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THE TRANSPLANTATION OF
HUMAN ORGANS ACT, 1994
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Dept of SurgeryPREDECESSORS
Eyes Act of 1982 and Ear Drums and Ear Bones Act
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of 1982 (Union Territory of Delhi)
Maharashtra Kidney Transplantation Act 1982 and
Bombay Corneal Grafting Act,1957
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Transplantation of Human Organs Bil , 1992 wasIntroduced in Lok Sabha on 20 August 1992.
This Bil was assented by the President on 08 July
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1994.It became `The Transplantation of Human Organs
Act',1994(42 of 1994).
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Donor ?means a person , not less than 18 years of age,
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who voluntarily authorises removal of any of his
organs for therapeutic purposes.
Hospital ? Nursing Home, Clinic, Medical Centre,
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medical or teaching institution for therapeutic
purposes.
Near Relative ? Spouse, Son, Son, Daughter, Father,
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Mother, Brother, Sister.
Registered Medical Practioner ? means a Medical
Practioner who possesses any recognized medical
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qualifications as defined in Clause (H) of section 2 of
the Indian Medical Council Act, 1956 (102 of 1956)
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and is enrol ed on a State Medical Council.BOARD OF MEDICAL EXPERTS
Registered Medical Practioner, in charge of the
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hospital in which brain-stem death occurred
An independent RMP, being a specialist nominated by
the RMP in clause (I) from the panel of names
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approved by appropriate authority
A neurologist or a neurosurgeon nominated by the
RMP in clause (I) from the panel of names approved
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by appropriate authority
RMP treating the person whose brain-stem death has
occurred
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_ _ _ _ _ _ _ _
No authority can be granted in cases an inquest is
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requiredIn unclaimed bodies (more than 48 hours) in a hospital
or prison, the authority may be given by the person in
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charge of management of the hospital or prison or aperson authorised in this behalf by the incharge
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APPROPRIATE AUTHORITY
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Central Govt. shal appoint ,by notification, one ormore officers as AA, and State Govt. for the
State.
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Duties ?
To grant, renew, suspend and cancel registration
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under sub-section(3) of that section.To enforce standards as prescribed.
To investigate any breach of provisions of act.
To inspect hospitals for examination of the quality of
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transplantation and fol ow-up care.Registration of Hospitals ? apply to AA within
sixty days of commencement of Act
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AA may reject the application, suspend orcancel the Registration (with or without
notice)
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Appeal within thirty days to Central/StateGovt against
Rejection/Suspension/Cancel ation
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OFFENCES AND PENALTIES
Removal of organs without authority :
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Imprisonment upto five years and fine of tenthousand rupees
RMP ? Removal of name from register of State
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Medical Council for two years for first offence andpermanently for subsequent offence
Punishment for commercial dealings in human organs ?
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Imprisonment for a term between two to seven years
and a fine of between Rs. 10000-20000
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THE TRANSPLANTATION OF HUMANORGAN RULES 1995
DUTIES OF MEDICAL PRACTIONER ?
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Authorization in Form no. 1 by donor
Medical fitness certificate (Form no. 2)
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If donor is a near relative then Form no. 3 is fil edafter establishing relation
If donor is spouse then sign a certificate in Form no.
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4
Donor had authorised in presence of two witnesses
authorised removal of organ from his body,in Form No.
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5
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There is lawful possession of dead body by a personhaving signed a certificate as specified in Form 6 or 7
Board of experts has signed Form 8
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Form 9 has been signed by either of parents in case
the deceased is less than 18 years of age
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Form 10 to be fil ed for transplantation by live donorother than near relative, to be signed by both
prospective donor and recipient with reason of
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affection and attachment. This has to be approved by
Authorisation Committee.
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CONDITIONS FOR GRANT OFCERTIFICATE OF REGISTRATION
GENERAL REQUIREMENT-
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SURGICAL STAFF
CARDIOLOGY STAFF
NURSING STAFF
COMMUNICATION SYSTEM
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INTENSIVISTMEDICAL SOCIAL WORKER
PERFUSIONIST
OPHTHALMOLOGIST
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NON TRANSPLANTATION PROGRAMME TEAM ?
