NHMRC Public Consultations

Skip Navigation and go to Content
Visit NHMRC website

Ethical Issues in research into alcohol and other drugs submission

Personal Details
Organisation Name: 
Deakin University
C. Additional Information
Please identify the best term to describe the Organisation: 
Specific Questions
Those making a submission are encouraged to comment on the need for an ethical guidance framework, on whether the values and principles in the National Statement are adequate to address the ethical issues in AOD research, on whether the specific issues identified in this paper are sufficiently distinctive of AOD research to merit specific consideration in the proposed ethical guidance framework, and on whether there are additional issues that should be specifically considered in that framework.
Section Two – 2.1.3: 

We suggest caution on the creation of additional guidelines with the same status as the National Statement.

While discussion and guidance on the issues specific to AOD are useful, creation of a series of binding guidelines that require additional compliance and regulatory activities is hard to justify unless there are:

  1. substantive issues to address which are not dealt with in the core documents, or
  2. elements of the core guidelines which should be waived in relation to the particular area.

In this instance, the distinctive nature of AOD is in the correlation and extent of the issues rather than their nature. As noted in 2.1.2 the five aspects noted – stigma, criminal behaviour, collection of sensitive personal data with a real possibility of harm if confidentiality is breached, adverse effects on family, and conflicted community attitudes – are all found in other fields. It is the potentiality for ‘several of these issues to arise at once and acutely’ that is the significant characteristic of the research.

This proposal provides a valuable discussion and supports the value of discussion and other materials such as case studies in assisting HRECs to interpret the National Statement in relation to the particular issues of AOD. However, it does not reveal any substantive difference in principle between AOD research and other areas which encounter similar issues.

Accordingly, we support publication of materials, such as this paper, preparation of case studies or other materials to assist HRECs in interpreting the existing guidelines, rather than creation of additional research guidelines.

Section Five - 5.1: 

5.1.5 suggests that there are other values that can inform the researcher-participant relationship, the utility of specialised ethical guidelines for research areas and the importance of context, but does not say what these new values, guidelines, or contexts should be. As noted in 5.1.6 the National Statement provides guidelines for interpretation by ethics review bodies, based on core values and principles, which gives HRECs a degree of scope to interpret the guidelines.

In the absence of obvious gaps in the National Statement, or a clear ethical requirement to deviate from the principles articulated in it, there does not appear to be any reason to look for new principles or values. Rather, assistance in interpreting the principles and values already articulated seems most useful.

Section Five – 5.4: 

Input from relevant community groups would be highly valuable in understanding how to best apply the National Statement guidelines. Again, its value would lie in having input into vexed questions such as:

  • the most appropriate way to deal with payment of participants so as to ensure that harm is minimised,
  • strategies to help reduce the power imbalance between researchers and participants with dependence issues.

This engagement would assist HRECs in interpreting the guidelines, where in the absence of specific expertise they might well be speculating about the feelings and motivations of the potential participants.

Section Six : 

As noted above, the problems articulated here seem different in intensity rather than in nature. What is required is practical guidance, of the sort that might be provided by stakeholder input, rather than a new set of guidelines.

Section Six – 6.1: 

Regarding participant payment in AOD research, there is additional risk in providing monetary payment to substance users. Additional guidance, particularly practical input from stakeholder groups, is required in the area of payment / reimbursement generally. Using AOD research as a starting point for a discussion on payment would be useful, bearing in mind that issues raised ought to be applicable (and should be applied) to other areas of research.

The issue of payment is only one of a number of concerns which arise when a potential participant is ‘experiencing withdrawal symptoms, intoxicated, or suffering an acute drug induced psychiatric condition’ (6.1.3). In such situations the individual would clearly have a diminished capacity to consent. Researchers should always be aware of these issues and the need to consider the requirements of chapter 2.2 of the National Statement.

Specific guidance in this area where capacity to consent may be transiently impaired and / or fluctuating may be helpful. HRECs should certainly encourage researchers to define clearly the strategies to be employed to ensure that the participant has the capacity to consent.

Section Six – 6.2.2: 

The main circumstances under which it is appropriate for minors to give their own consent are where:

  1. they clearly have the capacity to do so required by law, or
  2. they are living independently and making their own decisions without reference to a parent or guardian, or
  3. they are considered adult members of their own society. 

Point 1 requires some means of determining capacity, which is often the weak point in such requirements. This is something that would need to be assessed by the ethics review body in relation both to the risk level of the project, and to the reliability of the method of assessment.

Point 2 is a situation where, the young person is in the position of making their own life decisions, and if they are doing so with reasonable success this may be evidence of capacity in itself.

Point 3 relates to research in some other countries where young teenagers once they become parents themselves or heads of household are recognised as fully adult regardless of chronological age. Asking for parental or guardian consent in such situations would be highly inappropriate.

I note that these situations are not specific to AOD research. See further comments below.

Section Six – 6.2.3: 

The National Statement already provides for minors to provide their own consent in some circumstances. Primarily this is where

  1. the young person is sufficiently mature make their own decisions (4.2.8), or
  2. the research is low risk and the relationship between the minor and his or her parents/guardian has broken down to the point that parental input is inappropriate or ‘contrary to the young person’s best interest’ (4.2.9).

The current guidelines tend to be interpreted conservatively by HRECs, so in general there is more likelihood of ethically justifiable research being impeded than of research going ahead which ought not to.

We support, with caution, the removal of an absolute requirement for parental consent and suggest that it may be ethically justifiable to conduct research on minors to which only the minors are asked to consent. There would need to be safeguards in place, which should include the following:

  1.  The proposal is approved by an HREC
  2.  The potential benefits of the research should be substantial (some form of a public interest argument for the research should be made)
  3.  The research should not be contrary  to the best interests of the young person
  4.  The HREC must be satisfied that measures are in place to ensure that minors have the capacity to consent (or not), appropriate to the risk level of the study
  5.   Minors are given the opportunity to involve trusted others (e.g. grandparent, family friend, school mentor) in the decision-making process.

This issue (consent of minors) is not specific to AOD research, and should be dealt with by appropriate amendments to chapter 4.2 of the National Statement, rather than by specific guidelines for minors in AOD research.

Section Six – 6.3: 

The potential impact of research on third parties who may be identified in or affected by research is something that should be considered in general. An amendment to the National Statement to cover this for all areas of research would be appropriate.

Section Six - 6.4: 

Online methods pose significant questions for researchers, both methodological (How to confirm that a participant with whom you have no direct contact meets your criteria for the study?) and ethical (How to ensure confidentiality in an online environment? How to provide support services in an international environment?). These issues should be covered in relation to all areas of research, not just AOD. Consideration by amending the National Statement would be appropriate.

Section Six– 6.5: 

This is an area that is likely to provide considerable problems for ethics committees, which are not, in general, comfortable with payments to participants of any kind. It would certainly need considerable safeguards to be ethically acceptable.

Section Six – 6.6: 

As noted in 6.6.2 ‘more detailed guidance on the application’ of the National Statement guidelines would be welcome. As throughout this submission, we would argue that commentary, discussion and case studies/examples would be a more suitable approach to these matters than providing further and more detailed guidelines.

Section Six - 6.7: 

Researcher safety is another general issue which is usually considered by HRECs in terms of the risks of a project. It could be dealt with more directly in the National Statement. It applies to all areas of research, not just to AOD.

Page reviewed: 26 October, 2012