💥 If IRBs Want to Protect Us, They Need to Hear Us — All of Us

I’ve been thinking about something we don’t talk about enough in the research world: Sometimes the very systems meant to protect us end up silencing us. We see it with pregnant women being excluded from studies.

But let’s be honest — it doesn’t stop there.

🚫 Safety Shouldn’t Mean Exclusion

IRBs (Institutional Review Boards) exist to keep people safe. I respect that. Their mission is critical.

But safety shouldn’t mean exclusion. And protection shouldn’t mean making decisions about us without ever talking to us.

The assumption that certain groups must be excluded "for their own good" is a dangerous one. This exclusion happens with:

• Women: Whose unique responses to devices and drugs are often missed.

• People of Color: Leading to massive health equity gaps in treatment data.

• Older Adults: Despite being the primary users of many new therapies.

• Patients with Disabilities or Rare Diseases: Whose complex needs are simplified out of the protocol.

• Non-English Speakers: A lack of language access that acts as a powerful barrier.

• Heart valve patients like us: Anyone whose story doesn’t fit the “standard” research mold.

This isn’t just about pregnant women — it’s about any group IRBs think they’re protecting without ever talking to them.

📉 The Real Harm of Silence and Stagnation

Here’s the part no one really says: If people aren’t included in research, we won’t have data that reflects real life.

That means:

• We can’t understand how devices work in women.

• We can’t predict how new therapies affect different races or body types.

• We can’t prepare for how heart disease shows up in older adults.

• We can’t support caregivers who are already stretched thin.

• And we can’t learn what it feels like to live through these therapies — physically, mentally, emotionally.

When IRBs are too cautious or afraid to change old policies, whole groups of people get pushed aside. And when those voices are missing, the science suffers. That silence creates dangerous blind spots because we don’t have the data we need to make safer, better treatments.

Privacy shouldn’t mean secrecy. Being overly careful might feel like protection, but it actually stops progress. We need data from all kinds of people, or else the medicine we create ends up weak, unfair, and sometimes even dangerous. Research even shows that excluding groups in the name of “safety” can backfire and create bigger risks because the data becomes incomplete. 👉 https://pmc.ncbi.nlm.nih.gov/articles/PMC9926358/

As someone who survived hospice because of a clinical trial, I can say this clearly: Patients know the risks. Patients live the risks. And patients can help create safer, more human research when we’re invited in from the start.

🤝 From Protection to Partnership

IRBs shouldn’t just protect people — they should partner with people.

Because what scares researchers isn’t always what scares patients. And what IRBs label “too risky” often feels like: “No one bothered to ask us how to do this safely.”

That partnership looks like:

• Listening to Lived Experience: Treating the patient voice as essential scientific data.

• Inviting Diverse Patients into Study Design: Not just as participants, but as advisors.

• Understanding What Support is Actually Needed: Addressing real logistical barriers to participation.

• Asking What “Risk” Feels Like on Our Side of the Table: Recognizing the greater risk of inaction.

• Rewriting Outdated Policies: Policies that block whole communities from access to trials.

We don’t need perfect systems. We need systems built with us — not around us.

📣 Join the Conversation and the Collective

What has your experience been? Have you or a loved one been excluded from a trial, or have you participated and felt your voice made a difference?

Share your story in the comments below. Let us know what changes you believe IRBs and researchers need to make to truly partner with patients.

If you believe in research built with us, not around us, connect with the HeartBridge Collective today!

Better science starts with better listening. And research can’t be truly ethical if the people it affects aren’t at the table.

#HeartBridgeCollective #Heart2HeartTalk #PatientVoice #ClinicalTrials #HealthEquity #ResearchEthics #WomenInResearch #DiversityInTrials #TricuspidValveMiracle #HospiceSurvivor