Research Studies: Subjects Have No Right To Sue When Project Is Discontinued

Legal Eagle Eye Newsletter for the Nursing Profession

January 1997

   No former or potential future patient-participant in a medical research project has the right to sue to stop a project’s discontinuation or to compel a new project.  UNITED STATES DISTRICT COURT, TEXAS, 1996.

   Patients who had participated in a research project for lymphoma were "incidental, gratuitous beneficiaries" of the research, and, according to the U.S. District Court for the Southern District of Texas, they had no legal right to sue the cancer center over the research project’s discontinuation.

   The court said it sympathized with the former participants’ feelings of profound frustration over the project’s discontinuation. They were given a drug which may have been a cancer cure. But this was only for the cancer center's purposes in conducting research, not for the patients’ benefit in receiving a potential cure, the court ruled.

   Researchers may extend compassion to research subjects by allowing them the limited use of an experimental drug. However, the court said, scientific, administrative and fiscal concerns over the project’s management, and the core question of the drug’s efficacy, should not be clouded by the humanitarian impulses of those who carry on medical research. On top of that, the court said, it would be highly inappropriate to compound a difficult situation by opening the way for review of medical-research decisions in the courts.

   The court ruled the participants’ disappointment was real, but did not result from the denial of any legally-recognized right, and thus they had no grounds to sue. Spenceley vs. Hospital, 938 F. Supp. 398 (S.D. Tex., 1996).