The Association for Professionals in Infection Control and Epidemiology (APIC) warns that proposed revisions to the Common Rule may have unintended consequences if infection prevention research is not excluded from approval by IRBs.

Commenting on the recently issued Notice of Proposed Rulemaking (NPRM),1 APIC said infection control research conducted in quality improvement efforts should not require IRB approval.

“Our members have concerns related to activities that would meet the quality improvement (QI) exclusions,” APIC stated. “We believe that it is equally and in some cases more important to study the effectiveness (outcome measure) of a practice as it is to increase use of the practice (process measure). It is possible that increasing the use of a process may not provide benefit to a patient population or improve the outcome.”

For example, as currently written, evaluation of staff training to improve the use of gloves to prevent transmission of microorganisms would be excluded from the IRB process, but “evaluating the impact of the use of gloves on decreasing transmission of microorganisms would require IRB approval — despite the fact that the use of gloves is a well-established best practice,” APIC says in the comment letter. “In order for the intervention to be successful, investigators must know not only how to best educate providers on the process, but also be able to evaluate the outcome of the intervention, in this case the reduction in transmission.”

Many infection preventionists participate in state or regional QI collaboratives that measure the outcome of individual or bundled interventions. These QI collaboratives often have a rapid start-up and implementation phase, frequently with timelines mandated by the Centers for Medicare & Medicaid Services, APIC continued.

“Requiring such projects to be subject to IRB approval could act as a disincentive for participation in many organizations due to the added paperwork and burden,” APIC warns. “To support the work we perform on a daily basis, our members recommend that both QI processes and outcomes are included in the Common Rule excluded activities.”

In addition, APIC expressed concern about the unintended consequences when the regulations are put into place.

“The NPRM notes that public health activities that would not fall under the exemption act include exploratory studies to better understand risk factors,” APIC says.

Hospitals and other health settings are required by regulation to report healthcare-associated infections and certain process measures, such as healthcare personnel influenza immunization, to the CDC. The data are examined in efforts to better stratify risks and identify opportunities for improving the health of the population in the future. Furthermore, with new and/or rapidly emerging infectious diseases, the risks may be unknown, APIC stated.

“To require IRB approval before the public health authority can collect data on risk factors will unnecessarily delay detection of those risks,” APIC said in the comments. “Not exempting these activities could have a profound unintentional impact not only on public health’s ability to perform its duties, but also its ability to halt ongoing transmission of an infectious agent. As pointed out in the NPRM, the line between public health surveillance and epidemiologic research is difficult to establish. We recommend further defining the difference between the two activities, specifically under what purpose or context the activities would be excluded from the Common Rule.”

REFERENCE

  1. Federal policy for the protection of human subjects; proposed rules. Fed Reg 2015;80(173):53,933-54061.