Research: Human-Subject Research & IRBs

An aspect of research that you might not have considered is the need for oversight when you pursue a project that involves human subjects.  Say that you are a professor at a research university pursuing a research project that will involve identifying, interviewing, and publishing an article about individuals in your community who have overcome drug abuse and gone on to successful careers and lives. 

Or perhaps you’re a socio-linguist who is analyzing the dialect of elderly residents of a small town in Southwestern Virginia for a report that will be presented at the next meeting of the Appalachian Studies Association.  Who makes sure that your subjects are aware of all facets of your research, including potential risks, and ensures that they are protected as your study progresses?

The federal government and research institutions both have a vested interest in ensuring that all research conducted under their auspices follows ethical and safety guidelines. On a national level, according to a fact sheet from the organization, the United States Department of Health & Human Services’ Office for Human Research Protection (OHRP) provides “protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).” 

On a local level, each research institution or entity, like Virginia Tech, has its own panel — called variously an Institutional Review Board, an Independent Ethics Board, or Ethics Review Board — that approves, monitors, and reviews research projects that are based on human subjects (Figure 13.2). 

But why is such monitoring necessary? For an understanding of why institutional review boards exist, it might help to consider a single example of unethical research, the single project that actually brought IRBs into existence in the first place:  the Tuskegee Syphilis Experiment.

The Tuskegee Syphilis Study

What is now the Department of Health and Human Services thru the National Research Act of 1974 established IRBs in response to previous abuses of research, such as the Tuskegee Syphilis Experiement (or Study), which the US Public Health Service conducted between 1932-72 on impoverished African American males in rural Alabama (Figure 13.3). For this study, the PHS recruited 399 sharecroppers who suffered from syphilis in order to study what would happen to such men should the disease not be treated at all. 

The stated goal of the study was to justify the creation of treatment programs for all at a time when medical care for African Americans was poor if not nonexistent in some locations. To complicate matters, the earliest treatments for syphilis — including topical and intravenous applications of mercury and an antibiotic that contained arsenic — could be dangerous in themselves, so researchers also wanted to study whether, in fact, living with the disease itself was safer than attempting a cure that could in some cases kill.

However, the study was ethically flawed from the beginning and became a point of controversy for several reasons. The initial letter advertising the “group study” actually misrepresented the program itself. It promised a “special treatment” for syphilis sufferers, which actually was no more than a diagnostic lumbar puncture or spinal tap, a painful and often dangerous procedure. Additionally, participants had to sign an agreement that they would permit autopsies after they died — and if they refused, they were told they would not receive funeral or death benefits. 

The abuses continued. After penicillin became the standard cure for the disease in 1947, researchers in charge of the Tuskegee study did not provide it to their test subjects but allowed the disease to progress unchecked.  What is worse, some participants were told they were receiving real treatments when they were, in fact, being given placeboes. Finally, researchers prevented subjects from enrolling in real treatment programs. 

The study was not halted until 1972, when information about it was leaked to the press by Peter Buxton, a PHS venereal-disease investigator. Actually, Buxton had expressed his concern to the national division as early as 1966, but the study was at that point controlled by the Center for Disease Control, which argued that the project should continue until its natural completion — that is, until all of its subjects had died and their bodies had been autopsied.  Two years after Buxton first expressed concern, William Jenkins, a statistician in the PHS who was himself African American, called for a halt to the project but his pleas were ignored. It was not until 1972 that Buxton finally bypassed government channels and went directly to the press with the story.

By the time it was stopped, the Tuskegee Syphilis Study had affected at least two generations of families in the African American community. In addition to the men who died from the disease and its complications (128), other sufferers included 40 wives who contracted it and 19 children who were born with it. Even after the government stopped the study, Dr. John Heller, Director of PHS’s Division of Venereal Diseases, defended it, saying “The men’s status did not warrant ethical debate. They were subjects, not patients; clinical material, not sick people.”

Clearly, the Tuskegee experiment provides an extreme example of ethical abuse in research studies; however, even the smallest abuses should be guarded against.  At Virginia Tech, researchers follow clear guidelines established by the IRB.