Galea Jerome T, Greene Karah Y, Nguyen Brandon, Polonijo Andrea N, Dubé Karine, Taylor Jeff, Christensen Christopher, Zhang Zhiwei, Brown Brandon
School of Social Work, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, United States.
College of Public Health, University of South Florida, Tampa, FL, United States.
JMIR Res Protoc. 2021 Nov 23;10(11):e33608. doi: 10.2196/33608.
Monetary incentives in research are frequently used to support participant recruitment and retention. However, there are scant empirical data regarding how researchers decide upon the type and amount of incentives offered. Likewise, there is little guidance to assist study investigators and institutional review boards (IRBs) in their decision-making on incentives. Monetary incentives, in addition to other factors such as the risk of harm or other intangible benefits, guide individuals' decisions to enroll in research studies. These factors emphasize the need for evidence-informed guidance for study investigators and IRBs when determining the type and amount of incentives to provide to research participants.
The specific aims of our research project are to (1) characterize key stakeholders' views on and assessments of incentives in biomedical HIV research; (2) reach consensus among stakeholders on the factors that are considered when choosing research incentives, including consensus on the relative importance of such factors; and (3) pilot-test the use of the guidance developed via aims 1 and 2 by presenting stakeholders with vignettes of hypothetical research studies for which they will choose corresponding incentive types.
Our 2-year study will involve monthly, active engagement with a stakeholder advisory board of people living with HIV, researchers, and IRB members. For aim 1, we will conduct a nationwide survey (N=300) among people living with HIV to understand their views regarding the incentives used in HIV research. For aim 2, we will collect qualitative data by conducting focus groups with people living with HIV (n=60) and key informant interviews with stakeholders involved in HIV research (people living with HIV, IRB members, and biomedical HIV researchers: n=36) to extend and deepen our understanding of how incentives in HIV research are perceived. These participants will also complete a conjoint analysis experiment to gain an understanding of the relative importance of key HIV research study attributes and the impact that these attributes have on study participation. The data from the nationwide survey (aim 1) will be triangulated with the qualitative and conjoint analysis data (aim 2) to create 25 vignettes that describe hypothetical HIV research studies. Finally, individuals from each stakeholder group will select the most appropriate incentive that they feel should be used in each of the 25 vignettes (aim 3).
The stakeholder advisory board began monthly meetings in March 2021. All study aims are expected to be completed by December 2022.
By studying the role of incentives in HIV clinical trial participation, we will establish a decision-making paradigm to guide the choice of incentives for HIV research and, eventually, other types of similar research and facilitate the ethical recruitment of clinical research participants.
ClinicalTrials.gov NCT04809636; https://clinicaltrials.gov/ct2/show/NCT04809636.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33608.
研究中的金钱激励经常被用于支持参与者的招募和留存。然而，关于研究人员如何决定所提供激励的类型和金额，实证数据却很少。同样，在协助研究调查人员和机构审查委员会（IRB）进行激励决策方面，几乎没有相关指导。金钱激励，连同其他因素，如伤害风险或其他无形利益，会影响个人参与研究的决定。这些因素强调了在确定向研究参与者提供的激励类型和金额时，需要为研究调查人员和IRB提供基于证据的指导。
我们研究项目的具体目标是：（1）描述关键利益相关者对生物医学HIV研究中激励措施的看法和评估；（2）使利益相关者就选择研究激励措施时考虑的因素达成共识，包括这些因素相对重要性的共识；（3）通过向利益相关者展示假设研究的 vignette，让他们选择相应的激励类型，对通过目标1和2制定的指导进行试点测试。
我们为期2年的研究将每月与一个由HIV感染者、研究人员和IRB成员组成的利益相关者咨询委员会进行积极互动。对于目标1，我们将在全国范围内对HIV感染者进行调查（N = 300），以了解他们对HIV研究中使用的激励措施的看法。对于目标2，我们将通过与HIV感染者进行焦点小组讨论（n = 60）以及与参与HIV研究的利益相关者（HIV感染者、IRB成员和生物医学HIV研究人员：n = 36）进行关键信息访谈来收集定性数据，以扩展和深化我们对HIV研究中激励措施如何被认知的理解。这些参与者还将完成一项联合分析实验，以了解HIV研究关键属性的相对重要性以及这些属性对研究参与的影响。来自全国性调查（目标1）的数据将与定性和联合分析数据（目标2）进行三角验证，以创建25个描述假设HIV研究的 vignette。最后，每个利益相关者群体的个体将为25个 vignette中的每一个选择他们认为最合适的激励措施（目标3）。
利益相关者咨询委员会于2021年3月开始每月举行会议。预计所有研究目标将于2022年12月完成。
通过研究激励措施在HIV临床试验参与中的作用，我们将建立一个决策范式，以指导HIV研究以及最终其他类似研究类型的激励措施选择，并促进临床研究参与者的伦理招募。
ClinicalTrials.gov NCT04809636；https://clinicaltrials.gov/ct2/show/NCT04809636。
国际注册报告识别号（IRRID）：DERR1-10.2196/33608。
