Ethical and Medicolegal

aspects of ART

SIG Endocrinology 2019

Chairperson – Madhuri Patil
 Why law and
ethics?

ART has given new hope, but has also raised

several new issues
Ethical issues
Legal issues
Moral issues
Social issues

Third party reproduction

Court cases are on the rise
against doctors
IVF specialist is no more a
Violence against doctors is
special person in society, as is
becoming common
the case with many specialties
becomes a necessity in several
infertile couple that involves a
lot of ethical and legal issues
 Final Draft is
Absence of regulations has led to a huge spurt in the number of fertility
awaitingclinics
approval
in India
of the parliament

Purpose of the
The concern is whether these clinics have adequate infra structure and are able to provide optimalRegistration
ART treatment – Policy
Bill All ART clinics handling
gametes need to enroll in
a national registry (ICMR)
before they are allowed to
To ensure operateTherefore clinics
Medical, performing IUI are also
social and included
In order to regulate ART practice in India- GOI, ICMR & National academy of medical sciences (NAMS)
legal rights of appointed 19 members as an expert
Accreditation
group committee to frame ART Regulation guidelines..
To ensure 2010
all those
and
that ethical concerned
supervision of
services are are protected
ART Clinics &
provided with Clinics need to
Banks
maximum meet certain physical
benefit to the infrastructure
infertile requirements.
couples
have prescribed
technical expertise.
 THREE TIER SYSTEM OF
ART CLINICS

Level 1
Level 2
Infertility care units– with PG Level III
Infertility care units – involved in
qualification, doing OI, NO sperm ART Clinics - IVF – ICSI, PGD /PGS
IUI & sperm manipulation; need
manipulation – No accreditation …require further permission
GOI accreditation
under the guidelines
 ICMR will maintain a National
registry of ART clinics and
banks in India

A central database which will

maintain all information
related to services offered by
clinics
( Information regarding
infrastructure, trained
manpower and procedure
followed)

Unique Registration Number Permanent registration from

will be issued to clinic on
satisfactory report by
Verification through a sight visit
No new ART clinic may start the Centre or State’s
operating unless it has appropriate accreditation The registration must be
obtained a temporary authority within two years of renewed every seven years
registration to do so obtaining the temporary
registration
 CODE OF
PRACTICE UNDER
THE GUIDELINES

Number of Maintenance
Consent Counseling Confidentiality Storage of of Record for
embryos embryos - highest
transferred 10 years
possible standard
maintained

All information available to them in regard to progress of the patient should be put online within seven
days of the information being available, withholding the identity of the patient

Each ART clinic must have its own ethics committee as per ICMR guidelines or should take the help of
accreditation authority in forming an ethics committee to decide on what is morally and ethically right
 Record
Keeping

Later, the ART clinic In the event of the

Records should be shall transfer the closure of ART clinic/
maintained for at records to a central bank immediately
least a period of ten database of the transfer the records
years. national ART registry. to the central
(ICMR) database
 Third Party
Reproduction

ICMR Recommends
Sourcing Of Donors And Surrogate
Should Be Done Only Through ART Banks
Process that allows infertile couple to take (organization that is set up to supply
part in procreation of a child, while getting sperm or semen, oocytes or oocyte
help from an anonymous person
donors and surrogate mothers to the ART
clinics or their patients

Sperm donation Egg donation Egg donation Surrogacy

 Requirements for Semen bank
The bank must be run
professionally
A bank may advertise for semen
donors who may be
appropriately compensated
financially
The semen bank shall not supply
semen of one donor for more
than ten successful pregnancies
It must have facilities for
All semen banks will require cryopreservation, following
ICMR accreditation internationally accepted
protocols & Guidelines
Semen samples must be
Suitable records of all donors is
cryopreserved for at least 6
kept for 10 years, after which, or
months before first use, at which
if the bank is wound up during
time the semen donor must be
this period, the records should be
tested for HIV and hepatitis B and
transferred to an ICMR repository
C
Psychological evaluation and
counselling of both donor and Only adult child has the right to
recipient by a know about donor
mental health professional
 Legal and Ethical
aspects of donor
inseminations

