|Year : 2021 | Volume
| Issue : 1 | Page : 5-11
Ethics in organ transplantation
Department of Nephrology, Gandhi Medical College, Hyderabad, Telangana, India
|Date of Submission||27-Jan-2021|
|Date of Acceptance||04-Feb-2021|
|Date of Web Publication||21-Oct-2021|
Dr. Manjusha Yadla
Department of Nephrology, Gandhi Medical College, Hyderabad, Telangana
Source of Support: None, Conflict of Interest: None
Role of ethics in organ transplantation has been increasing with increasing number of organ transplants. Doing an ethical transplantation is of crucial importance. It is the liability of transplant team to follow the international and national ethical standards. Often, it is perceived that ethical and legal issues are the same. With the introduction of various ethical guidelines by international community, it is prudent that transplant team and the public abide by the existing regulations to avoid unanticipated outcomes of a successful transplant. Transplantation activity should be carried out with the premise that it is within the legal and ethical perspectives of that particular country. Transnational or transcontinental understanding of ethical perspectives by the nations actively involved in organ transplantation would definitely curb unethical and illegal elements.
Keywords: Ethics, India, organ transplantation
|How to cite this article:|
Yadla M. Ethics in organ transplantation. J Renal Nutr Metab 2021;7:5-11
| Introduction|| |
The term Ethics has been in vogue since the time of antiquity. Hippocratic Oath taken by all the medical fraternity emphasizes the role of Ethics in clinical practice. With the advancement of science in various fields, it is essential for every medical practitioner to have knowledge about Ethics.
Often in day-to-day practice, the ethical aspects are confused with the legal aspects.
Ethics is defined as the systematic questioning of what is right and what is wrong. An action that is taken in a particular issue if it is least wrong, best right, least harmful, and the associated with best benefits, then that action is ethical. An ethical action taken needs to be supported by moral reasoning.
Does ethics matter at all?
Ethical practice matters in all aspects of medicine for the following reasons:
- To preserve Rights of individuals
- Certain Rules for people to be aware of what is right and what is wrong
- More importantly, balancing the available resources with the ever-increasing demand in a more reasonable, amicable, and logical way.
Ethics in organ transplantation is of major and significant concern to all the transplant physicians, biologists, and researchers in the background of increasing legal and illegal modes of transplantation.
With the advent of three-dimensional organs, newer techniques in xenotransplantation, artificial intelligence (AI), and fast-expanding transplantation programs across the globe, the role and scope of Ethics is also increasing.
Certain gaps in the Act and areas of less understanding have being interpreted in.
Case scenario 1
The first case is Mr. X (50 years old) on dialysis seeking renal transplantation, with a 35-year-old donor Mr. Z, who is a tenant of Mr. X. The donor has a 6-year-old child born of wedlock. The donor is an orphan, working in a firm. The next of the kin of the donor is his wife, who is from other state, is also an orphan, and is an uneducated woman. The renal donation happened out of altruism, attachment, and affection as the donor has been a tenant for 10 long years. Mr. X and Mr. Z belong to different religions. After scrutiny of the required documents, permission was granted by the Authorization Committee. Is the decision of Authorization Committee legally right! Yes, but ethical perspective of the case is not clear.
Case scenario 2
Mrs. X, a 20-year-old working woman, an orphan by birth, was brought up by an affluent family of the patient of end-stage organ disease. She married 3 weeks ahead of the interview process in a brief ceremony with evidence submitted. The next of the kin is the newly married husband who gave consent for organ donation. After scrutiny of marriage photographs, marriage certificate, and an old photograph of donor, and recipient and donor together in a family function, case was submitted to th Ethics committee. Permission was granted. Is the decision legally Right? Yes. But is the decision ethically right?????
Ethics in organ transplantation and organ donation
Ethics in organ transplantation concerns donors, recipients, specific population, and areas. Moreover, Ethics in donors involves live donors and deceased donors [Table 1] and [Table 2].
|Table 1: Factors associated with Organ Donation,,,,,,,,,,,,,,,,,,,,|
Click here to view
Ethics in living related donors
In living donation program, the donor autonomy is of utmost importance. With the redefining of near relative, the Ethics in live related donation have gone deeper. There should be ways of assessment of factors like coercion, undue pressure (force) on the donor should be assessed, The response should be in a replicable and reliable manner.
There are three categories of living donors, namely directed donation to loved ones, nondirected donation, and directed donation to stranger. Directed donation to loved ones most often is out of emotional attachments.
