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A comment on participant reimbursement within Australian drug and alcohol research
Drug and Alcohol Review ( IF 3.0 ) Pub Date : 2022-02-28 , DOI: 10.1111/dar.13452
Daniel T Winter 1, 2 , Brennan Geiger 1, 2 , Carolyn A Day 1, 2
Affiliation  

Financial reimbursement for participation in drug and alcohol research has long been considered appropriate and is standard practice in Australia [1, 2]. Such payments afford a means to acknowledge participant value in advancing scientific knowledge, while recognising the time, inconvenience and expenses incurred. Furthermore, payments are considered scientifically and ethically valid [2, 3], can facilitate the recruitment of hidden or priority populations, and may increase retention in studies that require follow-up [4, 5].

Financial reimbursements, cash or shopping vouchers, are commonly provided as methods of payment for research participation [6]. However, while vouchers provide an equivalent monetary value to cash, they often restrict the recipient's autonomy by limiting use at specific retailers or may restrict the purchase of certain goods (e.g. alcohol or tobacco products). Vouchers can be traded by participants for cash, often at a depreciated value, as has been noted by some researchers [7].

Cash, on the other hand, provides greater flexibility and autonomy for participants, and use toward non-retail items, such as transport, personal grooming, rental or utility payments or pocket-money for dependents. Cash, however, can pose real and important challenges for administering institutions, in terms of both financial administration and, potentially, staff security. Non-financial reimbursements also exist (e.g. prize draws or raffles for vouchers) which, comparatively, provide little to no compensation for participation in research.

As we have previously described, there is currently little guidance around appropriate reimbursement practices for drug and alcohol research [8]. Most mechanisms for reimbursement are reliant upon individual researchers, availability of funds or institutional policies (which may be neither consumer nor evidence informed) to determine the type and value of reimbursement. As such, discrepancies in reimbursement provided across similar studies may exist or could be dictated solely by the sponsoring organisation without consideration of the broader ethical and scientific implications. Although there is broad guidance provided by the National Health and Medical Research Council on models for providing payments in research [3] and examples of payment policies for general consumer engagement, such as the National Mental Health Commission's Paid Participation Policy [9], there is no current policy on reimbursement in the drug and alcohol setting. Similarly, we are unaware of a scientific directive, such as the CONSORT (Consolidated Standards of Reporting Trials) [10] and STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) [11] statements, to report whether reimbursement is provided for research and, if so, the type and value of the reimbursement. Given the scientific and ethical implications of participant reimbursements, this is cause for concern.

In examining reporting of reimbursements for research published in Drug and Alcohol Review from 2017 to 2019 (Volumes 36–38), we found 215 research papers involving individual participants who may use a substance. Of these, 43% of papers were from research based in Australia, with half (51%) providing at least some information regarding reimbursement within the paper, and a further 13% by referencing methodology elsewhere.

Of the Australian papers, 13% specified reimbursement with vouchers, 3% by cash/money transfer and 13% explicitly mentioned that no form of reimbursement was offered for participation. Non-financial reimbursements were also identified (12%), most often a prize draw for a voucher or item of a large value. The remaining papers did not report on reimbursement. For those papers that did report reimbursement, however, one-quarter did not report the payment mode method (i.e. if cash or voucher was provided) and 5% did not report value (e.g. ‘Participants received a gift voucher in recognition of their contribution’).

For those papers that did provide details, the value of the reimbursement ranged from $10 to 80 AU (mean = $36.6 AU, SD = 14.08) and 44% also reported the approximate duration to complete the study tasks (mean = 46.7 min, SD = 26.75; range = 5–150 min). Five papers reported varied reimbursement value based on factors such as age (i.e. lower reimbursement value for those underaged), location of study (i.e. varied, or no, reimbursement based on location of study) or driven by local consumer perceptions as to what is considered fair value for reimbursement.

Most papers examined issues related to general drug use (32%), alcohol, (23%), tobacco/nicotine (19%) and opioids (13%). Financial reimbursements were most often provided for opioid-related research (75%), compared to alcohol (14%) and general drug use (37%) research. All other papers, based on substance type, provided financial reimbursement in 50% of cases.

