Research on prisoners requires OHRP approval

All IRBs should have a policy

The regulations regarding the use of prisoners in research have not changed since 1978, but the research community’s awareness and perception of these have changed. As a result it’s a good idea for IRBs to update policies regarding such research.

Last year, the Office for Human Research Protections (OHRP) published revised prisoner research guidance, says Karena Cooper, MSW, JD, compliance oversight coordinator for the OHRP.

While most IRB members know that if investigators enroll prisoners as subjects of a study there are regulations that apply to this patient population, it is less well known that the regulations also apply to subjects already enrolled in a study who suddenly become incarcerated.

The simplest solution might be to have that particular subject drop out of the study. But in cases where this is not a feasible idea, then the IRB and investigator will have to follow all of the rules that apply to prisoners in research, Cooper says.

These rules apply to any study supported by the U.S. Department of Health and Human Services (HHS), not by the Department of Justice, she reports.

Cooper outlines some of the key issues that should be addressed in any policy written to cover the use of prisoners in research:

• Are you really dealing with prisoners? Each state has a different way of organizing the criminal justice system, and everyone defines prisoners differently, Cooper notes.

"Some institutions say anyone who has anything to do with the court, supervised by the court, we’ll call a prisoner," she says. "OHRP’s definition of prisoner means any individual involuntarily confined or detained in a penal institution."

This issue can become tricky, particularly in cases where someone has been arrested and goes through the court process, but is offered an alternative to incarceration by the judge. The alternative may be that they have the option of enrolling in a study and going to a residential treatment centers, Cooper explains.

"That person may not be considered a prisoner at that point," he says.

One thing to keep in mind is that the federal regulations do not differentiate between jail and prison. People incarcerated in both places are considered prisoners, Cooper says.

• Is there a prisoner representative on the board or available to the board? "In order for the IRB to review a protocol that involves a prisoner subject, there needs to be a prison representative as a voting member on the roster," she says. "The IRB cannot review the protocol without a prisoner representative, and that’s specific in the guidance."

Cooper says that she knows that many IRBs use public defenders as prisoner representatives, and others may use chaplains who work in prison settings.

Basically, the important thing is that the prisoner representative is someone who doesn’t work for the jail and is someone who advocates for the prisoners, she notes.

"The prisoner representative has to be someone who is a member of the IRB and not a consultant," Cooper says.

For example, in the cases of IRBs who anticipate the rare research protocol involving one or more prisoners, a good strategy might be to have an IRB member who won’t be on the meeting roster most of the time, but who is available for the times when the IRB is reviewing a protocol that involves prisoner subjects, she suggests.

"They have to be on the roster, but don’t have to participate in other reviews and will only count toward the quorum when it’s a subpart C protocol," Cooper says.

Study must qualify

• Does the study fit into one of four regulatory categories? The four categories, which were written in 1978, do not always perfectly fit today’s prison environment, so institutions and IRBs may spend a lot of time figuring out which category applies, Cooper explains.

The four categories are as follows:

— Category 1: This applies to the study of possible causes, effects, and processes of incarceration and of criminal behavior, Cooper notes.

"Studies have to have no more than minimal risk or inconvenience," she says. "There’s a slightly different definition of minimal risk for prison research."

The baseline for rating health is the healthy, unincarcerated person, Cooper says.

— Category 2: This rarely used category applies to the study of prisons as institutional structures or of prisoners as incarcerated persons, and it involves no more than minimal risk, she explains.

"These are studies done in a prison setting," Cooper adds. "The regulations do not differentiate between juvenile and adult prisoners."

— Category 3: A wide-open category, there’s no discussion of risk in this category, and it applies to research on conditions that particularly affect prisoners as a class, Cooper says.

For example, this category might be used for vaccine trials for hepatitis, which is more prevalent in prison settings, Cooper notes.

This category often applies to the study of infectious disease, she adds.

Category 3 is not popular with investigators because it includes a step of involving OHRP in the approval of the protocol. OHRP has to convene a panel of experts from across the country to observe the study and write an opinion about it. Then the secretary of HHS decides whether HHS will fund the study, Cooper explains.

"This all takes a long time — I’ve never seen it happen in a shorter time than six months," she says. "We’ve seen very few studies that have fallen under category 3."

— Category 4: This category also does not mention risk, and it involves the research on practice and innovation of processes that might have an impact and reasonable probability of improving the health and well-being of a subject, Cooper says.

This category also applies to studies that have an intervention, so most medical-type of studies fall into this category, she notes.

"The second part of category four is that the studies that require the assignment of prisoners to a control group that may not benefit the prisoners have to go to a second step of consultation by OHRP," explains says. "The control group could be a study group that gets standard care."

When the approval from HHS is required, there will be a group of experts convened, including a bioethics expert, a medical expert, and others, Cooper says.

"If the study has a control group that is either a placebo arm or standard care, then it is a control group that has to have that extra OHRP consultation," Cooper explains.

One way that some investigators have avoided having to go through the process of having OHRP convene a panel of experts is by adding a little something extra to the control arm.

For example, if the control arm is getting standard care and treatment plus something extra, then it’s not a control group that requires the next step in category four, Cooper says.

• Has the protocol received certification under subpart C? The regulations say that the institution has to certify to OHRP that they have followed subpart C, she notes.

"What that means is that the study conducted with health and human services have sent us a letter with the research proposal and specific details, along with a grant application," Cooper says. "And they certify they are following subpart C, and the study cannot begin until we receive it and sign off on it."

This certification requirement has been in the regulations for more than 25 years but it’s more widely recognized now; it was formalized in 2000, Cooper says.

Institutions need to remember that if they review a study under subpart C, then they must notify OHRP before prisoners are enrolled and before they’re given any treatment, she says.

Typically, OHRP will respond to the notification promptly and clear the study to begin, Cooper adds.

"It depends on how complete the information is that comes into OHRP," she says.

This requirement has confused some institutions and IRBs, which are responsible to send in the letter requesting certification.

"People in some cases reviewed the protocols appropriately, and they probably had a prisoner representative locally on the board, but before 2000, they probably didn’t know they had to write a letter and send in the research proposal to OHRP," Cooper says.

"Now more people know about it, but we still find people reviewing it appropriately, but who haven’t sent a letter to OHRP," Cooper adds. "It’s the IRB’s responsibility — most investigators are unaware of subpart C and they don’t have the training in it."

The letter at the very minimum must certify that the IRB has made seven findings in the 305A regulations, and that they’ve chosen a category into which the protocol fits, Cooper says.

"That’s the minimal letter, and that’s OK, but it’s not helpful because we have to call them up and say, "What’s the grant award number?’ and What agency is funding this?’ and we have to ask them all kinds of other questions," Cooper says.