Research Errors and Compensation for Research Injuries

Objectives:

At the end of this session, participants should be able to:

1.  Describe UT Southwestern policy concerning compensation for research-related injuries.

2.  Describe how legal liabilities for injury enter into the relationships between research subject, investigator, institution, informed consent documents, and clinical trial agreements.

3.  Consider the ethical ramifications of compensation for research-related injury for (a) research institutions (b) clinical investigators (c) research sponsors (d) research subjects (e) public perception/interest.

4.  Describe what and who stand to lose, and gain, from the perspective of each the parties described in objective 3.

Cases:

Case 21

A new clinical investigator is puzzled by the UT Southwestern consent form template concerning compensation for research injury (below).  She would like to be sure her subjects are compensated in case they are accidentally injured by her research program.  She wants to know why she has to use this language.

UT Southwestern consent form template for compensation for injury:

What will happen if I am harmed as a result of taking part in this study?

It is important that you report any illness or injury to the research team listed at the top of this form immediately.

Compensation for an injury resulting from your participation in this research is not available from the University of Texas Southwestern Medical Center at Dallas or [insert if applicable] Children’s Medical Center, Parkland Health & Hospital System, Presbyterian Hospital of Dallas, Retina Foundation of the Southwest, and/or Texas Scottish Rite Hospital for Children.

If applicable: The sponsor has expressed a willingness to help pay the medical expenses necessary to treat such injury.

You retain your legal rights during your participation in this research

The investigator wants to know why her subjects can’t be compensated by someone in case they are injured in her study.

Case 22

A new monoclonal antibody Xamab is being tested by Dr. Comp in phase I trials with various cancers.  While previous studies have identified only minor side effects and toxicities, on her latest trials with cancer Y, four subjects out of an early cohort of 29 developed serious “cytokine release syndrome”, all requiring intensive care and one subject ultimately dying of complications.  Consider these questions and variations on this case:

22a.  Consider the ethics of providing compensation for the research-related injuries in this case.  What difference, if any, does sponsorship make?  NIH vs. Industry?  Who should pay?  Why?

22b.  For future subjects, how should the informed consent process be changed to reflect risks to Xamab analogues?  How would you answer questions from potential subjects who ask about risks with these compounds, and how would you answer questions about how research related injuries would be handled?

22c.  Do the ethics of compensation change relative to the severity of injury, from complete recovery with treatment, to partial recovery with treatment, and with deaths regardless of treatment?

Textbook: The Oxford Textbook of Clinical Research Ethics - Edited by Ezekiel J. Emanuel, Christine Grady, Robert A. Crouch, Reidar Lie, Franklin Miller and David Wendler.  New York, Oxford University Press. 2008 (ISBN13: 978-0-19-516865-5/ISBN10: 0-19-516865-8)

Textbook Reading:

Mariner, Wendy K. Liability and Compensation for Injury of Research Subjects.  The Oxford Textbook of Clinical Research Ethics.2008;62;682-696