In India, spousal transplantation is common, where more often wife donates to husband. In a study by Sakhuja and Kumar, it was observed that wives constitute 87%–92% of spousal donors. With changing scenario of society, family, employment, and education system, the circumstances where wife was forced to donate organ to husband, the sole breadwinner in a joint family system has slowly metamorphosed into a system where both the husband and wife are educated and employed, living as a nuclear family, but do not have a good relations with the sibling or if exist, the sibling's family is not accepting the sibling to be the donor. This again pushes the wife to become donor in compelling circumstance. Wife being the majority of donor population, a special psychosocial evaluation needs to be done in transparency.
Assessment of relationship is done by the certificates mentioned in the Rules and the Amended THOA. A special concern remains with spousal donation wherein the marriage certificate and the factum of marriage are assessed. Mere assessment of the duration, whether in days or in years, does not determine the emotional attachment or affection or the altruism in donation. Hence, it is also framed in Rules that in the case of a woman donor, special interview should be conducted to rule out coercion by family members.
In nondirected donation to a stranger, though not active in India, the concerned transplant teams should have liability to assess the donors in a comprehensive manner and discourage donations that are ambiguous.
Directed donation by a stranger through advertisement in public is illegal in India.
Altruistic donation out of love, emotion, attachment, and affection is assessed based on corroborative evidence only. The objective assessment of altruism, attachment, and affection cannot be done scientifically through certain questionnaires, which are available for assessment of altruism.
Under the broad umbrella of altruism, the sale of organs is continuing despite global prohibition. Through international laws and the Acts to curb organ trade, organ trafficking continues even today across many countries in the world, exploiting the poor, the vulnerable, and the needy by the rich and affluent groups. Iran is the only country where organ trade was legal till recent past.,
To have a uniform global practice of Ethics in the field of organ transplantation, which has expanded exponentially in the last two decades, certain yardsticks are defined by the international scientific committees.
- Declaration of Istanbul (DOI)
- Declaration of Istanbul Custodian Group (DICG)
- WHO Guiding Principles.
Declaration of Istanbul
To address the impending threats and unethical activities posed by organ donations, transplantation, The Transplantation Society, and the International Society of Nephrology convened a historical meeting at Istanbul in the year 2008. The consensus was endorsed by 135 countries.
The DOI expresses the determination of donation and the transplant professionals and their colleagues in related fields that the benefits of transplantation be maximized and shared equitably with those in need, without reliance on unethical and exploitative practices that have harmed poor and powerless persons around the world.,
It aims to provide ethical guidance for professionals and policymakers who share this goal. The Declaration thus complements efforts by professional societies, national health authorities, and intergovernmental organizations to support the development of ethical programs for organ donation and transplantation and to prevent organ trafficking and transplant tourism. These efforts have contributed to the considerable progress made in countries around the world since 2008.
Declaration has given definitions to identify illegal and unethical transplant or sale of organs from ethical and legal organ transplantation.
| Organ trafficking|| |
Organ trafficking is the recruitment, transport, transfer, harboring, or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability, or of the giving to, or the receiving by, a third party of payments or benefits to achieve the transfer of control over the potential donor, for the purpose of exploitation by the removal of organs for transplantation.
| Transplant commercialism|| |
It is a policy or practice in which an organ is treated as a commodity, including by being bought or sold or used for material gain.
| Travel for transplantation|| |
It is the movement of organs, donors, recipients, or transplant professionals across jurisdictional borders for transplantation purposes. Travel for transplantation becomes transplant tourism if it involves organ trafficking and/or transplant commercialism or if the resources (organs, professionals, and transplant centers) devoted to providing transplants to patients from outside a country undermine the country's ability to provide transplant services for its own population.
During Madrid Resolution held on March 23–25, 2010, 148 countries participated and a paradigm shift was called for the development of a comprehensive strategic framework for policy, practice directed at global challenges, and increased accountability and responsibilities of National Governments.
- Preventing the need for transplantation and increasing organ availability are national responsibilities
- Donation and transplantation should reflect comprehensive health care
- Opportunities to donate should be provided in as many circumstances of death as possible.
Declaration of Istanbul Custodian Group
The DICG has further defined the following activities:
- Organ trafficking
- Trafficking in persons for the purpose of organ removal
- Definition of resident and nonresident with respect to organ transplantation tourism
- Travel for transplantation
- Self-sufficiency in organ transplantation and donation
- Financial neutrality in organ donation.
The Indian Society of Organ Transplantation is one of the organizations endorsing DOI. For further details, please check website: www.declarationofistanbul.org. The latest edition of 2018 is available in English, Hindi, and Urdu.
Organ trafficking consists of any of the following:
- Removing organs from living or deceased without valid consent or authorization or in exchange for financial gain or comparable advantage to the donor/third person
- Any transportation, manipulation, and transplantation of the use of such organs
- Offering any undue advantage to, or requesting the same by, a health-care professional, public official, or employees of a private sector entity to facilitate or perform such removal or use
- Soliciting or recruiting donors or recipients.
