In rare instances, IRBs may need to go beyond regulatory framework
In rare instances, IRBs may need to go beyond regulatory framework
What's ethical might require planning, creativity
Sometimes IRB members will need to view a particular human subject research issue with more of an eye on what is the most ethical decision to make, as opposed to what is the best way to comply with rules and regulations.
"The issue is that the regulations provide the floor, but occasionally there are situations where there's a hole in what the regulations address or a context where the ethically sound thing to do is regulatory noncompliance," says Don E. Workman, PhD, interim associate vice president for research operations at Northwestern University in Evanston, IL.
While 99.9% of the time, the human subjects protection regulations address all ethical issues that might rise, there is that small minority of cases where they are inadequate, Workman says.
Sometimes, these cases involve an IRB's decision to not offer a waiver of consent because the regulations do not specifically address a research case in which the waiver would be necessary.
"We had one study in front of our IRB that wanted a waiver of informed consent in a trial that would randomize pregnant women in labor to get an epidural," Workman says.
"Occasionally, in the procedure they would have a wet stick where the cerebral spinal fluid leaks out of a small hole made when the anesthesiologist puts in the aesthetic agent," he explains. "A decision has to be made in one or two minutes, and it's a rare event, so researchers needed 1,200 women eligible for randomization in order to get 120 for the study."
The IRB reviewing the protocol would not accept the researchers' justification for waiving informed consent, saying the patients had a right to informed consent, Workman recalls.
"Since it would be impossible for the researchers to obtain informed consent from 1,200 women who come into the hospital in labor, they could not do the study," he adds.
So research that might have helped clinicians decide the best way to handle a rare medical emergency could not be conducted because of the IRB's literal reading of the regulations, Workman says.
Even the Office of Human Research Protection (OHRP) would argue that there may be times when interpreting the regulations allows for alternative decision making, Workman notes.
For example, there are social environments where there may be a high rate of HIV infection among young women, and their children are born with HIV infection, but the mothers do not want the fathers to know the babies are HIV-positive, Workman says.
"The mother may not know what the father's HIV status is," he explains. "So if the child is coming in for a clinical trial, the regulations would require the permission of both parents unless one is not reasonably available."
In this context, the father might be available, but the mother is not willing to jeopardize her social status with the father by letting him know about the child's and her HIV infection, Workman says.
"So how do you approve the participation of the minor in a trial with more than minor risk?" he says. "You can ask for a waiver, but that might not satisfy the problem."
IRBs can waive the consent requirement where there's a prospect of a direct benefit from the study, and that could be one answer to this dilemma, he notes.
The other issue is that young children sometimes are not aware they have HIV infection, and so how could researchers satisfy an IRB that requires assent for the trial, Workman says.
"Parents are reticent to let the child know they are HIV-positive because the child might tell someone else and that would be stigmatizing," Workman says. "That flies in the face of the reasonable assent basis."
Most IRBs will handle such ethical issues by asking their boards' regulatory experts or legal counsel to tell them what to do, Workman says.
"There are times when it's appropriate to ask what the state law is and follow that," he says. "Other times, the better thing to do is for the IRB to make an ethically sound decision, giving it reasonable thought."
Another problematic situation is when a study's subjects are recruited from a different cultural background in which there is no written language corresponding to the subjects' oral language, Workman says.
While rare, this has happened, he adds.
"So the family presents at the emergency room, and the language in which they're fluent doesn't have a written form, and someone needs to be enrolled in a clinical trial because it's the only available alternative," Workman explains.
Even if researchers use a short consent form, it has to be in a language that's understandable to the subjects, he says.
"So if the language doesn't have a written form, then there's no way to provide them access to the clinical trial," Workman says. "You could administer informed consent verbally, but you couldn't have written documentation of informed consent."
This also would be an instance when an IRB waiver wouldn't meet the criteria for waiver under current regulations, he adds.
What these unusual examples suggest is that there are instances where IRBs will have to think beyond the regulatory framework and look at making decisions that are ethical and will meet the law's intent of providing the best human subjects protection.
Sometimes IRBs have to make a decision that might not be explicitly addressed in federal, state, and local laws, Workman says.
For instance, in many states there are laws addressing when minors are emancipated, but they don't always address when they are emancipated for the purpose of participation in research, Workman says.
For example, in Illinois and some other states, the laws that address how and when minors might seek medical care without parental permission are not necessarily written with research studies in mind, he explains.
So an IRB that is reviewing a study that addresses environmental factors and the impact on premature babies, including babies who are born to mothers who are minors, could have a problem deciding whether the parents, who are minors, could ethically and legally give informed consent for the babies' participation, Workman says.
"And you can't go to the grandmother because the grandmother has no right to give consent, although she could give permission for medical care," Workman adds.
In these sorts of rare situations, an IRB might have to make an ethical decision that is not explicitly outlined in state laws and federal regulations, Workman says.
When such a case comes to an IRB, the IRB could always call OHRP and request guidance in thinking through the various ethical and legal issues, he suggests.
"If they encounter a situation where the regulations don't apply, they should look to sources of the information, like regulatory experts in the room," Workman says. "But in absence of a clearly articulated regulatory or legal solution, they need to step back and make an ethical decision."
Sometimes IRB members will need to view a particular human subject research issue with more of an eye on what is the most ethical decision to make, as opposed to what is the best way to comply with rules and regulations.Subscribe Now for Access
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