DRAFT: CONSULTATIVE DOCUMENT ON ETHICAL GUIDELINES ON BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS
( By Indian Council of Medical Research New Delhi )

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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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