Elizabeth Ripley

A Review of Paying Research Participants: It's Time to Move Beyond the ethical Debate.

Current regulatory guidelines require the ethical review committee to consider one question when evaluating payment: Is the payment to the participant undue or coercive? Although this is a seemingly simple question, determining appropriate payment involves a series of complex issues. There is limited empirical knowledge to assist with this determination and little consensus on which elements of a study should be considered in making these decisions. For example, should the culture of the study population or the potential risks and benefits of the research be considered in the selection of appropriate payment? Following a review of national and international guidelines, the concerns and benefits of paying research participants are presented, and prior ethical debate is outlined. The current research literature on the practice of paying participants and the impact of payment on participants and study integrity are reviewed. Finally, given continued debate with limited data to help determine best practices, a research agenda is proposed to assist in the development of an empirical basis to aid investigators and ethical review committees in making appropriate decisions about payment to research participants.

Complementary effects of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in slowing the progression of chronic kidney disease.

Chronic kidney disease (CKD) and end-stage renal disease continue to pose major healthcare challenges. Early initiation of therapy aimed at slowing the progression of CKD is essential. Increased renin-angiotensin-aldosterone-system activity and, in particular, elevated levels of angiotensin II (AII) play important roles in the development and progression of CKD. Therefore, pharmacologic therapies that block the effects of AII and reduce its pathogenic effects are cornerstones of clinical management. Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) have been shown to have renoprotective effects in addition to their ability to control blood pressure. There is accumulating clinical evidence that the combination of an ACEI and an ARB provides greater renal protection, particularly in decreasing proteinuria, than does either agent alone.

Why do we pay? A national survey of investigators and IRB chairpersons

The principle that payment to participants should not be undue or coercive is the consensus of international and national guidelines and ethical debates; however, what this means in practice is unclear. This study determined the attitudes and practices of IRB chairpersons and investigators regarding participant payment. One thousand six hundred investigators and 1900 IRB chairpersons received an invitation to participate in a web-based survey. Four hundred and fifty-five investigators (28.3%) and 395 IRB chairpersons (18.6%) responded. The survey was designed to gather considerations that govern payment determination and practical application of these considerations in hypothetical case studies. The survey asked best answer, multiple choice, and open text questions. Short hypothetical case scenarios where presented, and participants were asked to rate factors in the study that might impact payment and then determine their recommended payment. A predictive model was developed for each case to determine factors which affected payment. Although compensation was the primary reason given to justify payment by both investigators and IRB chairpersons, the cases suggested that, in practice, payment is often guided by incentive, as shown by the impact of anticipated difficulty recruiting, inconvenience, and risk in determining payment. Payment models varied by type of study. Ranges for recommended payments by both groups for different types of procedures and studies are presented.

Community Consultation and Public Disclosure: Preliminary Results From a New Model

Emergency medicine research conducted under the exception from informed consent (EFIC) regulation enables critical scientific advancements. When EFIC is proposed, there is a requirement for broad community consultation and public disclosure (CC/PD) regarding the risks and benefits of the study. At the present time, no clear guidelines or standards exist for conducting and evaluating the CC/PD. This preliminary study tested the feasibility and acceptability of a new approach to CC/PD for a large-scale EFIC trial by engaging community members in designing and conducting the strategies. The authors enrolled key community members (called community advocates for research, or CARs) to use community-based participatory methods to design and implement CC/PD. By partnering with community members who represent target populations for the research study, this new approach has demonstrated a feasible CC/PD plan with greater community participation and less cost than previous studies. In a community survey, the percentage of community members reporting having heard about the EFIC trial more than doubled after employing the new approach. This article discusses initial implementation and results.

Paying Clinical Research Participants: One Institution's Research Ethics Committees' Perspective.

Regulatory guidelines leave determination of coercion and undue influence of research participants open to interpretation. A web-based survey was conducted of the research ethics committees members at Virginia Commonwealth University (VCU) to evaluate their perspectives on paying participants in clinical research via general questions, as well as 8 short cases involving hypertension placebo-controlled trials, a pilot exercise study, a survey of substance abusers, a healthy-volunteer pharmacokinetic study, a twin study involving DNA samples, and an asthma medication study in children. Research ethics committee members were asked to state what payment they would consider appropriate for a given type of protocol. The results suggest that risk, time required, reimbursement for expenses, and inconvenience were important in determining appropriate payment, while income and funding source were not. The case studies revealed wide variation in recommended payments both within type of study and between studies.

