by Michele Russell-Einhorn, JD, senior director of the Office for Human Research Studies at Dana-Farber Cancer Institute

Imagine that you are an investigator and you have submitted a research protocol for review by the institutional review board (IRB) at your institution. The research involves a bone marrow biopsy. The approval comes back from the IRB with the following condition: The first subject enrolled in the research must be the investigator.

I will venture that the condition that the investigator participates in the research would be a surprise requirement for many IRBs and many researchers. Yet, that is precisely the prerequisite that Dr. Lawrence K. Altman, MD, proposes in his book, Who Goes First? The Story of Self-Experimentation in Medicine. “Why should a volunteer not connected with the research study go first and risk those consequences when the researcher has no valid justification for not having done so?” questions Dr. Altman (page 313).

Describing his own self-experimentation, Dr. Altman discusses his research into a rare genetic disease called pseudoxanthoma elasticum (PXE) that causes serious damage including blindness. The research required a skin biopsy which he did on himself first. He served as a normal control to those with the condition in the study. He explains the impact of his participation: “The fact that I had done it made it easier for me to explain the process to patients, and a bond developed between me and the people who volunteered for my research project” (Page 12).

That argument, though perhaps unsettling to many who review and approve research today, makes perfect sense once one reads this marvelous catalog of colorful stories about all of the discoveries that we may take for granted that indeed began with the investigator serving as the first human subject in the research. Dr. Altman takes us back to the life of Santorio Santorio, who lived from 1561 to 1636 and tested and retested various physiological and pathological conditions. He measured weight, fluid intake, the impact of the loss of waste and sweat—research all conducted on himself over a 30 year period. Other examples include Dr. Max von Pettenkofer who swallowed substances laced with cholera; Joseph Priestly who in the 1770’s experimented on himself with oxygen and nitrous oxide—important steps in the development of anesthesia; Dr. Werner Forssmann who in the early 1900’s inserted a tube through his elbow—on many occasions—to reach his heart and prove that a less dangerous route to treat heart conditions existed; and Drs. Kaplan and Koprowski who in the 1950s injected themselves with the first dose of an impure vaccine in research working towards a rabies vaccination.

These are but a few of the extraordinary stories  that are described in engrossing detail in Dr. Altman’s review of who has been, and his argument for who should be, the first human subject in the research we do today.