Lawrence Altman

"Self-Experimentation by Investigators: Panel and Case Discussion" produced a robust examination of the relationship between good ethics and rigorous science, between junior and senior investigators, and between scientists and institutional review boards (IRBs). The event on Friday, March 26 at HSPH, sponsored by the school’s Human Subjects Committee (HSC), drew researchers and IRB members from across Harvard, as well as from other universities and hospitals.

Greg Koski

Examples of self-experimentation range from physician Santorio Santorio’s 30-year, daily measurements of his weight, food intake, and bodily waste in the 16th century; to physician and physiologist Werner Forssmann’s experiments in 1929 and 1935 in which he inserted a catheter into a vein in his arm and pushed the tube up into his heart (He later won a Nobel Prize.); to less harrowing, contemporary blood draws, knee MRIs, or urine analyses. Said panelist Robert Banzett, associate professor in the Department of Environmental Health: "Scientists very often want to be subjects. We’re curious. We’re explorers."

As Altman noted, much self-experimentation took place before the development of regulations, ethical guidelines about human research subjects, or IRBs.

"IRBs were created," he noted, "because leading scientists committed serious ethical breaches." One such breach was an infamous U.S. Public Health Service project known as the Tuskegee Syphilis Study in which treatment was withheld from a group of poor, African-American men infected with syphilis who had enrolled in the study. A questioning of the ethics of the study helped lead to the establishment of IRBs, which act in part to protect volunteers from risk, coercion, or undue influence–volunteers who may include the researchers themselves.

Some IRBs have categorically excluded investigators from their own experiments; others have considered the issue case by case. Altman asked the question, "Why should the investigator not be included as a volunteer, where possible, under the assumption that the risk of the experiment cannot be measured?" He argued that the willingness of the investigator to undergo the experiment would serve as an example of "the golden rule" of "do unto others as you would have done unto you" and as a means of reassuring other potential study volunteers.

Noted Altman, the Nuremberg Code, developed in reaction to atrocities perpetrated by the Nazis during World War II, established that: "No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects."

Panelist Susan Reverby, professor of women’s studies at Wellesley College and editor of Tuskegee’s Truths: Rethinking the Tuskegee Syphilis Study, challenged Altman’s notion that scientists’ willingness to take part in their own experiments can be used as a means test for other participants.

Robert Banzett

A researcher’s motivations for undergoing experimentation may–and often will–differ substantially from those of a lay subject, she asserted. The participant may have a different set of concerns, understanding of risk, or level of willingness to undertake risk. Reverby touched on what she sees as bravado in science, noting that the Public Health Service had a long history of self-experimentation and had erected a wall devoted to individuals whom she described as "killed in action"—researchers who gave their lives for science.

Banzett sees value in self-experimentation. He has conducted respiratory experiments on himself with IRB approval, trying to elucidate in fine detail the mechanics of breathing and the relationship between respiration and the brain. In addition to the "golden rule," benefits of self-experimentation include providing the researcher with the perspective of a subject, suggested Banzett. He added that there is a practical aspect to self-experimentation–the ease of investigators recruiting, retaining, and monitoring themselves.

The conversation grew even more animated when the discussion turned from principal investigators to other lab members participating–or not–in their lab’s own studies. HSPH senior lecturer Richard Cash and HSPH research scientist Andrew Binks, both audience members, made the point that protecting lab members from undue pressure is important–but so is maintaining respect for the lab members’ autonomy if they truly wish to participate as subjects in their lab’s studies.

	Sarah Putney

Hohmann acknowledged that while "the IRB system is not perfect," it is the tool now used to protect human subjects, including researchers themselves.

Ultimately, said Koski, investigators and IRBs share "common goals and common responsibilities," both ethical and scientific.

Susan Reverby (l) and Elizabeth Hohmann

"The Human Subjects Committee plans to host another conference for the greater Boston research community to bring the complex issues surrounding self-experimentation to the fore for further debate and refinement of a set of proposed guidelines," said Putney.

-- Carisa Cunningham