legal and ethical aspects of organ donation.pptx

1. Legal and ethical aspects of organ
donation and transplantation
Dr.Nafeeya
Department of Forensic Medicine &Toxicology

2. Indian Journal Of Urology
• SUNIL SHROFF
• DEPARTMENT OF UROLOGY AND RENAL
TRANSPLANT ,SRI RAMACHANDRA MEDICAL
COLLEGE & RESEARCH INSTITUTE
,PORUR,CHENNAI,INDIA

3. Overview
• Introduction
• Aim of the study
• In detail about the
study
• Ethics of organ sale
• Limitation of the journal
• Discussion
• Conclusion

4. • Scientific achievements of medical science.
• Organ transplantation is a gift of second life
for thousand peoples of the world.
• It is possible to save many other lives
• Government make rules and act
• Lawful donation
• Brain-dead patients can be potential source
for this purpose.

5. AIM OF THE STUDY
• By This article -try to awake awareness in
general population.
• This article reviews the rules and Act related
to organ donation program in India.
• Promoting the deceased donation program

6. The laws and rules governing organ
donation and transplantation
• For living donation
• Mother, father, spouse, brother, sister ,son ,daughter
• Recently – grandparents
• Proof of their relationship –genetic testing /legal
• No need of Interview in front of committee

7. • Brain death & its declaration
• Criteria -2 certificates required
• 6 hours apart from doctors
• 2 doctors
• Appropriate authority
• One of them being –neurologist

8. Role of Authorization Committee
• To regulate the process of authorization to approve or
reject transplant
• To ensure that the donor is not being exploited for
monetary consideration to donate their organ.
• To ensure that the donor understands the potential
risks of the surgery
• Information about approval or rejection is sent by mail
to the concerned hospitals

9. Role of Appropriate Authority
• To regulate the removal, storage, and transplantation
of human organs.
• Licensed by the authority
• But eye donation -does not require any licensing
procedure
• Inspecting and granting registration to the hospitals for
transplant surgery
• 5yrs- renew after that
• Rights to cancel

10. Authority for removal of human
organ
• Any donor may authorize the removal, before his death, of
any human organ of his body for therapeutic purposes as
specified in
• Forms 1(A), 1(B), and 1(C).
• The new forms- proof of identity, address, marriage
registration certificate, family photographs, etc. with
attestation by a Notary Public.

11. • The donor is in a proper state of health and is fit to donate
the organ.
• The registered medical practitioner should then sign a
certificate as specified in Form 2.
• The donor is a close relative of the recipient as certified in
Form 3 and has signed Form 1(A).
• The donor has submitted an application in Form 10 jointly
with the recipient and the proposed donation has been
approved by the concerned authority.

12. RMP –Before removing organ from
deceased
• The donor had, in the presence of two or more
witnesses authorized as specified in Form 5.
• The person lawfully in possession of the dead body has
signed a certificate as specified in Form 6.

13. Brainstem death -RMP
• A certificate as specified in Form8-Board of Medical
Experts.
• In the case of brain-stem death of a person of less than
18 years of age, a certificate specified in Form 8 has
been signed by all the members of the Board of
Medical Experts
• Form 9 has been signed by either of the parents .

14. Working guidelines for the
Authorization Committee
• To check result of tissue typing & other tests
• NABL-National Accreditation Board for Laboratories
• Documentary evidence of relationship
• Married
• Non Indians –Senior embassy official should certify
• Check about commercial transaction –donor &
recipient

15. Hospital based AC
•Medical Director or Medical Superintendent of the
Hospital
•Two senior medical practitioners from the same hospital
who are not part of the transplant team
•Two members of high integrity, social standing, and
credibility
•Secretary (Health) or nominee and Director Health
Services or nominee

16. State or district level AC
• Medical Practitioner officiating as Chief Medical Officer
• Two senior medical practitioners who are residing in the
concerned district and who are not part of any
transplant team
• Two senior citizens of high reputation and integrity
residing in the same district
• Secretary (Health) or nominee and Director of Health
Services or nominee

17. Ethics of organ sale
• Like child labour & prostitution
• Ethical and legal framework is mandatory
• Kidney donation –safe
• It affects the younger's donors health
• Potentially risk for long term ill health
• Sale is contrary to human dignity, and
• Sale violates equity.

