Episode 19 - Mike Keens, CEO | Sabai IRB
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Episode 19 - Mike Keens, CEO | Sabai IRB
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What happens when an IRB's responsibility to protect research participants runs into the commercial realities of clinical research? Mike Keens, CEO of Sabai, joins Steve to discuss whether IRBs should flag protocols that are technically acceptable but unreasonable for patients, why certain private equity ownership structures raise difficult questions about independence, and what the industry gets wrong about IRB turnaround times. They also explore how an oversight organization can build a business around telling customers “no,” why Mike uses AI to challenge his own thinking, and whether the best regulatory response might actually be “no, but…”
Plus: Paul Simon, outlawing terrible meeting phrases, and a surprisingly consequential decision about finger guns.
00:00
Meet Mike Keens & Sabai
02:33
Should IRBs Judge Participant Burden?
06:15
AI as a Critical-Thinking Partner
09:28
Paul Simon & Setting Expectations
10:28
One Phrase Mike Would Ban From Research Meetings
12:20
Finger Guns, Bows or Salutes?
13:48
Private Equity & IRB Independence
18:40
When Is a Financial Conflict Too Close?
21:00
What People Get Wrong About IRBs
23:41
Are IRBs Just Rubber Stamps?
25:19
How Do You Build a Business Around Saying No?
28:15
Where to Find Mike & Sabai