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Table of Contents
REVIEW ARTICLE
Year : 2020  |  Volume : 16  |  Issue : 2  |  Page : 71-76

Certification of brain stem death in India: Medico-Legal perspectives


1 Department of Nephrology, Government Medical College, Thiruvananthapuram, Kerala, India
2 Department of Law, Dharmashastra National Law University, Jabalpur, Madhya Pradesh, India

Date of Submission30-Jan-2020
Date of Decision09-Mar-2020
Date of Acceptance19-Mar-2020
Date of Web Publication18-Aug-2020

Correspondence Address:
Dr. Noble Gracious
Department of Nephrology, Government Medical College, Thiruvananthapuram, Kerala
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/AMJM.AMJM_11_20

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  Abstract 


At present, the determination of brain stem death for the declaration of death in India is a clinical practice followed only in the context of organ donation. It has still not evolved into a standard clinical practice in the intensive care units for determination of death. The probable explanation for this could be that, in India, the declaration of death by determination of brain stem death is mentioned only in the Transplantation of Human Organs and Tissues Act, 1994. Even after 25 years of application of this legislation and the definition of brain stem death in place, no uniform guidelines on the procedure to be followed in the determination of brain stem death have been issued either by the statute or by a national or state authority. The article tries to analyze the lacunae existing in the legal framework in relation to the certification of brain stem death in India.

Keywords: Brain stem death, certification of brain stem death, consent, transplantation of human organs


How to cite this article:
Gracious N, Jose VR. Certification of brain stem death in India: Medico-Legal perspectives. Amrita J Med 2020;16:71-6

How to cite this URL:
Gracious N, Jose VR. Certification of brain stem death in India: Medico-Legal perspectives. Amrita J Med [serial online] 2020 [cited 2020 Nov 27];16:71-6. Available from: https://www.ajmonline.org.in/text.asp?2020/16/2/71/292422




  Introduction Top


Throughout the history, cutting across cultures, the moment of death is held in great fascination. The change in status from living person to corpse is not a mere clinical phenomenon; it has profound psychological, legal, moral, religious, and economic implications. However, the advent of medical technology has raised a new set of troublesome questions regarding the dividing line between life and death. Technology has made the determination of death more difficult and important. Even though cardiopulmonary criteria of death still hold good, the progress in medical science and life support systems with the capacity to prolong life has diminished the importance of the same, which was earlier used to determine the dividing line between life and death. Such a prolonging of life solely based on the life support systems has raised significant questions regarding the quality of life of a person. At the same time, it has also opened up the opportunity for procurement of the organs which could be utilized for transplantation.[1] Medical science is thus equipped with supporting the biological functions of such patients for long periods of time, in the absence of essential brain function. When the line between death and life became blurred, efforts were made to define it in accordance with the new scientific criteria.[2]


  Defining “brain Stem Death” Top


Clinically, death is defined as the complete and permanent cessation of circulation, respiration, and functions of the brain. It is the irreversible cessation of all vital functions, especially as indicated by permanent stoppage of the heart, respiration, and brain activity. Normally, a diagnosis of death was not difficult using this cardiopulmonary criterion. However, in the modern context, the determination of death has gathered much significance in the context of organ transplantation. For a successful transplant, the organs have to be procured immediately after the death of the donor. After death, the organs will undergo molecular changes and the viability will be lost immediately, except in the case of some tissues such as the cornea.[3] Thus, organs “beating heart donor.”[4] In other words, only those organs which are being perfused by a beating heart or have received perfusion until recently can be effectively used for transplantation.

The concept of “brain death” was proposed as one means by which all of the requirements for a definition of death could be reconciled for the purpose of facilitating organ/tissue procurement. The WHO, Global Glossary of Terms and Definitions on Donation and Transplantation, 2009,[5] defines brain stem death as: “Irreversible cessation of cerebral and brain stem function; characterized by absence of electrical activity in the brain, blood flow to the brain, and brain function as determined by clinical assessment of responses. A brain stem dead person is dead, although his or her cardiopulmonary functioning may be artificially maintained for some time.” In the case of brain stem death, though there is a complete and irreversible loss of all brain functions, the heart will be still beating, thus making it the right time to procure organs from the deceased's body.[6] Therefore, today, it is an accepted notion that even if a person's heart is beating, he/she may be declared as “brain-stem dead.”[7] Thus, in simple words, a person is “brain stem dead” when all the functions of the brain ceases.

