Published on September 20, 2025 3:28 PM GMT
I discovered a small error in Scott Alexander’s 2023 review of “From Oversight to Overkill” that conflates two different periods of aggressive research oversight enforcement. The review reads:
This changed in 1998. A Johns Hopkins doctor tested a new asthma treatment. A patient got sick and died. Fingers were pointed. Congress got involved. Grandstanding Congressmen competed to look Tough On Scientific Misconduct by yelling at Gary Ellis, head of the Office For Protection From Research Risks. They made it clear that he had to get tougher or get fired.
In order to look tough, he shut down every study at Johns Hopkins, a m…
Published on September 20, 2025 3:28 PM GMT
I discovered a small error in Scott Alexander’s 2023 review of “From Oversight to Overkill” that conflates two different periods of aggressive research oversight enforcement. The review reads:
This changed in 1998. A Johns Hopkins doctor tested a new asthma treatment. A patient got sick and died. Fingers were pointed. Congress got involved. Grandstanding Congressmen competed to look Tough On Scientific Misconduct by yelling at Gary Ellis, head of the Office For Protection From Research Risks. They made it clear that he had to get tougher or get fired.
In order to look tough, he shut down every study at Johns Hopkins, a measure so severe it was called “the institutional death penalty”.
I looked into it and to my surprise this mis-states the timeline. What actually happened was that there were two distinct periods of aggressive enforcement that got conflated:
- The Ellis Era (1998-2000): Gary Ellis at OPRR became much more aggressive following criticism in a 1998 Inspector General report, leading to multiple institutional shutdowns. Ellis left his post as director of OPRR in June 2000.
- The Roche Response (2001): Ellen Roche died on June 2, 2001 after participating in a Johns Hopkins asthma study. Greg Koski at the new OHRP shut down studies at Johns Hopkins following her death.
A more complete timeline of relevant events is as follows:
June 1998: HHS Inspector General report “Institutional Review Boards: A Time for Reform” criticizes the IRB oversight system, finding (according to Abbott and Grady) that “IRBs’ ability to safeguard the rights and welfare of human research subjects was seriously strained because of the high volume of studies and pervasive conflicts of interest”
Late 1998-2000: Ellis responds to IG criticism by dramatically ramping up OPRR enforcement. According to Frank (2004), Ellis “vigorously pursued a policy of regulatory compliance leading to the suspension of many prominent research institutions, a fact which dismayed and alienated the research community”
March 1999: OPRR suspends “over 1,000 experimental studies” at VA hospitals “due to violations of informed consent”
May 1999: For four days, OPRR suspends all human research at Duke University Medical Center, which one bioethicist called “the nuclear bomb of enforcement”
September 1999: Jesse Gelsinger dies in gene therapy trial at University of Pennsylvania, leading to broader scrutiny of research oversight
1999-2000: By 2000, “eight institutions had their research protocols halted” and “since 1995, 10 percent of the nation’s 125 medical schools have been targets of OPRR investigations”
June 2000: OHRP created to replace OPRR, with Greg Koski as first director. Ellis moves to Executive Secretary role at National Science and Technology Council
June 2, 2001: Ellen Roche dies after participating in Johns Hopkins asthma study
July 19, 2001: OHRP under Greg Koski suspends “all federally funded research on human subjects at Johns Hopkins University”
This article was written with the help of Claude Sonnet 4.0 but I’ve checked every link by hand.
Discuss