Written Informed Consent for Living Kidney Donors: Practices and Compliance With CMS and OPTN Requirements

Authors


Abstract

We sought to assess how written informed consent practices for candidate living kidney donors have changed over the last 5 years and to assess compliance with Centers for Medicare and Medicaid (CMS) and Organ Procurement and Transplantation Network (OPTN) regulations that took effect in 2007. We requested evaluation consent forms from US centers that performed >5 living kidney transplants during the prior year (n = 184). We received 148 consent forms; each was reviewed for information provided and inclusion of CMS– and OPTN–required elements. We found that nearly all transplant centers now obtain written consent for living kidney donor evaluation. However, 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. As centers revise their consent forms to address the 2013 OPTN policies, our findings may help them identify areas of potential deficiency. We propose that UNOS develop a uniform donor evaluation consent form to improve the clarity, consistency and efficiency of living donor consent.

Abbreviations
CMS

Centers for Medicare and Medicaid

DDKT

deceased donor kidney transplant

LKT

living kidney transplant

OPTN

Organ Procurement and Transplantation Network

SRTR

Scientific Registry of Transplant Recipients

Introduction

Today, one-third of the transplanted kidneys in the United States come from living donors. Although donors accept medical risk without the prospect of direct medical benefit during both evaluation and surgery, Rodrigue et al [1] found that 57% of US centers presumed consent and only 30% obtained written consent for donor evaluation in 2006. Rising awareness of the complications experienced by living donors [2-4] contributed to an increased focus on donor informed consent [5-8]. The Centers for Medicare and Medicaid (CMS) and the Organ Procurement and Transplantation Network (OPTN) promulgated donor consent guidelines that have had regulatory force since 2007 [9, 10]; OPTN's policies were updated in February 2013 [11]. CMS and OPTN review consent practices to ensure compliance with these regulations during transplant center audits.

Despite increased oversight, Gordon's [12] recent literature review highlighted living donor dissatisfaction with information about the evaluation and operative process, as well as lack of understanding of the long–term risks of donation. Gordon suggested that variability among centers' disclosure of information may contribute to these deficiencies. We therefore sought to determine: How often US centers obtain written consent for donor evaluation; how often consent documents incorporate all CMS– and OPTN–required elements; and whether presentation of required consent elements varies between centers.

Materials and Methods

On June 20, 2012, we accessed the Scientific Registry of Transplant Recipients (SRTR) to identify all US kidney transplant centers, as well as their living kidney donor transplant (LKT) and deceased donor kidney transplant (DDKT) volumes. Institutions that evaluated living donors and performed >5 LKTs between July 1, 2010 and June 30, 2011 (n = 171) were asked via e-mail or telephone to share their English consent form for donor evaluation. Forms were collected during the period June 25, 2012 to November 30, 2012, before implementation of the new OPTN policies. Centers were deemed nonresponders if they neither declined to participate nor provided consent forms after ≥5 email and/or telephone contacts. Centers that shared a consent form with a partner institution (n = 10) were treated as separate throughout the analysis. Figure 1 provides sample frame details.

Figure 1.

Sample frame.

We identified 9 required CMS elements and 40 required informational components in the 2007 OPTN guidelines. Additional OPTN items that were duplicative (n = 3), procedural (evaluation of donor comprehension, distribution of additional materials and provision of reflection time) or about nondirected donation were omitted. Two authors (C.T. and Y.K.) independently reviewed and coded each consent form to determine if it contained mandated elements and recorded the most recent date of revision documented in the form. Following an iterative coding process, the final average unweighted Cohen's kappa coefficient of inter-rater reliability was 0.76 (range 0.21–0.97). Discrepancies were resolved by joint re-review of the material.

Standard descriptive statistics were used to determine how often centers included each required element according to four standards developed by the authors. 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. Table 1 includes examples of our four analytic standards as applied to three OPTN–required elements; Tables S1 and S2 detail the criteria and omission frequencies for each element and standard. The moderately inclusive standard is the primary basis of the results presented in the Results section and was used in stratified analysis.

