Important considerations for research

Confidential Information accessed as part of research is regulated by the following legislation:

• Hospital and Health Boards Act 2011 (Qld) (‘HHB Act’) Sections 142-161
• Public Health Act 2005 (Qld) (‘PH Act’) Sections 279-292
• Information Privacy Act 2009 (Qld) (‘Privacy Act’)

Restrictions on use of confidential information under the Hospital and Health Boards Act 2011 (Qld)

Section 142 of the HHB Act prohibits the disclosure of confidential information to another person unless the disclosure is required or permitted under the Act. While there are limitations on this prohibition, including where the disclosure is allowable under another Act, researchers should seek advice if they are unsure of their obligations.

Section 150 of the HHB Act provides that a ‘designated person’ may disclose ‘confidential information’ to another ‘designated person’ if the disclosure is for the purpose of ‘evaluating, managing, monitoring or planning health services’.  Disclosure between Queensland Health employees or other designated persons, if the purpose of the disclosure is to evaluate, manage, monitor or plan health services. This occurs, for example, when a Queensland Health employee is supported to conduct research to evaluate the impact of a new treatment/process and the HREC has waived the requirement of consent.  Section 150 of the HHB Act operates regardless of whether the evaluating, managing, monitoring or planning of health services occurs as part of a ‘research’ project. The ‘research’ aspect is irrelevant. It is the purpose of each disclosure that is relevant, not the purpose of the project to which the disclosure relates. Section 150 cannot be applied on a blanket basis. It must be applied on a case-by-case basis.

If no permission to use or disclose data exists under this Act, then it may be that the Public Health Act 2005 (Qld) must be consulted to determine either an approval is required under this Act.

Restrictions applying to the use and disclosure of confidential information under the Public Health Act 2005 (Qld)

Section 279A of the Public Health Act 2005 (Qld) (PH Act) applies to all information held by RBWH if the information relates to an individual and is identifiable. Where this is the case, the use of such information by researchers is subject to approval under this Act through by a delegate of the Director general of the Department of Health unless there are specific exceptions. This mean that where the information is not identifiable this Part of the PH Act doesn’t apply and no approval is required.

Sections 281-286 of the PH Act list the information that is required under a PHA application for information to be provided for research by the Chief Executive or a relevant person.

Section 291 of the PH Act provides that a person given health information held by a health agency must not disclose the information, whether directly or indirectly except in the following situations:

(a) the disclosure is to a person named in a notice under section 284(3) or 286 as a person who will be given the information for the research; or

(b) the disclosure is made with the written consent of the person to whom the information relates; or

(c) the disclosure is made in a form the person reasonably believes could not identify any person; or

(d) the disclosure is authorised under an Act or another law.

This means that unless the disclosure of the information meets one of the above criteria, it cannot be disclosed without approval as a PHA application.

Further Details on PHA applications can be viewed at:  Access to Confidential Health Information held by Queensland Health.

Restrictions applying to the use and disclosure of confidential information under the Information Privacy Act 2009 (Qld)

The use and disclosure of personal information is subject to the requirements of the Privacy Act and the National Privacy principles. For the avoidance of doubt, personal information is defined as: ‘information or an opinion, including information or an opinion forming part of a database, whether true or not, and whether recorded in a material form or not, about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.’

The NPPs, and in particular NPP 2 limit the use and disclosure of personal and health information. Some requirements are inter alia:

A health agency must not use or disclose personal information about an individual for a purpose (the secondary purpose) other than the primary purpose of collection unless—

1. both of the following apply—
   1. the secondary purpose is related to the primary purpose of collection and, if the personal information is sensitive information, directly related to the primary purpose of collection;
   2. the individual would reasonably expect the health agency to use or disclose the information for the secondary purpose; or
2. the individual has consented to the use or disclosure; or
3. if the information is health information and the use or disclosure is necessary for research, or the compilation or analysis of statistics, relevant to public health or public safety—
   1. it is impracticable for the health agency to seek the individual’s consent before the use or disclosure; and
   2. the use or disclosure is conducted in accordance with guidelines approved by the chief executive of the health department for the purposes of this subparagraph; and

• for disclosure—the health agency reasonably believes that the entity receiving the health information will not disclose the health information or personal information derived from the health information.

If you are in doubt about requirements under these pieces of legislation please contact the Ethics or Governance Office in the first instance. Please note that this does not constitute legal advice and should not be used as such.

Some research requires enrollment of participants who do not have capacity. This may be common in research that takes place in Intensive Care situations. There is some confusion as to when participants can be enrolled, when their substitute health attorney can provide consent, and when approval from QCAT is required.

When participants do not have capacity to consent for themselves, participation in health research in Queensland is regulated by the following legislation and guidelines:

• Guardianship and Administration Act 2000 (Qld) (‘GA Act’)
• Power of Attorney Act 1998 (Qld) (‘POA Act’)
• National Statement on Ethical Conduct in Human Research 2007

The ability of the substitute health attorney (SHA) or QCAT or an HREC to approve participation of a person without capacity into research is dependent on the type of research that is taking place. The GA Act differentiates between a number of types of research:

Special medical research or experimental health care (SMR/EHC): is defined in GA Act Schedule 2 section 12 and POA Act Sched 2 section 12 as:

(a) medical research or experimental health care relating to a condition the principal has or to which the principal has a significant risk of being exposed; or

(b) medical research or experimental health care intended to gain knowledge that can be used in the diagnosis, maintenance or treatment of a condition the principal has or has had.

In this type of research, only QCAT can approve enrolment of a person without capacity into research, and only on a case by case basis through completion of a QCAT Form 14. The decision cannot be made either by a substitute health attorney or by an HREC.

