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Review of Chapter 2.3 of the National Statement: Qualifying or waiving conditions for consent submission

Personal Details
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Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
It would also be useful to qualify that the “potential participant or next of kin” be provided with the information as it is not always practical to provide the information directly to the patient, for example when information is provided during a hospital admission. It should also state “…their involvement and/or the purpose for which their data will be used..” to cover data collection systems such as clinical quality registries. These additions would make the ‘opt-out definition’ more consistent with the definition used by the Australian Commission on Safety and Quality in Healthcare in their Strategic Principles for a National Approach to Australian Clinical Quality Registries
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
An opt-out approach (in most cases) should be the preferred method of consent for studies that have public health significance and where low participation rates will bias results - this includes clinical quality registries, health services research or epidemiological studies where primary data are collected and it is necessary to retain personal identifiable information e.g. in the situation where follow-up of patients will be undertaken (and potential participants can freely opt-out at that stage i.e. refuse follow-up but at least their clinical data can be kept in a potential re-identifiable format where it is foreseen that data may be probabilistically linked to another dataset and person level information is needed for analysis e.g. cohort studies of the quality of care and outcomes.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
The proposed limitation does not differentiate between research and clinical quality registries. The use of opt-out consent, or waiver where relevant, is considered the gold standard for clinical quality registries, for the reasons outlined in Section 3. Therefore, a separate section added to Section 4 on clinical quality registries should be added to ensure clarity.
4: Please comment on the flow chart (i.e. Section 4).: 
The flow chart covers the situation in which there are two discrete uses of data. The flow chart does not specifically cover situations where a researcher, or data custodian, may want to link data from source 2a (e.g. a clinical quality registry) with source 2b (e.g. health information data). Does the opt-out consent obtained under 2a also provide consent for linkage with 2b in situations where participants in 2a are informed that their data may be linked with administrative or other relevant datasets or is this covered in box 6d? If so it would be useful to clarify this. (see response to question 11 general comments). Under the flow diagram for 2a, ‘waiver of consent’ may also be relevant and should be added as a level 3 option since this is different from 3c. For example, in a clinical quality registry that collects information about hospital care, information on patients who die in hospital or are unconscious, a waiver of consent will ensure next-of-kin members are not confronted about making a decision to include their relative’s information in the registry. In addition, it will mean that family members will not be required to be contacted if the patient has died, alleviating unnecessary potential distress. In a clinical quality registry, identifying data may be held for patients, who are eligible for waiver of consent and therefore that is not the same as 3c. For example, these identifying data may be required in order to be able to link to administrative data to understand the potential factors related to the health system for better understanding causes of death. Item 3b and elsewhere in the document refer to use of an opt-out approach only in ‘low risk/negligible risk’ situations. This requirement is potentially misleading and could confuse ethics committees. Where a clinical quality registry obtained personal identifying information, to be able to contact registrants for follow-up, we have found that the majority of HRECs deem this to not be ‘low risk’ but have approved the use of an opt-out approach to consent and a waiver of consent under specific circumstances. Identifying that opt-out is only applicable for low risk situations may compromise a large number of existing initiatives and the wording around these statements should be revised.
5. Please comment on the appropriate mechanism for providing information to participants for the opt-out approach represented at box 6d of the flow chart.: 
Data that would qualify for box 2b would generally fall under the category of administrative data. It is not clear what the value of an opt-out approach would be over waiver of consent for these types of data, especially if the use of the data has already been identified as being of low or negligible risk and of significant value. We do not support the use of opt-out consent in situations where waiver of consent would otherwise be applicable. This scenario would be of particular concern where it would be impractical to undertake this process in large numbers of people whose health status may be unknown. In data linkage projects, the protection and handling of personal and identifying information should be governed by the information privacy principles outlined in the Privacy Act 1988.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
We suggest that the wording be amended in 2.3.10a to cover the situation where a HREC application for a clinical quality registry or other research project may not be deemed ‘low risk’ since personal identifying information are collected, but use of an opt-out approach is still justified.
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
This is generally well covered in section 3. There should also be improved clarity around situations in which opt-out should be used. It should be made clear that opt-out consent should be used as an alternative to explicit consent in situations such as those outlined in Section 3. Opt-out consent should not be offered as an alternative to waiver of consent, in situations where waiver of consent would otherwise be granted. A statement on data linkage should be included. For example that opt-out consent provides consent for data linkage activities in situations where participants have been made aware that their data may be linked with other health information data for quality assurance purposes and for HREC approved research purposes.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
The timeliness between when the data were collected and when opt-out consent is obtained needs to be taken into account. For secondary use of data, that may have been collected a year or more ago, consideration needs to be given to the research population and the likelihood that participants may have changed address or died. In these cases it would not be possible to know if most people had been given the opportunity to ‘opt-out’ and waiver of consent may be a better option.
9. Can you provide examples where an opt-out approach may be useful?: 
Health services research or program evaluations of health care including cluster trials and cohort studies for assessing quality of care or alternate methods of providing evidence-based care (not experimentation for new treatments/therapies. For example, telemedicine consultations with specialists to advise on acute care therapy already accepted as best-practice but where there is poor uptake by generalists.
General Comments

The document does not differentiate between clinical quality registries and research studies, even though clinical quality registries are specifically referred to in the document. Although data from clinical quality registries can be used to answer research questions, they are primarily discrete data systems that are used to monitor and report on the appropriateness and effectiveness of health care. Registries also tend not to be time limited and it is important that person level, and not just episode level data are able to be examined in these clinical registries.

It would be useful for the document to include specific definitions to differentiate between: research studies; clinical quality registries; quality of care assessment projects such as clinical audit; administrative data; and stored data. Clarification of the level of consent and HREC review around each of these different types of activities should be provided and links to other relevant NHMRC Statements made such as “When does quality assurance in health care require independent ethical review? The detail in such documents may also need to be updated with changes to information within the National Statement on Ethical Conduct in Research Involving Humans.

Opt-out consent to cover data linkage between clinical quality registries and health information data

It would be helpful if the NHMRC were to provide a statement regarding opt-out consent and collection of personal identifying information (the factor which may determine that a HREC does not view a registry as a ‘low risk ‘application) for clinical quality registries. We would also like this statement to acknowledge that the collection of identifying information by Clinical Quality Registries is essential for data linkage with health information systems for registry quality assurance purposes. Linking registry data with health information data, or other complementary datasets, is considered to be a mandatory requirement for registries under the requirements specification for Australian Clinical Quality Registries (1). Under Section 3.1 Business requirements, it is stated that: “Registries shall have the capacity to support linkage with other datasets”; “Registries shall use data from existing sources (including administrative data) where they are of a satisfactory standard”; and, “Registries shall be able to generate detailed longitudinal information about patient outcomes through the use of data linkage in order to monitor the effect of healthcare”.

Data linkage is recognised as essential for validating the data collected by clinical quality registries in regards to their completeness, representativeness and generalisability. Section 3.2 Functional Requirements (1) states that “there is considerable value to be gained by linking data from different sources. Each Australian clinical quality registry should examine what opportunities exist to obtain broader safety and quality data through data linkage”.

Given that data linkage is an integral part of the function and quality assurance processes of clinical quality registries we feel that the National Statement on Ethical Conduct in Research Involving Humans should explicitly recognise that opt-out consent for clinical quality registries includes consent for data linkage between quality clinical registries and health information systems/complementary datasets for the purposes stated above.

Page reviewed: 28 March, 2014