How Healthcare Founders Can Navigate IRB Reviews to Accelerate Clinical Trials

If you're building a startup to bring a new drug, diagnostic or healthcare solutions to improve patient outcomes, clinical trials will define your path to market. And no human studies will move forward without an Institutional Review Board (IRB) approval.

For healthcare entrepreneurs, an IRB is no mere formality. It’s a gatekeeper that ensures patient safety, protects research integrity, and ultimately enables your innovation to reach patients.

Approaching the IRB early, and treating it as a partner rather than an obstacle, can accelerate your path through the clinic. From shaping informed consent documents to managing protocol deviations, IRBs are committees of experts that set the guardrails that keep your science credible and fundable.

"The IRB deserves the respect of entrepreneurs. Sometimes people think an IRB is just another panel or hoop that they have to jump through. But it's not a remote organization that just looks at a bunch of paperwork. It is actually a group of objective people that includes both scientific experts and community representatives who are concerned about what's happening in their own home territory, where the clinical trial will take place," explained Thomas Sakmar, MD, Richard M. and Isabel P. Furlaud Professor Senior Physician at The Rockefeller University. He has been involved in Rockefeller's IRB for 15 years and oversees the institution's Human Research Protection Program.

How IRBs Protect Research Participants

IRBs review research studies involving human subjects to ensure they comply with applicable regulations, meet commonly accepted ethical standards, follow institutional policies and — most importantly — adequately protect research participants.

By reviewing clinical trial documents before a study can proceed, IRBs ensure that the study protocol is designed to protect study participants from research-related risks and that they receive ethical treatment. This protection maintains the public's trust in the research enterprise and enables science to advance for the common good.

Experts from science and healthcare comprise about half of an IRB, which typically includes about 20 individuals. The other half are lay people, such as patient advocates, social workers, clergy, lawyers, ethicists and community members with a vested interest in clinical science.

Here are some tips for entrepreneurs on how to collaborate well with IRBs and give your product the best chance of moving forward in the clinical research process.

Types of IRBs

All institutions where clinical research takes place have an IRB, but they can vary by the type of IRB. Some examples include:

• Institutional IRBs affiliated with universities, hospitals, and research enterprises review research conducted by members of that institution.

• A "controlling IRB" is the designated IRB for a multicenter clinical trial. The IRBs at other sites participating in the study are called "reliant IRBs" and report back to the controlling IRB.

• Independent or commercial IRBs offer services to investigators not affiliated with an institution or to clinical trial sponsors, such as pharmaceutical companies conducting multicenter studies.

• Community IRBs are hosted by community organizations or entities to ensure that research aligns with community values, brings value to patients and protects participants.

Free IRB Guidance from the FDA

Reginald Swift, PhD, CEO of Rubix Life Sciences, a clinical research organization (CRO), advises reaching out to the FDA before you start designing a clinical trial. The FDA provides free consultations for developers of new drugs and medical devices.

Speaking with the FDA about the population you intend to enroll in the clinical trial and getting the agency’s feedback can help refine your trial design for better selection of the participants you would like to enroll.

"The FDA is being much more open and interactive," said Swift. "Companies need to start having these conversations earlier instead of just saying, 'We're about to do a phase 1 trial and need your help to approve this protocol,' and then having the FDA say, 'Well, you actually missed these types of patient groups and we need more information.' These conversations need to start many months before you're ready to engage. Then you can start looking into IRBs."

To discuss protocols with the FDA, you can schedule a Type C meeting for a drug development consultation or a 513(g) meeting regarding a medical device.

Communicate Early with the IRB

It’s essential to engage with an IRB early to identify any community concerns in your study location and ensure full compliance with federal regulations. Gaining a clear understanding of the process and requirements upfront can help shape your study’s timeline and avoid or minimize delays.

"If you think you have a completely airtight clinical trial to submit to the IRB, think again," said Sakmar. IRBs generally have a minimum turnaround time of one month, and sometimes longer. Some meet weekly and some biweekly. Learn how frequently your IRB meets and schedule that into your trial’s strategic timeline.

How early is early? After your Investigational New Drug (IND) application has been approved by the FDA and you start designing a phase 1 or phase 1/2 study, you should also be drafting the Investigator's Brochure. This document is essentially a condensed version of the IND and summarizes all relevant data on an investigational product, such as preclinical and clinical data about dosing, administration, safety, and monitoring. Sakmar suggested reaching out to the IRB once you have completed the Investigator's Brochure, as the group will review it and the trial protocol.

Get Smart About Federal Regulations

The U.S. Department of Health and Human Services (HHS) protects the rights, welfare and wellbeing of volunteers who participate in research in the United States through the Office of Human Research Protections (OHRP).The federal code that describes the function of IRBs is called 45 CFR 46. Part of this code is the New Common Rule, which requires the establishment of a controlling IRB and affiliated reliant IRBs for multicenter protocols.

Every clinical trial site must have a Federal Wide Assurance (FWA) document. This document serves as a contract between the site and the federal government. It says that the site will abide by all federal regulations.

Work Carefully on the Informed Consent

Informed consent is a key component of clinical research. It's not just a form that a participant signs at trial enrollment. It's a process the study team uses to ensure that each human subject volunteer understands precisely what to expect during the study, including any possible risks, potential benefits, confidentiality policies and potential compensation.

"It's not uncommon for an IRB to look at the informed consent document and say, 'We're not sure the informed consent is quite right.' Some IRBs will accept an informed consent with stipulations, which can then be made by the submitter. But if the IRB sends it back and says, 'We think you need to do a little bit more work before we are in a position to make stipulations,' then you have to wait for the next meeting, or maybe two meetings to go by," explained Sakmar. "So, focus on the informed consent and communicate as early as possible with the controlling IRB."

Informed consent documents should also be written for the clear understanding of the participants. The documents usually are written in lay language following health literacy best practices and advice from community IRBs. They also may be translated into languages other than English depending on the patient population investigators are seeking to enroll.

Report Any Deviation from the Approved Protocol

After your clinical trial is approved to proceed, the IRB still remains engaged. The IRB conducts an annual review of each clinical trial through progress reports submitted by the investigators.

They also expect to hear about any deviations from the approved protocol. The IRB is responsible for determining how serious the protocol deviation or violation was, and can stop or suspend a clinical protocol and report back to HHS’ OHRP.

"So the IRB isn't just 'approve it and then see you later,'" said Sakmar. "The IRB is 'approve it and keep us posted.'" Any changes you want to make once a study protocol has begun need to be approved by the IRB through formal amendments before you can proceed.

By treating the IRB as a strategic partner, not just a regulatory hurdle, you’ll build a stronger, more ethical clinical trial and improve the chance that your innovation will improve lives.

Learn more about IRBs from the FDA.