The declaration of death by brain stem death criteria has been given a legal recognition in India in the Transplantation of Human Organs and Tissues Act, 1994 (hereinafter referred to as THOTA). This has led to more confusion than clarity in the minds of many Indian physicians.[8] In India, the determination of death using brain stem death criteria is generally used only in the context of organ donation and that too in the recognized institutions where transplantation surgeries can be performed. Hence, a larger question of declaration of death using brain stem death criteria independent of organ donation remains an unsettled question in the minds of health-care providers in India.

Section 2 (d) of the THOTA defines brain stem death as “the stage at which all functions of the brain stem have permanently and irreversibly ceased” and is so certified under Section 3 (6) of the Act. The brain stem death can be certified only by a board of medical experts nominated by the registered medical practitioner from the panel of names[9] approved by the appropriate authority.[10] The certification shall be done in such form and such manner and on such conditions and requirements as prescribed. The Union Government has not issued the guidelines for brain stem death till now, and hence, there are wide variations in practice of certification of brain stem death in various states.[11]

Form 8 of THOTA Rules provides for the brain stem death certification format is to be used to certify brain stem death. It states that a team of four medical experts including (1) Registered Medical Practitioner, in charge of the hospital in which brain stem death has occurred, (2) R. M. P., nominated from the panel of names approved by the appropriate authority, (3) neurologist/neurosurgeon nominated from the panel of names approved by the appropriate authority, and (4) R. M. Ptreating the aforesaid “deceased person” should determine and certify the brain stem death. Amendments in the THOTA have allowed selection of a surgeon/physician and an anesthetist/intensivist, in the event of the nonavailability of approved neurosurgeon/neurologist. The Rules also prescribes the tests to be followed to ascertain the absence of brain stem functions. All the prescribed tests are required to be repeated, after minimum interval of 6 h “to ensure that there has been no observer error” and persistence of the clinical state can be documented. It is to be noted that the diagnosis is based only on the clinical examination. A neurophysiological or imaging study neither forms part of the diagnostic requirements nor is legally required. Confirmatory tests may however be carried out if the panel of doctors is in doubt or disagreement of the diagnosis.[12]

The wording of THOTA has given an impression to the medical practitioners that they are supposed to declare death using brain stem death criteria only if organ donation is contemplated. This is in contradiction to the scheme provided in the THOTA that the request for organ donation should be made only after declaring death. To make matters worse, the THOTA or the Rules[13] are silent as to the question what if the relatives of the deceased person are not giving consent for organ donation. In such an event of not giving consent by the relatives for removal of organs, what should be the further course of action? Is the treating doctor legally allowed to withdraw all life support measures?

Form 10 given as an annexure in the THOT Rules, 2014, clearly states that, on certification, the patient is declared dead. At this point, the next question that arises is whether it is justifiable to continue intensive care for a dead individual? In reality, this is happening in many intensive care units (ICUs) in this country. It is worthwhile mentioning in this context that intensive care beds are a scarce and expensive resource, and populating ICU beds with individuals who do not benefit from it often means denial of care to deserving individuals. There should be clear and unambiguous guidelines on how to respond to objections to the determination of death by neurologic criteria and how to respond for the requests from the relatives for temporary or indefinite accommodation of such “brain stem dead persons” who are not consenting to donate organs for transplantation. This is much needed to clear the doubts of the medical practitioners and other professionals involved in transplantation as well as to maintain public's trust in the system.


  Procedure for the Certification of Brain Stem Death in India Top


In India, as per se ction 3(6) of THOTA, a panel of four physicians including the treating physician, a physician representing the treating hospital, an independent specialist, and a neurologist or neurosurgeon is convened to determine brain stem death along with the registered medical practitioner in charge of that hospital. The burden of proof for diagnosis resides with the neuroscience's specialist.[14]

The THOTA does not address the level of expertise involved in the determination of brain stem death and presumes that the doctors have the requisite skills to do a thorough and complete examination consistent with best practice in the determination of brain stem death. The criteria in use for determining death are of exemplary standard, ethically sound, and supported by robust scientific and physiological rationale. However, it is always desirable to institute a certification program for determination of brain stem death akin to those provided for resuscitative programs.