18. Lawrence cohen
• Anthropologist from Berkeley
• Most of the donors were womens
• kidney belt region –southern India
• Poor rural womens
• To get money – support families
• No follow up care to prevent infection
One
way
trade

19. Nancy scheper hughes
Anthropologist from Berkeley
THE END OF THE BODY :THE GLOBAL
TRAFFIC IN ORGAN S FOR TRANSPLANT
SURGERY
Social suffering, violence,Motherhood
‘kidney sellers’ from impoverished
communities in Recife.
In her early investigations of an
international ring of brokers and their living
organ sellers based in New York, New Jersey
and Israel led to a number of arrests by the
FBI
Bought
sold
Trade
Stolen

20. Limitation of the study
• Does not mention the age limit
• Blood bank donation & tissue
• Transplant co-ordinator

21. NOTTO-NATIONAL ORGAN & TISSUE TRANSPLANT ORGANISATION

27. Harvard criteria of brain death
• Whole brain death
• Unreceptivity & unresponsivity
• No movements or breathing( apnoea for 3mins)
• Fixed dilated pupils
• No reflexes
• Flat EEG
• Repetition of test

28. Philadelphia protocol
• Lack of responsiveness
• Absence of spontaneous breathing movements
• No muscular movements
• No Reflexes & responses
• Falling arterial pressure
• Flat EEG
• Repetition of test
Respirator
must be
put off

29. Minnesota criteria of brain stem
death
• No spontaneous movement
• No spontaneous respiration
• Absence of 5 major brainstem
reflex
• EEG NOT MANDATORY

30. APNOEA TEST FOR BRAIN STEM DEATH
• Mandatory test for brainstem death
• Definite loss of brain stem function
• If respiratory movements are absent and PaCO2 is ≥ 60
mm Hg
• Disconnection of Ventilators
• Raise PCO2 TO 60 mmHg
• 3-4 mm Hg under normal physiological
• Terminal illness

31. Brain stem death reflexes
Reflexes Cranial nerves
Pupillary reflex Optic (1),Occulomotor(3)
Corneal reflex Trigeminal(5), Facial (7)
Cilliospinal reflex Trigeminal(5), Facial (7)
Vestibular reflex (calorie test ) Vestibulocochlear (8),
Occulomotor(3)
Abducent (6)
Gag reflex Glossopharyngeal (9) Vagus (10)

32. Scope of deceased donation
program
• There are currently over 120 transplant centers in India
• Approximately 3,500 to 4,000 kidney transplants
annually.
• 150 to 200 liver transplants annually
• Occasional heart transplant.
• Approximately 50 liver transplants are done from
deceased donors and the rest are from living donors.

33. • RTA- approximately 90,000 – 2005 Tamil Nadu
• 40-50% -the cause of death is head injury
• 5% to 10% of all these deceased patients became organ
donors.
• No requirement for a living person to donate an organ.
• Promoting the deceased donation program
• Alternative to living organ transplant

34. Conclusion
• The transplantation act has evolved over last few
decades.
• The latest rules are available on the website of Indian
Society of Organ Transplantation as well.
• As transplant physicians and surgeons, students in the
transplant program we should make ourselves aware of
the existent rules.
• This will go a long way in avoiding legal issues in
day-to-day transplant practice.

36. References
• Government of India. Transplantation of Human Organs Act, 1994. Central Act 42 of 1994.
[cited 2007 Mar 9].
• Cohen L.R. Where It Hurts: Indian Material for an Ethics of Organ Transplantation. Daedalus
1999;128:135-65.
• Shroff S, Navin S, Abraham G, Rajan PS, Suresh S, Rao S, et al. Cadaver organ donation and
transplantation-an Indian perspective.Transplant Proc 2003;35:15-7.
• Shroff S. Working towards ethical organ transplants. Indian J Med Ethics 2007;4:68-9.
• Available from: http://www.easydriveforum.com/about_easydriveforum.