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

This submission reflects the views of
Organisation Name: 
University of Sydney
Please identify the best term to describe the Organisation: 
Educational institution – tertiary
Personal Details
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
We suggest revising to include the following: A method used in the recruitment of participants into research where information has been provided to the potential participant regarding the research activity/project and their proposed involvement, and, in which their participation is presumed unless they take action to decline to participate.
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
The formal recognition of “opt-out” consent is a positive move to enable researchers to draw upon existing information where there is negligible or low risk of harm to subjects in ways that positively impact on society. Although we support the initiative, our concern is to ensure that an opt-out approach promotes the right of individuals to exercise control over information about them. The substantial differences in participation rates between “opt out” and “opt in” consent motivate the choosing of “opt out” consent over “opt-in” consent when sampling rate is critical for the statistical power and/or feasibility of a project. However, “opt-out” consent should not be considered a work-around for the poor participation rates of “opt-in” consent, and the reasons for differences between out-out and opt-in participation rates bears closer inspection. Are “opt-in” participants being improperly informed or feeling coerced to participate, or are participants reluctant to opt in more generally even if they are not opposed to taking part in the research because they find the process of opting in burdensome. We noted the justification in 3.3 regarding the potential for investigators to manipulate results in opt-in research design through selective inclusion of particular patients, leading to potential biases in results. Another related advantage of the opt-out approach is that more generally, where opt-in rates are as low as the 30-40% quoted in the document, there is potential for selection bias in terms of the types of people who opt in. An interesting related study is here http://www.bmj.com/content/331/7522/940. See also http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1955004/ It is recognized that in some circumstances the public interest in allowing particular research to be conducted outweighs the privacy requirement to gain consent of the people whose data is to be used. The consequences of incomplete or skewed data sets on the validity of research outcomes are important considerations when weighing the public interest in research. One option, rather than creating a third mechanism for waiving or qualifying conditions for consent to participate in research, would be to expand the Waiver mechanism at 2.3.6 using a set of criteria similar to those set out at 1.2 in the Statutory guidelines on research (2004) issued under the NSW Health Records and Information Privacy Act 2002 (HRIP Act): 1 The use or disclosure is reasonably necessary for research, or the compilation or analysis of statistics, in the public interest. 2 You have taken reasonable steps to de-identify the information, or the purpose of the research cannot be served by using or disclosing de-identified information and it is impracticable to seek the consent of the person to the use or disclosure. 3 If the information could reasonably be expected to identify individuals, the information is not published in a generally available publication. 4 The use or disclosure of the health information is in accordance with the statutory guidelines on research. There is some concern an opt-out approach may also put considerable recordkeeping and administrative burden on researchers who will be required to demonstrate that sufficient attempts have been made to contact participants.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
While recognizing that some research projects will require a combination of approaches relating to consent, the rationale does not provide any guidance on how decisions will be made by an ethical approving body in choosing between the alternatives. We consider that point 4.3 requires further clarification. What activities would be seen as falling within these guidelines? Section 4.4 speaks specifically to health data and the examples referred to throughout the document relate to medical/ health research. Is it the intention to not allow this change in low risk research within the humanities?
4: Please comment on the flow chart (i.e. Section 4).: 
The flowchart is useful in defining “opt-out” consent and for clarifying the relation of opt-out consent to explicit consent and waiver. Branch Section 2b implies ethical approval for the conduct of research can be granted retrospectively. This is in contrast to the National Statement. Page 7-9, Purpose, Scope and Limits of this Document, When is ethical review needed? Institutions are responsible for….….. A judgement that a human research proposal meets the requirements of this National Statement and is ethically acceptable must be made before research can begin and before full funding for the proposal is released We recommend point 7. Research state “7. Researchers access data and conduct research” or something similar to clarify that research commences at the point of access to the data (and therefore the nature of the dataset at the point of access, not extraction, is the critical factor when determining the type of consent/ethical review that is required).
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.: 