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NEUROLOGIST
NEUROSURGEON
MEDICAL SUPERINTENDENT
ANY OTHER HOSPITAL STAFF
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EYE DONATION COUNSELLOR/GRIEF COUNSELLORCORNEAL SURGEONS
DEPARTMENTS ? 18 (Neurology,Microbiology,
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Mycology,Pathology,Virology,Nephrology,GI Surgery,Anaesthesiology,
Paediatrics,Physiotherapy,Immunology,Haematology,
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Blood Bank, Imaging Services
ClinicalChemistry, Cardiology,Ophthalmology,Psychology)
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BASIC EQUIPMENT ?OPERATING ROOM FOR ROUTINE OPEN
HEART SURGERY WHICH INCLUDES HEART
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LUNG MACHINE AND ACCESSORIES.
SLIT LAMP
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SPECULAR MICROSCOPEOPERATING MICROSCOPE
ADDITIONAL EQUIPMENT ?
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CELL SAVER
ASSIST DEVICE LIKE IABP AND
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CENTRIFUGAL PUMPMOBILE C ARM
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RADIOIMMUNOASSAY FOR MEASURING
CYCLOSPORIN LEVELS
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LAB FACILITIESAUTOCLAVE
UV LAMP
LAMINAR FLOW
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RECENT ORGAN TRAFFICKING SCANDALSNMC NOIDA IN 1998 ? Kidney Transplantation
Racket
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KAKKAR HOSPITAL, AMRITSAR ? Kidney
Transplantation Racket
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Kidney Transplantation Racket in five Hospitals ofHyderabad In 1993
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In USA, a total of 97,179 patients were waiting for
a transplant as of September 17, 2007. Fol owing is a
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list by type of transplant needed:73,149 patients waiting for a kidney transplant
16,702 patients waiting for a liver transplant
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1,640 patients waiting for a pancreas transplant
2,316 patients waiting for a kidney-pancreas transplant
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209 patients waiting for an intestine transplant2,626 patients waiting for a heart transplant
115 patients waiting for a heart-lung transplant
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2,336 patients waiting for a lung transplant
97,179 TOTAL PATIENTS
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WAITING* * Some patients are waiting for more thanone organ, therefore, the total number of patients is
less than the sum of patients waiting for each organ.
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Numbers of Transplants Performed During 2006
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17,092 kidney transplants
6,650 liver transplants
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463 pancreas transplants954 kidney-pancreas transplants
175 intestine transplants
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2,192 heart transplants
31 heart-lung transplants
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1,405 lung transplants28,932 TOTAL TRANSPLANTS PERFORMED*
? Based on data from the Organ Procurement and
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Transplantation Network of the U.S. Department of
Health and Human Services, as of June 29, 2007 -- data
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subject to change due to future submissions orcorrections.
THE REPORT
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OF
TRANSPLANTATION OF HUMAN ORGANS ACT
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REVIEW COMMITTEEAS PER THE DELHI HIGH COURT JUDGEMENT
DATED 06.09.2004 IN W.P. NO.813/2004 TO
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REVIEW THE PROVISIONS OF THE
TRANSPLANTATION OF HUMAN ORGANS ACT,
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1994 AND THE TRANSPLANTATION OF HUMANORGANS RULES,1995)
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BACKGROUND
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A committee, hereinafter referred to as the THOA
review committee, was constituted in terms of the
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judgement dated September 6, 2004 passed byHon'ble Mr. Justice Manmohan Sarin of High Court of
Delhi in WP(c) 813/2004 titled Balbir Singh vs. The
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Authorisation Committee and others (Balbir Singh
Case) with direction to review the efficacy, relevance
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and impact of the legal provisionsContained in the transplantation of human organs act,
1994 (TOHO Act) And The Transplantation Of Human
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Organs Rules, 1994 (TOHO Rules).The review committee commenced its working under
the chairpersonship of Additional Secretary (Health)
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to the Government of India and set out to objectively
and critical y appraise and analyse the practical
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functional y of the provisions of the TOHO act andthe TOHO rules, as defined by the Hon'ble High Court
of Delhi in the Balbir Singh case.
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Make its recommendations on the
composition of Authorisation Committees
Jurisdiction of the Authorisation
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Committees should be enlarged by
bringing within its ambit the process of
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certifying a "near relative" or the taskbe assigned to another designated
authority
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Develop a mechanism where al proposeddonors including `near relatives' should be
scrutinised by a committee (The
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Authorization Committee)
Composition of hospital based authorisation committees :
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(to be proposed by institution and notified by govt.)The senior most person officiating as medical director /
medical superintendent of the hospital.