EMS Providers and Exception from Informed Consent Research: Benefits, Ethics, and Community Consultation

Abstract Background. As attention to, and motivation for, emergency medical services (EMS)-related research continues to grow, particularly exception from informed consent (EFIC) research, it is important to understand the thoughts, beliefs, and experiences of EMS providers who are actively engaged in the research. Objective. We explored the attitudes, beliefs, and experiences of EMS providers regarding their involvement in prehospital emergency research, particularly EFIC research. Methods. Using a qualitative design, 24 participants were interviewed including nationally registered paramedics and Virginia-certified emergency medical technicians employed at Richmond Ambulance Authority, the participating EMS agency. At the time of our interviews, the EMS agency was involved in an EFIC trial. Transcribed interview data were coded and analyzed for themes. Findings were presented back to the EMS agency for validation. Results. Overall, there appeared to be support for prehospital emergency research. Participants viewed research as necessary for the advancement of the field of EMS. Improvement in patient care was identified as one of the most important benefits. A number of ethical considerations were identified: individual risk versus public good and consent. The EMS providers in our study were open to working with EMS researchers throughout the community consultation and public disclosure process. Conclusion. The EMS providers in our study valued research and were willing to participate in studies. Support for research was balanced with concerns and challenges regarding the role of providers in the research process.

Who’s Doing the Math? Are We Really Compensating Research Participants?

Although compensation for expenses to participants in research projects is considered important and the primary reason for paying, there is no evidence to support that investigators and IRB members actually calculate participant cost. Payment recommendations for six hypothetical studies were obtained from a national survey of IRB chairpersons (N = 353) and investigators (N = 495). Survey respondents also recommended payment for specific study procedures. We calculated participant cost for the six hypothetical cases both by procedures and by time involvement. A large percentage recommended only token payments for survey, registry, and medical record review studies. Most chose payment for pharmaceutical studies but the recommended payment did not compensate for calculated costs. Results suggest that compensation and reimbursement as the primary reasons for paying research participants may not match actual practice.

Reorganizing the General Clinical Research Center to Improve the Clinical and Translational Research Enterprise

In 2010, Virginia Commonwealth University (VCU) was granted a Clinical and Translational Science Award which prompted reorganization and expansion of their clinical research infrastructure. A case study approach is used to describe the implementation of a business and cost recovery model for clinical and translational research and the transformation of VCU’s General Clinical Research Center and Clinical Trials Office to a combined Clinical Research Services entity. We outline the use of a Plan, Do, Study, Act cycle that facilitated a thoughtful transition process, which included the identification of required changes and cost recovery processes for implementation. Through this process, the VCU Center for Clinical and Translational Research improved efficiency, increased revenue recovered, reduced costs, and brought a high level of fiscal responsibility through financial reporting.

Training NIH K award recipients: the role of the mentor.

Mentors play important roles in training new investigators. This study was designed to determine characteristics of NIH mentored K award recipients and their mentors, their interpersonal interactions, and the factors, which influence satisfaction within this relationship.

Getting Started with Research: TIPS FOR SUCCESS

Just as clinical care has requirements for documentation, so does research. Having a contract or memorandum of understanding with research partners outside your organization can establish responsibilities and expectations of all parties, and can provide the groundwork for a solid partnership. Keeping a regulatory binder with all required forms, such as protocol versions, consents, IRB approvals, contracts and signature pages, will keep the study organized. Before beginning a trial, determine how study data will be recorded. For multicenter studies, there are often prepared case-report forms to be completed. If there aren’t any prepared forms, then create one to ensure that all data is collected and documented (time, date and recorder). Follow regulations regarding how long study documents must be maintained after the study is completed. These regulations may vary depending on the type of study, so be sure to determine this before discarding any documents. As you can see, you have many things to consider when getting involved in research. If this is your agency’s first attempt at getting involved in research, it may be beneficial for you to partner with an EMS agency that has experience with conducting research, a product manufacturer interested in testing a product or an academic institution. A seasoned investigator can guide you through what may seem like a complicated process. Eventually, as your agency gains experience, you’ll be able to take on greater responsibility in the research process.