How Are PIs Paid? All The Options For Clinical Research Investigator Compensation

By Suzanne J. Rose, executive director of research, Stamford Health

At the heart of every clinical trial is the principal investigator (PI), tasked with overseeing the study's execution, ensuring compliance with regulations, and safeguarding participant welfare. Their work is much needed and appreciated, but the issue of PI compensation poses challenges for both sites and sponsors. Fair compensation is essential to attract qualified investigators and incentivize their participation in often complex and time-consuming studies. Yet, determining an appropriate compensation structure that balances financial incentives with ethical considerations and avoids conflicts of interest can be a daunting task.

Challenges In PI Compensation

One of the primary challenges in PI compensation arises from the diverse nature of clinical trials. Trials vary widely in scope, duration, complexity, and therapeutic area, making it difficult to establish standardized compensation models. Moreover, the level of effort required from investigators can fluctuate significantly throughout the course of a trial, further complicating compensation calculations. For example, at the beginning of a therapeutic trial, there is extensive oversight and effort needed from the PI. However, as a trial exits the intense intervention stage and reaches a cadence of fewer visits with fewer or no procedures, the PI time burden diminishes.

There are also several different types of places research can occur, such as academic medical centers, community hospitals, and independent research sites. At academic medical centers, PIs often receive salary support from their institution, which may include dedicated research time, administrative support, and access to facilities. Additionally, academic PIs may receive grant funding to cover research expenses and may negotiate indirect costs with sponsors. In community hospitals, PIs may receive a combination of salary support from their clinical practice and compensation from the research sponsor for their time and effort. Independent research sites typically negotiate payment structures directly with sponsors, which may include a fee-for-service model, milestone-based payments, or a fixed payment per participant enrolled in the trial.

Additionally, ethical considerations such as ensuring that compensation does not unduly influence the conduct or reporting of study results add another layer of complexity. Striking a balance between adequately compensating investigators for their expertise and time while maintaining the integrity and ethical standards of the research is crucial yet challenging.

Furthermore, the financial aspects of PI compensation in clinical trials are subject to regulatory scrutiny and evolving industry standards. Failure to appropriately compensate investigators or properly disclose financial arrangements can result in regulatory sanctions, reputational damage, and even legal consequences for sponsors and researchers alike. Navigating this regulatory landscape therefore requires careful attention to detail and proactive engagement with all stakeholders involved in the clinical trial process.

Various investigator compensation structures are well-discussed in literature.^1–6 Below are some guidelines for creating a compensation system that aligns investigator objectives with those of the clinical research site and sponsor, while also complying with applicable laws, regulations, guidelines, and professional standards.

Paying PIs Fair Market Value

American Medical Association (AMA) guidelines on managing physician conflicts of interest in the conduct of clinical trials state that financial compensation should be at fair market value (FMV).⁷ At the same time, payments to physician-investigators that exceed FMV may violate the Stark Law and the Anti-Kickback Statute.² However, these laws and guidelines do not explain how to determine FMV, which puts research sites and sponsors at risk. Leaving aside the legal ramifications if an investigator is paid above FMV, an investigator may seize the opportunity to make money, for example, by signing up for a poorly designed study, enrolling unqualified patients in a study, pressuring unwilling patients to enroll in a study, or improperly prescribing a study sponsor’s medications. If the investigator is paid below FMV, they may, for example, take shortcuts in study conduct, compromise human subjects’ protection, or not conduct the study at all. For study sponsors, not adhering to FMV can result in allegations of improper financial relationships or conflicts of interest, which can damage the sponsor's reputation and lead to regulatory penalties or legal action.

Therefore, here are some hints to help comply with FMV rules in making payments to sites and investigators:

• Create, maintain, and comply with an FMV policy. This policy should be consistent with the above requirements and be defensible in any government investigation. This policy should be shared with study sponsors to ensure transparency.
• Create, maintain, and comply with an investigator fee schedule. An external consulting firm can lend expertise and give credibility to the fee schedule. This policy should be shared with study sponsors to ensure fairness.
• Develop a chargemaster (list detailing the official rate charged by a hospital for individual procedures, services, and goods) consistent with the investigator fee schedule. Involve your billing team in developing the strategy. It is perfectly acceptable to charge a study sponsor more than you pay the investigator, but there should be a relatively consistent markup on these fees (for example defined overhead).
• Explain investigator charges to study sponsors. Include this explanation with your initial budget proposal. Sponsors should be asking for justification for charges consistently.
• Document any deviations from FMV. If investigator fees are bundled into, for example, visit fees, document the allocation of charges. During budget negotiations, if the negotiators move fees around to get to a mutually agreeable bottom line, be careful not to violate FMV rules.

Types Of Investigator Compensation Models

Investigators can contribute to a study in many ways, and therefore the compensation model should be fair, motivational, affordable, practical, legal, and agreeable. To structure the investigator compensation model, include considerations for (clinical) relative value unit (RVU)-based services vs. administrative work, such as review of adverse and serious adverse events, signing the case report forms, and other research-specific tasks not involving patient care. Administrative fees are included in the study line-item budget and should also include site overhead.