WHO has laid down certain guiding principles on human organ transplantation in WHA 44.25 and WHA 63.22. This refers to the framework of ethical principles that need to be followed across the globe to maintain an orderly, acceptable, transparent organ and tissue transplantation activity. Although the essential points of the version made in 1991 are preserved, these principles do not deal with transplantation of gametes, ovarian or testicular tissue, embryo, blood, and blood products.
Ethics in deceased donation and in recipient allocation
In deceased donation program, the major emphasis of Ethics lies in allocation of organs. Organ allocation should be done in a systematic way with the prior approved criteria of beneficiaries. No organ retrieved can be wasted. Apart from the medical criteria for allocation, the points of concern today are:
- Should a second transplant get a preference over first transplant?
- Should a person with degenerative neurological diseases get a preference or be allotted an organ?
- Should the allotment be based on the societal productivity of an individual?
- Should the organ be allotted to kin on waitlist when his kith becomes a brain-dead donor?
- Should the organs be allotted from children? What are the medical criteria and ethical issues?
- Should a married person get preference over unmarried person?
- Should a parent of a child get preference over childless parent?
- When should a foreigner be allotted an organ?
In addition, the declaration and determination of brain death continues to be associated with unanswered questions. This would continue till an evidence-based brain death procedure is evolved. As of today, the best way of pronouncing brain death is based on two-time apnea test. All the other tests are only ancillary, unlike cardiac death where the death can be pronounced by an electrocardiogram. Hence, the enigma of time of death in the case of brain death donors continues to prevail. An ethical question remains: when is time of declaration of death: is it the brain death or is it the complete cessation of cardiac activity?
Why is there a need to redefine the definition of death?
Death is defined as brain stem death in THOA Section 2 (d). Brain stem death is certified by a board of members according to the Act and Rules. However, the Registration of Births and Deaths Act, 1969, defined death as permanent disappearance of life at any time after live birth has taken place and Section 46 of IPC defines death as the death of a human being, unless contrary appears from the context.
The discrepancy noted in the definition of death between the above Acts gives a scope for diverse interpretations. A person pronounced dead by THOA is not truly dead according to IPC 46 and the Registration of Births and Deaths Act, 1969. Hence, a unified definition needs to be achieved in order to curb the inconsistencies in understanding and the declaration of death.
Ethics in xenotransplantation
With the vast expansion of different aspects of organ transplantation, apart from the homograft (graft from the same species), xenograft (graft from animal species) is thought to meet the increasing demand of organ supply. Xeno in Latin means Alien. Pig is one of the animals which was tried the most in xenotransplantation. Due to lack of accepted scientific principles in transplanting animal organs to humans, the usage of this procedure remains unethical.
Ethical aspects involved with xenotransplantation are two-fold: overcoming the theological opinion of man taking over as “creator” rather than the “created” and “unnatural human interference” against the natural structure and order.,,,,
In anthropocentric Ethics, the human-based Ethics are given importance either individually or in a collective way. With transgenic transplantation, the individual is affected psychologically, is expected to take more immune suppression, and is prone for the development of known Porcine endogenous retroviruses (PERV) and unknown viruses, infections, etc. Collectively, transmission of infection to immediate family members, origin of certain epidemics in the society,defeats the very purpose of xenotransplantation.,,,,
As this is against the concept of animal welfare, which involves three Rs – Replacement, Reduction, and Refinement – the xenotransplantation is being criticized by animal supporters.,,,,
Ethics in foreign transplantations
The issues of concern in foreign transplantation are:
- Recipient and donor pair coming from the same country for organ transplantation: Model II
- Recipient from India traveling abroad for organ transplantation with donor from India or from the country of transplantation
- Donor of Indian origin traveling abroad to donate, i.e., organ trafficking
- Recipient from India traveling abroad for organ transplantation with donor from India or from the country of transplantation:
There is no mention of such a scenario in either the THOA or in the Rules., Hence, the affluent Indians would travel abroad for transplantation with or without the donor. If the donor is from India, he/she would invariably be a person working under the affluent. Legal permission from authorities should be made mandatory for such travel for transplantation. In a scenario of Model III, wherein the recipient is of country different from that of donor's and the transplantation center being in some other country, legal permission for recipient's transplantation (if recipient is from India) should be made mandatory. A registry should be maintained to such an effect. Till date, there is no authentic list of maintenance of such patients. Hitherto, it should be made essential, otherwise to be considered as illegal transplantation.
- Donor of Indian origin traveling abroad to donate, i.e., organ trafficking.
