Innovation in Human Research Protection: The AbioCor Artificial Heart Trial

Click to increase image sizeClick to decrease image size

Notes

¹. As a matter of semantic housekeeping, this article will not dwell on the choice of terms between patient, subject, volunteer, participant, or other terms referring to people who enroll in clinical research. Assuredly the choice can be important. Some commentators find subject impersonal or confusing (Dresser, 2001, 5). Volunteer does not apply to everyone because people lacking decision-making capacity can be enrolled in research. Participant can characterize investigators as well as enrollees. Patient can invite a therapeutic misconception in which research interventions are mistakenly seen as treatment. At the same time, patient can seem more applicable than subject for people who are seriously ill and receiving a mix of standard medical care and trial-related interventions, as was the case in the AbioCor trial. This question will not be resolved here. By stipulation, we will primarily use patient simply because the term patient advocate is used in this context more often than subject advocate or any alternative. Nevertheless, patient is admittedly problematic.

². At one site, litigation followed the patient's death. Although detailed discussion is beyond the scope of this paper, for further information see Morreim (2005).

³. Jewish Hospital addressed this issue by creating a web page that explained the first AbioCor recipient's financial situation and inviting community members to contribute to a trust fund for their benefit. See Robert (Bob) Tools Benefit Fund (2001).

⁴. In Goodman v. United States, 298 F.3d 1048 (9th Cir 2002), the Ninth Circuit Court expressly held that in a National Institutes of Health (NIH) trial for cancer with metastases to liver, providing isolated liver perfusion [ILP] with direct drug injection, the investigators were not required to inform prospective enrollees about prior patients' course. “As the district court recognized, 'there is no legal requirement that the consent form developed for [the ILP] study must be amended as each group of patients proceeds through the study.' To hold that the signed consent form was inadequate would require the NIH to update its already detailed consent form every time a patient experiences any sort of complication from an experimental procedure. The NIH was not required to update the consent form under these circumstances. The consent form and procedures were medically reasonable and legally adequate” Id., at 1059.

⁵. This presumes, of course, that persons on both sides are indeed acting in good faith—arguably a prerequisite for ethics consultation to corporations (Brody et al., 2002; Green et al., 2002; Sharpe 2002; Youngner and Arnold 2002).

⁶. For alternative conceptions of the “patient advocate” role, see Morreim (2004a).

⁷. See Morreim (2004b). In this particular trial, the company makes a one-of-a-kind device that will succeed or fail on the basis of how patients do (a fairly strong disincentive to enroll patients who are anything less than ideal candidates). The clinical centers, in contrast, compete in a much different marketplace. They may compete with each other to be the first, or to do the most, or to gain recognition as a hospital on the leading edge of medical miracles.