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Draft: Consultative Document on Ethical Guidelines on Biomedical Research involving Human Subjects
Appendix: Consent Forms for Assisted Reproductive Technologies
3.1 CONSENT FORM
We, Mr.
________________________________________________ and Mrs.
__________________________________ hereby give consent to
donate sperms of Mr. __________________________________
to Mrs. ____________________________________ for purpose
of artificial insemination with donor's sperms and we
agree that we will have no legal claim on the baby born
to Mrs. ___________________________________ by the above
procedure of artificial insemination.
Mr.
Mrs.
DONOR
SPERM DONATION
3.2 CONSENT FORM
We,
Mrs.________________________________________________ and
Mr. ______________________________________________ state
that we are lawfully married and have no children. We
desire that Mrs.
_________________________________________ should be
artificially inseminated with donor sperms as we are both
desirous that we should have a child by that means. The
procedure of artificial insemination has been explained
to us and we hereby give consent to such artificial
insemination. I, hereby request you to inseminate my wife
Mrs.______________________________________. I,
Mr.____________________ will take responsibility of
bring-ing up the child born by my wife Mrs.
_____________________________________ as above procedure.
Mr.
Mrs.
RECIPIENT
ARTIFICIAL INSEMINATION
3.3 CONSENT FORM
We,
Mrs.________________________________________________ and
Mr. ______________________________________________ state
that we are lawfully married and have no children. We
desire that Mrs.
_________________________________________ should be
artificially inseminated as we are both desirous that we
should have a child by that means. The procedure of
arftificial insemination has been explained to us and we
hereby give consent to such artificial insemination.We
agree that identity of the donor for the purpose of such
insemination is not to be disclosed to us. We ourselves
are not able to procure such donor and agree to accept
such donor for the purpose as you may procure. We
understand that since fresh samples may be used, small
risk of getting AIDS infections cannot be ruled out.#
Mr.
Mrs.
RECIPIENT
ARTIFICIAL INSEMINATION
WITH
UNKNOWN DONOR
# All ART Centres should
only use frozen sperms
3.4 CONSENT FORM
This is to certify that I
_______________________________ and my husband
__________________________________ hereby give consent to
donate my oocytes to any infertile couple who wishes to
receive them. The procedure of oocyte collection is
explained to us in detail and I understand the risk
involved in the procedure as well as premedications and
protocols for monitoring of ovulation induction. The
identity of recipients of the oocytes will remain unknown
to us and we will not have any claim on offsprings that
will be produced by donation of my oocytes.
Mrs.
Mr.
(Signature)
DONOR
OOCYTE DONATION
3.5 CONSENT FORM
We,
Mrs.________________________________________________ and
Mr. ______________________________________________ state
that we are lawfully married and have no children. We
desire that Mrs.
_________________________________________ should have
IVF-ET/GIFT by oocyte/embryo donation as we are both
desirous that we should have a child by that means. The
procedure of IVF-ET/GIFT has been explained to us and we
hereby give consent to such treatment.We agree that
identity of the donor for the purpose of oocyte/embryo
donation is not to be disclosed to us. We ourselves are
not able to procure such donor and agree to accept such
donor for the purpose as you may procure.
Mrs.
Mr.
(Signature)
RECIPIENT
OOCYTE/EMBRYO DONATION
3.6 CONSENT FOR
EMBRYO REDUCTION
We, Mr. &
Mrs.___________________________________________ hereby
give fully informed consent for the procedure of Embryo
Reduction, to attempt the reduction, of our
______________________________ to
__________________________. We have been informed that
this procedure can lead to the termination of the whole
pregnancy or failure to reduce the number of embryos to
the desired number of continuation of the pregnancy with
the original number of embryos.We do not hold the doctors
responsible for any other future complications in this
pregnancy.We have been explained that since this
procedure is done in the first trimester, therefore it is
not possible to detect the future anatomical or
functional abnormalities of the embryos and therefore a
selective reduction may not be possible. We solemnly
pledge that we are giving this consent without any
pressure and with full awareness of the consequences.
Mr.
Mrs.
(Signature)
3.7 CONSENT FORM
FOR SURROGATE MOTHER
We,
Mrs.________________________________________________ and
Mr. ______________________________________________ state
that we are lawfully married. We give consent that Mrs.
_________________________________________ should have
IVF/ET by embryos of Mrs.