Table 1. Examples of four standards used to determine if a consent form addressed an OPTN Guideline
OPTN 2007 Guideline (verbatim excerpt)Most inclusive standardModerately inclusive standardLeast inclusive standardLeast inclusive standard without other materials
“An explanation that medical information on the potential donor may not be revealed to a potential recipient unless authorized by the potential donor.”Includes statement that donor health informationIncludes statement that donor health informationIncludes statement that donor health informationExcludes
Is shared only “as required by law” or will be “confidential”, but does not specify what this means for sharing with the recipientIs shared only “as required by law” or will be “confidential”, but does not specify what this means for sharing with the recipientWill never be shared with anyone elseReference to other materials only
Will never be shared with anyone elseWill never be shared with anyone elseWill be confidential, but the donor's name will be shared
Will be confidential, but only when discussing what happens if the donor opts outWill be confidential, but the donor's name will be shared 
Will be confidential, but the donor's name will be shared  
“The agreement of the potential donor to commit to post-operative follow-up testing coordinated by the recipient transplant center for a minimum of two years.”IncludesIncludesRequiresExcludes
Statement of agreement or that follow-up is a “duty” or a “responsibility”Statement of agreement or that follow-up is a “duty” or a “responsibility”Statement of agreementReference to other materials only
  Follow-up ≥2 years
 Requires 
 Follow-up ≥2 years 
“Disclosure that it is unlawful for any person to knowingly acquire, obtain or otherwise transfer any human organ for valuable consideration.”IncludesSame as most inclusive standardRequiresExcludes
Statement that receipt of money or valuable consideration is not permitted Statement that receipt of payment or valuable consideration is illegalReference to other materials only

Centers were divided into quartiles based on LKT and total kidney transplant volumes. The relationship between program volume and likelihood of including all CMS– and half of the OPTN–required items were assessed with chi–squared or Fisher's exact tests (categorical variables) and t-tests (means). A two–tailed p-value of <0.05 was considered statistically significant. SAS 9.3 was used to perform all statistical analysis including the kappa coefficient.

The Yale University IRB determined that this study did not involve human subjects and did not require review.

Results

Sample characteristics

The response rate was 87%; participants included 148 of 171 eligible centers. We received 143 unique forms; 5 additional centers shared a consent form with another respondent. Participating centers performed 89% of LKTs during our sample frame period. Six (4%) centers declined to participate for undisclosed reasons. Nine (5%) centers were nonrespondents. Consent was not available from eight centers due to ongoing revision (4%), use of computerized forms only (1%) and absence of written evaluation consent (1%). Decliners performed significantly fewer LKTs than participants (mean 13 vs. 35, p < 0.0001). Respondents, nonrespondents, decliners and centers without available forms were otherwise similar in respect to transplant volume and location.

Consent practices

All but one contacted center (99%) obtained consent for donor evaluation, and 98% used written consent forms. Seventeen centers had simple checklists that asked the donor to acknowledge receipt of other documents or discussions with transplant team members. The remaining consent forms (n = 131) averaged six pages in length (range 1–15 pages). Revision dates for the detailed forms were 2012 (42%), 2010–2011 (28%), 2008–2009 (10%) and unknown (20%).

Centers with checklists did not differ from those with full consent forms in respect to volume, location or recentness of revision. However, checklists were significantly less likely to include all CMS–required elements (0% vs. 39%, p < 0.0005). Because we could not assess the content of material or conversations referenced in the 17 checklists, the remainder of this analysis focuses on the 131 detailed consent forms. Seventy–six percent of centers mentioned distribution of supplementary information including center–developed booklets (35%), the OPTN/UNOS website addresses (31%) or factsheets (11%) and the UNOS hotline number (73%).

Consent form contents

Voluntariness and comprehension

Most centers (72%) indicated that the decision to donate needed to be “voluntary,” “freely chosen” or “free from pressure or coercion.” Ninety–eight percent of centers stated that the donors could withdraw from evaluation at any time, up to the start of surgery. Further data about practices surrounding donor withdrawal, including offers of an “alibi,” are presented elsewhere [13]. Sixty–four percent 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. Few centers (11%) required a formal “cooling off” period before the donor could proceed with surgery. Although only 41% of centers referenced a process to assess donor comprehension, 75% indicated that an independent donor advocate would be assigned to safeguard the donor's interests.

Confidentiality

The majority of centers (92%) addressed the confidentiality of donor health information. Some centers said that donors' information would be kept “confidential” (10%) or “confidential except as required by law” (18%). Others specifically assured donors that their information would not be divulged to the recipient except with the donor's written consent (26%), with the donor's “authorization” (11%) or never (14%). A few centers stated that a recipient would be told the donor's compatibility status (2%), name (2%) or “some information” (6%). Infrequently (5%), centers noted that some donor information would be placed in the recipient's chart. Centers usually (87%) notified donors that their information would be shared with UNOS, but few (21%) indicated that a new diagnosis could prompt mandatory public health authority notification. Confidentiality of recipient information was rarely addressed. If the recipient had a preexisting life–threatening condition, a donor was informed she would be told about the condition (5%), told only with the recipient's consent (5%), notified that the recipient was “high risk” (1%) or never informed (2%).