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DM/ADM/SDM of the district which include the
officers holding equivalent post in hierarchy
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irrespective of nomenclature of the designation. (To benominated by concerned State/UT GOVT.)
Two senior medical practitioners from the same hospital
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who are not part of the transplant team.
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Two members being persons of high integrity, social
standing and credibility, who have served in high
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ranking government positions, such as in higherjudiciary, senior cadre of police service or who have
served as a reader or professor in UGC approved
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university or are self-employed professionals of repute
such as lawyers, chartered accountants, writers,
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journalists and doctors (of Indian Medical Association)etc.
One medical practitioner working in a government
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hospital to be nominated by the Central/Stategovernment.
Composition of state/ district level Authorisation
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Committees (to be constituted by Concerned state/UTgovt.)
A medical practitioner officiating as chief medical
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officer or any other equivalent post in the main/majorgovernment hospital of the district.
DM/ADM/SDM Of the district which include
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the officers holding equivalent post in hierarchy
irrespective of nomenclature of the designation.
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Two senior medical practitioners to be chosen
from the pool of such medical practitioners who
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are residing in the concerned district and who
are not part of any transplant team.
Two senior citizens, non-medical background
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(one lady) of high reputation and integrity to be
chosen from the pool of such citizens residing
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in the same district, who have served in
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high ranking government positions, such as
in higher judiciary, senior cadre of police
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service or whohave served as a Reader
or Professor in UGC approved University
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or are self-employed professionals of
repute such as lawyers, chartered
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accountants, writers, journalists anddoctors (of Indian Medical Association)
etc.
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One medical practitioner working in agovernment hospital to be nominated by
the concerned state/UT government.
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ADDITIONAL FORMS
FORM 1A
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FORM 1BFORM 1C
FORM-2:AMENDED
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FORM-4:DELETED
FORM-7:DELETED AS IT IS IDENTICAL TO FORM
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6FORM-10:AMENDED
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Where the proposed transplant is between persons
related genetical y, (e.g. Brother, sister, mother, father,
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children above the age of 18 years)The Authorisation committee must evaluate:-
Results of tissue typing and other basic tests.
Documentary evidence of relationship e.g. Relevant birth
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certificates and marriage certificate, certificate fromsub-divisional magistrate/ metropolitan magistrate/or
Sarpanch of the Panchayat;
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Documentary evidence of identity and residence of theproposed donor e.g. Ration card/voters identity
card/passport/ driving license/ pan card/bank account
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and family photograph depicting the proposed donor and
the proposed recipient along with another near relative.
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If in its opinion, the relationship is not conclusivelyestablished after evaluating the above evidence, it may in
its discretion direct further medical tests as prescribed
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in rule 4(1).
b) Where the proposed transplant is between a
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married couple:The authorisation committee must evaluate al
available evidence to establish the fact and
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duration of marriage and ensure thatdocuments such as marriage certificate,
marriage Photograph is placed before the
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committee along with the information on the
number and age of children and a family
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photograph depicting the entire immediatefamily, birth certificate of children containing
particulars of parents.
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c) Where the proposed transplant is between persons
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who are related genetical y but whose relationship
cannot be established in accordance with rules:-
Results of tissue typing and other tests with the name
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of the HLA laboratory and if possible the statistical
estimation of the probability of a genetic relationship;
Documentary evidence of relationship
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Ex. Relevant birth certificates and marriagecertificate,
certificate
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from
sub-divisional
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magistrate/ metropolitan magistrate/or Sarpanch ofthe Panchayat; documentary evidence of identity and
residence of the proposed donor e.g. Ration
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card/voters identity card/passport/ driving license/
pan card/bank account and family photograph
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depicting the proposed donor and the proposedrecipient along with another near relative.
WHERE THE PROPOSED TRANSPLANT IS
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BETWEEN INDIVIDUALS WHO ARE NOT
"NEAR RELATIVES"
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The authorization committee must evaluate:-That there is no commercial transaction between the
recipient and the donor. That no payment of money or
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moneys worth as referred to in the sections of the act,
has been made to the donor or promised to be made to
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the donor or any other person.That the fol owing is specifical y assessed by the
authorisation committee :-
An explanation of the link between them and the
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circumstances which led to the offer being made;
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Reasons why the donor wishes to donate?
