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Ethical Issues in research into alcohol and other drugs submission

ID: 
22
Personal Details
Organisation Name: 
Eastern Health Research and Ethics Committee
C. Additional Information
Please identify the best term to describe the Organisation: 
Other
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: 

Issues identified in 2.1.3 are participant payment; consent in minors and parental consent; dependents of participants; online methods in recruitment and data-collection; contingency management payments; legal risks for participants and researchers; and protection of researchers.

These issues also relate to other research. More guidance can be given within the National Statement but a separate AOD guidance framework may not be warranted.

In particular more guidance for Online Research will be welcome.

Section Five - 5.1: 

No specific comment for this section but as noted above guidance for all research issues is helpful and welcome.

Section Five – 5.4: 

Requirement for community approval at all times may be too limiting.

Section Six : 

Comments as for section 2.1.3

 

Section Six – 6.1: 

6.1 Participant payment in AOD research

This is already covered in the National Statement 2.2.10 and 2.2.11 and could be added to if necessary. While it is possible that potential AOD research participants may be experiencing withdrawal at the time of participation this is given undue emphasis.

6.1.3 Withdrawal symptoms increasing risk of monetary payment as an inducement

Given that anyone experiencing withdrawal would not be capable of giving informed consent and therefore ought not to be participating, the issue of payment as incentive is not relevant here.

6.1.6c and 6.1.6d Withholding payment or non-monetary payments

These measures may be paternalistic and not respectful of participants’ autonomy. If participants are considered capable of making an informed decision to take part in research, they should be considered capable of being given monetary payment in that same way as participants in other research.  

Section Six – 6.2.2: 

6.2 Consent in minors and parental consent

This is already covered in the National Statement 2.212 and 4.2 and can be added to if necessary.

Section Six – 6.2.3: 

No specific comment for this section.

Section Six – 6.3: 

6.3 Ethical issues concerning the dependants of participants

Dealing with this ethical issue in the context of AOD use, rather than a broader context may contribute to entrenching prejudicial attitudes to people who use drugs.

6.3.2 Disclosure of illegal activity

This can be dealt with as outlined in 6.6.

6.3.3 Duty of care to dependents of participants

This issue is more reflective of prejudicial attitudes to ‘drug users’ than any research on the subject. (It is noted that no research is cited for this section.) There are other research contexts where such issues may also arise and is better dealt with in the context of ‘any research which may reveal child abuse or neglect’ rather than further stigmatising ‘drug users’.

Section Six - 6.4: 

6.4 Online methods in recruitment and data-collection

None of these issues are specific to AOD research although guidance is needed.

Online AOD research may be better served by a section in a separate guidance framework on online research. The same issues as canvassed in this section would apply equally to other areas of research, eg sexual health.

Section Six– 6.5: 

6.5 contingency management payments

None of these issues are specific to AOD research although guidance may be warranted.

Issues raised under this heading apply to any motivational issue in health, not just problematic AOD use, eg obesity. It is noted that incentive payments are part of the treatment intervention, not for participation in research. Therefore the ethical issues are not the same as payment for participation in research. They would concern the efficacy and clinical ethics of contingency management as a treatment intervention, not the design of research about contingency payment.

Section Six – 6.6: 

6.6 Legal risks for participants and researchers:

This is covered in the National Statement 4.6 and could be added if necessary.

It may be useful to state this more explicitly in the National Statement. It is important that there is sufficient de-identification of data of participants to protect their privacy. This is particularly relevant when information is being given about criminal behaviours such as illegal drug purchase, use, trafficking or other related crimes. If there is reference to participation in this study in say for example a counsellor-psychologists’ notes, then it is possible that a subpoena for production on the survey results pertaining to the individual could occur. This is possible if that individual was involved in either criminal or civil proceedings.

Section Six - 6.7: 

6.7 Protection of researchers

This issue is of paramount importance.

However it should not be assumed that this applies only to researchers undertaking AOD research.

A requirement should be training for researchers and research assistants who will do interviews, in assessing competence of potential participants who may be intoxicated or experiencing withdrawal to give informed consent, putting the emphasis on the researcher’s or interviewer’s skill in determining capacity to give informed consent and to participate.

Arguably this should be best practice because anyone participating in almost any research may be affected by alcohol or other drugs, including prescription medication. For example, National Drug Strategy Household Survey is of the whole population, some of whom report drug use.

To ensure the safety of the actual interviewers, care should be taken in the study design so as not to expose interviewers to unnecessary risk or harm, given the type of participants they may be interviewing and the context (eg observational studies in pubs and nightclubs). Guidelines in terms of minimum number of persons present whilst interviewing; and whether interviewers have suitable training for risk avoidance may be helpful.

General Comments
Comments: 

In general having more guidance for research issues is helpful and welcome.

However most of the AOD issues are not so different from other research so a separate guidance framework may not be warranted. In addition separate guidance may imply an artificial differentiation between areas of research.

It is appropriate to provide more guidance within the National Statement on these AOD issues which also apply to other research.

In particular, there is insufficient guidance for Online Research in the National Statement. General guidance is appropriate and needs not be specific to AOD online research.

Additional comment

4.1 The four domains of epidemiological and social science research

The first two are about AOD use, the third is about harm, and only the fourth includes ‘addiction’. Much in the issues papers emphasises dependence and addition; therefore it runs the risk of conflating ‘use’ with ‘addiction’.

Page reviewed: 26 October, 2012