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

ID: 
41
This submission reflects the views of
Organisation Name: 
Australian Defence Human Rsearch Ethics Committee
Please identify the best term to describe the Organisation: 
HREC
Personal Details
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
a. Some members of the committee felt the definition provided was unclear, and used research jargon which could be confusing to lay persons and potential participants. b. One such alternative could be to break the definition into several shorter sentences, for example: A method used in the recruitment of participants into research where: • information is provided to potential participants regarding the activity and, • the involvement of participants is presumed unless they take action to decline to participate within the timeframe specified by the researcher in a public information notice.
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
a. The rationale provided appears to be limited. While members agreed there would be benefit in improving the integrity of research, and several have experienced the difficulties in achieving recruitment rates to research which allows for robust results, there were concerns about the proposed approach. b. Several Members felt the rationale provided was biased in favour of increasing research participant rates, and did not demonstrate respect for persons or research justice by adequately considering the potential implications for participants. c. There were also concerns as to how information would be conveyed to potential participants to give them an adequate opportunity to opt-out. To not provide this information in an accessible way does not acknowledge the value of human autonomy. d. There are many examples of studies which target sub-populations. Examples discussed by members included studies on Cystic Fibrosis, Tay-Sachs disease, Sickle Cell anaemia, exposure to jet fuels, or “Gulf War Syndrome”, based on ethnicity, race, or membership to a particular cultural group, such as the Australian Defence Forces (ADF). e. Some of these populations are vulnerable to being over-researched (NS 4.3.4), and by increasing this ease of access through an opt out approach, this may further encroach on research justice (NS1.4 (c)). f. Where people are in dependent or unequal relationships they may also perceive pressure to not decline for their information to be used (NS 4.3.1). g. The need to actively withdraw may create an unmanageable burden. For example, if there are approximately 100 studies conducted in the Australian Defence Organisation per year , it is not reasonable to expect this population be expected to continually monitor newspapers, websites etc. for research activities, and read through all proposals to determine which are applicable to themselves, in order to register their choice to opt-out. h. Members voiced concerns that opt-out approaches may be more likely to breach the Privacy Act (1988) and/or State or Territory legislation. i. It is not clear how an opt-out approach can be used for data where consent was not given for future research use (whether collected for research purposes or not). Per the ADHREC 2012 annual report to NHMRC, there were 122 protocols considered in 2012 through the committee or a low-risk process, 96 of which were approved at the time of the report. This figure does not include negligible risk or quality assurance activities, or studies which may be ongoing from previous reporting periods. It also does not include studies of the general Australian population.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
a. Section 4.1: Members commented that is essential to provide guidance to researchers advising of circumstances where it may or may not be appropriate to use an opt-out approach. b. Section 4.2: This section of the consultation paper acknowledges there are circumstances where potential participants may not be “contactable”. This is open to interpretation, where some populations may be deemed less “contactable” than others, further heightening their vulnerability. Some examples include Aboriginal or Torres Strait Islander communities, especially those in remote locations, and ADF personnel who are overseas for long periods of time on deployment. c. Section 4.3: 4.3 Determining the limitations of an opt-out approach requires consideration of three major issues: i. strategies that are used to ensure appropriate respect for potential participants as part of the recruitment process for research; - See comments under section 3. - For any study using an opt-out approach, there will have to be a reasonable way to communicate to the general population that it is occurring. Suggestions include making this requirement, as a minimum, for notices to be consistent with the NHMRC Act (1992) requirements for public consultations as a minimum; to include the details as required at National Privacy Principle (NPP) 1.3. Members were concerned that publishing any notice in a newspaper classifieds section would not be accessible to many individuals who do not access print media for a variety of reasons. ADF deployments will restrict the ability for any individuals to access notices due to media access limitations and involvement in activities which would prevent them from doing so. ii. the spectrum of activities for which participants may be recruited (or for which access to their data may be obtained); and - Table 1 states that “Review by HREC is proposed for medical research that uses identifiable personal information. Non-HREC review can apply to other research.”. This is inconsistent with NS 3.2.10 and potentially conflicts with NPP section 2.1(a)(b)(d). iii. the character and identifiability of the data required to conduct the research. - Identifiability can be a difficult area in the ADF. Even where traditional identifiers such as name and date of birth are removed, individuals are often readily identifiable through their service, rank and/ or deployment history. ADHREC as a committee has had many discussions where research proposes to use data after removing “identifiers”, and notes that, especially where the research proposes to link data sets, there is relative ease of identifiability of information in a small, vulnerable population such s the ADF. Self-identification or identification of peers is also difficult to safeguard against in such a small population (NS 3.1.10; 3.1.11). This enhances the potential for social and economic harms . Tolich, M (2004). Internal Confidentiality: When Confidentiality Assurances Fail Relational Informants. Qualitative Sociology (27,1).
