcare require independent
ethical review?

1. Is the consent from participants inadequate, or
   is the activity inconsistent with National
   Privacy Principle 2.1(a)
2. Does the QA pose any risks for patients beyond
   those of their routine care?
3. Does the QA impose a burden on patients beyond
   that experienced in their routine care?

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When does QA in healthcare require independent
ethical review?

• 4. Is the QA to be conducted by a person who does
  not normally have access to the patients
  records?
• 5. Does the proposed QA risk breaching the
  confidentiality of any individuals personal
  information, beyond that experience in routine
  care?
• 6. Does the QA involve any significant departure
  from the routine clinical care provided to
  patients?

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When does QA in healthcare require independent
ethical review?

• 7. Does the QA involve randomisation or the use
  of a control group or a placebo?
• 8. Does the QA seek to gather information about
  the patient beyond that collected in routine
  clinical care?
• 9. Does the QA potentially infringe the rights,
  privacy or professional reputation of carers,
  health care providers or institutions?

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When does QA in healthcare require independent
ethical review?

• Are you planning to publish your results?

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Other complicating factors

1. NSW Health Records and Information Privacy Act
   2002
2. NSW Human Tissue Act, amended 2002
3. NSW Guardianship Act 1987 amended 1998

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Health Records and Privacy Act 2002

• 15 Health Privacy Principles set out in Act
• Does this project involve the collection, use, or
  disclosure of personal health information which
  is identified, or from which the identity of the
  person can be reasonably ascertained?
• Could the purpose of this project be served by
  collecting, using or disclosing de-identified
  information?

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Health Records and Privacy Act 2002

• 3. Why cant the purpose of the project be
  achieved using de-identified information?
• 4. Are you proposing to collect, use or disclose
  the health information with the consent of the
  individual(s) concerned?
• 5. From which organisations/bodies are you
  collecting personal health information?
• ..

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Health Records and Privacy Act 2002

• 10. Why is it impracticable to obtain the consent
  of the individual to collect, use or disclose
  their health information?
• 11. Please provide reasons why the collection,
  use or disclosure of this information is in the
  public interest, and why the public interest in
  the project substantially outweighs the public
  interest in the protection of privacy.

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Human Tissue Act 2002

• Human tissue, including blood, cannot be used for
  research without a priori consent from the
  patient
• Person responsible cannot consent
• Unless the tissue was collected for usual
  clinical purposes
• Or unless the patient is under an order under the
  Guardianship Act

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Guardianship Act 1987Section 5 Division 4A
Clinical Trials

• Allows proxy consent by person responsilbe for
  participation in a trial in which the individual
  cannot consent
• Trial must first be approved by local HREC
• Broad definition of clinical trial
• Interested in new and experimental treatments
• Not phase 1 and 2 trials

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Guardianship Act 1987Section 5 Division 4A
Clinical Trials

• 45AA The Tribunal may give approval only if it is
  satisfied that
• (a) the drugs or techniques are intended to cure
  a particular condition from which the patients
  suffer
• (b) the trial will not involve any substantial
  risk (or .. not material risk greater than the
  risks associated with treatment)

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Guardianship Act 1987Section 5 Division 4A
Clinical Trials

• 45AA The Tribunal may give approval only if it is
  satisfied that
• (c) the development of drugs or techniques has
  reached a stage at which it is appropriate they
  be available to patients who suffer from that
  condition even if not able to consent
• (d) it is in the best interests of patients
  that they take part in the trial

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Guardianship Act 1987Hierarchy of Persons
Responsible

1. A guardian (including an enduring guardian)
2. The most recent spouse or de facto spouse with
   whom the person has a close, continuing
   relationship,
3. An unpaid carer who is now providing support to
   the person or provided this support before the
   person entered residential care
4. A relative or friend who has a close personal
   relationship with the person

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Conducting Quality Research in Intensive Care

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Conducting Quality Research in Intensive Care

• Formulate a question
• Literature review, prior negative studies
• Studies in progress (Cochrane database)
• So what?
• Will the results be meaningful?
• Is the intervention SAFE?
• Preclinical and pilot studies
• Phase I and II studies using SAME methodology
  before progressing to a phase III study

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Conducting Quality Research in Intensive Care

• 4. Is the study adequately powered?
• An underpowered study is worthless
• Pilot study to get data for accurate sample size
  calculation
• 5. How will consent be handled?
• Prospective consent by patient?
• Proxy consent by family or person responsible?
• Retrospective or no consent in resuscitation
  studies

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Conducting Quality Research in Intensive Care

• 6. How will patients be randomised?
• How will treatment allocations be concealed?
• Have sources of bias been minimised?
• 7. How will the study run logistically?
• Is the protocol idiot proof?
• Does the entire ICU staff understand the study?
• Conflicts of eligibility

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Conducting Quality Research in Intensive Care

• 8. What are the study outcomes?
• Primary outcome should be unambiguous, easily
  measured and clinically important
• Surrogate end points must be validated
• 9. How will the data be captured?
• Data de-identified
• Case record form should be comprehensive without
  being onerous

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Conducting Quality Research in Intensive Care

• 10. How will the data be analysed?
• Are the statistics valid
• Consult a statistician!
• 11. How will the results be published or
  communicated?
• Negative studies are just as valuable as positive
  ones
• Avoid publication bias

Good luck!
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