The scams in this scenario are on rise despite the Act and Rules. This is because the country of transplantation does not inform the country of origin of donor before organ transplantation. In an international platform, when citizens are traveling abroad to donate organs, the country of transplantation center should need to confirm the same with the embassy of country of origin. Global Acts and Rules addressing this particular issue should be made stringent and acted upon.
In addition, many a time, the middlemen, who advertise for probable donors, are never caught and are let scot free because of lack of stringent laws. Both Section 18 and Section 19 of THOA mention about the commercial dealing of organs and illegal dealing of organs, wherein only punishment is mentioned, not the type and nature of offence, for example, cognizable versus noncognizable (cognizable offence is an offence where police can arrest the person without warrant – no need to wait for complaint being launched, etc., vis-à-vis noncongnizable offence is where police can arrest only with warrant).
Section 22 of THOA states that cognizance of the offence would be taken by the court only if reported by the appropriate authority concerned, or a person who has given notice to the concerned appropriate authority of the offence.
| Use of artificial intelligence in organ trafficking|| |
In the recent Sri Lanka-Hyderabad organ transplant scenario, where the middleman lured the prospective, vulnerable donors through website, www.ineedkidney.com, a regular check on such websites would definitely curb the organ trafficking. Such websites may be tracked with special AI technology and the respective web accounts may be officially suspended. As it is impossible to identify the persons traveling abroad to donate, it is the moral responsibility of the recipient country to scrutinize the travel documents and the permissions and appraise the donor's country immediately.
Most often, the cases surface with the lack of payment or inadequate payment by the recipient, wherein donor comes forward to report the illegal surgery. Contrary to offering protection to the donor who is often from poor economic status, they are arrested and tormented for further information. A special protection cell should be setup for such people to guide legally and also for social, mental rehabilitation.
Case scenario 3
A 24-year-old woman from Foreign country is on medical tourism to India for renal transplantation with the donor being her cousin, who is a 19-year-old woman. Neither the donor nor the recipient has parents or siblings or other kith and kin alive (all of them died during the countrywide protests, information elicited during interview process). Hence, only the donor and recipient appeared for the interview by the Authorization Committee. Scrutiny of documents included Form 21 from embassy, stating the relationship to be cousin. Permission was granted for renal transplantation. Is the decision legally right? Yes.
Is the decision ethically right ?
In THOA and Rules, there are no clear guidelines and Rules made for foreign transplants. With an intention to improve medical tourism, the Ethics cannot be compromised. A clear assessment and scrutiny should be made for foreign transplants instead of depending on Form 21 alone. The genuinity of Form also needs to be cross-checked. With the present AI technology, having a transparent interview process of the local authorization committee, embassy of the country, and the referring country doctor may be feasible. This would make the global platforms reliable and transparent.
The treatment certificate by the doctor concerned, the relationship certificate from the local authorities as well as embassy, family structure certificate from the appropriate local authorities, and involvement of concerned state and/or central government with a referral letter mentioning in detail the relevance for live related/otherwise near relative transplantation are of crucial importance.
In case scenario 3, permission otherwise is difficult if both were from India, but the contrary happened based on Form 21.
Ethics in genetics and transplantation engineering and ethics in sexual tissue transplantation are beyond the scope of this article.
| Conclusion|| |
Ethics is an important aspect of organ transplantation and organ donation. Guidelines should be framed in concurrence with the DOI, DICG, and WHO Principles in order to have a global appeal of the quality of organ transplants in India. Quality and the outcome measures do not mean graft survival and patient survival but the transparency of Ethics and the legal issue pertinent to the current scenario. The paradigm shift of focus should be on quality, not on quantity.
Following may be considered to achieve a global standard of transparency and efficacy in the field of organ transplantation and donation.
- Formation of Transplant Ethics committee at Center and State level Issues to be assessed by the committee include
- Guidelines for transparency in allocation of organs to be applicable across the country and the surveillance of the same
- Guidelines for maximum retrieval of organs in an ethical way from the untapped potential of deaths in hospital and the surveillance of the same
- Globally applicable standard approach for patients coming under travel for transplantation.
- Global networking of all the countries which are active participants of transplantation. This curbs the trafficking and illegal transplantation with the clause that information needs to be essentially shared with all the members of international platform
- In the current Indian scenario, redefining brain death, registration of all the transplant centers under National Organ & Tissue Transplant Organisation (NOTTO) with an issue of online license numbering system aka Clinical Trial Registry/MCI Recognition. This helps in identifying the centers which perform illegal transplants
- An active Role for Medical Council and NOTTO on Ethical Issues in implementing the given Rules and the Act
- Formation of TaskForce India to curb the unethical and illegal organ sale and trade practices involving Indian citizens.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]