4: Please comment on the flow chart (i.e. Section 4).: 
a. 6d. of the flow chart may be inconsistent with NPP 2.1 (where the information is not medical information and s95 or 95A guidelines are applied). b. The definition of low risk research is open to interpretation, with levels and potential causes of “discomfort” being broad. Research ethics support staff also have many discussions with potential researchers, who interpret the National Statement through a risk management perspective, i.e. that if they can mitigate any potential harms with appropriate controls, that it reduces the risk level. This creates the potential for self-assessment as “negligible risk”, and the belief that proposals do not require HREC review. As such the flow chart should not stand independently from the National Statement or be recommended as a decision making tool in its own right, as it may be misleading. As a committee, ADHREC has also seen protocols which have been approved through university low risk panels that contain risks to Defence personnel which may not be immediately apparent to the general community (for example economic risks in the event of Notifiable Incidents being identified under the Defence Mandatory Reporting requirements). c. It is noted that all outcomes in the flow chart lead to “Research”, and that the role and place of HREC review is not clearly articulated. d. The flow chart would be more usable in combination with a guide such as Table 1 (page 6 of the consultation paper).
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.: 
a. For any study using an opt-out approach, there will have to be a reasonable way to communicate to the general population that it is occurring. Suggestions include making this requirement, as a minimum, for notices to be consistent with the NHMRC Act (1992) requirements for public consultations, and to include the details as required at National Privacy Principle 1.3. b. Members were concerned that publishing any notice in a newspaper classifieds section would not be accessible to many individuals who do not access print media, for a variety of reasons. ADF deployments will restrict the ability for any individuals to access notices in any format due to media access limitations and involvement in activities which would prevent them from doing so. Similarly, any remote communities with limited internet or print media access, will have difficulty accessing notices in any format, creating a substantially inequitable research burden for these groups to be able to opt out (NS 1.4(a)(c)). c. It is very important for the information in any notice to be presented in an appropriate plain language format, per the suggested 2.3.10 (d). d. There should be a minimum time for notices to be published prior to research commencement to allow participants a fair opportunity to opt out (NS 1.4(b)). e. Some standard clauses could be developed as mandatory for use in opt-out approach consent/ participant information sheets/ notices to achieve consistency and ensure information is communicated accurately.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
a. Opt-out approaches are likely to be open to interpretation as to the appropriateness of when they can or should be used. Suggest a “Using the National Statement” document should be created for this topic. b. It is not clear how the Privacy Act (1988) interacts with opt-out approaches in research where the information being used is not medical. c. Regarding the final paragraph of the introduction: It is not clear how an HREC should consider a protocol where elements are split, if not all were presented to the committee for consideration. As it currently reads, it could be interpreted that a researcher could commence a protocol with an opt-out approach and later apply to an HREC for approval to recruit further participants for another arm of the study and obtain explicit consent. d. It is foreseeable that in the event that a participant has not seen or been aware of the notice to opt out of a study, and then identifies themselves, or is contacted by a researcher for their permission to publish identifiable data, will have the potential for creating distress. This would mean the research cannot be classed as “low risk”, and questions the viability of an opt-out approach where participants had not previously consented to being contacted for future studies. These risks will be heightened in any population as listed at 5.1.6 or in Chapter 4.3 of the National Statement.
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
a. Nil comment.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
a. Where research is targeting specific subgroups of the population, as outlined at comment 3.f., and there may be associated risks to these groups in their ability to obtain for example health or life insurance. b. Where there is the likelihood that information will be identifiable, as there may be harms not only to individuals but to their families and communities. c. Some members commented that as there is a possibility of down playing risks to achieve the “low risk” rating and avoid HREC review, opt-out approaches should possibly be limited to negligible risk research activities only.
9. Can you provide examples where an opt-out approach may be useful?: 
a. Wide scale whole of population studies.
General Comments
Comments: 

a. The committee has concerns about introducing the use of opt-out approaches inAustralia. As outlined in the comments in this submission it is not feasible to expect people to regularly read and review notices providing information to opt-out of studies. For populations such as ADF members, who are frequently absent from the country and may not have an opportunity to access any media, it creates a significant additional burden on an already vulnerable population, and likely to become more open to being over-researched.

b. There are concerns that this approach will not be consistent with existing Commonwealth, and State and Territory legislation.

c. An opt-out approach may significantly reduce respect for humans in burdening them with the responsibility of having to actively opt out, reducing their ability to act autonomously or to have fair control over their own information.

Page reviewed: 28 March, 2014