Documentary evidence of the link e.g. Proof that they
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have lived together etc.Old photographs showing the donor and the recipient
together.
That there is no middleman/tout involved;
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That financial status of the donor and the recipient isprobed by asking them to give appropriate evidence of
their vocation and income for the previous three
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financial years. Any gross disparity between the status
of the two, must be evaluated in the backdrop of the
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objective of preventing commercial dealing.That the donor is not a drug addict or a known person
with criminal record;
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That the next of kin of the proposed unrelateddonor is interviewed regarding awareness
about his/her intention to donate an organ, the
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authenticity of the link between the donor and
the recipient and the reasons for donation.
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Any strong views/ disagreement/objection ofsuch kin may also be recorded and taken note
of.
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E) When the proposed donor or the recipient or
both are foreigners:
A senior embassy official of the country of
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origin has to certify the relationship between
the donor and the recipient or where they are
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not related the reasons as to why the proposeddonor is desirous of donating his organ to the
proposed recipient.
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Authorisation committee can examine the cases of
Indian donors consenting to donate organs to a foreign
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national, including a foreign national of Indian origin,
with greater caution. This should be done rarely in
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deserving cases only.In case where the donor is a woman greater
precautions ought to be taken. Her identity and
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independent consent should be confirmed/ verified by aperson other than the recipient. Any document with
regard to the proof of residence/ domicile and
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particulars of parentage should be relatable to the
photo identity of the applicant in order to ensure that
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the documents pertain to the same person, who is theproposed donor and in the event of any inadequate or
doubtful information to this effect, the authorisation
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committee may in its discretion seek such other
information or evidence as may be expedient and
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desirable in the peculiar facts of the case.In al cases of non-near relatives, the interview of the
donor should specifical y deal with the aspect of
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affection/attachment/ other special reason, in order torule out commercial considerations.
Further al donors should specifical y be interviewed to
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rule out any element of coercion, undue influence, fraudor misrepresentation in the proposal of donation. The
authorization committee should state in writing its
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reason for rejecting/approving the application of the
proposed donor and al approvals should be subject to
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That the approved proposed donor has been
and would mandatorily be subjected to al such
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medical tests as required at the relevant
stages to determine his biological capacity and
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compatibility to donate the organ in questionand further that the psychiatrist clearance
would also be mandatory to certify his mental
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condition, awareness, absence of any overt or
latent psychiatric disease and ability to give
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free consent. The committee also takes note ofthe recent judgement of the Hon'ble Supreme
Court of India, where the "authorisation
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committee" of Punjab was directed to examine
the donor and the recipient, while the
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transplantation was to be carried out atChennai.
While an endeavour has been made to recommend the
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enhanced jurisdiction of the authorisation committees
as envisaged in the judgement of Hon'ble Supreme Court
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of India, yet it is felt that several aspects peculiar tothe attending ground realities were not brought to the
notice of the Hon'ble apex court. For instance what
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happens if the donor and the recipient hail from
different states; what happens if one of them or both
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hails from a state/states where there is/are no"authorisation committee" and lastly it is not clear as to
whether the "authorisation committee" of the state
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where transplantation is taking place, shal retain some
jurisdiction or wil be completely without jurisdiction
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and if latter is the case then how wil the medicalevidence if required to be assessed, wil be assessed by
the domicile "authorisation committee" without
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resulting in delays and without compromising the other
laudable objectives of the TOHO act.
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Benefits for Live Donors
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Comprehensive health care scheme may be evolved by
the government.
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Life long free renal/liver checkup, fol ow-up and carein hospital, (including its other branches, if any),
where organ donation has taken place.
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To secure the donor against mortality risk due to
organ donation related reasons, a customized life
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insurance policy of Rs. 2 Lakhs for 3 years with onetime premium to be paid by recepient.
Certificate of appreciation to al live donors by
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state/local government with an identity card
Endorsing his eligibility to obtain and avail various
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benefits recommended here. The card shouldprominently display a slogan such as "thank you for
saving a life".
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Compensation for any expenses / loss of incomeincurred as specified in section 2 (k) of the THOA act.