Almost half (46%) of the papers assessed were focused on general population recruitment, specific populations recruited included people who use drugs (23%), people in or seeking drug and alcohol treatment (11%), and Aboriginal or Torres Strait Islander peoples (7%), among others. Financial reimbursements were commonly provided for inmates (100%), people who use drugs (77%), Aboriginal and Torres Strait Islander peoples (71%), but was less frequently provided in studies that recruited from the general population (21%) or those underaged/school students (17%).

Just over half (55%) of studies recruited from outside of health-care services. Where recruitment occurred within or, in collaboration with, a health-care service, just over half provided financial reimbursements (57%). Studies that did not involve a health service in recruitment reported the provision of reimbursement less often (27%).

We applaud the reported use of financial reimbursement in research, such as with people who use drugs and in opioid-related research (77% and 75% of papers, respectively), which is consistent with both ethical and scientific principles described previously [1-3]. However, this raises two important questions. First, should these basic principles be extended to all drug and alcohol research, or indeed research in general? Second, is there an appropriate amount to provide for participation and, if so, what is that and how should this relate to participant's time spent on the research? We argue that the later point can only be answered in close consultation with relevant consumer groups. The former point regarding principles of reimbursement should at least be considered for all groups and also requires greater consumer input. However, this is arguably more challenging outside the illicit and, especially, the injecting drug use areas, or other areas of research where consumer representation may be less established.

We also argue for clear and precise reporting on participant reimbursement in all research papers. While it is evident that providing a financial reimbursement to participants is generally accepted in drug and alcohol research, particularly in Australia, there is arguably greater need for transparency, clarity and openness regarding disclosure of participant reimbursement within the literature to ensure ethical and scientific principles of research are upheld.

In conclusion, greater discussion and consideration for guidance regarding appropriate reimbursement is warranted across the drug and alcohol research sector, and consumers must play a central role in such a process. Without input from consumers, in determining whether participants should be reimbursed for research participation and the type and value of that reimbursement, researchers are inadvertently assessing the ‘value’ of the participant. Finally, research reports should be more transparent in their reporting of participant payment to increase scientific rigour and reproducibility.



中文翻译:


关于澳大利亚毒品和酒精研究参与者报销的评论



长期以来,参与毒品和酒精研究的经济报销一直被认为是适当的,并且是澳大利亚的标准做法 [ 1, 2 ]。此类付款提供了一种承认参与者在推进科学知识方面的价值的方式,同时承认所产生的时间、不便和费用。此外,付款被认为在科学和伦理上有效 [ 2, 3 ],可以促进隐藏或优先人群的招募,并可能增加需要后续研究的保留率 [ 4, 5 ]。


财务报销、现金或购物券通常作为研究参与的支付方式提供[ 6 ]。然而,虽然代金券提供与现金等价的货币价值,但它们通常通过限制在特定零售商处使用来限制接收者的自主权,或者可能限制购买某些商品(例如酒精或烟草产品)。正如一些研究人员所指出的那样,参与者可以将优惠券换成现金,通常会以贬值的价格进行交易 [ 7 ]。


另一方面,现金为参与者提供了更大的灵活性和自主权,并可用于非零售物品,例如交通、个人美容、租金或水电费或家属的零用钱。然而,现金可能对管理机构在财务管理和潜在的工作人员安全方面构成真正且重要的挑战。还存在非经济补偿(例如抽奖或代金券抽奖),相对而言,它们对参与研究提供的补偿很少甚至没有。


正如我们之前所描述的,目前关于药物和酒精研究的适当报销实践的指导很少[ 8 ]。大多数报销机制依赖于个体研究人员、资金的可用性或机构政策(可能既不通知消费者也不通知证据)来确定报销的类型和价值。因此,类似研究中提供的报销差异可能存在,或者可能仅由主办组织决定,而不考虑更广泛的伦理和科学影响。尽管国家卫生和医学研究委员会就研究付费模式提供了广泛的指导 [ 3 ] 以及一般消费者参与的付费政策示例,例如国家心理健康委员会的付费参与政策 [ 9 ],但目前没有关于吸毒和酗酒的报销政策。同样,我们不知道有科学指令,例如 CONSORT(报告试验的综合标准)[ 10 ]和 STROBE(加强流行病学观察研究的报告)[ 11 ]声明,来报告是否为研究和研究提供报销。 ,如果是的话,报销的类型和价值。考虑到参与者报销的科学和伦理影响,这是令人担忧的。


