Think far beyond ethical requirements set in regs

IRB’s need more intuition, compassion

One of the drawbacks for research conducted in this age of checklists and strong regulatory oversight is that IRBs and research institutions do what they’re required to do and sometimes neglect to address the bigger picture, an ethics expert says.

"I think that research with human subjects is governed by regulations, which set the bare minimum for conversations that need to happen," says Nancy Neveloff Dubler, LLB, director of the division of bioethics and vice chair of the Montefiore Medical Center IRB, department of epidemiology and population health, at Montefiore Medical Center in Bronx, NY. Dubler also is a professor of bioethics in the Albert Einstein College of Medicine in Bronx, NY.

"In addition to regulatory steps, an IRB needs to be thoughtful, intuitive, compassionate, and learned about the population in its area, so it can learn about vulnerable populations," Dubler says. "These processes all are facilitated by the regulations. The regulations provide a platform, but they don’t in fact demand that you go into these directions, which I think are ethically required."

Dubler has co-written a new book on research ethics titled The Ethics and Regulation of Research with Human Subjects, published in 2005 by LexisNexis Group in Newark, NJ.

The goal of ethical consideration is to delve deeper into issues and considerations before approving a particular research project, Dubler says.

A first step to a more thoughtful and intuitive IRB review is for the IRB member to read the protocol carefully and think about who the stakeholders are in the proposal and what their interests are, Dubler suggests. "Then step back and ask, Who are the people being asked to become research subjects?"

Other questions to ask are:

  • Are they insured or uninsured?
  • Are they rich or poor?
  • Are they in the community or in nursing homes?
  • What is the situation of the possible human subjects?
  • What could that situation mean for the quality of independent consideration of the protocol and for quality of the consent process?

IRB members can apply compassion to their review work by thinking about what it would be like to be a person in the place of this possible research subject, Dubler says.

These questions to ask oneself are as follows:

  • What would you want to know?
  • How might you want to be protected?
  • What information would you want shared?
  • How might the protocol change your life?

"So I think that what this requires is an in-depth, thoughtful exploration of who these possible research subjects are and what might be important to them," Dubler says.

For example, if an IRB is considering approval of a research project involving children, the regulations will require the board to address the various situations in which the children will find themselves during the study, as well as the nature of the research and the possible risks and benefits of the research, Dubler says.

"I would argue that you then have to step back and think, What is the quality of parental permission that we would require to enroll a child?’" Dubler says.

Other ethical questions to consider in this example are these:

  • Is it possible that parents will enroll their children as a way to gain access to care?
  • Does that change how we think about the consent process?
  • How might economic or social factors play on the willingness of parents to agree?
  • How does the system for delivering care that forms the background of the protocol interact with this protocol?

"Those are not issues that naturally come to the fore when you read the regulations," Dubler says.

"You need to think about what are the larger sets of issues that we should be concerned with since it’s clear that the regulations do provide a minimum basic framework," Dubler adds. "But then the research must be considered by the IRB in light of all the conditions that are in effect in the community in which the IRB sits."

Also, IRB members should give thoughtful consideration to the terms assent and consent when applied to research involving children, Dubler suggests.

Researchers need both permission from the parent and assent from the child who is capable of providing assent, she says. "Those two ingredients are necessary, but I’m suggesting they are not ethically sufficient," Dubler says.

When research issues involving consent and assent are considered beyond the regulatory box, it’s more likely an IRB will avoid approving some of the research that later becomes controversial or the subject of lawsuits.

For instance, in the Grimes v. Kennedy Krieger Institute Inc. case in Maryland, a research institute created a non-therapeutic trial in which different levels of lead abatement modifications were performed in homes with children, Dubler says. The families involved were mainly poor and African American, and investigators placed their children at risk for lead poisoning without clearly indicating the dangers to them, Dubler explains.

"They wanted to find out what was the cheapest level of lead abatement that would give them a safe home setting," Dubler says. "The critics of the research were parents who sued, and the court was very critical. All of this could have been avoided by having greater sensitivity to the children, the setting, the family, and the issues."

Authors of the recent ethics book state: "Moreover, in our view, parents, whether improperly enticed by trinkets, food stamps, money or other items, have no more right to intentionally and unnecessarily place children in potentially hazardous non-therapeutic research surroundings, than do researchers. In such cases, parental consent, no matter how informed, is insufficient."1

"There are a lot of IRBs who think their job is to protect human subjects and that their obligation is completed if they respond to issues in the regulations," Dubler says.

The problem is that most IRB members probably don’t really know the regulations, Dubler notes. "So they use a sort of shorthand for quoting the risk-benefit ratio without most members of the IRB actually having grappled with the actual language of the regulations," she says.

To make changes in an IRB so that it will more fully consider ethical issues, there will have to be a strong commitment on the part of the IRB chair and administrator, Dubler says.

"They have to find and educate nonaffiliated members of IRBs and give them the real education and tools they’ll need to move forward," Dubler says.

Reference

  1. Coleman CH, Menikoff JA, Goldner JA, Dubler NN. The Ethics and Regulation of Research with Human Subjects. LexisNexis Group; Newark, NJ. 2005:1-746.