Informed Consent in 2025 Requires Two New Disclosures

Congratulations to BEACONS! Now let's talk about ownership options and AI training transparency.

Congratulations to the Entire BEACONS Collaboration!

🎉 A Historic NIH Initiative

Your emphasis on parental consent, community engagement, and ethical governance is exemplary. As a member of ICoNS (International Consortium on Newborn Screening) since 2022, I'm thrilled to see this groundbreaking work bringing whole genome sequencing to 4 million newborns annually for early detection of 400+ treatable genetic conditions.

This is precision medicine becoming truly democratic.

The BEACONS team has assembled world-class researchers, bioethicists, and patient advocates. The science is solid. The goals are noble. The structure is thoughtful.

And that's exactly why I want to contribute to making the informed consent protocol even stronger by addressing two critical 2025 realities that we need to discuss with parents.

What's Missing from the NIH Infographic?

The NIH published an excellent infographic explaining the BEACONS workflow to families:

NIH BEACONS NBSxWGS Collaboratory Structure

Click image to view full PDF →

The infographic shows an excellent workflow with Community Advisory Boards, ELSI (Ethical, Legal, Social Implications) considerations, and Return of Results protocols. It's thorough and thoughtful.

But here's what I noticed is missing - not as criticism, but as opportunities to strengthen parental understanding:

What the NIH Infographic Shows:

  • ✅ "Informed consent" mentioned
  • ✅ "Data storage" in Administrative Function
  • ✅ ELSI (Ethical, Legal, Social Implications)
  • ✅ Community Advisory Board oversight
  • ✅ Return of Results protocol

What's NOT Disclosed (Yet):

  • ❌ What "informed consent" includes - ownership vs custody?
  • ❌ AI training use - will WGS data train models?
  • ❌ Ownership alternatives - blockchain options available?
  • ❌ Age 18 transition - who owns data when child becomes adult?
  • ❌ Irreversibility - AI model training can't be undone

⚠️ The Gap

The infographic shows "data storage" but doesn't explain the difference between storage (institutional custody) and ownership (family sovereignty). It mentions "informed consent" but doesn't detail whether parents are told about blockchain ownership options or AI training implications.

These aren't minor details - they're fundamental to what "informed" means in 2025.

Here's Our Version: The 2025 Informed Consent Workflow

BEACONS with Blockchain Ownership Integration

What's Different: We've added the purple "Blockchain Ownership Notarization Function" module in the center. This shows how blockchain ownership integrates seamlessly with the existing BEACONS infrastructure.

View Interactive Version →

Why This Matters: A Real User's Wake-Up Call

"My brother is adamant I delete my data... I use many of these sites (myheritage, ftdna, 23&me, ancestry, gedmatch) as I find out more about my bio family. When I read about GenoBank, it was the most passion-inducing startup I've found - because I'm living this problem right now."

— Recent grad student searching for biological family

This message arrived the same week NIH announced BEACONS. Here's a young woman who navigated five ancestry platforms while searching for her biological family. She consented to everything. Read every terms of service. Clicked every "agree" button.

Then her brother warned her: "You don't actually own it. Delete your data."

She discovered she couldn't. Despite all that consent, she had zero ownership. Her DNA was training AI models. Her genetic variants were part of valuations in acquisition discussions. And nobody had told her any of this upfront.

⚠️ The Uncomfortable Truth About Genetic Testing in 2025

When 23andMe's value collapsed, 15 million customer genotypes became assets in bankruptcy proceedings. Those customers had "consented" - but they didn't own their data. They couldn't revoke it. They couldn't delete it. They couldn't control how AI models used it.

This is what happens when consent doesn't include ownership disclosure.

What Genetic Testing Companies Currently Offer (Web2 Consent)

Most genetic testing companies in 2025 are still using static consent forms from the Web2 era:

  • ❌ "We'll use your data for research" (Reality: Your genome trains AI models that drive our valuation)
  • ❌ "You can withdraw consent" (Reality: We can't delete your vectors from already-trained models)
  • ❌ "Your data is protected" (Reality: We own it as an asset during acquisitions)
  • ❌ "This helps future patients" (Reality: Pharma partnerships monetize your rare variants)

Where's the transparency about AI usage? Where's the disclosure that customers' biodata is THE competitive advantage - not the algorithms, which are being commoditized?

Those 1.2 million SNPs you're collecting aren't just data points—they're the AI Training Treasury that drives valuations. Every rare variant, every mutation, every unique sequence feeds models that pharma partnerships monetize.

