Academic journal article The Hastings Center Report

AbioCor: An Experiment in Research. (in Brief)

Academic journal article The Hastings Center Report

AbioCor: An Experiment in Research. (in Brief)

Article excerpt

The trials of the AbioCor artificial heart feature an essentially unprecedented strategy for protecting human research subjects. Call it an experiment in human research. For every person who is determined to be eligible to enter these trials at any of the six sites nationwide, an independent patient advocate is provided to help patients and their families understand and weigh the relevant risks and benefits. The PA is also available throughout the patient's participation to help the patient and family consider any further important decisions--including whether to reveal the patient's identity to the media or whether to withdraw from the trial. Patients are free to accept or reject these services, although it is expected that most patients will accept them.

The PAs are provided by the Independent Patient Advocacy Council (IPAC), created by Abiomed, manufacturer of the AbioCor artificial heart. The IPAC also advises the corporation regarding the ethics of the AbioCor trials. Although created by the company, the IPAC is independent--not only of the corporation, but also of the physician-investigators and the hospitals and institutions in which the trials are conducted. Its expenses are funded by an irrevocable trust, and members are self-governing. The company chose the first four members, who then chose the rest. …

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