University’s Institutional Review Board Upholds Ethical Treatment in Human Research

The 20th century saw its share of notorious research abuse cases in the United States.

The Department of Public Health administered a study from 1932 to 1972 in Tuskegee, Ala., of 399 African-American men who were infected with syphilis. The study included the measuring of symptoms in patients deliberately left untreated.

At Yale University in the 1960s, psychologist Stanley Milgram charted the willingness of human subjects to administer a shock as great as 450 volts to what they believed were other humans, when commanded by an authority figure.

The serious ethical questions raised about scientific and medical research was ultimately addressed in the federal Research Act of 1974. By 1979, Institutional Review Boards (IRBs) were mandated to review, approve and monitor all federally funded research involving humans.

Today, IRBs are critical to the function of any research institution or university. Fordham’s IRB works cooperatively with all University faculty, staff and students to ensure that all research conducted using human subjects or research participants meets the federal standards of the 1974 act.

“From the 1930s right through the 1970s, there was a sense that the [human]benefits of science were growing in power and influence,” said E. Doyle McCarthy, chair of Fordham’s IRB and professor of sociology. “But there was also a realization that the public should be aware of how scientific experiments could harm them.

“Limits had to be placed on what researchers could do,” she continued, “and IRB guidelines were developed to assist us in defining the standards of ethical and humane research.”

The first standard is to make certain that research participants are not placed at undue or high risk.

“When the research subjects are, say, patients in a psychiatric hospital or incarcerated young people or members of a racial minority, as in the Tuskegee experiments, they are seen as socially powerless but they also lack power relative to the researcher-scientist,” McCarthy said. “You can only imagine the importance of [protection]when you think of what history has shown us.”

The second broad standard involves ensuring that research participants understand the nature of the research and give their non-coerced, informed consent.

“Research participants have to have full knowledge of what they are doing in order to fully give their consent,” she said.

For example, if a scholar is researching how college students form social groups on Facebook, interviewees must be told what the researcher is actually investigating and are required to sign a consent form that includes information on the research and the investigator.

“The importance of this [standard]becomes clear when you think of human beings as subjects of research for an investigation conducted without their permission, or without knowledge or understanding of what they are doing,” McCarthy said.

Fordham’s 11-member board, carefully culled from the range of faculty and administrative departments, meets routinely during the academic year to review research protocols, approximately 30 projects per month. Its chair is elected by the board and normally serves a three-year term.

McCarthy noted that not all research projects come before the full board; some are expedited and reviewed by local review boards. Research involving vulnerable populations—such as studies of incarcerated youths or patients in hospitals—are typically reviewed by the full board, as is all research receiving external funding.

“When there is funding, there is the added responsibility to the funding agency as well as to the researcher,” McCarthy said. “This type of research is often closer to public policy and public welfare, so there’s an added responsibility when a public institution, such as the National Institutes of Health, is involved.”

The IRB maintains an office at the Lowenstein Center on the Lincoln Center campus, in Room 203C, whose administrator is David Wilber. The IRB soon will be distributing a brochure to inform faculty, staff, and students of its work. The IRB chair and administrator also visit graduate classes to discuss IRB procedures, in part a response to the increased research being done at Fordham by faculty and students.

“There is clearly a greater emphasis and investment in research here at Fordham,” McCarthy said. “There’s no question that in recent years the number of research protocols sent to us has increased.”