Approved clinical research (ACR): is defined in GA Act Sched 2 section 13 and POA Act Sched 2 section 13 as:

(a) medical research approved by QCAT intended to diagnose, maintain or treat a condition affecting the participants in the research; or

(b) a trial of drugs or techniques involving the carrying out of health care that may include the giving of placebos to some of the participants in the trial.

For clinical research to be approved, a QCAT Form 16 must be completed. Once QCAT approves the research as approved clinical research, it then reverts to being a health matter and is then subject to the GA Act. When this occurs, a substitute health attorney can agree to the enrolment of a person lacking capacity into research in the absence of an advanced health directive, an appointed guardian or an enduring power of attorney for that participant.

Does this apply to all clinical trials?

No. A comparative assessment of health care already proven to be beneficial to participants is not medical research as defined by the GA Act and does not require an application to QCAT to address participant consent for incapacitated participants. Instead, approval can be given by a substitute health attorney (usually next of kin), or failing that, if the study has been approved by an ethics committee, then the HREC can, having ensured that the study meets the requirements of 4.4.11 of the National Statement, approve enrolment subject to certain conditions. This may apply to some comparative effectiveness clinical trials.

In Guardianship terms, what is the difference between Special Medical Research/ Experimental Health care and Approved Clinical Research?

The provisions surrounding SMR and ACR differ as QCAT’s approval of an SMR application provides the consent for the treatment of a specific individual whereas an application for ACR grants approval for the research itself.

QCAT can provide its consent for an adult’s participation in SMR if it is satisfied of the following criteria outlined by s.72 of the GA Act:

(a) the special medical research or experimental health care is approved by an ethics committee;

(b) the risk and inconvenience to the adult and the adult’s quality of life is small;

(c) the special medical research or experimental health care may result in significant benefit to the adult or other persons with the condition;

(d) the special medical research or experimental health care cannot reasonably be carried out without a person who has or has had the condition taking part;

(e) the special medical research or experimental health care will not unduly interfere with the adult’s privacy.

QCAT’s approval of the SMR application is specific consent for the enrolment of that adult into the research.

ACR on the other hand is an approval of the clinical research itself. This allows for consent for any incapacitated participants to be determined in accordance with the usual procedures applicable to health care matters in Queensland as outlined in in s.66 of the GA Act. In order for QCAT to approve the Clinical Research, it must be satisfied of the following matters—

(a) the clinical research is approved by an ethics committee;

(b) any drugs or techniques on trial in the clinical research are intended to diagnose, maintain or treat a condition affecting the participants in the research;

(c) the research will not involve any known substantial risk to the participants or, if there is existing health care for the particular condition, the research will not involve known material risk to the participants greater than the risk associated with the existing health care;

(d) the development of any drugs or techniques on trial has reached a stage at which safety and ethical considerations make it appropriate for the drugs or techniques to be made available to the participants despite the participants being unable to consent to participation;

(e) having regard to the potential benefits and risks of participation, on balance it is not adverse to the interests of the participants to participate.

For further information or advice please contact the HREC Chairperson or Metro North Legal Services. Please note that the above information does not constitute legal advice.

The Human Rights Act 2019 (Qld) came into force on 1 January 2020. As a result, all research applications that are submitted to RBWH HREC must include a consideration of whether the research may infringe any of the 23 listed fundamental human rights. These are:

1. recognition and equality before the law
2. right to life protection from torture and cruel, inhuman or degrading treatment
3. freedom from forced work
4. freedom of movement
5. freedom of thought, conscience, religion and belief
6. freedom of expression
7. peaceful assembly and freedom of association
8. taking part in public life
9. property rights
10. privacy and reputation
11. protection of families and children
12. cultural rights—generally
13. cultural rights—Aboriginal peoples and Torres Strait Islander peoples
14. right to liberty and security of person
15. humane treatment when deprived of liberty
16. fair hearing
17. rights in criminal proceedings
18. children in the criminal process
19. right not to be tried or punished more than once
20. retrospective criminal laws
21. right to education
22. right to health services

If it is considered that any of these rights are being infringed, they must be considered in the context of limitations of Human Rights articulated in Section 13 of the HR Act which states: ‘A human right may be subject under law only to reasonable limits that can be demonstrably justified in a free and democratic society based on human dignity, equality and freedom.’

If you believe that any human rights are being limited, you must provide the following information about the limitation:

1. the nature of the human right;
2. the nature of the purpose of the limitation, including whether it is consistent with a free and democratic society based on human dignity, equality and freedom;
3. the relationship between the limitation and its purpose, including whether the limitation helps to achieve the purpose;
4. whether there are any less restrictive and reasonably available ways to achieve the purpose;
5. the importance of the purpose of the limitation;
6. the importance of preserving the human right, taking into account the nature and extent of the limitation on the human right;
7. the balance between the matters mentioned in paragraphs (e) and (f).

In the event that the limitation is not justified, you must propose how the research will be conducted to obviate that limitation.

In practice, for health research, it may be that the only applicable rights which may be infringed would be limited to a smaller number such as:

1. freedom of expression
2. cultural rights—Aboriginal peoples and Torres Strait Islander peoples
3. right to liberty and security of person
4. humane treatment when deprived of liberty
5. right to health services

What do I have to do to ensure I have considered whether any human rights are being infringed prior to submission of an ethics application?

Before submitting your application, you must do the following:

1. Consider which human right may be being limited.
2. Determine whether the limitation permitted under a specific provision of the Human Rights Act.
3. Determine whether the limitation is acceptable by considering this in the context of section13 of the Act.
4. If the limitation is not acceptable, provide information as to how the research will be modified to address this limitation.
5. Submit this information with your ethics application.

Template for consideration of human rights.