Compensation for research injury: Why the US isn’t a world leader

by Julie Fine, BS, Legal Specialist, Legal Division, Worldwide Research and Development, Pfizer Inc. (Please note: The views presented here are my own and do not reflect the positions or policies of Pfizer Inc.) 

“Medical care generally makes one whole again–before the injury occurred--but some economical expenses ethically ought to be considered.” - Elizabeth Pike

Still interested in learning more about compensation for research-related injury, I attended Panel XII: Compensation for Research-Related Injury: Is it Finally Time for a Nationalized System? on the final day of the 2012 Advancing Ethical Research Conference. The session was moderated by Daniel Nelson, MSc, from the University of North Carolina, Chapel Hill, and the panel included attorney Elizabeth (Lizzy) Pike, JD, LLM, former post-doc at the National Institutes of Health; Efthimios Parasidis, MBE, JD, from Saint Louis University; and Karen Moe, PhD, from the University Washington.

Lizzy provided some history and perspective on U.S. views regarding ethical justifications for compensation, including:

• Distributive justice (equitable risk-benefit) 
• Compensatory justice
• Internalization of costs (weigh true costs) 
• Trust in research 
• Reciprocity 

She then outlined two prevailing counterarguments against these justifications:

1. Subject assumes risks by way of informed consent; and 
2. The high cost of compensation given limited research funds. 

Lizzy believes there has been so little progress around this issue in the U.S. because of:

• Lack of political will; 
• Legal challenges to implementation; 
• Incorrect assumptions about lawsuits, and 
• Lack of empirical data. 

Her last point segued perfectly into Efthimios’ presentation on a study being conducted by Saint Louis University School of Law. Two hundred of the top funded research institutions participated in an examination of their research injury compensation policies. Four policy models were identified from the preliminary data:

• Model 1: Policy does not require the consent form to state that compensation will be provided 
• Model 2: Policy requires that consent form states that compensation is at the discretion of sponsor or institution 
• Model 3: Policy requires that the consent form state that compensation is available as long as certain conditions are met (i.e., if you can’t pay, if sponsor pays) 
• Model 4: Policy requires that compensation be paid 

Karen concluded the panel by describing the University of Washington’s Human Subjects Assistance Program. In place since 1982, the program was motivated by a combination of risk management and ethical principles. She explained that the program works because of its creative approach to risk management, the commitment and support of the University of Washington School of Medicine and units across the University, and its simple implementation for researchers and subjects.

During the question and answer portion of the panel, specific models for compensation programs were discussed. Universal healthcare coverage appears to make it easier for countries to support national compensation systems. The U.S. military has a closed healthcare system that works for providing treatment and compensation for research injuries, but it’s unclear whether the Patient Protection and Affordable Care Act will make it easier to require that medical care costs for research injury be paid across the board. The presenters suggested that a worker’s compensation type system might also be effective.

Ultimately, as the session concluded, the fundamental question remained: Should research subjects be entitled to compensation? What do you think?

I really enjoyed my first Advancing Ethical Research conference and sharing my experience here on Ampersand. Thank you all for reading!