We’re all eagerly watching the evolving ethical and regulatory landscape in research, with updated guidance from several agencies and organizations, the unknown implications of AI and the increasing dependency on technology to conduct our trials.
For those who have been in the research industry for a while, this is a lot of change in a short amount of time, and it often feels like we’re being reactive rather than proactive.
So, let’s be proactive about something that hasn’t changed much in the past 30 years – the composition of the IRB Roster.
IRB Committee Composition Goals
To take a step back, let’s talk through the purpose of the IRB composition. The goal is to minimize the risk for human subjects in research, right? We all know an IRB must have at least 5 members with varying backgrounds, expertise and diversity, including at least one scientific, one non-scientific and one unaffiliated member.
Varying Background and Expertise – Future Needs
The question is, with this quickly evolving landscape, are we meeting the “varying backgrounds and expertise” mandate? Our focus is generally on having the appropriate scientific or scholarly expertise to review the research. That will always be essential in properly protecting human subjects.
However, with the growth of AI and technology, how many IT experts are on our boards? With the recruitment strategies increasingly using social media and such, how about a marketing expert on our board? With protocol designs and logistical considerations becoming more and more complicated, how many boards include an expert in project management?
Recommendation: Be Proactive
Being proactive means staying in front of the problem. We don’t want to look back on our board roster composition and realize we may have missed potential risks in a research study because we focused so heavily on the scientific aspects and ignored the social and logistical aspects of a research study.
Looking for IRB consulting around your roster, services or operations? Contact your friends at The HRP Consulting Group.