If an opt-out approach were to be adopted a mandatory minimum set of requirements would need to be set for contacting participants. The mechanism for providing information to participants would depend on the nature of the study. Some examples we have seen in areas outside of medical research include: • A study gauging patron’s reactions to art work in an art gallery. In this study, details were included in a poster on the wall next to the art work within the gallery. This would include information on how to opt out of the research. Also, information is provided to the patrons at the entrance to the gallery. • An engineering study involving gait analysis for robotics. The researchers videoed the lower limbs of all persons who entered a specific room. Details of the study and the option to opt out were placed in a visible poster at the entrance of the room as well as details forwarded via email to all persons who have access to the area. For health related research this would include communication to the last known address, either physical or electronic. A standard period of time would need to be established for replies to be received. After this deadline their participation will be presumed, with the assurance that they can withdraw at any point. There should be an appropriate contact for them to withdraw and these contact details.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
The addition to the introduction is clear and acceptable. There needs to be clarity around whether all conditions under 2.3.10 must be met or whether only a subset must be met. Following are comments on specific clauses under 2.3.10 2.3.10b: needs further clarification. Define “importance” ¬ to whom/what? Scientifically? To certain groups of people? How does this differ from serving the public benefit? Define “serve the public benefit” or give some examples of key criteria, as provided for the “public interest” section of S95 and S95A of privacy guidelines. 2.3.10d Examples/further clarification of “reasonable attempts” (see 2.3.6c) should be included as a footnote, as for the “impracticable to seek consent” clause in the waiver of consent guidelines of the current National Statement, as this is highly subjective. Too much or too little contact would be problematic. 2.3.10g and 2.3.10h do not provide adequate detail; we suggest an inclusion such as in 2.3.6e and 2.3.6f of the National Statement. 2.3.10i it is unclear what governance process this is referring to; is the governance process the institutions responsibility or the researchers responsibility and what does the NHMRC expect this process to look like and how would the HREC assess it? There is no reference to personal information management, privacy or confidentiality as there is in the conditions attached to granting a waiver for the need to gain consent. These conditions should be added. There is reference to a governance regime for managing the project and the data, but not to recordkeeping which is essential if evidence of appropriate steps to get consent on the opt-out basis is to be created and kept for as long as the data set is used.
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
Although the proposed changes to the National Statement appear to apply to all disciplines, the examples presented in the consultation document refer to health/ medical research. There is very little reference to how this would be implemented for low risk humanities (and other non-medical) projects.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
We consider where participants are unable to understand and communicate their wishes, it would not be appropriate to have an opt-out approach. Following are examples where we consider opt-out consent inappropriate: • Vulnerable participant groups and those groups unable to give consent; • Research which is intended to uncover illegal activities; • Research involving conditions that have some public stigma attached, such as mental illness, infectious diseases, infertility etc ; and • Research that has implications for third parties beyond the participants. If only a subset of 2.3.10 needs to be met we could envisage many situations where opt out approach is not appropriate.
9. Can you provide examples where an opt-out approach may be useful?: 
As described above: • A study gauging patron’s reactions to art work in an art gallery. In this study, details were included in a poster on the wall next to the art work within the gallery. This would include information on how to opt out of the research. Also, information is provided to the patrons at the entrance to the gallery. • An engineering study into gait analysis for robotics. The researchers videoed the lower limbs of all persons who entered a specific room. Details of the study and the option to opt out were placed in a visible poster at the entrance of the room as well as details forwarded via email to all persons who have access to the area. Other examples: • Review of health courses for professionals where there isn't an obvious power imbalance between researchers and participants. Since these participants are generally busy individuals the consent process would be viewed as burdensome and the conduct of the study would have a direct benefit. • Conducting observations in a public place (e.g. hospital/nursing homes, or schools, etc.) to examine interpersonal interactions where it is not always possible to get explicit consent prior to the observation. An opt-out approach using a newsletter, flyer/brochure or notice board in a place where the observation takes place which can be made available to everyone entering into the research scene well before commencing observations, would be helpful.
General Comments

The University of Sydney welcomes the opportunity to comment on the proposed changes to section 2.3 of the National Statement and supports the initiative to introduce an opt-out consent process. The material presented in the consultation document is in the context human research related to health, which is understandable given the role of the NHMRC.  It is relevant to note that there is currently no standardised means for balancing the public interest in research with privacy considerations for human research that is not medical or health related.  The importation of the process for assessing the public interest in research from the NSW Statutory Guidelines would provide such a mechanism.


Page reviewed: 28 March, 2014