• Relative Value Units. RVUs are measures constructed by Medicare to estimate productivity by calculating the relative level of physician time, skill, and expertise. Medicare relies on these measures to establish payment levels for physicians’ services, which are then described by Current Procedural Terminology (CPT) codes. This compensation model is typical when a hospital also employs physician-investigators as clinicians, and they earn RVU credits when they perform clinical services with CPT codes that are part of the clinical trial. By employing research RVUs (rRVUs) for clinical research-related activities, hospitals can smoothly integrate clinical research into their physician management and compensation systems. Investigators earn a set number of rRVUs for clinical research activities, ensuring clinical research is not viewed as competing with standard of care visits.
• Fixed fee or percentage. The site pays the investigator a fixed fee or percentage of the study’s revenue, regardless of their contributions. These options are simple to manage. However, it is difficult to assess whether they accurately reflect the investigator’s contribution or the FMV of the investigator’s services. These options may not align with site and investigator motivations.
• Salary. The site pays the investigator a full-time or part-time salary for working on clinical trials.
• Hourly rate. The site compensates the investigator with a specialty-specific hourly rate, which may be based on the nature of the activities performed.
• Fee for service. The site compensates the investigator for specific activities performed. This option takes relatively more time to administer. However, it motivates investigators to perform the contracted services, although not necessarily at the level of quality and timeliness desired. This option can work well for sub-investigators.
  • Sub-Investigators: While the role of the investigator is usually limited to a licensed physician, the sub-investigator role can be much more inclusive to include mid-level providers, such as physician assistants, nurse practitioners, and, at academic medical centers, residents, and fellows. They play various roles in a study and are often essential for the success of the trial. Fee for service typically works well for sub-investigators and can be tracked inside the budget, via a spreadsheet or clinical trial management system. It is important to understand any sub-investigator’s current payment structures inside the site or healthcare system and work with the administration to ensure that salaried positions are capable of being compensated above and beyond their current salary structure, as well as being compensated for RVUs similar to their physician counterpart. At AMCs, payments to residents and fellows in addition to their salary will need to be carefully discussed and negotiated with the Graduate Medical Education Office and adhere to AMA guidelines.
• Hybrid model. The site combines two or more of the compensation options above. Fixed fees could be utilized for costs that are consistent from study to study, such as site initiation or monitoring visits. Fee for service would then be utilized for study procedures because they would be variable from visit to visit and study to study. An agreed-to administrative fee (in line with FMV) per visit type also can be included in this model along with research RVUs. The investigator then understands that compensation will be adjusted from study to study. This system is consistent with the financial success of the study while remaining within the regulatory guidelines. This program works well for incorporating the concept of rRVUs, as well as for RVU-based providers.

Regardless of the model or models the site utilizes and the type of site performing research, compensation structures should consider several factors. First, the study sponsor and the study participant or their third-party payor cannot both be billed for the same activity. Second, there is a need for clear documentation of the investigator’s activities associated with the clinical trial. In addition, the site needs to document mutual expectations in contracts that comply with guidelines outlined in the Personal Service Exception provision of the Stark Law and the Personal Services and Management Contracts Safe Harbor provision of the Anti-Kickback Statute. Also, the site should compensate investigators for their activities in the patient enrollment process, but they should not be compensated based on the number of study participants enrolled. FDA, ICH, and AMA rules prohibit bonuses, finder’s fees, and pay-for-performance to investigators based on the number of participants enrolled in or completing a clinical study.⁸ Finally, compensation can be paid to individual investigators, shared evenly across a group of investigators, or paid to their department or business entity.

Striking The Right Balance With PI Payments

Investigator compensation must comply with laws, regulations, guidelines, and professional standards. However, within the bounds of FMV, sites have substantial flexibility in designing compensation structures that align investigator objectives with those of the clinical research site.

References:

1. Bowler A. Effort-Based Salary Support for PI Oversight Charges. Journal of Clinical Research Best Practices. Published online 2017:4.
2. Cramer P. Investigator Compensation: Motivation vs. Regulatory Compliance. Journal of Clinical Research Best Practices. Published online 2016:5.
3. Gibson M. Developing an Investigator Compensation Plan. Journal of Clinical Research Best Practices. Published online 2016:4.
4. Goldfarb NM. Investigator Compensation by the Research Site. Journal of Clinical Research Best Practices. Published online 2010:4.
5. Rose S. Investigator Compensation: The Best (and Worst) Kept Secret. Journal of Clinical Research Best Practices. Vol. 17, No. 12, December 2021.
6. Rose SJ. Investigator Compensation: No One Size Fits All. Clinical Researcher. Volume 35, Issue 9, December 2021.
7. Affairs AC on E and J. AMA Code of Medical Ethics’ Opinions on Clinical Research. AMA J Ethics. 2015;17(12):1136-1141. doi:10.1001/journalofethics.2015.17.12.coet1-1512.
8. Ilancheran M, Kulasekaran H. Clinical Investigator Payment Best Practices. Accessed October 24, 2019. https://www.clinicalleader.com/doc/clinical-investigator-payment-best-practices-0001.

About The Author:

Dr. Suzanne J. Rose, the executive director of research for Stamford Health holds an M.S. and Ph.D. in biomedical science from Albany Medical College. She was inducted into the 2021 class of Fellows of the Association of Clinical Research Professionals (ACRP).

Her role as executive director entails overseeing the Department of Research and Discovery, which includes the Clinical Trials Office, Center for Simulation and Learning, Office of Academic Research, and Office of Grants. Dr. Rose is also an assistant professor in the Department of Medical Sciences, Quinnipiac University, and an adjunct professor for the Sacred Heart University Master of Physician Assistant Program.

Dr. Rose is an avid speaker at conferences and webinars on various topics including team building, leadership, principal investigator compensation, and clinical research coordinator workload assessment tools. Her publication focuses include best practices in clinical research and health economics outcomes research (HEOR).