__________________________________ The procedure of
IVF/ET has been explained to us and we hereby give
consent to such treatment. We agree that we will have no
legal claim on the baby born by that procedure and we
will hand over the child to the genetic parents on birth
of the baby. Mrs.
___________________________________________________ is
volunteering to become surrogate mother purely to help
Mrs.
______________________________________________________ .
Mr.
Mrs.
(Signature)
SURROGATE MOTHER
3.8 CONSENT FORM :
Participation in IVF Program
Note : This Consent Form
should be signed at the time of the initial consultation
with the IVF team.
1. I hereby authorize and
direct Dr. __________________ ________ and such
assistants as may be selected by him/her to administer to
and treat me __________________________ in accordance
with the attached IVF protocol, which have been discussed
with me, and I here by consent to such treatment.
2. I understand that the
purpose of my participation in the program is to attempt
to become pregnant by means of in vitro fertilization,
and embryo transfer because I have been unable to become
pregnant due to conditions which have not been, treatable
by other currently available methods and procedures.
3. I understand from my
reading of the attached IVF brochure and counselling by
the IVF team physician that the following is an outline
of the IVF process and procedures which will be followed
during my participation in the programme :
a. Administration of
medications to assist my ovulation.
b. Frequent blood tests,
pelvic examinations and ultrasound studies to determine
development of ovulation.
c. Admission to the
hospital for a laparoscopy or ultrasound retrieval when
my ovulatory process is at the appropriate state, as
determined by the IVF team, in order to obtain as many
eggs as possible from my ovaries (usually one to four).
d. Mixture of my eggs with
my husband's sperm to attempt to allow fertilization, to
occur.
e. Transfer of my
fertilized egg into a different medium outside the uterus
for growth.
f. Transfer of the
embryo(s) into my uterus by means of a small plastic tube
following several cell divisions.
g. Frequent blood tests
through the remainder of my cycle to determine hormone
levels and whether pregnancy has occured.
4. I am advised of all the
reasonably known risks and consequences associated with
this treatment. Those reasonably known risks and
consequences have been fully explained to me.
5. I am advised that there
are no guarantees that I will become pregnant through my
participation in the IVF program or that, if I do achieve
pregnancy, a successful full-term pregnancy will result.
6. I understand that the
factors that may prevent my becoming pregnant or carrying
a fetus to full-term during my participation in the IVF
program include, but are not limited to, the following:
a) The time of ovulation
may not be accurately predictable, or ovulation may not
occur in the monitored cycle, thereby precluding any
attempt at obtaining an egg.
b) The attempt to obtain
an egg may be unsuccessful.
c) My husband may be
unable to obtain a semen specimen.
d) Fertilization or
splitting of the egg outside the uterus may fail to
occur.
e) A laboratory accident
may result in the loss of an egg.
f) Following successful
establishment of pregnancy, there is the possibility of
miscarriage, ectopic pregnancy (tubal pregnancy), or
stillbirth.
7. I understand that
should I carry the fetus to fullterm, there are no
guarantees that congenital anomalies (birth defects) will
not occur.
8. I understand that the
chances of multiple pregnancy are higher by this
procedure than by natural conception.
9. I understand that there
is indication in the scientific literature that the
occurrence rate of any of the events stated in paragraph
6(f) or 7 is increased or decreased by the procedure.
10. I understand that
according to information currently available from other
in vitro fertilization centers, pregnancies resulting
from the procedure occur at a maximum of 20 percent per
cycle attempted. I also understand that the Fertility
Clinic program does not guarantee that its success rate
will be similar to that of other programs.
11. I understand that I am
free to discontinue participation in the program at any
time, either verbally or in writing, and that my decision
to discontinue will in no way prejudice other treatment
that I may receive from the Fertility Clinic. I also
understand that if I decide to discontinue participation
in the IVF program, I will be responsible for all
expenses incurred during the periods of time prior to
such discontinuation and which relate to my treatment in
the program.
12. I understand that this
consent extends from the original period of my
participation in the program ucompleted or until I decide
to ntil the program is discontinue participation.
13. I understand that
should the results of my treatment or any aspect of it be
published in medical or scientific journals, all possible
precautions will be taken to protect my anonymity. I
grant permission to the IVF team to publish in
professional journals statistics relating to my case,
provided my name is not used.
Date :
____________________________ Patient:________________
Time :
____________________________ Spouse : _______________
Witness
:__________________________ Physician Obtaining
Consent
:_________________________
G/SGPNOV97/11-12-97
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