Patient Application Consent Form

Kidney Exchange Program: Patient Application Consent Form

This Patient Application Consent Form (“Form”) is intended for patients awaiting kidney transplantation who have a willing living donor but cannot proceed with direct donation because of ABO blood type or immunologic incompatibility and for those donors.

If you are not accompanied with at least one willing living donor, you are not allowed to proceed and join the program. Your application will be denied and the process will stop at any point if such criteria is understood to be not met.

It also includes compatible couples who are willing to participate in the PIN Kidney Exchange Program (“PIN” or “Program”) via Barış Akın Organization (“BAO”) to enable a better HLA Match and potentially improve transplant outcomes. It explains BAO, the Program, the assessment process, how your data will be used and your rights, and seeks your informed consent to participate.

Please read each section carefully and ask your physician or transplant coordinator about anything you do not understand before signing it.

A. Information of the Applicants (“Patient & Donor”)

A.1 Patient (Recipient):

Full Name:

National ID No / Passport No:

Date of Birth:

Gender: Female [ ] / Male [ ]

Blood Type: A [ ] / B [ ] / AB [ ] / O [ ] | Rh: (+) [ ] / (-) [ ]

Mobile Phone:

Email:

Address:

A.2 Living Donor:

Full Name:

National ID No / Passport No:

Date of Birth:

Gender: Female [ ] / Male [ ]

Blood Type: A [ ] / B [ ] / AB [ ] / O [ ] | Rh: (+) [ ] / (-) [ ]

Degree of Relationship to Patient: Spouse [ ] / Sibling [ ] / Mother/Father [ ] / Child [ ] / Other: _____

Mobile Phone:

Email:

Address:

B. Information About BAO and the Program

B.1 What is paired kidney transplantation?

Paired kidney transplantation can be considered when your living donor cannot donate directly to you because of ABO blood-group incompatibility or immunological incompatibility. In this process, your donor gives a kidney to another compatible patient, and that patient’s donor gives a kidney to you. This allows both patients to receive kidneys from compatible donors. It may also be performed for compatible couples who are willing to participate either to help another patient-donor pair or to achieve a better immunological match and potentially improve transplant outcomes.

How does the process flow?

If you want to participate in the PIN kidney exchange program, contact PIN directly. You can also be referred to PIN through BAO; the head consultant of the program; Dr. Barış Akin- Professor of Surgery, Transplant Surgeon.

Your medical and immunologic data will be implemented in the PIN by BAO. Once you are listed you will be evaluated for possible matches. The PIN plans 2-way, 3-way, and 4-way exchange cycles, with surgeries planned to proceed simultaneously at a competent transplant center. The PIN allows BAO to run the Program within their own lists. As the number of participating couples increases, the chance of better matches increases. Therefore, PIN also evaluates matches on the global list and asks BAO to contact their couples to approve or decline the offered matches.

B.2 What is BAO and What does PIN do ?

BAO is a kidney transplant organization focused on advocacy, guidance, management, and continuity of care throughout every stage of the transplant journey.

The organization supports patients and donors before, during, and after transplantation, even when transplantation is performed elsewhere, helping them move through the transplant process with clearer guidance, stronger coordination, continuous care, and more informed decision-making.

Built around the experience and medical leadership of Prof. Dr. Barış Akın, the Organization aims to simplify transplant pathways, support faster and smarter processes, and help patients and donors navigate transplantation with greater clarity, continuity, and confidence.

When appropriate, patients may also be evaluated within the PIN system to identify the right match and support better transplant outcomes.

Information about PIN:

PIN is a medical decision-support platform owned by Clarus Technologies LLC. It requires the tissue typing and immunologic data of the non-identified (secured) subjects to participate and offers matching of couples regardless of their identities. You should be in direct contact with the Participating Partner assisted your introduction to exchange list. The experts will either run the PIN program to find matches at their listed couples or they will evaluate the resulting matches offered by PIN to determine whether that offer can become a real match. If you are listed through BAO, you will be in direct contact with BAO. Then, BAO contacts the candidates (patient-donor couples) and helps them accept or refuse the offer. Therefore, the main principle of PIN is to gather immunologic data and identify better matches for everyone, even for compatible pairs, to achieve the best outcome.

PIN matches patient-donor pairs from different participating partners in various countries by assessing the blood type, HLA tissue compatibility, and anti-HLA antibody profiles, including DSA and MFI values. PIN performs matching through virtual crossmatch and outcome-focused scoring algorithms. When PIN identifies a suitable match, it notifies BAO as your representative.

B.3 What does BAO NOT do?

Does not act as an “match making” platform: BAO only accepts applications from patients who has donor(s), who cannot donate to himself/herself for medical mismatch but can donor to any other suitable patient, who also has donor(s). BAO never accepts any patient without a donor or anyone for organ donation as a trade. At least 4 degree kinship needs to be documented)

Does not guarantee a transplant or match: The program aims to increase the probability of finding a compatible pair; it does not commit to it.

Does not replace laboratory tests: Virtual crossmatch on the platform does not replace physical laboratory crossmatch tests to be performed prior to transplantation. Physical tests can cause unexpected results and cause cancellation of that paired surgeries.

Does not replace your transplant center: All medical processes are conducted in licensed organ transplant centers and under their physician’s responsibility.

B.4 Participation fees and costs

No fee is charged for registration to BAO or to the program’s matching list. Costs for medical and immunological evaluations, laboratory tests, and transplant surgery will be defined in your engagement with the transplant centers and your health insurance coverage. Please contact them for detailed information.

