Socio-behavioral studies sometimes offer fewer risks
Socio-behavioral studies sometimes offer fewer risks
Can there be too much scrutiny?
[Editor’s note: In this issue of IRB Advisor, we will discuss research and IRB topics highlighted at the annual conference sponsored by the Public Responsibility in Medicine and Research (PRIM&R) and at the 18th annual meeting of the Applied Research Ethics National Association (ARENA). The conference and meeting were held Dec. 5-7, 2003, in Washington, DC.]
Sometimes the risk in socio-behavioral studies is not as great as an IRB fears, and it’s a good idea for an IRB to work with investigators to find a compromise approach in such research, a criminology researcher says.
IRBs need to be aware that the tools and data collection techniques used in socio-behavioral research may appear riskier than they actually are, and the public benefits may be greater; therefore, it’s a good idea to refrain from categorically rejecting research that involves unknown factors, suggests John Laub, PhD, a professor of criminology and criminal justice at the University of Maryland in College Park. He spoke about respect for people in research at the PRIM&R 2003 annual IRB conference.
"What I’d like to suggest to IRBs is that they keep an open mind and really look at protocols," Laub says.
A good example of how research could be less harmful than an IRB anticipates is a long-term study that he and a colleague recently completed. It involved a follow-up study of men who had been put in reform schools in the 1940s and ’50s. The study resulted in a book recently published by Harvard University Press, Shared Beginnings, Divergent Lives: Delinquent Boys to Age 70. Robert Sampson, PhD, Henry Ford II Professor of Social Sciences at Harvard University in Cambridge, MA, co-wrote the book.
For this study, Laub and Sampson found the original records of a Harvard University study of 1,000 male youths. Five hundred of them had been detained in reform schools as adolescents, and the remaining 500 had not been labeled "delinquents." The original study followed the youths to ages 25 and 32.
"I came across the original records for this study in the basement of the Harvard Law School," Laub says. "We resurrected data and computerized the data and did a longitudinal study of it and wrote a book about how many of the delinquents grew up to be adult offenders."
After Harvard University Press published that book, titled Crime in the Making: Pathways and Turning Points Through Life, in 1993, Laub and Sampson decided to contact the original delinquent subjects for a longitudinal study that would span 50-60 years.
These men were in their 60s or 70s and had not been contacted by researchers for 35 years, Laub notes.
"So how do you demonstrate respect for persons with this very different follow-up study?" Laub asks. "We were careful in contacting these men because we didn’t necessarily know whether people knew about their past."
Initially, the IRB that reviewed the protocol was skeptical and greatly concerned that the investigators would be disruptive in these men’s lives, he recalls.
During discussions with the IRB, Laub and his co-investigator convinced IRB members to permit a two-person pilot study.
"To get the IRB to reconsider the initial reaction, we did a pilot study of two cases where I traced and searched and interviewed two men and reported back about what happened in these interviews to convince them that this was a feasible project," he says. "The pilot study basically gave a report on how we approached the men and what their reactions were."
The IRB decided to approve the protocol, but placed limitations on how researchers could contact the subjects.
"We were allowed to contact the men by mail only and then place a follow-up phone call," Laub says. "What we could not do is any kind of unannounced visits to a man’s house."
The initial letters provided a telephone number for the men to call, and some did so. Others waited until the researchers called them, and interviews were arranged in this way, he explains.
This more passive approach to recruiting subjects worked alright, but it was somewhat awkward and time-consuming. Generally with longitudinal research, investigators want to be aggressive in approaching and recruiting subjects, Laub says.
"We don’t know whether or not we would have been more successful if we’d been able to knock on doors and show up," he adds.
Nonetheless, investigators were able to interview 52 men out of the 255 they tracked; about half had died, Laub notes.
They did interview some prisoners for the study and had to make it very clear that they were not part of the correctional system and that participating in the study would not benefit them in any way, he says.
"We had to get their permission and permission from the supervisor of the unit," he recalls.
The IRB also required the researchers to obtain for the study a certificate of confidentiality from the U.S. Department of Health and Human Services, Laub says. "Basically, that ensured that these data would be protected and not released to any third party, and we made it explicit in the interview that any reports of child abuse or reports of injury to others or to one’s self would have to be reported to some authority," he adds.
As it turned out, the men who were interviewed were positive about the process, Laub says.
"What we found is that many of these men really enjoyed being part of this study, and they liked talking about their lives," he says.
For some of the men, it was painful to discuss their pasts, because some had lived very tragic lives, Laub notes. "It was not unusual for the men to express emotion during these interviews about their wasted lives."
But the process also validated the men’s lives in some sense. "They were quite fascinated that someone would take the time to follow them over such a long period of time," Laub recalls. "They didn’t have a real sense of how important the original study was that they were involved in — it was the most famous study in criminology that was ever done, yet they didn’t have a sense of that."
Some of the strategies investigators used to protect the subject’s confidentiality included scheduling interviews at the time the spouse would be out or meeting the subject at a different location whenever these were requested, Laub says.
The public benefits to such research are considerable, and IRBs need to keep this in mind, he notes. "This is the longest longitudinal study in the world," he says. "You cannot recreate this information in any way and, luckily for us, we were able to take a very longitudinal study, ages 14-32, and extend it to age 70 in less than a five-year period."
All of this was done with a very small private grant, Laub adds. "If we only have cross-sectional data, then we have kids who are juvenile delinquents and we conclude that things would be pretty grim for these kids," he says. "But what we’ve learned by doing a longitudinal study is that many of these kids had positive outcomes, led extraordinary lives and were able to overcome these disadvantages."
The first book, titled Crime in the Making: Pathways and Turning Points Through Life, received the outstanding book award from the American Society of Criminology, the Academy of Criminal Justice Sciences, and the Crime, Law, and Deviance Section of the American Sociological Association.IRBs need to be aware that the tools and data collection techniques used in socio-behavioral research may appear riskier than they actually are, and the public benefits may be greater; therefore, its a good idea to refrain from categorically rejecting research that involves unknown factors, suggests John Laub, PhD, a professor of criminology and criminal justice at the University of Maryland in College Park.
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