The authors examined written informed consent forms from 148 U.S. transplant centers to assess their compliance with OPTN and CMS regulations passed in 2007.
…most centers’ evaluation consent forms do not include all CMS and OPTN requirements. Multiple items balancing donor and recipient interests and confidentiality were omitted. In addition, information about payment for routine follow-up care, complications related to surgery and other health problems following surgery were highly variable and frequently ambiguous.
The authors identified 9 CMS (federal, Medicare) elements and 40 additional OPTN components.
For the most inclusive standard, a center received credit for addressing any aspect of an element, even if its consent form did not incorporate all the specified details. The moderately inclusive standard
generally required a consent form to address the element’s major subcomponents, even if it did not use language completely in line with the guideline. The least inclusive standard reflected a strict interpretation of each guideline. For these first three standards, centers that referred to other material or discussion for a cluster of elements (e.g. medical risks) or specific element (e.g. renal failure) were treated as though the relevant guideline(s) were fulfilled. In contrast, the fourth standard, least inclusive excluding other materials, required the consent form to contain the information, with an exception made for separate distribution of SRTR data.
Highlights of results using the “moderately inclusive” standard (any emphasis is mine):
- 72% indicated that the decision to donate needed to be ‘‘voluntary,’’ ‘‘freely chosen’’ or ‘‘free from pressure or coercion.’’
[note: so the other 28% are okay with coercion??]
- 98% of centers stated that the donors could withdraw from evaluation at any time, up to the start of surgery.
- 64% of centers warned that it was illegal to receive compensation for donation, 19% noted that donors could not receive payment but did not say this was illegal and 17% did not address donor payment.
[note: how many recipients are told it’s illegal to pay for an organ? Serious question: is the burden of this illegality put on the person relinquishing the organ because of public sympathy toward the ‘sick’ recipient?]
- Few centers (11%) required a formal ‘‘cooling off’’ period before the donor could proceed with surgery.
- 75% indicated that an independent donor advocate would be assigned to safeguard the donor’s interests.
- 92% addressed the confidentiality of donor health information.
- Only 21% indicated that a new diagnosis could prompt mandatory public health authority notification.
- Nearly all centers (98%) noted the need for a medical assessment;
[note: Why not 100% – seriously??]
- While 89% of centers mentioned psychosocial evaluations, only 46% explained their purpose.
- 60% of centers offered details about the donor operation, often briefly describing a laparoscopic donor nephrectomy and noting that conversion to open might be required
- Postoperative care was discussed extensively by 66% of programs. “The anticipated duration of hospitalization, pain management, Foley catheters and postoperative physical activity limitations were common topics.”
- Only 54% stated that donation posed risks without the prospect of medical benefit.
- Centers described satisfaction from helping another (34%) and possible discovery of a previously
undiagnosed health problem (31%) as benefits to the donor.
[note: propaganda, propaganda, propaganda]
- Although most centers (97%) discussed postdonation follow-up, only 65% said it was mandatory.
[note: and this is partially why we have no data]
- Only 36% of centers told the donor who would pay for routine follow-up care.
- Half the centers (55%) discussed who would pay for surgical complications.
- Few centers (24%) provided or referenced national or center–specific living donor outcomes data.
[note: I’m actually surprised it’s that much]
NO CENTER INCLUDED ALL 40 OPTN-MANDATED ELEMENTS UNDER ANY STANDARD OF INCLUSIVENESS. Applying the moderate standard, 68% of centers addressed half the components and 18% incorporated 30 items.
Under the moderately inclusive standard, only 40% of programs incorporated all nine federally mandated elements, although 83% discussed at least seven of them. Even under the most inclusive standard, 29% of centers did not address all CMS elements.
Make no mistake, not conforming to policies passed five years ago is more than problematic. It also underscores the imperative for potential living donors to embark on independent research and *not* rely on the transplant center to protect and care for them. (It *also* means that CMS and OPTN are doing a shoddy job in enforcing their own policies.)
Random note: of the 171 U.S. transplant centers with active living kidney donor transplant programs, *two* had no written consent. FIVE YEARS after policy implementation and they still had NO WRITTEN CONSENT?! Someone should be publicly shaming those institutions.
Thiessen C, Kim YA, Formica R, Bia M, & Kulkarni S (2013). Written Informed Consent for Living Kidney Donors: Practices and Compliance With CMS and OPTN Requirements. American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons PMID: 24020884