B.5 How does the process work?

Pre-application and informing: Reading this form carefully, answering your questions accurately and signing it.

Medical and immunological evaluation: Evaluation of blood type, HLA tissue typing, anti-HLA antibody screening, and donor health eligibility for patient and donor.

Registration in the matching pool: BAO will register your medical data on the Program under an anonymous encrypted code.

Match proposal: When the Program’s algorithm finds a suitable exchange scenario, the proposal is transmitted only to BAO using anonymous encrypted codes.

Evaluation of match and approval: BAO reviews the proposal, can perform additional immunologic tests and then informs you.

Final evaluation by admission to the transplant center and legal & ethical approvals: Ethics Committee approval, National Coordination System notifications and other approvals required by legislation are completed at the medical center that will proceed with paired exchange surgeries.

Simultaneous transplantation: Surgeries for all pairs participating in the exchange are planned and performed in a coordinated manner at BAO that has the outnumbered matched couples.

B.6 Legal framework of organ transplantation

Living-donor organ transplantation is governed by various international bodies like UN and WHO. Therefore, donoring, receiving or brokerage of organs or tissues in return for any financial gain or benefit is prohibited by the relevant legislation of these bodies and constitutes a serious crime. The program is designed to comply with all these related legislation, including living-donor kinship requirements, Ethics Committee approvals, and simultaneous exchanges involving up to four pairs.

C. Dependencies & Limitations

Enrolment does not provide priority, entitlement, or a guaranteed position for transplantation.

Finding a suitable match is not guaranteed and the timeframe is unpredictable. Highly sensitized (high PRA) patients have a lower match probability.

A match proposed by the platform may be deemed unsuitable following laboratory crossmatch testing or clinical evaluation.

Withdrawal of any participating pair for any reason may cause postponement or cancellation of the entire exchange cycle.

The donor has the right to withdraw from donation at any stage up until surgery without stating a reason and without facing any sanctions.

In a paired transplant, the kidneys are exchanged and the transplanted kidney to the patient will belong to the paired donor, not their own donor.

Identities of participating pairs are kept mutually confidential unless explicitly requested by the parties and approved by BAO. The authorised transplant center (Hospital) going to perform the surgery will finally know the matched couples, will admit to hospital and proceed the simultaneous kidney transplantations.

Program participation does not automatically alter your status on the deceased-donor waiting list.

This form is not a surgical consent form and is used solely for informative purposes. You or your donor do not pledge or commit any medical action.

Risks related to donor nephrectomy and kidney transplant surgeries will be detailed in separate surgical consent forms at the respective medical center.

D. Eligibility Criteria & Evaluation Process

Eligibility Criteria: The eligibility criteria and evaluation process will be handled by BAO as stated below, in line with the assessment made via the Program.

The Donor’s relationship to the Recipient must be documented and verified by BAO.

The living donation may be permitted from:

A spouse, who has been married for more than 2 years, subject to the conditions established by applicable regulations;

Blood relatives within the legally permitted 4th degree;

Relatives by marriage within the legally permitted 4th degree; or

In cases outside the ordinarily permitted relationship categories, persons who receive any required ethics committee or other competent-authority approval could not be involved in paired donation listing according to applicable legislations.

For enrolment under the ordinary relationship pathway, the donor and intended recipient must fall within the legally recognized relationship limit, commonly expressed as up to and including the fourth degree of blood relationship or relationship by marriage, and must provide the documentation requested by BAO.

Therefore the Patient understands and accepts that:

a stated relationship alone is insufficient; official documentation will be required; especially at the time of hospital admission to proceed the surgeries.

BAO does not independently establish or legally certify kinship.

Enrolment does not waive the jurisdiction any health institutions, ethics committees, Center or any other legal requirement.

If the required relationship, documentation, or authorization cannot be verified, the pair may not be accepted into the active paired-donation listing or may be removed from it.

Evaluation Process:

The Patients understands that BAO’s match via PIN does not establish direct medical suitability for donation or transplantation. PIN’s duty is completed once there is a possible match identified by the experts at the Participating Partners approve.

Before any transplant can proceed, the Participating Partner or BAO must determine and give the final decision in accordance with the following:

Whether the recipient is medically suitable for transplantation;

Whether each donor is medically and psychosocially suitable for living donation;

Whether the suggested donor and recipient are sufficiently compatible;

Whether additional laboratory testing or crossmatching is required;

Whether there are clinical risks that make the proposed exchange unsuitable;

Whether all legal, ethical, administrative, and institutional conditions have been satisfied; and

Whether the exchange can be organized safely among the participating partners.

BAO is not a transplant center and thus is not the final authority regarding the operation. Therefore, the transplant center shall check all the outputs and shall have the final saying regarding the transplantation process, in line with the local legislation and national health procedures.

F. Signatures & Acceptance

By signing below, the patient and the donor confirm that they have read or had all pages of this form read to them, understood its content and freely made the decision. A copy of this Form is provided to the patient and donor physically or in digital platform and the original copy is kept by BAO.

The Patient accepts and confirms that; he/she read or fully informed the Donor about this Form and the he/she is authorised to sign this Form on behalf of the donor. The Patient shall be fully liable for any discrepancies on the Program and/or or any personal rights claims against BAO that may be raised by the Donor.

Patient (Recipient) and on behalf of the Donor

Full Name: ________________________

Signature: ________________________

Date: ____ / ____ / ________

Legal Representative / Guardian (if applicable):

Relationship: ________________________

Full Name: ________________________

Signature: ________________________

Date: ____ / ____ / ________