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

ID: 
2
This submission reflects the views of
Organisation Name: 
General Ethical Issues S-C, Alfred Hospital Ethics Committee
Please identify the best term to describe the Organisation: 
Hospital – public
Personal Details
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
The definition is clear about ‘opt-out’ being a method of inclusion rather than a type of consent (the latter view is contested). In relation to this: in the proposed addition to the Introduction of Chapter 2.3, the words “opt-out approach to consent” are used. It is recommended that the words “to consent” be removed. [Second-last paragraph of the Introduction to Chapter 2.3: “…it may be justifiable to employ an opt-out approach to consent.”]
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
The rationale provided is sound, particularly with regard to clinical registries where maximum inclusion of eligible participants is essential. There may be other kinds of research where an opt-out approach is preferable for different reasons – e.g. to avoid burden to participants when the research is very low risk.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
Section 4.4: the requirement to accord with the relevant Privacy guidelines is not captured in the proposed addition to the National Statement under ‘Opt-out approach’. In the ‘Waiver’ section of Chapter 2.3, it says: “the waiver is not otherwise prohibited by State, federal, or international law.” [2.3.7(d)] If an opt-out approach is not considered to be a form of consent, then such a statement would also be needed in the ‘Opt-out approach’ section.
4: Please comment on the flow chart (i.e. Section 4).: 
The limiting of ‘opt-out’ to low/negligible risk research is of concern as this kind of research may be considered by alternative review processes rather than full HREC review. Our ethics committee is of the view that clinical registries employing an opt-out approach should have full HREC review.
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.: 
Perhaps the most common scenario represented by box 6d is the use of information already collected in patients’ medical records. An opt-out approach can be a valid way of including and informing participants, particularly where the collection of further information from the patient is intended (e.g. follow-up phone calls). Mechanisms for providing information will depend on factors such as the nature of the research, data and cohort. HRECs need to look closely at the plan for disseminating information and assess whether it is likely that all participants will receive it. The potential that families of deceased patients could be contacted (and distressed by this) should be taken into account. More prescriptive guidance is not recommended as the appropriate approach may vary according to the research, cohort, etc.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
Introduction to Chapter 2.3: As discussed in the response to q.2 above, the words “to consent” should be removed from “…it may be justifiable to employ an opt-out approach to consent.” Section 2.3.9: Paragraph 2.3.9 says: “In accordance with paragraph 5.1.7 of this National Statement, institutions may choose to establish other levels of ethical review for research to which this section applies. These levels are described in paragraphs 5.1.18 to 5.1.21.” This is ambiguous and needs further clarification. As discussed in the response to q.5 above, some types of research using an opt-out approach should have full HREC review. Section 2.3.10: a) Involvement carries no more than low risk to participants: The meaning of ‘low risk’ is open to interpretation. Data may be considered ‘low or negligible risk’ in terms of repercussions to the individual if there was a confidentiality breach, but the individual may nevertheless feel sensitive about its potential disclosure. Data collected in ‘opt out’ registries should not be unduly sensitive. While this concept is implicit in the requirement that involvement carry no more than low risk, an explicit statement on this is recommended. b) Public benefit: This criterion would be more useful or meaningful if there was some guidance (or reference to guidance) on what constitutes ‘public benefit’. All research is ostensibly done for the greater good/public benefit. c) Near 100% participation is essential and not achievable via opt-in consent: This is relevant chiefly to registries, but there may be other kinds of research where an opt-out approach is preferable for different reasons – e.g. to avoid burden to participants when the research is very low risk. d) Provision of information to participants: This point includes (i) the requirement for ‘reasonable attempts’ to be made, as well as (ii) four areas that information should cover (what data, what purpose, how to decline, how to withdraw). It is suggested that these be split into two separate points. (i) needs to be strengthened and the following wording is suggested: “a method is in place to ensure that every participant is provided with written information”. An explicit statement, that HRECs should look at the plan for disseminating information and assess whether it is likely that all participants will receive it, is recommended. (ii) would be more helpful if it included a more detailed list of the areas that written information should cover (as is the case for ‘standard’ consent in NS Chapter 2.2, Section 2.2.6). These could include: - a 1800 number or an equivalent minimally-burdensome means of opting out - easily located opt-out information. - a time frame for opting out before data is used (or transferred to a registry) - follow up contacts and the timing of these - data confidentiality A short (e.g. one page) information sheet should be specified. An opt-out situation requires short information for a quick decision. If opt-out information is too long, complex or otherwise onerous, it is likely that it will not be read or understood. It could not therefore be claimed that there was a genuine attempt made to inform participants. Different standards apply to information-giving for opt in and opt out settings. e) Mechanism for further information/to register non-participation: We agree with this point. f) Conduct of follow-up contacts: Follow up should be done under the name of the relevant hospital or institution (i.e. with which the participant is associated) to prevent participant concern at being contacted by, and/or their information being accessed by, a body with which they have no connection. g) No publication of identifiable information without explicit consent: We agree with this point. h) Data collected and maintained in accordance with accepted technical standards: We agree with this point. i) Governance process: This point could be strengthened, make mention of accepted Standards, and include the essential elements of a good governance process, in particular the guardianship of data.
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
No comment.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
Some clinical research may be perceived as low risk (and therefore suitable for an opt-out approach). Depending on how ‘low risk’ is defined/understood, a clinical trial comparing equal treatments might satisfy criterion 2.3.10(a) (involvement carries no more than low risk). This criterion needs to be strengthened.
9. Can you provide examples where an opt-out approach may be useful?: 
An opt-out approach is most useful for clinical registries. In may also be useful in general epidemiological studies.
General Comments
Comments: 

The proposed addition is a useful expansion of the National Statement and contains the main issues that HRECs and researchers should, or may wish to, consider.

Overall, the proposed addition allows room for HRECs to make decisions and judgments at their discretion.  This leeway is necessary and appropriate.  It enables HRECs to take account of their own constituencies and provides flexibility which may reduce the need for amendments to the NS in the future.

The NHMRC might consider issuing an addendum or supplementary guidance, particularly in the area of registries.  The Background Paper contains some valuable information and context which would also be of help to HRECs.

Page reviewed: 28 March, 2014