Policy
Subject:
Patient Consent for Observational Research and Case Studies
in Australia
Approval Date: March 2001, March 2004, March 2007
Review Date:
March 2011
Review By:
BPPQ
Number:
10/2001
This Policy covers 2 areas:
1. Undertaking observational research when the research is looking back at data
and the individual patient would not be identifiable.
2. To publish individual case studies.
In both of these situations, the College considers that Fellows and Trainees
recommend that a request for an opinion from the appropriate Institutional Ethics
Committee be made so that the need for patient consent can be examined on an
individual study or case basis.
In the opinion of the College, provided that the patient information was in no way
identifiable and the outcome of the research on the individuals was not harmful, then
consent in these circumstances would not be required.
Background to the Policy
This issue is covered to some extent in the National Health and Medical Research Council
(NHMRC) National Statements on Ethical Conduct in Research Involving Humans - June
1999, in particular section 15 “Use of Human Tissue”.
In addition, the NHMRC has produced Guidelines Under Section 95 of the Privacy Act 1998
which need to be referred to in the context of the above National Statement. Guideline 2.3
(Principles to be Followed by Researchers) is relevant as is Information Privacy Principle 11
(Limits of Disclosure of Personal Information).
Essentially there is provision for a researcher to apply to a Human Research Ethics
Committee (HREC) for exemption from obtaining patient consent for the use of personal
information, if the research is considered to be in the public interest.
The Federal Privacy Act contains eleven Information Privacy Principles (IPPs) which apply to
Commonwealth and ACT government agencies. It also has ten National Privacy Principles
(NPPs) which apply to parts of the private sector and all health service providers.
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From 21 December 2001 the private sector amendments to the Privacy Act 1988
(Cth) became operative. The new provisions provide for ten National Privacy Principles
(NPPs), found in Schedule 3 of the Act, which apply to health service providers.
Since the NPPs have been effective, two public interest determinations relating to the health
sector have been issued by the Commissioner.
Four other significant areas which are monitored by the Commissioner which affect parts of
the health sector are in relation to:
•
•
•
•
the storage, use, disclosure and retention of individuals' claims information under the
Pharmaceutical Benefits Scheme and the Medicare program;
privacy standards in the conduct of human medical research in Australia;
the collection, use and disclosure of personal medical information in relation to the
conduct of research, compilation and analysis of statistics relevant to public health,
safety or health service management activities; and
the collection, storage, use and security of personal tax file numbers by organisations
that are authorised or approved to record such information under taxation, assistance
agency or superannuation law.
State Privacy Acts
NSW - The Health Records and Information Privacy Bill 2002 was passed in September
2002 and commenced on 1 March 2004. The Act will apply to the State public sector and will
also apply to acts or practices in the private sector not covered by the Privacy Act.
Victoria - The Victorian Health Records Act came into effect from 1 July 2002. This Act
covers the handling of all personal information held by health service providers in the State
public sector and also applies to acts or practices in the Victorian private sector that are not
covered by the Privacy Act.
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