How to Get IRB Approval for Your Trial

If you're planning a clinical trial for your supplement, skincare product, cosmetic, or wellness device, one of the first, and most crucial, steps is securing IRB approval. This ensures your study is ethical, compliant, and credible in the eyes of both regulators and consumers.

But if you're not from an academic or medical research background, the Institutional Review Board (IRB) process can seem daunting. The good news? It’s very achievable, even for small brands. In this guide, we’ll break down how to get IRB approval for your trial, why it matters, and how to do it efficiently.

What Is an IRB and Why Do You Need One?

An Institutional Review Board (IRB) is an independent ethics committee that reviews and monitors research involving human participants. Their job is to protect the rights, safety, and well-being of your participants.

If you want to make claims like:

• “Clinically tested for skin hydration”

• “Shown to improve energy levels in human trials”

• “Validated in a human-use study”

…you’ll need IRB oversight to back those statements credibly, and in compliance with FTC guidelines on marketing claims.

Step 1: Determine If Your Study Requires IRB Approval

Not all consumer product testing requires IRB review, but any study involving human subjects with the intent to publish results or make substantiated marketing claims should go through an IRB.

Ask yourself:

• Will human participants be involved?

• Will the data be used for public claims, publishing, or regulatory submissions?

• Are you collecting health-related data, even if non-invasive?

If the answer is yes to any of these, you likely need IRB approval.

Step 2: Choose the Right IRB for Your Trial

There are two main types of IRBs:

• Academic or Institutional IRBs: usually tied to universities or hospitals; often slower and more rigorous.

• Independent IRBs: private organizations that offer faster, more flexible reviews (ideal for consumer health brands).

Independent IRBs are a great option for non-pharmaceutical studies like:

• Supplement trials

• Cosmetic product studies

• Skincare efficacy tests

• Pet health product evaluations

Look for an IRB that:

• Specializes in consumer health or wellness products

• Offers electronic submission portals

• Provides quick turnaround times (some review within a week)

Some well-known independent IRBs include:

• Elemental IRB

• WCG IRB

• Advarra

• IntegReview (now part of Advarra)

• Salus IRB

• Ethical & Independent Review Services (E&I)

Step 3: Prepare Your Documentation

Before submitting to the IRB, gather the following materials:

• Study Protocol: a detailed plan of your trial: objectives, methods, participant criteria, timeline, etc.

• Informed Consent Form (ICF): clearly explains the study to participants, including risks, benefits, and data use.

• Recruitment Materials: ads, emails, or flyers you’ll use to recruit participants.

• Investigator CVs: credentials of the people running the trial.

• Product Information: including safety data, ingredient lists, and intended use.

Make sure everything is clear, transparent, and participant-friendly.

Step 4: Submit Your Application

Submit your full IRB packet through the IRB’s online portal or via email, depending on their process. You’ll typically receive:

• An acknowledgment of receipt

• Requests for clarifications or revisions (this is normal)

• Final determination (usually approval, conditional approval, or denial)

Turnaround time:

• Independent IRBs can approve simple consumer trials in 1–3 weeks.

• Academic IRBs may take 4–8 weeks or more.

Step 5: Maintain Compliance Throughout the Study

IRB oversight doesn’t stop at approval. You’ll need to:

• Report any adverse events

• Submit progress reports (for longer studies)

• File a final report at study close

Staying compliant ensures your trial remains credible and your marketing claims stay FTC-safe.

Bonus Tips: Make the IRB Process Smoother

• Hire a CRO or consultant with IRB experience to help you draft documents.

• Pre-test your protocol with a small advisory group for clarity.

• Use a decentralized or virtual trial design to speed up recruitment and data collection.

Why IRB Approval Is Your Brand’s Hidden Superpower

Getting IRB approval for your trial may seem complex, but it's a vital step in conducting ethical, high-quality research, especially if you’re aiming for clinically validated product claims. With the right approach, independent IRBs, and well-prepared documentation, even small wellness brands can get approved quickly and confidently.

Investing in IRB approval not only boosts your brand credibility but also protects participants, builds trust, and positions your product as science-backed and market-ready.

Need help with an affordable IRB-approved clinical trial?

We specialize in helping wellness and beauty brands design and launch human participant studies that are FTC-compliant, fast, and affordable. Contact us to learn more.