In lieu of an abstract, here is a brief excerpt of the content:

  • The Institute of Medicine’s Report on Non-Heart-Beating Organ Transplantation
  • Roger Herdman (bio), Tom L. Beauchamp (bio), and John T. Potts Jr. (bio)

In December 1997, the Institute of Medicine (IOM) released a report on medical and ethical issues in the procurement of non-heart-beating organ donors. This report had been requested in May 1997 by the Department of Health and Human Services (DHHS). We will here describe the genesis of the IOM report, the medical and moral concerns that led the DHHS to sponsor it, the process of producing it, and its conclusions. The analyses, findings, and recommendations of the report are also reviewed, in particular the central issues that led to suggestions for policy changes.

Transplantation Background

As a first step, some background in the relevant aspects of organ transplantation will prove useful. For the purposes of this analysis, “transplantation” involves the transfer of cells, tissues, or solid organs from one human to another to replace the structure or function of comparable body components that, through injury or disease, are defective or of inadequate function. The IOM report deals with solid organs, primarily kidneys and livers, whose blood supply is reconnected in the organ recipient, in contrast to cells, like bone marrow, and tissues, like corneas. A variety of donor types exists for organ transplantation, each with particular medical and scientific conditions.

Living donors are healthy (and usually genetically related) individuals who volunteer to provide either a whole, paired organ such as a kidney or a section of an organ such as a liver. Cadaver donors are individuals who have died and from whom a full array of organs can be taken. “Heart-beating” cadaver donors are individuals who have suffered “brain death,” that is, irreversible cessation of function of the whole brain including the brain stem; and “non-heart-beating” donors (NHBDs) are individuals who are ill or injured, but not “brain dead,” and who have suffered cardiopulmonary death, that is, irreversible cessation of cardiac and respiratory function. NHBDs can be “controlled,” which means that [End Page 83] they can be sustained by artificial life support systems until a medical and family decision is made to terminate futile life support. This can be done at a scheduled time and in a controlled manner, and organs can then be recovered for transplantation. NHBDs can also be “uncontrolled,” which means that their hearts and breathing have stopped through disease or injury at an unexpected time or in an uncontrolled manner, and they cannot be resuscitated; the organs of some individuals of this description can be recovered for transplantation. The IOM report focused on both controlled and uncontrolled NHBDs and on problems specific to them.

The questions that were asked and addressed in the IOM report became current and salient beginning in 1992 with the establishment of the University of Pittsburgh “Policy for the Management of Terminally Ill Patients Who May Become Organ Donors After Death.” This policy addressed controlled NHBDs and the ethical questions raised by their use; much of the discussion was reported in the June 1993 special issue of the Kennedy Institute of Ethics Journal. Public notice and anxiety about some of these concerns were sharpened and refocused by national and local media allegations of improper treatment of donors at the Cleveland Clinic in 1997, specifically premature—i.e., antemortem—recovery of organs and administration of drugs that allegedly might hasten donor death.

The DHHS Request for Study

It is not surprising that several federal actions would be taken in response to these events. Some, such as the results of a transplantation task force, remain largely internal to DHHS at this writing. Others are public, such as the IOM study of the NHBD situation. In May 1997, the DHHS initiated contacts with the IOM with the goal of exploring federal concerns about the medical and ethical treatment of NHBDs, in particular the allegations directed at the Cleveland Clinic.

The DHHS response should be understood in at least three contexts. First, living donors and uncontrolled NHBDs were essentially the only donor types in the early days of transplantation in the United States. The technologies, ethics, and social acceptance of controlling and terminating life support for...