Science and Law: Grimes v. Kennedy Krieger Institute, INC.: When does research on human subjects become exploitation?

February 10, 2015

Science and Law

gavel


GRIMES v. KENNEDY KRIEGER INSTITUTE, INC.
782 A.2d 807 (Md. 2001)
Circuit Court for Baltimore City, Maryland

Today’s case involves an extremely controversial example of research on human subjects that can be seen as beneficial for a larger population at the expense of a smaller one. This raises important questions about the responsibilities of both researchers and their subjects – researchers to divulge risks and prevent unnecessary harm, and subjects to understand the risks before agreeing to participate. Furthermore, this case involved children, which are considered a vulnerable and protected population in research. What say do children have when their parents consider joining a research study?

Case Background

  • The Kennedy Krieger Institute designed a study to understand the effects of lead paint in houses on the lead levels in the blood of people living there.
  • The study was classified as non-therapeutic, meaning that unlike many other medical studies, there were no anticipated benefits for the participants as a direct result of the study (although indirect benefits could come from health monitoring by a prestigious medical institute).
  • To test the effectiveness of varying levels of lead removal, some houses only received partial lead abatement procedures.
  • The study would require periodic sampling over two years to determine the remaining lead levels, and the amount of lead in the blood of residents
  • Subjects included families with children, and many were from lower economic strata, and some also minorities.

What issues are being debated?

  • Did the researchers essentially exploit poor people for their study?
  • Did the researchers adequately explain risks to subjects?
  • Were healthy children negligently exposed to unsafe lead levels despite researchers’ ability to prevent this? Can parents consent for children, or are parents also responsible for exploiting children?
  • On the other hand, were the children receiving an adequate standard of care, since most of them would end up in houses with the same or worse lead levels?
  • Is there really any way to include children in studies without exploiting them?
  • What mechanisms should be in place to prevent researchers from exploiting subjects?

How was the law interpreted and applied?

  • Judge Cathell found that the Institutional Review Board (IRB) in this case did not fulfill its role to protect subjects for two reasons:
    • The IRB did not fully understand the difference between therapeutic and non-therapeutic studies.
    • The IRB expressed willingness to help researchers circumvent federal regulations on research using children.
  • The court also found that parental consent is insufficient for research on children, as parents are also capable of acting against a child’s interests.
  • The potential overall benefit to society does not in any way make up for the harm done to the individuals involved.
  • The court ruled that the trial court erred in granting summary judgment, meaning that this case would go to trial.

Further analysis

Studies on human populations are subject to oversight by IRBs, which in theory should protect the interests of the people involved. In this case the IRB – the Johns Hopkins University Joint Committee on Clinical Investigation – did not object to the study, perhaps because they accepted parental consent for the children’s participation as sufficient, but the court found that they had failed in multiple ways to act in the subjects’ best interest.

It is difficult to say if there really is a way to conduct research without risking exploitation, especially when dealing with vulnerable populations. These include children, those with mental disabilities, and prisoners. In some cases, researchers inevitably need to enroll children, for example if they are testing a medication specifically for children. In this case, it is clear that the court found that children cannot be enrolled by parents in a non-therapeutic study.

See: Bioethics and Public Health Law by Orentlicher, Bobinski, and Hall, pages 239-255

http://www.lawschoolcasebriefs.net/2013/11/grimes-v-kennedy-krieger-institute-inc.html

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About jslachman381

I'm a Yale graduate who majored in History of Science, Medicine, and Public Health.

View all posts by jslachman381

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