Are Transplant Recipients Human Subjects When Research Is Conducted on Organ Donors?

Abstract

Interventional research on deceased organ donors and donor organs prior to transplant holds the promise of reducing the number of patients who die waiting for an organ by expanding the pool of transplantable organs and improving transplant outcomes. However, one of the key challenges researchers face is an assumption that someone who receives an organ that was part of an interventional research protocol is always a human subject of that same study. The consequences of this assumption include the need for oversight by an institutional review board and for research-level informed consent from transplant recipients, all within the complex practical realities of the organ donation and transplantation process in the United States. The current national focus on this issue provides an opportunity to think critically about the policy goals of the human subjects regulations and their application to the nascent field of deceased organ donor intervention research. We propose that for donor research where the transplant recipient does not fall under the definition of human subject, the clinical consent model-rather than the consent model used for human research subjects-best facilitates the policy objectives of balancing clinical innovation, transparency, and protection of patients in an ethically responsible and legally compliant manner.

Transplant candidates’ perceptions of informed consent for accepting deceased donor organs subjected to intervention research and for participating in posttransplant research

“…8 Regardless of whether these recipients are technically "human subjects," most candidates in our study wanted to be informed and provide consent to receive an intervention organ, regardless of whether data collection occurred posttransplant. 8 Regardless of whether these recipients are technically "human subjects," most candidates in our study wanted to be informed and provide consent to receive an intervention organ, regardless of whether data collection occurred posttransplant.…”

“…In this patient-centered study, transplant candidates seemed optimistic about the value and likely outcomes of organ donor in- There is controversy over whether recipients of intervention organs comprise "human research subjects" research. 8 Regardless of whether these recipients are technically "human subjects," most candidates in our study wanted to be informed and provide consent to receive an intervention organ, regardless of whether data collection occurred posttransplant. This preference to give consent was consistent across organ types.…”

“…5 The Institutional Review Board had approved the study as non-human subjects research because the intervention research was conducted on deceased donors, and was deemed minimal risk to recipients despite the collection of outcomes data on recipients. 8 Organs must be procured and allocated quickly to minimize cold ischemic time, but time spent obtaining clinical and research informed consent can prolong ischemia, injure the organ, and delay organ distribution (Figure 1). 6 The National Academies of Sciences, Engineering, and Medicine Determining whether and how to obtain informed consent from candidates offered intervention organs and/or participation in organ donor intervention research, in a timely manner is an ethical and logistical challenge.…”

“…7 Determining whether and how to obtain informed consent from candidates offered intervention organs and/or participation in organ donor intervention research, in a timely manner is an ethical and logistical challenge. 8 Organs must be procured and allocated quickly to minimize cold ischemic time, but time spent obtaining clinical and research informed consent can prolong ischemia, injure the organ, and delay organ distribution (Figure 1). 7 The time available for discussions about the donor and organ quality necessary for clinical consent competes with time for research informed consent.…”

“…2,9 Some contend that receiving an intervention organ without data collected from the recipient does not make recipients human subjects, and that clinical, but not research, consent is necessary. 8 Alternatively, regulations mandate consent from recipients if data collected may affect their health or welfare (eg, organ biopsy). Even if no recipient data are collected, interventions performed on the organ may pose risks to the recipient, possibly affecting their decision-making.…”