ART clinic & couple, both shall have the fullest

possible information from the semen bank of the
donor such as
---- height, weight, skin colour, blood group,
education qualification, profession, family
background, freedom from any known diseases or
carrier status, medical or genetic diseases, ethnic
origin

Sperm donor must be

One donor can donate up to
informed that the offspring Informed Consent essential
75 times
will not know his identity.
 Requirements for Oocyte Donation
Following blood tests should
Donor should be healthy be carried out: Blood group,
She should be married and
women in the age group of HIV, hepatitis B and C, VDRL,
having at least one child
18-35 years Blood sugar, Thyroid function
tests

Anonymous donors
Established egg donation Comprehensive physical Strong family H/O inherited
programs Agencies or ART examination essential diseases should be ruled out
Banks

Known donors – Not allowed; No woman shall donate
so also oocytes more than 3 times in
her life, with not less than a 3
Newspaper or internet – month interval between the
advertisements oocyte pick – ups
Eggs from one donor can be
shared between 2 recipients
only, provided that at least 7
oocytes are available for each
recipient
Ethical issues of Legal aspects of
egg donation egg donation
program

College girls donating eggs Donor must know that the

for quick money offspring will not know her
identity

Egg donor seeks parental

rights. The donor and the
recipient will remain
anonymous to one another
Excess eggs from IVF patients
with / without consent
Donor will not have
parental rights over the
Egg donor recruiters ignore child
ethical standards

Donor requires her

Menopausal recipient above spouse’s consent to donate
50 years egg
Embryo Donation

Surplus embryos of couple who achieve a

pregnancy can not be used for another
couple ,even if the owners of embryos give
consent

Monitory gains from donor embryos are not

allowed for the clinic

A couple can get donor embryo treatment by

going for a donor oocyte cycle and donor sperm if
husband’s sperm has genetic defects
 Surrogacy
Commercial surrogacy - surrogate is paid over and
above the necessary medical expenses

Altruistic surrogacy- Surrogate is paid only the

necessary pregnancy related expenses and at
times nothing at all

Selection of Gestational Carrier

Legal contract should include:
Details regarding financial
obligation
Expected behavior of surrogate to
ensure healthy pregnancy
Prenatal diagnosis tests
Agreement regarding
Fetal reduction
Therapeutic abortion
Declaration of parentage of child’s
birth obviating the need for
adoption proceedings
Known/anonymous.
Minimum of 21 years of age and < 38 years.
Preferably in a stable marriage.
Delivered a live-born child at term.
STI- screening-once when she agrees and once before
embryo transfer.
Medical and psychological assessment.
 Legal Aspects of Instructions issued on
Surrogacy 3-11-2015 by MHA to
Legal Aspects of
Surrogacy ART clinics
Surrogate mother Art clinics offering
should be from same surrogacy services will
generation and If a surrogate is not import human
between of 21- 35 married, the consent of embryos for offering
years her spouse shall be Financial transactions surrogacy services
required
Woman can become a The financial aspect of Foreign nationals and
surrogate mother for the process has to be overseas citizens of
up to 5 live births, A couple or an decided independently India (OCI) cannot
including her own individual shall not by the woman and the commission surrogacy
have the service of couple in India
more than one
Genetic parents are
surrogate at any given
legally bound to accept The ART center can in No exit permit for
time
the custody of the child no way become children born through
irrespective of any involved in the money surrogacy for foreign
abnormality: the that the surrogate nationals and OCI
refusal to do so shall mother receives cardholders
A couple shall not have
constitute an offence commissioned after
simultaneous transfer
under this Act this circular
of embryos in the
woman and in a
Surrogate mother shall surrogate Provide surrogacy only
not act as an oocyte for heterosexually
donor for the couple or married Indian couples
individual only in India
 Other Ethical
Issues

No ART clinic shall offer to provide a couple with a

child of a pre-determined sex

No ART clinic will carry out any ART procedure to

separate, or yield fractions enriched in sperm of X or Y
chromosomes

All unused oocytes and Embryos The collection of gametes from a

would be either appropriately
preserved by the ART clinic for use
on the same recipient(s), or given
for research to a bonafide
organisation
One sample of semen supplied by
an ART bank shall be used by the
ART clinic only once on only one
recipient
person whose death is imminent
shall only be permissible if such
person’s spouse intends to avail
assisted reproductive technology
to have a child.