Ivf Fertility Treatment Informed Consent Art Act Surrogacy Forms Explained

Earlier this month, a Gurgaon-based couple accused a Delhi fertility clinic of an embryo mix up after the birth of twin girls, which, the parents claimed, are not biologically theirs. They also told a Delhi court that the clinic allegedly forged consent forms.

On June 5, the court dismissed a petition by the hospital challenging a magistrate’s order directing criminal prosecution against it.

The couple alleged that the hospital “created forged documents with their forged signatures to create the false impression” that the couple’s own egg and sperm “were not viable to create an embryo,” pointing out fake certificate numbers on an insurance record for a purported donor.

According to the couple, the clinic claimed that the couple gave written informed consent through an affidavit and a form on May 14 agreeing to use of anonymous donor oocytes and sperm. The couple has denied this.

The Indian Express breaks down why Assisted Reproductive Technologies (ART) and surrogacy involves laborious paperwork and what is the process involved.

Under the Assisted Reproductive Technology (ART) Act and its Rules, as well as the Surrogacy (Regulation) Act and its rules, consent is required to commence fertility treatment. The law also demands consent at every pivotal stage.

All forms of consent are signed at the initial stage.

However, In vitro Fertilisation (IVF) specialist Dr Aniruddha Malpani points out, “Consent is not just a signature on a form. The law says your clinic cannot give you treatment unless you provide informed, written consent. This means you must be given time to read, understand, and ask questions — not simply sign because you feel you have no choice. That signature you gave last week does not take away your right to say ‘I am not ready’ or ‘I have changed my mind’ on the day of the procedure.”

Dr Malpani, co-founder of Malpani Fertility Clinic in Mumbai, says there never is an emergency situation with ART. “A good clinic will be transparent with the process throughout. For example, if a clinic tells you that the embryo was viable earlier but is not on the day of fertilisation, a good clinic will show the photographs of the embryonic development, will show that the development was arrested, explain why the cycle can’t be gone ahead with, and discuss the way forward.”

Form 6: A couple or a woman opting for IVF first signs Form 6 under the ART Act, authorising a particular clinic to provide the IVF treatment.

Under this form, consent is given for procedures and administration of drugs and anesthetics as may be necessary, or to any other operative measures which might be necessary during treatment.

The form also notes that the couple/woman are free to withdraw or vary the terms of this consent until the gametes and/or embryos have been used in accordance with their wishes, in a written request.

Form 12: In case of IVF, a woman consents for egg retrieval by the administration of hormones and other drugs, and their removal from her ovaries under ultrasound guidance/laparoscopy.

Form 8 also includes a declaration from the husband that should his wife bear any child or children as a result of such insemination, the child shall be his own and his legal heir.

Form 10: In case a couple or a woman does not opt for fertilisation, they can freeze their individual gamete material by consenting to it under Form 10.

Form 9: Embryos formed with the sperm and egg can also be frozen through cryopreservation in storage, by providing consent to such freezing by signing Form 9.

Both forms 9 and 10 also factor in the individual’s wish as to what is to be done with the embryo or gametes in case of either spouse’s death. The embryos can either be allowed to perish, handed over to the surviving partner, or used for research purposes in such a scenario.

Form 11: Minors too can opt and assent for gamete freezing, subject to parental consent, under this form.

Form 13 records willing consent of couples/individuals who are unable to have a child by other means to donate eggs. It also waives the egg donor’s rights on the resulting child and vice versa.

Donated sperms and eggs are subjected to a range of tests for diseases such as HIV, Hepatitis B and C, etc.

The ART Act and Rules also stipulate insurance coverage for an egg donor by the commissioning couple or woman for 12 months from an insurance company or an agent recognised by the Insurance Regulatory and Development Authority (IRDAI).