Research funded by private donors in exchange for research-related benefits has long been criticized as a “pay to play” research that undermines the core validity of medical research. However, in an article published in the Journal of Medical Ethics, investigators suggest that donor-funded research is not inherently exploitative and is permissible if appropriately regulated.1

Specifically, suggested Mike King, PhD, and Angela Ballantyne, PhD, both of the Bioethics Centre at the University of Otago in Dunedin, New Zealand, donor-funded research should undergo scientific peer review, regulation per standard clinical research legislation, and Institutional Review Board revision.

Drs King and Ballantyne described donor funding as a means to overcome “traditional…funding limitations” encountered in biomedical research. Although there is room for exploitation in such a research model, Drs King Ballantyne cited liberty and public good as grounds for the permissibility of donor-funded research.

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In particular, donors should be allowed the autonomy and liberty to “exchange money for access to [a] trial,” given that such a transaction between the donor and research parties is “informed [and] consensual.” Beyond this, clinical research is an essential component of public health; discoveries from research can promote proper medical care, identify innovative therapies, and explore the benefits of new drugs. The need for new research typically outstrips existing funding supplies, the researchers wrote, which validates the use of donor-funded trials if regulated properly.

The investigators supplied 3 donor-funding models and assessed each for ethical legitimacy and social value: (1) the Plutocratic proposal, (2) the play to try model, and (3) the pay to play/participate model.

Per the Plutocratic proposal, a donor funds a phase 1 or phase 2a clinical trial in exchange for participation either by them or a nominee, thus receiving the intervention.2  Such an exchange is mediated by a “matching agency” and moderated by a medical charity to guarantee that donors/nominees meet the trial inclusion criteria. The pay to try model (PTT) involves a private donor (or nominee) accessing the trial intervention not as a participant but through “compassionate use exemption alongside the trial.”3 Finally, similar to PTT, the pay to play/participate model (PTP) involves donors paying a fee for clinical trial enrollment.4

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In the Plutocratic and PTP models, access to interventions is contingent on trial participation, which introduces potential conflicts of interest. The structure of the Plutocratic model also relies on the existence of a “matching agency,” for which there is no existing infrastructure or guidelines. Dissenters typically describe the exchange as “exploitative” of the donor and ethically improper; the potential risks and/or benefits of a trial should not be exchanged for money. In addition, many argue that donor funding inherently undermines the scientific validity of any trial results. The researchers challenged each of these assertions in turn. Specifically, appropriate regulation of donor-funded research should eliminate these concerns.

The investigators first addressed the notion that “therapeutic misconception” among donors may undermine capacity to provide consent. Therapeutic misconception is not exclusive to donor-funded research; it is a problem across many modes of research, particularly research that concerns cancer or terminal patients. A 2012 study suggested that 68% of patients believed they were receiving standard care rather than participating in research.5 In addition, not all donors are necessarily in poor health; many are “explicitly wearing a…funding hat” and others have performed risk assessments themselves prior to participation. That the researchers may benefit more than the donors is not enough reason to invalidate donor-funded research entirely, the researchers wrote.

Addressing concerns about fair subject selection, the investigators wrote that donor-funded research is ideally regulated by an agency to prevent participation from donors who do not meet eligibility criteria. Citing modern practices that restrict certain expensive trials to wealthy hospitals in high-income countries (eg, surgical robot trials), they asserted that it would be inconsistent to prevent donor-funded research on unfair selection grounds.

Further, participation in research conducted at private facilities is usually restricted to those that can purchase the clinical services in the first place (weight management, sleep clinics, etc.). Regarding the perception that donor-funded research models may “undermine…the research agenda,” the researchers noted that all pharmaceutical industry-funded research is, in principle, restricted to patients in wealthy markets.6 And, like all research, donor-funded trials are required to undergo research ethics board and scientific peer review. Scientific validity is typically secured through these vetting procedures. That said, of all the models the investigators identified PTT as the “least risky” with respect to scientific validity, as the intervention is accessed off-trial.

Drs King and Ballantyne concluded that existing concerns regarding donor-funded research, while valid, can be addressed through appropriate review and vetting procedures by ethics review boards. The Plutocratic model appears to minimize risks compared with other donor-funded models, while PTT is most appropriate for preserving scientific validity. Still, the researchers concluded that none of the donor-funded models, if monitored appropriately, is inherently inappropriate for clinical research.

References

  1. King M, Ballantyne A. Donor-funded research: permissible, not perfect [published online September 18, 2018]. J Med Ethics. doi:10.1136/medethics-2018-104966
  2. Masters A, Nutt D. A plutocratic proposal: an ethical way for rich patients to pay for a place on a clinical trial. J Med Ethics. 2017;43:730-736.
  3. Masters A. Mosaic. October 27, 2014. A plutocratic proposal. http://mosaicscience.com/story/plutocratic-proposal. Accessed November 14, 2018.
  4. Emanuel EJ, Joffe S, Grady C, et al. Clinical research: should patients pay to play? Sci Transl Med. 2015;7:298ps16.
  5. Pentz RD, White M, Harvey RD, et al. Therapeutic misconception, misestimation, and optimism in participants enrolled in phase 1 trials. Cancer. 2012;118:4571-4578.
  6. Røttingen JA, Regmi S, Eide M, et al. Mapping of available health research and development data: what’s there, what’s missing, and what role is there for a global observatory? Lancet. 2013;382:1286-1307.

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