  Standard Operating Procedure in the State of Kerala for the Certification of Brain Stem Death Top


Kerala was the first state in India to adopt a standard operating procedure (SOP) for determining brain stem death.[15] The said guidelines are to be followed to confirm brain stem death with an aim to make organ transplantation transparent in the state and the same has to be followed mandatorily by all government and private hospitals in the state, prior to the consideration of deceased donor organ donation. The SOP states that before subjecting a patient to the tests for declaring brain stem death, as a prerequisite, excludes any reversible causes of coma. Intoxicants, use of neuromuscular relaxants, depressant drugs, hypothermia, hypovolemic shock, or some endocrine disorders may induce coma which might be reversible and these should be ruled out.[16]

Clinical or neuroimaging evidence of an acute central nervous system catastrophe which is compatible with clinical diagnosis of brain stem death should be established before subjecting a person to further tests for evaluating brain stem death. Assessment of brain stem reflexes should be done using a series of tests, which are to be repeated within an interval of 6 h[17] by a panel of four doctors, including a doctor attached to the State Health Service.[18] It is mandatory that all four doctors witness these tests done 6 h apart and the procedures are videographed (although the videography clause has subsequently been revoked).[19]

The apnea test is the last brain stem reflex test to be performed, and that too, only if the previous tests confirm that there are no more brain stem reflexes.[20] At this stage, informed written consent is to be obtained by the doctor.[21] If any member feels that residual neuromuscular blockade should be tested, they may perform the peripheral stimulation test, which has also been detailed in the SOP. All four members – doctors of the brain stem death certifying team – should sign in the relevant documents. The procedure for documentation of brain stem death is as follows: (1) to ensure that all data are entered in Form 10 of the Rules, 2014, (2) ensure that all four doctors are signed and dated the Form 10, (3) time of brain stem death is documented in medical records including electronic medical records, if any, (4) after the completion of second apnea test, the patient is declared brain stem dead, and (5) inform the next kin of the results. Furthermore, to provide added clarity, the Government of Kerala has issued the Guidelines for the Brain-Stem Death Certification. This Government Order (GO) intends to streamline the procedure for the declaration of brain stem death, and for that, uniform procedure was laid down.[23] The GO also intends to remove the ambiguities in the minds of health-care providers as well as the public, thereby making the process of declaration of death transparent. The GO thus clarified that the declaration of brain stem death means declaring a person to be dead clinically and legally.


  The Crucial Question of Consent Top


In deceased organ donation, the consent of the deceased before his/her death is a prerequisite for removal of his/her organs on death. There are three variants of consent in practice in relation to organ harvesting. First type of consent is informed consent, also known as the “opt-in” consent. A person's agreement to allow something to happen to him made with full knowledge of the risks involved and the alternatives is termed as informed consent.[24] The second type of is known as presumed consent or “opt-out” consent. Under presumed consent, the decedent would be “presumed” to be willing to have their organs harvested on death. The third is “mandated choice,” where all adults are required to express their preferences regarding donation at the time they execute a state-regulated task[25] and their decisions would be controlling.

In India, we follow the “opt-in” form of consent for retrieval of organs from deceased. It is based on the principle of “authorization,” an expression which is intended to convey that people have the right to express, during their lifetime, their wishes about what should happen to their bodies after death, in the expectation that those wishes will be respected.[26] Authorization to remove an organ of a deceased reflects the principle of “consent” on which the THOTA is based.

According to the Section 3 (2) of THOTA, “If any donor had, in writing and in the presence of two or more witnesses (at least one of whom is a near relative of such person), unequivocally authorised at any time before his death, the removal of any human organ of his body, after his death, for therapeutic purposes, the person lawfully in possession of the dead body of the donor shall, unless he has any reason to believe that the donor had subsequently revoked the authority foresaid, grant to a registered medical practitioner all reasonable facilities for the removal, for therapeutic purposes, of that human organ or tissue or both from the dead body of the donor”. Here, the only embargo being that relative or person in whose possession the body is should be sure that deceased had not subsequently revoked that authority or person other than the relative has a reason to believe that any near relative has no objection to such a removal. This type of consent is known as opt-in consent, in which the deceased person has already opted for the removal of the organ before his/her death. Under the THOTA, even if the individual has opted-in or has given his/her consent for donation of his/her organs after death, his/her wish to donate his/her organs will not come true if his/her family is not permitting the donation. Despite the open declaration of his/her consent and wish to donate organs after his/her death, ultimately, it is the approval of family which is needed for such donation. Thus, the provision of free-will of the deceased is nothing but a misnomer, because in spite of his opting for the organ donation, his/her wish becomes secondary to the wishes of his/her family. For the THOTA to be effective in its real sense, provisions governing consent should be made effective meaningfully to respect the wish of the deceased donor and maintain the autonomy of deceased.