The New Standard for Informed Consent in the AI Era

If your consent forms don't mention AI training, blockchain ownership options, or value sharing—you're not obtaining truthful informed consent for 2025's reality.

The Four Requirements for Truly Informed Consent:

  1. Ownership Option: Blockchain-verified control (not just access). Offer BioNFTs™ - digital birth certificates for DNA 🧬.
  2. AI Transparency: Disclose which AI models will train on their data. Explain that once genomic information contributes to model training, those individual vectors and weights cannot be deleted from the trained model, even if consent is later revoked.
  3. Value Sharing: If their data generates intellectual property or commercial value, they should share in it. Story Protocol enables automatic royalty distribution.
  4. Revocation Rights: REAL deletion capability via BioNFT burning (for data not yet in AI models), not "we'll stop using it eventually… 😜"

What This Means for BEACONS

I'm offering this framework not as criticism, but as a contribution to make BEACONS' already excellent consent protocol even stronger:

1. Blockchain-Based WGS Ownership Options

Parents should be clearly informed that cryptographic ownership of their newborn's WGS datasets through blockchain technology is now available.

Technologies like BioNFTs™ can provide families with immutable, portable control over their child's genomic data throughout their lifetime—extending far beyond study participation.

2. AI Training Disclosure

If WGS datasets or derivatives will train AI models, parents must understand the irreversibility.

Once genomic information contributes to model training, those individual vectors and weights cannot be deleted from the trained model, even if consent is later revoked.

This is fundamentally different from deleting a database record.

The Ethical Imperative: This IS About Informed Consent

Here's the uncomfortable truth we need to acknowledge:

🔴 The 2025 Informed Consent Standard

Asking parents for their baby's blood spots without disclosing that they can now assert digital ownership of their baby's WGS datasets, and without disclosing if those datasets will be used for AI training, is no longer considered informed consent.

It is unethical, regardless of the pretexts from legacy researchers or institutional convenience.

This isn't about being anti-research or anti-BEACONS. This is about updating our ethical standards to match technological reality.

Why This Matters for Every Stakeholder

  • For Parents: Their baby's genome is their baby's future. They deserve to know ALL options for protecting it, not just the institutional custody model from 1990.
  • For Researchers: Building BEACONS on genuine informed consent strengthens public trust. The 23andMe crisis taught us what happens when families feel deceived.
  • For BEACONS: Being the first major genomics initiative to offer blockchain ownership options would be transformative. It would set the new global standard.
  • For The Field: Genomic medicine's future depends on public trust. That trust requires transparency about AI training and ownership alternatives.

The Technology Exists. The Question Is: Do We Have The Will?

BioNFTs™ are not vaporware. They're deployed and working (US Patents US-11984203-B1, US-11915808-B1). Story Protocol enables programmatic IP licensing and royalty sharing. Smart contracts can manage consent with automatic revocation.

The infrastructure is ready. What we need is the ethical courage to tell parents the full truth:

"Your baby's genomic data can now be owned by your family via blockchain. If we use it to train AI models, those models can't un-learn it later. Here are your options..."

— What 2025 informed consent actually sounds like

Let's Collaborate: I'm Ready to Help

To the BEACONS team: I'd be honored to contribute to your informed consent protocol. Specifically, I can help with:

  • Ownership Module Integration: How to offer BioNFT™ ownership alongside traditional institutional custody
  • AI Training Disclosure: Clear, parent-friendly language explaining model training irreversibility
  • Smart Contract Consent: Programmatic consent management that reduces burden while increasing control
  • Pilot Programs: Test blockchain ownership in 2-3 BEACONS states as proof-of-concept

To My Peers in Genetic Testing & Biosample Collection:

Your customers pay for extracting & processing their DNA 🧬, yet you claim it as your asset during acquisitions.

The solution exists: Offer BioNFTs™ - their genome, their rules, their value.

This is the key to your sustainable, ethical business model in the era of AI 🤖.

Let's Talk

Are you a BEACONS researcher ready to update informed consent standards?

A bioethicist concerned about AI training transparency?

A parent who wants ownership options for your child's genomic data?

Schedule a Discussion

About GenoBank.io

GenoBank.io has pioneered blockchain-based genomic data ownership since 2018, with 2 granted US patents for BioNFTs™ technology (US-11984203-B1, US-11915808-B1). We believe genomic data ownership isn't optional - it's the ethical foundation that informed consent requires in the AI era.

As a member of ICoNS (International Consortium on Newborn Screening) since 2022, we're committed to supporting BEACONS and the broader genomics community in establishing the new standard for truly informed consent.

Contact: [email protected] | Learn more: genobank.io

References & Further Reading