在审查 2017 年至 2019 年《药物和酒精评论》 (第 36-38 卷)上发表的研究报销报告时,我们发现了 215 篇研究论文涉及可能使用某种物质的个人参与者。其中,43% 的论文来自澳大利亚的研究,其中一半 (51%) 至少在论文中提供了一些有关报销的信息,另外 13% 则引用了其他地方的方法。


在澳大利亚报纸中,13% 明确指出以优惠券报销,3% 通过现金/汇款方式报销,13% 明确提到不为参与提供任何形式的报销。还确定了非财务报销(12%),最常见的是对礼券或大价值物品的抽奖。其余论文均未报道报销情况。然而,对于那些确实报告报销的论文,四分之一没有报告付款方式(即是否提供现金或代金券),5% 没有报告价值(例如“参与者收到了一张礼券以表彰他们的贡献”) )。


对于那些确实提供了详细信息的论文,报销金额从 10 美元到 80 AU(平均值 = 36.6 AU,SD = 14.08)不等,44% 的论文还报告了完成研究任务的大致持续时间(平均值 = 46.7 分钟,SD = 26.75;范围 = 5–150 分钟)。五篇论文报告了不同的报销价值,这些因素取决于年龄(即未成年人的报销价值较低)、学习地点(即根据学习地点的不同报销或不报销)或受当地消费者对考虑因素的看法驱动补偿的公允价值。


大多数论文探讨了与一般药物使用(32%)、酒精(23%)、烟草/尼古丁(19%)和阿片类药物(13%)相关的问题。与酒精(14%)和一般药物使用(37%)研究相比,阿片类药物相关研究(75%)最常获得财务报销。所有其他论文(根据物质类型)在 50% 的案例中提供经济补偿。


几乎一半(46%)的评估论文集中在一般人群招募上,招募的特定人群包括吸毒者(23%)、接受或寻求药物和酒精治疗的人(11%)以及原住民或托雷斯海峡岛民(7%) 等。通常为囚犯(100%)、吸毒者(77%)、原住民和托雷斯海峡岛民(71%)提供经济补偿,但在从普通人群(21%)或其他人群中招募的研究中提供的频率较低。未成年人/在校学生(17%)。


超过一半 (55%) 的研究是从医疗保健服务机构之外招募的。在医疗保健服务机构内部或与医疗保健服务机构合作进行招聘的情况下,只有超过一半的人提供财务报销(57%)。在招募过程中不涉及医疗服务的研究报告称,提供报销的情况较少(27%)。


我们对研究中使用财务报销的报道表示赞赏,例如对吸毒者和阿片类药物相关研究(分别占论文的 77% 和 75%),这符合前面描述的伦理和科学原则 [ 1- 3 ]。然而,这提出了两个重要问题。首先,这些基本原则是否应该扩展到所有药物和酒精研究,或者一般研究?其次,是否有适当的参与金额,如果有,那是什么?这与参与者花在研究上的时间有何关系?我们认为,后一点只能在与相关消费者群体密切协商后才能得到回答。前一点关于报销原则至少应该考虑到所有群体,也需要更多的消费者投入。然而,在非法领域之外,尤其是注射吸毒领域或消费者代表可能不太确定的其他研究领域,这可能更具挑战性。


我们还主张在所有研究论文中清晰、准确地报告参与者的报销。虽然很明显,在毒品和酒精研究中,特别是在澳大利亚,向参与者提供财务报销已被普遍接受,但在文献中披露参与者报销方面,可以说更需要透明度、清晰度和开放性,以确保研究的伦理和科学原则。研究得到支持。


总之,整个药物和酒精研究部门有必要对有关适当报销的指导进行更多讨论和考虑,并且消费者必须在这一过程中发挥核心作用。如果没有消费者的意见,在确定参与者是否应该因参与研究而获得补偿以及补偿的类型和价值时,研究人员会无意中评估参与者的“价值”。最后,研究报告在参与者付款的报告中应该更加透明,以提高科学严谨性和可重复性。

更新日期:2022-02-28
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