50% concession in 2nd class by Indian railways.
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Recommended procedure for medical tests forestablishing genetic relationship between the recipient
and "near relatives" are as fol ows:-
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The tests for HLA, HLA-B al eles to be performed by
the serological and/or PCR based DNA methods.
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Test for HLA-DR beta genes to be performed using thepcr based DNA methods.
Test for HLA-DR beta genes to be performed using the
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PCR based DNA
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? Methods where the above two tests does not
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establish a genetic relationship between the donorand the recipient, the same tests to be performed on
both or at least one parent. If parents are not
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available, same tests to be performed on such
relatives of donor and recipient as are available and
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are wil ing to be tested.? Where the tests referred to above do not establish a
genetic relationship between the donor and the
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recipient,
Tests for DNA fingerprinting using single
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locus/multilocus polymorphic probes to be performed.The head of the testing laboratory should state in
writing whether or not he/she is satisfied that the
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claimed genetic relationship between the donor and the
recipient is established
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Promote Swap Operations:Swap operations that is to say that two different wil ing
but incompatible `near relative' donors (vis-?-vis their
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intended related recipient) are permitted to donate
their organs in exchange without any commercial
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interest and only due to the reason that despitewil ingness, their organ was not found medical y
compatible for their intended recipients. This would
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greatly help patients who have `near relatives' wil ing to
donate but incompatible for their recipient. Swap
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operations may be considered by authorizationcommittee on case to case basis and as per the existing
THOA act and rules.
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Unrelated donors can donate `by reason of affection or
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attachment' towards the recipient (Ch 2, Sect 9(3))
This requires obtaining prior approval from an
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authorising committee.EFFECTIVENESS OF ACT
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"THE ACT HAS BECOME USELESS BECAUSEIT HAS NOT HELPED STOP THE
COMMERCIALISATION OF ORGAN
DONATION. IN FACT, IT HAS INCREASED
OVER THE RECENT PAST."
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[NEPHROLOGIST]
"I RECEIVED SOME MONEY FROM THE
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RECEPIENT FOR DONATING MY KIDNEY ANDI DONATED IT BECAUSE OF MONEY.'"
[DONOR]
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CONSTRAINTSON
IMPLEMENTATION
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COMMERCIAL INTERESTS (MIDDLEMEN AND
SERVICE PROVIDERS):
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" I paid my broker his due as i was wheeled into the operationtheatre. He didn't move away from the stretcher until i paid
because he was not sure of me coming back alive. He made sure
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of getting paid for arranging a donor for me."
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(RECEPIENT)
`...It is possible for us to cut corners and lower the norms
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required for performing transplantation....... The lack of
standards and economic pressures means that people will cut
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corners.'(NEPHROLOGIST)
CONSTRAINTS
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ON
IMPLEMENTATION
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AMBIGUITIES AND LOOPHOLES IN THE ACT`I was asked to pose for a photograph with the recipient
and act as his wife for a while. I was told that this
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arrangement wil help me in escaping the rules and
regulations and wil also expedite payments to me.'
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(DONOR)` My second daughter soon after her marriage was advised
to undergo transplant surgery. Although my first
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daughter was wil ing to donate her kidney, her husband
demanded a sum of money ... I helped out with my own
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savings and we paid nearly Rs 100,000 US $2,298;1,890] to my first son-in-law.'
(MOTHER OF RECIPIENT)
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CONSTRAINTS ON IMPLEMENTATION- LOW
MONITORING CAPACITY OF REGULATORY
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AUTHORITIES
`I was asked by the recipient and the middleman to
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report a wrong address to the ac to escape policeinquiries later.'
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(DONOR)... It is not possible for us to go on checking this as we
have a large number of such applications to scrutinise
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Every week. As such, we have no mechanism to police
this practice and the rules as they exist do not require
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of us such monitoring.'(MEMBER OF AC)
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CONSTRAINTS ON IMPLEMENTATION PRESSURES
AND RESPONSIBILITIES EXERTED ON THE ACS
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Imagine you are in need of a kidney and have been waitingfor a year or so. This is a life and death situation. What
can you do if you don't find a related donor? Is it
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correct to stop a donor from giving his/her organ, even
though he/she may receive some money in return for his
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organ? Is it correct to stop a patient receiving anunrelated kidney from a donor?'