In practice, generally, the power given under Section 3(2)[27] is not used. It is the duty of the medical practitioner to ascertain that and shall proceed to obtain the documentation for such authorization in a prescribed form.[28] If there is no such authority as previously referred to, the relative(s)/person(s) in lawful possession of the dead body can authorize for organ removal or decline for donation. The Act is not clear about the standard of care to be followed by the hospital when near relative[29] is not authorizing organ removal. The near relative as defined may not be available or may not be maintaining a good relationship with the deceased person; then, obtaining consent from a person in lawful possession of the dead body is mandatory.

Another issue with regard to the determination of death by neurological criteria in India arises because of its religious and cultural diversity and the conscientious objection to the concept of brain stem death. This aspect may also have an impact on the informed consent of the patient's surrogate sought before performing the death determination based on brain stem death criteria including the performance of apnea test.


  Providing Accommodation to the Brain Stem Dead in Icus Top


Indian law on the determination of brain stem death is clear that the declaration of brain stem death means declaring a person to be dead, both clinically and legally. In the practical realm, the certification of brain stem death and convincing the relatives about the same is not easy. Laymen cannot be expected to know the intricacies of brain stem death or the difference between death by cardiopulmonary criterion or death by neurological criterion. Many a time, the intensive care specialists have to face the problem of educating the bystanders about the concept of brain stem death of the person in the ICU.

The general practice is to provide with continued application of organ-sustaining technology to the brain stem dead if they are proceeding for donation. If the deceased's relatives have not agreed for donation, the problem becomes all the more complex when it comes to the question of removal of life support systems. Allowing the brain stem dead to continue on ventilators may lead to potential harms which include mistreatment of the dead, deprivation of dignity, provision of false hope with resultant distrust, prolongation of the grieving process, undermining the professional responsibility of the physician to achieve a timely and accurate diagnosis, and an anticipated societal harm arising from a negotiated and inconsistent standard of death.[30] Hence, it is pertinent that the legal framework provides a clear guidance on the treatment of brain stem dead whose organs are not available for donation. The latest clarification by the Government of Kerala is a healthy step in that direction.[22]


  Role of the Transplant Coordinators Top


The role of a transplant coordinator is only to assist the registered medical practitioner in examining and verifying the authorization given by the deceased and or obtaining the consent for removal of organ from the legal heir or the person who is in lawful possession of the body of the deceased person. According to the Section 14 (4) of THOTA, hospitals engaged in transplants and related activities along with organ retrieval centers engaged in organ retrieval activities are required to register and obtain registration from the appropriate authority appointed for the purpose of the Act. The registration of such facilities would be done only if they have appointed transplant coordinators. It is mandatory for the registered hospitals to appoint transplant coordinators who are duty bound to ascertain, in consultation with the registered medical practitioner, that the deceased person has authorized at any time before his death the removal of his/her organ and if not authorized to make a request to the near relative. This should be done only after the certification of brain stem death by the board of medical experts nominated by the registered medical practitioner from the panel of names approved by the appropriate authority. The role of the transplant coordinator is to counsel the family members of the deceased person about organ donation and also to coordinate the process of donation and transplantation.


  Conclusion Top


Determination of death using brain stem death criteria is the integral initial step toward harvesting vital organs for transplantation from patients who suffer from catastrophic brain injury or apneic coma. Despite the fact that 25 years have passed since Indian law has defined brain stem death and has laid down procedure for the declaration of brain stem death, medical, social, religious, and legal controversies exist. The lack of uniform code of Indian practice guidelines in brain stem death diagnosis and after care of those individuals who are not organ donors are the most important hurdles in bringing determination of death using neurological criterion into common clinical practice. The Transplantation of Human Organs and Tissues Act, 1994, clearly states that the request for organ donation must be made only after certification of brain stem death, but the law is silent on whether consent of the relatives is required for declaring death using brain stem death criteria. Hence, it is the obligation of the authorities to bring out best practice guidelines in diagnosing brain stem death, approaching family, and to the consenting process. To improve public's trust in organ donation, the government and professional societies should develop initiatives to promote brain stem death determination training and credentialing programs to ensure that the determination of the brain stem death is consistent, accurate, and flawless.

