Institutional Review Boards (IRBs) play a key role in research oversight. Their job goes far beyond reviewing study designs and consent forms. IRB members are responsible for protecting the rights, safety, and well-being of human subjects. But another part of their role often receives less attention: making sure the research setting is also safe for investigators and site staff. Safety must be balanced with ethical responsibility, and that includes everyone involved in the research process, not just the participants.
This article explores the key safety responsibilities of IRB members. It explains how they can help protect both subjects and research teams through careful review, thoughtful questions, and strong communication with investigators.
Reviewing Study Protocols for Safety
IRB members must carefully read every study protocol with safety in mind. They look for risks to subjects, like exposure to an experimental drug, long procedures, or psychological distress. But they should also pay attention to risks that could affect staff, such as the handling of hazardous materials, long work hours, or procedures done in tight, confined spaces.
If a protocol involves complex equipment, staff may need special training. If it includes working with infectious agents or toxic chemicals, the IRB should ask how workers will be protected. IRBs must not skip over these questions just because the focus is usually on participants.
Informed Consent and Risk Communication
The informed consent process is about giving clear, honest information to study participants. But part of that responsibility also includes making sure research teams understand what participants are told, and what those expectations mean for them. For example, if a consent form promises participants they can withdraw “at any time,” the site team must be trained to honor that without hesitation or confusion.
IRB members can ask how staff are prepared to deal with questions from participants, unexpected emotional reactions, or even medical emergencies. Helping staff communicate risks clearly also protects them from misunderstandings or complaints.
Monitoring Risk to Staff in High-Risk Studies
Some studies carry more risk than others, especially those involving new drugs, biological materials, or exposure to radiation. IRBs are required to monitor these studies more closely, but not just for participant safety.
If a study involves frequent blood draws, repetitive physical tasks, or night shifts, the IRB should ask how site staff are being protected from physical or mental strain. Are they trained? Is their workload manageable? These small steps help prevent burnout, injury, and accidents.
Handling Adverse Events and Near Misses
When something goes wrong during a study, such as an adverse reaction or a safety incident, it’s not only the subject who might be harmed. Staff could also be affected. For example, if a subject collapses or becomes aggressive, the research team may be exposed to harm.
IRBs need to review reports of adverse events, including those that impact staff. They should ask whether new training, revised protocols, or better equipment is needed to keep everyone safe. A serious incident involving a staff member should be treated with the same urgency as one involving a subject.
Encouraging Safety Reporting Culture
Many research teams hesitate to report small incidents, either because they think it’s unnecessary or fear being blamed. IRBs have the power to change that. They can build a culture where safety is everyone’s job, and where speaking up is expected.
IRB members should ask investigators how they encourage safety feedback from staff. Is there a process to report unsafe equipment, unclear instructions, or emotional stress? Are staff protected from retaliation when they raise concerns? By promoting open communication, IRBs help reduce future risks.
Reviewing Investigator Training Programs
Before a study begins, investigators and research staff should be trained, not only in protocols but in safety practices. This includes how to use personal protective equipment (PPE), how to handle biohazards, and how to respond in case of a medical emergency.
IRBs should check that investigators have proper training systems in place. They can ask: Are new hires trained before they interact with participants? Are there refresher courses? Are safety drills conducted? These checks improve both subject protection and workplace safety.
Site Inspections and Audits
While most IRBs do not perform routine site inspections, they may request one if a safety concern arises. In such cases, IRBs should be prepared to assess not just regulatory compliance, but also basic safety conditions. Are exits clear? Is protective equipment available? Is there a first aid station?
If problems are found, the IRB has a duty to follow up and confirm that corrections were made. This shows that safety is not just a box to check, it’s a real responsibility with real-world consequences.
Addressing Ethical Concerns Around Overwork
In some studies, especially those with tight deadlines or long hours, staff can become exhausted or overworked. IRBs should ask about work schedules, staff rotation, and how much time team members are spending on the study.
Ethically, pushing staff to the point of burnout puts both them and participants at risk. Fatigue can lead to mistakes, forgotten steps, or poor judgment during critical moments. IRB members should be ready to speak up if workloads seem too high to allow safe, quality work.
Pandemic Considerations and Remote Monitoring
During events like pandemics, safety risks change. Face-to-face visits may increase exposure, while remote work can lead to isolation and confusion. IRBs must be flexible and thoughtful during such times. They should ask whether new protocols put added stress on staff or open new safety gaps.
For example, if in-person visits are limited, is the staff trained to monitor signs of distress over video? Are PPE supplies available for site visits? These questions help maintain balance between research goals and safety priorities.
Protecting Whistleblowers and Raising Red Flags
Sometimes, staff notice serious ethical or safety issues and don’t know how to report them. IRBs must offer clear paths for whistleblowing. They should explain how to submit concerns anonymously and what actions will follow.
When staff feel protected and heard, they are more likely to speak up early, before a minor issue turns into a crisis. This protects both subjects and the people working closest with them.
Conclusion
IRB members hold a powerful position in the research process. Their choices directly impact the safety and rights of human subjects, but they also affect the people conducting the studies. By asking better questions, encouraging open discussion, and paying close attention to staff well-being, IRBs can create a safer, more ethical research environment for everyone involved.
Their role is not just about reviewing paperwork. It’s about protecting lives, both in front of and behind the data.
