ART Rules 2022 consent forms 6 to 15: which form for which IVF and IUI step, and how to keep them.

Twelve forms, split by who keeps them. Titles below are as they appear in the notified Rules:

The obligation sits in Rule 13, clinics under 13(1)(f), banks under 13(2). The official copy of the notified Rules, forms included, is on the National Registry portal; check it for later amendments before you print stock.

Consents are one part of an inspection. Our free ART clinic requirements self-check covers the rest, staff, equipment, donors, storage and records, with your renewal deadline and fee.

Because they are the draft. The ART Rules went through a published draft in early 2022 before being notified on 7 June 2022, and the draft numbered the consent forms from 12 upwards, couple’s consent, IUI, freezing, withdrawal, donor consents and so on under numbers that no longer match. Draft copies are still hosted on government and court websites and still rank in search.

Three quick checks tell you which one you are holding:

• The notification number. The notified Rules are G.S.R. 419(E), dated 7 June 2022. A document without that number, or marked as a draft inviting objections, is not the operative text.
• Form 6.In the notified Rules, Form 6 is the consent signed by the couple or woman. If your “Form 6” is something else, you have draft-era stock.
• The clinic’s range. The notified Rules put clinic consents at Forms 6 to 13. A set running into the twenties is the draft.

This matters beyond neatness. A file of consents on superseded forms is the kind of finding that turns a routine inspection into a long one, and it is entirely avoidable.

Walk the cycle and the forms fall into place:

1. Before anything starts, Form 6, signed by the couple or the woman, after counselling. This is the umbrella consent for ART treatment.
2. Oocyte retrieval, Form 12, before OPU.
3. Surplus embryos to be frozen, Form 9, before cryopreservation, with the storage period explained.
4. Donor oocytes involved, Form 13for the donor; the bank’s own records (Forms 14, 14A, 14B) sit behind the gametes it supplies, and donor gametes may only come through a registered ART bank.

An IUI cycle is simpler: Form 6 plus Form 7 (husband’s semen) or Form 8 (donor semen). Fertility preservation adds Form 10 for gametes, or Form 11 where the patient is a minor, her assent together with parental consent. The per-cycle checklist in the download walks every line so nothing proceeds on a missing signature.

The form is the minimum. What an inspector, or a court, years later, actually tests is whether consent was informed:

• Counselling before signature, recorded with date and counsellor. The Act makes counselling a statutory step, not a courtesy.
• A language she understands. Record which language the form was explained in, and any interpreter. In Gujarat that usually means Gujarati alongside the English form.
• Both signatures where the form asks for both, dated and timed, with a witness.
• Filed against the cycle, so “show me the consents for cycle 214” is a minute’s work, not an afternoon.

The same principles apply to every other consent in the hospital; our informed consent guide covers the general surgical and caesarean forms.

Forms 9 and 10 do more than authorise freezing, they set the storage period, which in the normal course runs to ten years, with extension possible. Rule 13(1)(b) separately allows oncofertility patients’ gametes to be stored beyond ten years with the National Board’s permission. Rule 13(1)(a) adds that unused gametes or embryos are preserved only for the same recipient, never used for anyone else.

In practice that makes the consent file a diary. Every Form 9 and Form 10 carries a date on which a decision falls due, often years after the cycle, when the staff who took the consent may have moved on. The consent register in the download has a column for exactly that, and a clinic that tracks storage in software rather than a cupboard is the one that notices the date before the couple does.

Three working layouts in one file, a form map (which form, kept by whom, triggered by what), a per-cycle consent checklist, and a clinic-wide consent register with storage-review and withdrawal columns:

• Excel (.xlsx), one sheet each, headers frozen.
• Word (.docx), landscape, editable.
• PDF, print-ready.

These are record-keeping tools, not the statutory forms, the notified Forms 6 to 15 remain the documents that must be signed. More templates are in the formats library.

By tying each consent to the event it authorises. When the OPU cannot be scheduled until Form 12 is on file, when a freezing event records the Form 9 it relies on and the date storage review falls due, and when every consent prints bilingually and is retrievable by cycle, the checklist above stops being a sheet and becomes the way the lab works.

MedStream’s IVF & Embryology suite is built on that record: cycles, OPU, embryology grading, double-witnessed vitrification and thaw, cryo storage mapped to the straw, and bilingual English–Gujarati consents against the same patient. Whichever system you evaluate, ask the vendor to show a freezing event and the consent behind it, live, our twelve demo questions explain how.