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NEUROSCIENCE OF PSYCHOACTIVE SUBSTANCE USE AND DEPENDENCE
Informed consent
Informed consent to participate in a research study is usually a matter of
asking the research participant to consent to their participation after a
detailed discussion of what it will entail and a description of any adverse
events that may occur (Brody, 1998). The participation of persons under the
age of 18 years would normally require the consent of a parent or guardian,
along with the assent of the participant. Any uncertainty about the risks of
participation must be accurately communicated and there must be close
monitoring of any adverse events, with medical care promptly provided for
any adverse outcomes. The inclusion of persons with cognitive impairments
in a study may require special consideration (see below). Consent may need
to be obtained from a surrogate who makes a decision on behalf of the
impaired research participant (Brody, 1998). This has implications for research
involving persons with substance dependence if the person has long-term
cognitive, psychiatric, or neurological dysfunction as a result of substance
use (see Chapter 4), or if the person has a concurrent psychiatric illness (see
Chapter 6).
All forms of consent must be given after the participants are informed of
what their involvement in the research will require of them. Research
participants should have time to reflect on and consider their obligations at
each stage of the consent procedure. Ideally, the consent process should
include a third party, usually a clinician not involved in the study, to ensure
the integrity of the process. Participants must be allowed to withdraw from
the study at any time. If they decide to withdraw, their decision must be
respected and they must be informed that they will not suffer any
consequences, such as refusal of routine counselling or medical care (Brody,
1998). If any participant withdraws from the study, the data collected from
them must be omitted from the final results.
Recruitment of subjects
The conditions under which persons are recruited into a study must not
involve any form of coercion or the use of excessive inducements to
participate (Brody, 1998). In recent years, it has become common to reimburse
participants for their involvement in some research studies. The most
common justification is that reimbursements maximize initial recruitment
and retention of participants in a study. Small reimbursements are offered to
compensate participants for the time spent participating in a trial or for their
travel expenses. Reimbursements may be interpreted by some potential
subjects as rewards for participation, and by researchers as a way of increasing
the number of trial participants. Ashcroft argues that inducements are
ethically acceptable if the inducement serves to recompense a participant
for the inconvenience, as long as it is not seen as a payment for any harm
caused (Ashcroft, 2001). In Australia, for example, it has been common
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