Posted by Joan Rachlin, executive directorI spent time at the ACRP/APPI meeting in Denver last month and wanted to share with you some of the highlights of a panel that PRIM&R helped organize in conjunction with APPI. Before starting, though, I’d like to extend my boundless thanks to Greg Koski and Hugh Tilson for organizing the panel, and to Nancy Dubler, Norm Fost, and Debra Lappin for their wise, principled, and thoughtful comments during the session.The panel was on the topic of human subjects research. Dr. Koski, quoting Dr. Fost, noted that the system of protecting human subjects, and the regulations surrounding it, needed “diagnostics.” He cited the Journal of the American Medical Association paper written by Dr. Fost and Robert Levine, titled “The Dysregulation of Human Research.”Dr. Dubler explained that the research protection system arrived at its current point “because it seemed like the right thing at the time.” She elaborated and pointed out that in the 1950s post-war era, America was quite smug, and following the Nuremberg trials, the country insinuated, “things like that don’t/won’t happen here.” Despite that denial, though, abuses of research subjects in the United States— most notably, Tuskegee, but also the Jewish Chronic Disease Hospital, Willowbrook, radiation studies, etc.—began to come to light in the 1970s. The response was to regulate researchers, NOT research. In those early years, the main question was whether the risks of the research were reasonable in light of the benefits to be gained.Another watershed moment in the early years of research protections was Henry Beecher’s article, “Ethics and Clinical Research,” published in the New England Journal of Medicine in 1966. Dr. Beecher found more than 100 examples of ethical lapses in research studies, but still concluded that regulations were not necessary unless there was an egregious violation of ethical principles or established policies.And egregious violations did, sadly, occur: Ellen Roche died in a study at Johns Hopkins (JHU) in 2001, and another normal volunteer died in a study at the University of Rochester (UR) in 1996. Both of these tragedies involved investigator-initiated protocols, and together with the death of Jesse Gelsinger at the Hospital of the University of Pennsylvania in 1999, the problems began to feel cumulative. Some felt the respective institutional review boards (IRBs) should have been more involved in those protocols. Others were more blunt, implying that the IRBs seem to have been “asleep.” Most acknowledged that in both cases, the system for protecting human subjects broke down. Dr. Dubler underscored that asleep-at-the-wheel perception by noting that what began as a structure for the protection of human subjects had become, in many places, a structure for the protection of the institution. The purpose of the regulations was to implement the principles of the Belmont Report: to help those working with human subjects think about autonomy, protection, and justice. The regulations failed in that respect, she said, as had IRBs to really though about autonomy, they would not have put a 20-page consent form in front of the subject. Dr. Fost agreed and said there is a widespread obsession with documentation and compliance that has consumed IRBs and investigators with unreasonably high volumes of paperwork. The panelists then turned to the challenging problem of how to reverse this process. Ms. Lappin expressed her belief that an interactive process should be developed whenever an individual is approached about entering a trial, so that s/he can meaningfully participate in the decision-making process.Changes such as these often require a culture change on the institutional level. What can change realistically, though? The panelists advocated for including a short consent cover sheet with every consent form. Louis Lasagna’s research demonstrated that the short form had the highest comprehension rate. Researchers can have BOTH kinds of forms, but NEED a short (no more than 150 words) form that includes the essential facts of the study. Sadly, though, the panelists agreed that a lot of folks don’t want to change the system. Institutions feel protected by the IRB, and thus there is no widespread movement to change the focus. All told, this session at the ACRP/APPI Conference allowed me the privilege of listening to four leaders in the human subject protections field. Thanks again to Drs. Koski, Fost, Dubler, and to Ms. Lappin. Thank you for keeping our shared fires burning.