Donor consent and access records for Indian biobanks that share samples
TL;DR Tetherleaf is consent software for Indian hospitals, research institutes and genomics labs that store blood, tissue or DNA. It keeps each donor's choices current, asks them again when a new study wants their sample, and logs every access. Institutions pay a yearly licence because their ethics committees and partners want proof.
India now holds large collections of human samples and genomes. GenomeIndia, a national sequencing effort, published its first diversity map in 2025[1], and hospital and private biobanks keep growing. Yet there is no specific biobank law in India[2]. What exists is the ICMR's 2017 ethical guidance, which asks for clear custodianship, consent options set out in advance, and benefit-sharing planned before any commercial use[3].
In practice, consent is often a single signed paper form in a file room. When a new study or an overseas partner wants old samples, nobody can say quickly what each donor agreed to, or reach them to ask. The DPDP Act now lets a person withdraw consent at any time[4], and most paper systems cannot act on that.
What it does, in regulatory terms: consent and records management for research data and samples. It makes no clinical use of genetic data and gives no health results. Ethics committee oversight under the ICMR guidelines still applies to every study.
The seed proposed a blockchain market where people sell their own genomes, and I reframed it. Consumer DNA marketplaces have struggled with what happens to data when a company is sold or fails, as the attempted sale of 23andMe's holdings showed[5], and no Indian demand for paying individuals per genome has been documented. The institutions that already hold the samples are the better buyer.
Tetherleaf replaces the paper form with a tiered consent record in the donor's language, captured on a tablet at collection. Each sample's code links to that record. When a researcher requests samples, the system shows which donors allowed that kind of use, flags those who need asking again, and sends the request by SMS or a call from a coordinator. ICMR already names this approach "dynamic consent"[3]. Every release is written to a tamper-evident log, with no token or coin involved, that the ethics committee can audit.
The donor uses it and pays nothing. The payer is the institution that holds the samples - a teaching hospital's research office, a private biobank, a genomics lab or a contract research organisation. I found no public price for consent software of this kind in India. My assumption is an annual licence of ₹3–12 lakh per site, depending on sample volume, plus paid set-up for migrating old forms.
The DPDP Act passed in 2023, with consent that can be withdrawn and penalties of up to ₹250 crore for security failures[4]. GenomeIndia's 2025 publication and the push to include under-studied Indian populations in global research[1][6] mean more requests to share Indian samples, and partners abroad expect donor-level consent records.
I found no public figure for biobank consent software in India, and no Indian vendor selling it. Adjacent: IMARC values India's genetic testing market at US$1.96 billion in 2025 (about ₹19,000 Cr), rising to US$3.69 billion by 2034[7]. That is the activity that creates samples, not money spent on consent tools, so treat it as context. Count biobanks and research ethics committees bottom-up before raising money.
A DNA-vault startup is the closest match to the seed - a user-held DNA vault with a blockchain access log and token rewards for answering research queries[8]. It sells to individuals, not institutions. Large hospitals in India mostly run consent on paper or inside general lab software. In my limited checks I found no Indian company focused on dynamic consent for biobanks. The gap is a product built around ICMR's consent categories and the DPDP Act.
| Difficulty | Moderate (46/100) |
| Starting capital | ₹1.2–2.2 Cr |
| Time to launch | 9–12 months |
The software is not exotic. The hard parts are elsewhere, which is usually the case. Ethics committees must accept a digital record as valid consent, and donors in rural or low-literacy settings must understand it in their own language. Hospital sales cycles are slow, and migrating years of paper forms is tedious work no one wants to pay for.
No licence to sell the software, but your buyers work under ethics and data rules, and your product has to fit them.
Building this outside India? The categories above usually have a local equivalent, so check with your own regulator.
Don't let AI decide whether a consent covers a use. It can shortlist, but a coordinator or the committee makes the call.
Want to work out the AI layer for Tetherleaf? Talk to Yash →
Here's what can go south -
I like this for a founder who has worked inside a research hospital, an ethics committee or a clinical research organisation, and who is patient with committees. If the token-marketplace version is what drew you in then skip it. First prove that two ethics committees will approve a digital tiered consent and that one biobank will pay to move its paper records onto it.
Expect roughly ₹1.2–2.2 Cr, mostly product build, security work and long sales cycles with institutions. The free kit has the line-by-line capital breakdown.
No sector licence. You need DPDP compliance and a product that meets the ICMR ethical guidelines ethics committees apply.
Yes, dynamic consent is an issue everywhere. Map your local data protection law and ethics rules before you sell.
The free Tetherleaf validation kit has the line-by-line capital breakdown, the effort scoring, the consent and data-protection checklist, a 14-day validation sprint with pass/fail targets, a 90-day launch plan, 10 interview questions for biobank heads and ethics committees, and 5 assumptions to test. Download the kit →
Thinking about building Tetherleaf or something close to it? The make-or-break work is getting ethics committees to accept digital consent and signing the first paying biobank. If you need a hand, you know where to find me. Talk to Yash →
For illustration only. Names are fictional and ideas hypothetical; sourced facts are real but may be out of date. Nothing here is legal, financial or professional advice, and Yash Khatri is not personally liable for any use of it. Read the full disclaimer.