Have you reviewed your IRB policies lately?

OHRP’s QI program could help

IRBs may think their policies and procedures have covered all federal and state regulations, but in the experience of federal officials, there commonly are some lapses.

For that reason, IRB regulatory experts recommend that IRBs update and revamp their policies, sticking close to the intent and language of regulatory rules.

"In the regulations there are seven required policies and procedures, and usually [research institutions] are missing a couple," says Judith Brooks, MS, public health analyst in the Division of Educa-tion and Development of the Office for Human Research Protections (OHRP) of Rockville, MD.

OHRP has a quality improvement (QI) program in which research institutions and IRBs voluntarily may be visited and checked for compliance with federal rules and regulations. The program, which provides consultation but not actual compliance auditing, has resulted in more than 60 QI visits so far.

Based on those visits, there often are policy gaps in at least two regulatory areas, Brooks explains: the policy for determining which projects require review more often than annually and the policy for determining which projects need verification from sources other than the investigator to show that no material changes have occurred since the previous review.

One way to avoid these mistakes is to rewrite policies in a language that stays close to the wording of the federal regulations, suggests Robert Bienkowski, PhD, executive director of research at Iowa Health-Des Moines.

"At this institution, we thoroughly revamped our policy," he says.

Beginning in 2002, Bienkowski organized a working group that looked at the institution’s current policies and procedures and compared them with federal regulations, as well as with policies at other research institutions.

"The working group rewrote and revised the policies," he reports. "We literally incorporated the federal regulations into the policies and procedures and then took all the relevant steps to indicate how the federal regulations would be implemented."

Also, the working group incorporated state regulations into the policies when these imposed additional requirements. "In addition, the IRB was empowered to become much more proactive in its responsibilities," Bienkowski says.

"If you look at the policies and procedures of other institutions you do have the federal regulations included, but people take bits and pieces of it and rewrite parts of it, and it gets mixed up," he says. "It doesn’t flow in a straightforward way as the regulations do, so my operational approach is that the regulations are what the government wants, and so these are written [directly] into our policies and procedures."

Ongoing endeavor

The working group met separately from the IRB on a monthly basis, beginning in May 2002 and completing the revision in January 2003, Bienkowski says.

"It took about eight months for the policy to be rewritten. [We went] through multiple drafts, and then it was presented at the IRB meeting for their consideration," he says.

IRB members who had not participated on the working group had some insightful comments that also were incorporated into the policies and procedures, Bienkowski adds.

Once the revised policies and procedures were complete, the working group was made a permanent entity so that it could update the policies when needed and to handle some aspects of the IRB’s work that could not be handled at the regular IRB meetings, he says.

Also, there often are new interpretations of rules and new guidance for regulations, and these may require the institution to review its policies from time to time.

For example, although the institution does not engage in prisoner research, the IRB soon found that it was necessary to have a policy that addresses prisoner research. In one study, there was a subject who became incarcerated after beginning participation in the study, Bienkowski says.

"We didn’t know what to do," he recalls. "The investigator took it to the IRB, and the IRB said there are regulations about prisoner research and there has to be a prisoner advocate, so let’s disenroll the subject from the study."

This raised a question among IRB members about what would happen the next time this unusual circumstance occurs.

"So now we’re developing contacts with the sheriff’s office so that we have in place some procedures to be activated when we need them in order to offer appropriate treatment to a subject who has become incarcerated," Bienkowski explains. "Even if it’s necessary for the person to be disenrolled from the study, the person may need treatment."

This scenario was something IRB members never imagined when they wrote the policies and procedures, he says.

"We probably won’t go so far as to have a prisoner advocate, but we’ll have policies and procedures in place to show what will happen if a subject becomes a prisoner," Bienkowski says. "And in the case of an exceptionally urgent situation, the IRB chair or I will have the authority to tell the investigator that the person should be disenrolled."

QI incentive

While IRBs could benefit from revising policies and procedures to avoid these types of uncommon scenarios, another good reason for dusting off the policy books is to avoid compliance problems in the case of an OHRP not-for-cause visit.

OHRP compliance officials will randomly choose institutions to audit, and they look at the exact same material that the OHRP consultants in the QI division reviews in the voluntary program, Brooks says.

"We have had some serious problems that have closed down institutions," she says.

One way to avoid a not-for-cause visit is to voluntarily participate in the QI program of OHRP, Brooks says.

QI consultants do not share any of their findings with the OHRP compliance officials, nor do they even keep documentation of any of their findings, but they do share the names of the institutions that they visited, she says.

"If you had a recent QI visit then you would not be identified as a not-for-cause visit," Brooks explains. "We make sure [OHRP compliance] knows who we are going out to visit so they won’t go back to the same place in three months and do the same thing."

This also gives institutions time to make changes according to the QI consultants’ recommendations.

"The reason we’re encouraging participation in the QI program is because the push for accreditation is rising, and this is a nice place to start with the IRB component of it," Brooks says.

"Accreditation involves the whole human subjects protection program, and this way they know their policies and procedures are in good shape before they become enrolled."