Safety in drug and alcohol research

Day, Carolyn; Topp, Libby

doi:10.1111/j.1360-0443.2003.00486.x

Cited by 7 publications

(5 citation statements)

References 16 publications

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“…The threats to personal safety related to fieldwork in drug scenes are recognized by ethnographers and other field-based researchers, who have identified strategies for navigating these hazards (Day et al, 2002; Williams et al, 1992). Our study protocol employed these conventional approaches to minimizing potential for harm to researchers, and a unique community consultation process involving a drug user group was utilized.…”

Section: Discussionmentioning

confidence: 99%

Institutional ethical review and ethnographic research involving injection drug users: A case study

Small

Maher²

2014

Social Science & Medicine

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Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators’ responses to the committee’s concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality.

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Section: Discussionmentioning

confidence: 99%

Institutional ethical review and ethnographic research involving injection drug users: A case study

Small

Maher²

2014

Social Science & Medicine

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“…As compensation for their time and travel, participants were offered an AUD$40 food voucher [ 33 ]. All researchers completed a three-hour training session on administering the client survey and adhering to an interviewer safety protocol [ 34 ]. On average, surveys took 45 minutes to complete.…”

Section: Methodsmentioning

confidence: 99%

A place to call home: study protocol for a longitudinal, mixed methods evaluation of two housing first adaptations in Sydney, Australia

et al. 2015

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BackgroundThis protocol describes a study evaluating two ‘Housing First’ programs, Platform 70 and Common Ground, presently being implemented in the inner-city region of Sydney, Australia. The Housing First approach prioritises housing individuals who are homeless in standard lease agreement tenancies as rapidly as possible to lock in the benefits from long-term accommodation, even where the person may not be seen as ‘housing ready’.Methods/DesignThe longitudinal, mixed methods evaluation utilises both quantitative and qualitative data collected at baseline and 12-month follow-up time points. For the quantitative component, clients of each program were invited to complete client surveys that reported on several factors associated with chronic homelessness and were hypothesised to improve under stable housing, including physical and mental health status and treatment rates, quality of life, substance use patterns, and contact with the health and criminal justice systems. Semi-structured interviews with clients and stakeholders comprised the qualitative component and focused on individual experiences with, and perceptions of, the two programs. In addition, program data on housing stability, rental subsidies and support levels provided to clients by agencies was collected and will be used in conjunction with the client survey data to undertake an economic evaluation of the two programs.DiscussionThis study will systematically evaluate the efficacy of a scatter site model (Platform 70) and a congregated model (Common Ground) of the Housing First approach; an examination that has not yet been made either in Australia or internationally. A clear strength of the study is its timing. It was designed and implemented as the programs in question themselves were introduced. Moreover, the programs were introduced when the Australian Government, with State and Territory support, began a more focused, coordinated response to homelessness and funded rapid expansion of innovative homelessness programs across the country, including Common Ground supportive housing developments.Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-015-1700-y) contains supplementary material, which is available to authorized users.

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“…Data are collected on an electronic Case Report Form (eCRF) implemented using Research Electronic Data Capture (REDCap) [ 34 , 35 ]. Each eCRF is manually reviewed by data monitoring personnel for accuracy and completeness.…”

Section: Data Collection and Managementmentioning

confidence: 99%

“…Data are being collected via a secure password-protected data platform (REDCap [ 34 , 35 ]) maintained by the University of New South Wales. Access is password-protected and requires two-factor authentication.…”

Section: Data Collection and Managementmentioning

confidence: 99%

A phase 3 randomised double-blind placebo-controlled trial of mirtazapine as a pharmacotherapy for methamphetamine use disorder: a study protocol for the Tina Trial

McKetin,

Degan,

Saunders

et al. 2024

Trials

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Background There are no approved pharmacotherapies for methamphetamine use disorder. Two preliminary phase 2 randomised controlled trials have found mirtazapine, a tetracyclic antidepressant, to be effective in reducing methamphetamine use. The proposed Tina Trial is the first phase 3 placebo-controlled randomised trial to examine the effectiveness and safety of mirtazapine as an outpatient pharmacotherapy for methamphetamine use disorder. Methods This is a multi-site phase 3 randomised, double-blind, placebo-controlled parallel trial. Participants are randomly allocated (1:1) to receive either mirtazapine (30 mg/day for 12 weeks) or matched placebo, delivered as a take-home medication. The target population is 340 people aged 18–65 years who have moderate to severe methamphetamine use disorder. The trial is being conducted through outpatient alcohol and other drug treatment clinics in Australia. The primary outcome is measured as self-reported days of methamphetamine use in the past 4 weeks at week 12. Secondary outcomes are methamphetamine-negative oral fluid samples, depressive symptoms, sleep quality, HIV risk behaviour and quality of life. Other outcomes include safety (adverse events), tolerability, and health service use. Medication adherence is being monitored using MEMS® Smart Caps fitted to medication bottles. Discussion This trial will provide information on the safety and effectiveness of mirtazapine as a pharmacotherapy for methamphetamine use disorder when delivered as an outpatient medication in routine clinical practice. If found to be safe and effective, this trial will support an application for methamphetamine use disorder to be included as a therapeutic indication for the prescription of mirtazapine. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12622000235707. Registered on February 9, 2022.

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Safety in drug and alcohol research

Cited by 7 publications

References 16 publications

Institutional ethical review and ethnographic research involving injection drug users: A case study

Institutional ethical review and ethnographic research involving injection drug users: A case study

A place to call home: study protocol for a longitudinal, mixed methods evaluation of two housing first adaptations in Sydney, Australia

A phase 3 randomised double-blind placebo-controlled trial of mirtazapine as a pharmacotherapy for methamphetamine use disorder: a study protocol for the Tina Trial

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