IVF Consent: Beyond Signatures – What Couples Must Know Before Treatment
Earlier this month, a couple from Gurgaon accused a Delhi fertility clinic of an embryo mix-up after the birth of twin girls, whom the parents claim are not biologically theirs. The couple 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 they gave written informed consent through an affidavit and a form on May 14 agreeing to use anonymous donor oocytes and sperm. The couple has denied this.
This case highlights the importance of understanding consent in Assisted Reproductive Technologies (ART) and surrogacy, which involve extensive paperwork. The Indian Express breaks down what consent means under the law and 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, 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 is never 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.'
The various forms required include:
Form 6: A couple or a woman opting for IVF first signs Form 6 under the ART Act, authorising a particular clinic to provide treatment. Under this form, consent is given for procedures and administration of drugs and anaesthetics 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 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 or laparoscopy.
Form 7 and 8: For intrauterine insemination, the couple under Form 7 authorises the specific doctor and consents to insemination of the wife with the semen or sperm of the husband. Form 8 provides similar authorisation but with donor semen or sperm. 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.
Understanding these forms and the rights they entail is crucial for any couple considering ART procedures. The law ensures that consent is informed, voluntary, and revocable, protecting the autonomy of intending parents throughout the process.