Evaluation process

Nearly all centers (98%) noted the need for a medical assessment; 77% described at least one radiological or laboratory study. While 89% of centers mentioned psychosocial evaluations, only 46% explained their purpose. Thirty percent of programs listed at least one donor eligibility criterion. Forty percent of centers stated that a committee would determine donor suitability, with 11% also indicating that evaluation continued until surgery.

Operation and postoperative course

Sixty percent of centers offered details about the donor operation, often briefly describing a laparoscopic donor nephrectomy and noting that conversion to open might be required. Another 19% indicated that this information would be provided elsewhere; 11% stated only that a nephrectomy would be performed and 10% did not mention the donor operation. 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.

Health risks and benefits

Table 2 details the percentage of centers addressing each OPTN–required medical and psychological risk. Nearly all centers (99%) described at least one of these risks, but only 54% stated that donation posed risks without the prospect of medical benefit. While 32% of centers noted that the transplant team would stop the donation if it presented a risk to the donor, only 11% stated that it would be interrupted if it created risks for the recipient. Centers described satisfaction from helping another (34%) and possible discovery of a previously undiagnosed health problem (31%) as benefits to the donor. Many centers (44%) also listed a recipient benefit from LKT compared to DDKT, most commonly longer graft survival and decreased waiting time.

Table 2. Percentage of centers omitting OPTN requirements, moderately inclusive standard
Requirement (excerpted verbatim from the guidelines)Percentage of centers omitting the requirement
“The assurance that the potential donor is willing to donate, free from inducement and coercion.”28
“The assurance that the potential donor understands that he or she may decline to donate at any time.”2
“The disclosure that the donor will receive a thorough medical and psychosocial evaluation.”12
“A disclosure that living donor transplant programs must provide an Independent Donor Advocate (IDA)…”25
“Disclosure of alternate procedure or course of treatment of treatment [sic] for the potential donor and recipient including deceased donation.”7
“All potential donors should be informed if the intended recipient has or has not been listed for deceased donation.”76
“Pre-existing life threatening conditions of the potential recipient should be disclosed to the potential donor prior to obtaining consent.”89
“Explain that a decision by the potential donor not to proceed with the donation will not be disclosed without the prior consent of the potential donor.”52
“A determination that the potential donor understands that he or she will undertake risk and will receive no medical benefit from the operative procedure of donation.”46
“A disclosure that the potential donor's medical evaluation could reveal conditions that the transplant center must report to governmental authorities such as HIV or certain venereal diseases.”79
“An explanation that medical information on the potential donor may not be revealed to a potential recipient unless authorized by the potential donor.”19
“If the potential donor has a condition that might harm a recipient the medical team in charge of his or her evaluation will not allow the donation to occur.”79
“A specification of the medical, psychological, and financial risks associated with being a living donor. These risks may be transient or permanent and include, but are not limited to the following…”n/a
“potential for surgical complications including risk of donor death”5
“potential for decreased kidney function in kidney donors…”52
“potential for organ failure and the need for a future organ transplant for the donor”21
“potential for other medical complications including long-term complications currently unforeseen”58
“scars”45
“pain”8
“fatigue”57
“abdominal or bowel symptoms such as bloating and nausea”47
“increased risk with the use of over the counter medications and supplements”73
“potential for problems with body image”60
“possibility of post surgery depression, anxiety, or emotional distress”15
“possibility of transplant recipient rejection and need for re-transplantation”17
“possibility that the transplant recipient will have a recurrence of disease”54
“possibility of transplant recipient death”39
“potential impact of donation on the donor's lifestyle”63
“personal expenses of travel, housing, and lost wages related to live donation might not be reimbursed; however, the potential donor should be informed that resources may be available to defray some donation-related costs”28
“child care costs”61
“possible loss of employment”70
“potential impact on the ability to obtain future employment”66
“potential impact on the ability to obtain or afford health, disability, and life insurance”8
“health problems experienced by living donors following donation may not be covered by the recipient's insurance”50
“Disclose that transplant centers are required to report living donor follow-up information for at least two years, so the donor should expect to the contacted by the transplant program regarding the current health status.”40
“Disclose that living donor follow-up is the best method for the collection of information on the health implications of living donation.”36
“Disclose that centers will specify who is responsible for the cost of follow-up care.”64
“The agreement of the potential donor to commit to post-operative follow-up testing coordinated by the recipient transplant cent[er] for a minimum of two years.”58
“Disclosure that it is unlawful for any person to knowingly acquire, obtain or otherwise transfer any human organ for valuable consideration.”17
“The stipulation that transplant centers will provide potential donors with both national and their center-specific outcomes from the most recent SRTR center-specific report…”20
“notification about all Medicare outcome requirements not being met by the transplant center.”27