To avoid confusion among the medical practitioners and persons involved in transplantation as well as the public, it is essential that the clause in the THOTA which states that the brain stem death determination is for the purpose of organ removal should be taken away and a uniform criterion for the declaration of death by brain stem death criteria along with the cardiopulmonary criteria has to be laid down by a separate legislation. Determination of brain stem death should not be limited to organ donation but should be a standard clinical practice to ensure that appropriate level of care is provided to patients. The certification of death (be it the cardiopulmonary criterion or brain stem death) should imply the withdrawal of all therapies, and further ventilation and homeostatic stabilization should be permitted only for preserving organs. Such a statutory provision may remove ambiguities in the minds of health-care providers as well as the public, thereby making the process of dying more dignified.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Though the term 'brain-stem death' is defined by various statutes, the definition given by the Uniform Determination of Death Act, 1980, of the United States of America seems to be the most appropriate. § 1 explains 'determination of death' as “an individual who has sustained either (1) irreversible cessation of respiratory and circulatory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead”. Available at: https://www.uniformlaws.org/HigherLogic/System/DownloadDocumentFile.ashx?DocumentFileKey=341343fa-1efe706c-043a-9290fdcfd909&forceDialog=0, [Last accessed on 2018 Nov 06].  Back to cited text no. 7
    
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11.
The Government of Kerala has issued an Executive Order prescribing standard procedures to be adopted for declaring brain-stem death. This may be the only document in the country issued by a state Government for determining brain-stem death. Kerala G.O (MS) No. 36/2012/H&FWD, dated 04/02/2012. Available from: http://www.dme.kerala.gov.in/pdf/gov_orders/go_ms_36_2012.pd. [Last Accessed on 2019 Aug 13].  Back to cited text no. 11
    
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[PUBMED]  [Full text]  
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14.
The Government of Kerala has made some modifications to this Rule by adding a doctor from a Government hospital and also video recording of the procedure of certification to impart transparency and accountability in the death certification process. Kerala G.O.(MS) No. 16/2017/H&FWD, dated 01/02/2017. Availlable at: https://kerala.gov.in/documents/10180/36fe55bc-9bae-4e66-a024-864c52b0ceec, [Last accessed on 2020 May 14].  Back to cited text no. 14
    
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Step I, Prerequisite for Brain Stem Death Testing, Kerala G.O. (Ms.) No. 53/2018/H&FWD, Dtd. 03/04/2018. Available from: http://knos.org.in/pdf/532018-BRAIN%20DEATH-SOP.pdf. [Last accessed 2020 Jan 05].  Back to cited text no. 16
    
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“Brain Death Certification is to be done by a team of 4 doctors, of which at least 2 doctors must be from outside the hospital. One of them must be a doctor from Government service who has been empaneled for the same by the appropriate authority”, Kerala G.O. (Ms.) No. 16/2017/H&FWD, Dtd. 01/02/2017. Available from: ttp://knos.org.in/pdf/go_ms_40_2018.pdf. [Last accessed on 2020 Jan 07].  Back to cited text no. 18
    
19.
“Real time (time and date stamped) Videography of the brain stem death certification must be produced for both the Apnoea tests”, Kerala G.O. (Ms.) No. 16/2017/H&FWD, Dtd. 01/02/2017. Available at: https://kerala.gov.in/documents/10180/36fe55bc-9bae-4e66-a024-864c52b0ceec. [Last accessed on 2020 Jan 05].  Back to cited text no. 19
    
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The term 'near relative' means, “spouse, son, daughter, father, mother, brother, sister, grandmother, grandfather, grandson or granddaughter” as defined in section 2(i) of THOTA, 1994. The full text of the statute is available in the website of Ministry of Health & Family Welfare, accessible at: https://indiacode.nic.in/bitstream/123456789/1962/1/199442.pdf [Last accessed on 2020 May 15].  Back to cited text no. 29
    
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James A. Russell, Leon G. Epstein, David M. Greer, et al., Brain death, the determination of brain death, and member guidance for brain death accommodation requests: ANN Position Statement, https://n.neurology.org/content/neurology/early/2019/01/02/WNL. 0000000000006750.full.pdf [Last accessed on 2020 Jan 05]..  Back to cited text no. 30
    




 

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