| Opting out of Research |
Research Participants | Databases and
| Alfred Health -
Health Privacy Principles and Research | Using information from the Electoral Roll |
Opting out of
Patients have the right to opt out of any participation in research, and
if they choose this option, the hospital has an obligation to ensure
that they are not contacted inadvertently for research purposes. Health
Information Services (HIS) keeps a database of all such patients.
Before any patients are approached via a mail-out approach or "cold
call", researchers need to check with the HIS Privacy Officer (ph:
9076 2644, email: email@example.com), that none of these people have opted out of any involvement
Please follow this procedure before approaching patients.
The Victorian legislation on health records and
information privacy requires Human Research Ethics Committees to monitor
adherence to the Health Services Commissioner’s statutory guidelines on
research when reviewing and approving research proposals. So that the
Ethics Committee can determine whether a research protocol satisfies the
requirements of the Act and the Health Privacy Principles, it needs more information about
recruitment procedures than previously.
In completing Question 17 ‘Recruitment of Participants’
in Module 1 of the common ethics application form, researchers must
provide a clear, detailed, step-by-step description of all aspects of
the recruitment procedure, including full details of any ‘screening’
that may be done before researchers meet participants face-to-face.
Particular attention is to be paid to:
name(s) and position(s) of those doing the recruiting;
of where and when recruitment will take place (e.g. “in X Outpatients
Clinic at The Alfred hospital when patients attend their next
scheduled visit ”);
source(s) of the participants (relevant questions here include: How
did participants come to be seeing the researchers? Are they public
or private patients of the researchers? Have they been referred by
another physician? Are patients responding to an advertisement,
of any form of “screening” of records, files or databases to be used
to identify potentially suitable participants before a direct approach
is made (e.g. what type(s) of records will be looked at, to whom do
the records belong, who will be viewing the records and doing the
screening, what information will be collected etc.)
and copies of all forms of advertising material that may be used in a
recruitment strategy (include printed advertisements and letters of
invitation, transcripts of television and radio advertisements etc).
The new Victorian legislation on health records and
information privacy, which came into effect on 1 July 2002, sets out
requirements for the collection, handling, use and disclosure of
personal and health information. Much of this information is held in
identifiable form on various “research” databases within The Alfred
hospital. Staff and researchers should be aware of their obligations
with regard to the creation and use of such databases.
Databases maintained and used for internal
These are typically
maintained at a ward, department or unit level and are used for internal
audit or quality assurance. These databases and information systems do
not include those that are maintained for direct patient care purposes.
Privacy principle 1.4 of the Health Records Act 2001
allows the collection of information for the purpose of database
management provided that the organisation takes steps to ensure that the
individual is generally aware of the purposes for which the information
is being collected, who you would usually disclose information of that
kind to, how they can gain access to the information about them if they
wish and the main consequences for the individual (if any) if the
information is not provided. The Ethics Committee recommends that
patients be given this information at their first or next contact with
you, preferably in writing.
Section 2.2(f) of the Health Records Act 2001 permits the
use and disclosure of information for the purpose of funding,
management, planning, monitoring, improvement or evaluation of health
services provided that reasonable steps are taken to de-identify the
information. It is acceptable for a research nurse or other staff member
associated with a unit to access the information in its identifiable
form as long as this information is de-identified prior to it being
presented in any way.
Any formal research in which the information
contained within the database is to be used or disclosed must first be
approved by The Alfred Ethics Committee as has always been the case.
Disclosure of information for the purpose of
National or International database management
You may share or disclose information to other
organisations if the information is de-identified (i.e. stripped of
details such as UR, name, address, initials, etc.).
If it is necessary to provide identifiable information to
national or international databases, then it is acceptable for this
information to be provided if the purpose of the database is continuing
care of the patient. This type of information disclosure is permitted
under S141 of the Health Services Act 1988.
If the purpose of the database is not continuing
care of the patient, and it is absolutely necessary to provide
identifiable information, then information can be provided as long as:
consent to disclose this information for this purpose is obtained.
Consent can be explicit (i.e. written) or implied. For instance, if
patients are provided with information that tells them that this type
of information is disclosed for this purpose and they are given
information about how they can “opt-out” of this type of information
sharing, then their consent is implied if they do not “opt-out”. Note
that this implied consent can be sought prior to the disclosure of
information, at the time of disclosure or as soon as practicable;
The disclosure of the information has been appropriately considered and
approved by The Alfred Human Research Ethics Committee; AND/OR
The database had been established prior to 1 July 2002 and
the disclosure of the information was legally permissible prior to 1
July 2002. To assess this, units and departments that disclose
identifiable information that they believe falls into this category
should endeavour to ascertain with the database administrators exactly
what processes occurred in the past to establish the database (e.g.
government approvals, ethics approvals, etc.).
Alfred, first option is the preferred mechanism for appropriate
disclosure of identifiable information for this purpose.
Alfred Health - Health Privacy Principles and Research
was provided by the
Alfred Health Privacy
Officer, June 2002.
new Health Privacy Principles (HPPs) and the associated Regulations
are binding on all Victorian health service providers, public and
private, from 1 July 2002. They form part of the Health
Records Act 2001.
HPPs apply whenever patient information is collected, used or
disclosed for the purposes of research.
consent is required if the information is identifiable. The only
exemption is as follows:
research is deemed necessary; AND
the research is in the public interest; AND
purpose cannot be served by collection that does not identify the
is impracticable to seek consent.
these situations, Alfred and/or other appropriate ethics approval
would be vital. It is not up to individual researchers to make this
is not required when de-identified health information is collected,
used or disclosed. This is defined as information from which the
identity of the person to whom the information relates cannot be
disclosing information without patient consent, the disclosing agency
must reasonably believe that the recipient of the information will not
further disclose the information, and that the disclosure will not be
published in an identifying form.
the point of information collection, it will be up to the hospital
(either orally or through pamphlets) to advise patients that their
health information may be used for research purposes. They will be
given the option of “opting out”.
patients participating in a clinical trial or study will need to
provide informed consent. The pamphlet will advise them that they may
be approached to be involved in a trial or study.
involving humans is defined as systematic investigation to establish
facts, principles and knowledge. It is important to distinguish it
from QA, which is a monitoring activity performed to assess the
effectiveness and appropriateness of a service, and determine whether
the outcome was satisfactory. QA activities can be conducted by
hospitals without the consent of patients. Certain QA privileges are
provided in the Health Services
detailed information can be obtained from the Health Services
Commissioner’s website at www.health.vic.gov.au/hsc.The issues paper can be obtained as a
Using information from the
Electoral Roll in Medical Research
In January 2011, the Australian Electoral Commission (AEC) undertook a review of the information it
provides about access to data from the Commonwealth Electoral Roll for the purposes of research.
You can find a summary