Follow-up

Although most centers (97%) discussed postdonation follow-up, only 65% said it was mandatory. However, many programs informed donors that signing the evaluation consent form constituted a “duty,” a “responsibility” or a “commitment” to adhere to scheduled follow-up (47%). The recommended follow-up duration varied from several weeks (2%) to “for life” (8%), with most centers (73%) specifying 2 years. Half the programs (52%) noted that follow-up was important for research on the long–term effects of donation; another 12% just indicated that it was to monitor the donor's personal health. Only 36% of centers told the donor who would pay for routine follow-up care, mostly frequently the center, Medicare, or the recipient's insurance (19%) or the donor (9%). Five percent of centers noted that the donor would be billed but “could not be forced” to pay for follow-up. In a few cases (2%), the information was so unclear that we could not determine expected fiscal responsibility.

Postdonation health problems

Half the centers (55%) discussed who would pay for surgical complications. Donors were occasionally warned that their (24%) or the recipient's (8%) insurance might not cover complication–related expenses, and 34% of centers said that the donors might be liable for them. Only 17% of programs unequivocally stated that the center or the recipient's insurance would pay for donation–related complications. Others suggested that they might cover such care (8%), would pay “as appropriate” (7%) or would provide “emergency care” (2%). Seven percent of centers specified a coverage duration of 3 months to 1 year. In addition, some centers indicated that the donor's insurance might not cover unrelated postdonation medical problems (44%) or preexisting conditions (5%). Fewer centers (19%) explicitly noted that the recipient's insurance might not pay for unrelated postoperative problems; another 20% implied this. Only 1% of centers stated that they paid for postdonation expenses unrelated to surgery.

Outcomes

Most donors received national LKT recipient outcomes data in the consent form (32%) or in supplementary documentation (35%). Likewise, many centers provided center–specific recipient outcomes in the consent form (29%) and in additional material (52%). Less frequently, donors were told that recipient outcomes data “met expectations,” could be requested or “were available,” or were accessible on the SRTR website. Few centers (24%) provided or referenced national or center–specific donor outcomes data.

Compliance with regulations

OPTN

Table 2 lists the OPTN–required elements and rates of omission. 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 (Figure 2A). Centers in the lowest quartile of total transplant volume were significantly less likely than higher–volume centers to include more than half of the OPTN–required elements (42% vs. 71%, p = 0.0035).

Figure 2.

(A) Centers meeting OPTN requirements according to four standards of inclusiveness. (B) Centers meeting CMS requirements according to standards of inclusiveness.

CMS

The rates of omission for each CMS requirement are presented in Table 3. Under the moderately inclusive standard, only 40% of programs incorporated all nine federally mandated elements, although 83% discussed at least seven of them (Figure 2B). Even under the most inclusive standard, 29% of centers did not address all CMS elements. There were no significant differences in compliance with all CMS items and transplant volume. A trend approaching statistical significance suggested that consent forms revised in or before 2009 might be less likely to contain all CMS requirements (15% vs. 42%, p = 0.075).

Table 3. Percentage of centers omitting CMS requirements, moderate analysis standard
Requirement (excerpted verbatim from the guidelines)Percentage of centers omitting the requirement
“The fact that communication between the donor & the transplant center will remain confidential, in accordance with the requirements at 45 CFR parts 160 and 164.”8
“The evaluation process.”12
“The surgical procedure, including post-op treatment.”24
“The availability of alternative treatments for the transplant recipient.”2
“The potential medical or psychosocial risks to the donor.”3
“The national & center-specific outcomes for recipients & living donors as data are available.”20
“The possibility that future health problems related to the donation may not be covered by the donor's insurance and that the donor's ability to obtain health, disability, or life insurance may be affected.”29
“The donor's right to opt out of donation at any time during the donation process.”2
“The fact that if his or her transplant is not provided in a Medicare-approved transplant center it could affect the transplant recipient's ability to have his or her immunosuppressive drugs paid under Medicare Part B.”19

Discussion

This study is the first to systematically examine informed consent for living donors in the United States since implementation of the OPTN and CMS guidelines for their protection in 2007. We found that 99% of centers now obtain written consent for evaluation, compared to 57% of centers that sought neither verbal nor written consent in 2006. However, the majority of programs utilize consent forms that do not incorporate all the CMS– or OPTN–mandated elements. As centers revise their consent forms to comply with the 2013 OPTN policies, our results can help identify areas where their documentation is most likely to lack adequate detail or clarity.