(FORMER MEMBER OF AC)
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CONSTRAINTS ON IMPLEMENTATION
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We too are human beings and we cannot easily say `no' to
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applicants seeking our approval for receiving unrelatedkidneys, even when we strongly suspect monetary
transactions between them. It is very difficult to
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disapprove them especial y when they are in tears crying
for our help and have been suffering from want of a
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kidney for several months. We tend to give in especial ywhen patients undergo transplant surgery for the second
time, which is not uncommon.'
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(FORMER GOVT OFFICIAL)
Summing up, commercialisation is widely acknowledged to
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exist.Factors that explain failure of THOA
Key commercial interests (notably middlemen/brokers
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and service providers)
The ambiguities and loopholes in the act,
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The low monitoring capacity of regulatory authoritiesThe pressures and responsibilities exerted on the ACs
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ETHICS
" Ethics does not treat the world. Ethics must be a
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condition of the world, like logic."WITTGENSTEIN
Ethical issues related to the donor's family.
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Relation between brain death & organ donation.Decision maker in the family.
Incentives
Religious issues
Medico-legal case
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Conditions / choice regarding recepients.ETHICAL ISSUES FACED AT THE HOSPITAL LEVEL
ROLE CLARIFICATION & AUTHORITY IN TEAM
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PRESSURE FROM TRANSPLANT TEAMCOMFORTABILITY
FACTOR
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INNON-
NEUROLOGISTS & SURGEONS.
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RELATION BETWEEN BRAIN DEATH & ORGANDONATION.
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LEGAL ASPECTS
No actual penalization of people involved in organ
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rackets til date.
Al ows brain death to be recognized in only selected
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recognized organizations.GLOBAL ETHICAL ISSUES
INTERNET SOLICITING
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DIFF. SOURCES OF ORGANS"ORGAN MARKET": IMPACT ON CADAVER
TRANSPLANT.
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RECOMMENDATIONS / POSSIBLE SOLUTIONS
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NO MATTER WHAT THE SITUATION, THESOLUTIONS PROPOSED, "THE DIGNITY OF THE
LIVING & THE DYING REMAINS AT STAKE &
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MUST BE FACTORED INTO THE EQUATION."
POSSIBLE BIOLOGICAL SOLUTIONS
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XENO-TRANSPLANTATIONCLONING
DEVELOPING ARTIFICIAL ORGANS.
DEVELOPING ORGANS FROM PATIENT'S STEM
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SOCIETAL / GLOBAL SOLUTIONSROLE OF MEDIA TO INCREASE AWARENESS OF
ORGAN DONATION.
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PROMOTE ORGAN DONATION IN ALLCOMMUNITIES.
STATE LEVEL SOLUTIONS
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REQUIRED CHANGES / MODIFICATIONS IN
EXISTING LAW IN INDIA.
CONSENT: INFORMED V/S PRESUMED.
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MANDATED CHOICE OR REQUIRED RESPONSEPOLICY.
PROVISION OF REQUIRED FACILITIES.
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INSTITUTIONAL LEVEL SOLUTIONS
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COUNSELING AT HOSPITAL LEVEL.APPROACHING EVERY BRAIN DEAD PATIENT.
MULTI-DIMENSIONAL APPROACH TO MEET
PHYSICAL,
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PSYCHOLOGICAL,
SOCIAL
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&SPIRITUAL NEEDS.
INDIVIDUAL ACTIONS AS SOLUTIONS
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DONOR CARDS / ADVANCE DIRECTIVES
MOTIVATING ONESELF AND OTHERS
MEDICAL
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PROFESSIONALSTO
PROMOTE
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UNDERSTANDING OF BRAIN DEATH & ORGAN
DONATION
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Possible Policy Options
Tighten Wording Of Act.
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Remove Provisions For Spouse And `Affection AndAttachment'
Mandate 3rd Party Tissue Testing
Promote Cadaveric Program
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What is truly distinctive about transplantation is not
technology but ethics. Transplantation is the only
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area in all health care that cannot exist without theparticipation of the public. It is the individual citizen
who while alive or after death makes organs and
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tissues available for transplantation. If there were no
gifts of organs or tissues, transplantation would come
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to a grinding halt.Arthur Caplan,
Bioethicist
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Thank you
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