Informed consent is an ongoing and iterative process of communication [14] that develops throughout all donor interactions with the transplant team and review of materials. Written informed consent is one component of this process, although it does not guarantee the donor's understanding or voluntariness. Therefore, the primary limitation to our study is that we only captured information documented in the evaluation consent form. Unlike the newly revised OPTN guidelines, the 2007 OPTN policies did not explicitly require documentation of informational disclosures. Centers may not have viewed the written consent form as a comprehensive record of everything that was addressed throughout the remainder of the consent process. However, most evaluation consent forms were extremely detailed and extensive. Many omissions seemed to be inadvertent. In one representative case, a center that mentioned all the OPTN–required medical risks except unforeseen complications identified 10 other medical risks not described in the OPTN guidelines. Even our own center's consent form, which we previously believed to include all the OPTN–mandated elements, had deficiencies.

Our results may underestimate written disclosure of medical risks, which may be included only in operative consent forms that we did not review. Our results may not generalize to institutions that perform ≤5 LKTs annually. Due to the relatively small number of transplant centers, some findings approached but did not attain statistical significance. Other interpretations of the guideline requirements may differ from the four standards that we developed. Finally, we were unable to assess if donors comprehended the information presented in the consent forms.

Areas where consent documentation frequently diverged from the requirements may highlight the issues with the greatest ongoing ethical debate. For example, multiple elements balancing the interests and confidentiality of the recipient and donor were omitted. The absence of disclosure of a recipient's preexisting life–threatening conditions was particularly notable, with several centers explicitly rejecting OPTN's position. Centers that adopted OPTN's policy occasionally encountered difficulties when it was perceived as conflicting with the recipient's privacy and/or federal or state regulations [15-17]. Moreover, a recent study found that most donors wanted to know if a recipient had health problems that could decrease graft longevity, but they were less likely than transplant candidates to believe this information should be shared [18]. Of note, the revised OPTN policy requires that donors only be informed that “any transplant candidate may have high–risk factors for increased morbidity or mortality that are not disclosed to the potential donor” [11].

Both the 2007 and the 2013 OPTN guidelines require centers to acknowledge that “health problems experienced by living donors following donation may not be covered by the recipient's insurance” [emphasis added]. This obscures a distinction between problems following donation that are complications of the nephrectomy and those that are not attributable to the procedure. The OPTN guidelines also do not address whether a donor should be informed that the donor's insurance may not cover these expenses. To their credit, many centers attempted to address these omissions. Yet wording about payment for routine follow-up care, surgical complications and other postdonation health problems often remained ambiguous or confusing. Additional regulatory clarification of these issues may be warranted.

We join Gordon [12] in calling for UNOS to develop a uniform living donor evaluation consent form. Many consent forms already contain similar (or identical) language; this tendency was most pronounced among geographically proximate centers. A standardized document could allow for state-to-state variations regarding liability, donor expense reimbursement and mandatory disease reporting. Approximately 40% of consent forms were revised last year, suggesting that management of this documentation poses a significant, ongoing administrative burden to centers. Furthermore, our results indicate that low–volume programs may have difficulty adapting rapidly to a changing regulatory environment. Adoption of a uniform consent form could increase the efficiency of the transplant system.

A standardized consent form would minimize the interpretive confusion arising from variations in wording and omission of information. We believe that the CMS and OPTN guidelines could be addressed without substantially lengthening the consent form from its current average of six pages. If a uniform document is developed, attention should be paid to simplifying its language and streamlining its structure, particularly since other studies suggest that evaluation consent forms are written at a college reading level [19]. Focus groups might be helpful in developing clearer discussions about donor financial responsibilities.

We believe that consent forms should do more than merely document informational disclosures or informed consent. Well-crafted consent forms may play an integral role in the consent process by facilitating donor comprehension and providing an opportunity for discussion or questions. Further improvements to the written consent process may also help alleviate donors' concerns and encourage more individuals to pursue evaluation as living kidney donors.

Acknowledgment

Many thanks to Manuel Rodriguez-Davalos and Antonios Arvelakis for facilitating contact with transplant centers.

Disclosure

The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation.

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