In 2018, the National Institutes of Health continues a series of initiatives meant to enhance the “accountability and transparency of clinical research.”
The changes affecting NIH applications with due dates on or after January 25 include a new single IRB Policy for Multisite Research, as well as changes to grant application forms (FORMS-E Application Package). Additionally, the NIH has developed a toolkit for researchers to determine if they might be conducting a clinical trial.
These and other fundamental changes to NIH policy have been months, and even years, in the making. In preparation, Northwestern’s Office for Sponsored Research, Institutional Review Board Office, and other Office for Research units have been collaborating to ensure that the University is ready for the new framework, which has sweeping implications for research faculty.
“These initiatives will reengineer the process by which clinical investigators develop ideas for new trials, how NIH reviews and selects clinical trials for support and oversees the progress of the research, and how results and aggregate data are shared broadly and rapidly,” wrote NIH Director Francis Collins and co-authors in the Journal of the American Medical Association. “Specifically, these changes are aimed at enhancing the application and award processes, increasing NIH’s ability to assess the merits and feasibility of clinical trial applications; improving oversight and transparency; and increasing the sharing of clinical trial results.”
In 2014, the NIH revised its definition of a clinical trial to enhance clarity. The definition now states: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” The expansion of the clinical trials definition means research studies not previously considered to be clinical trials human subjects research, will now be included.
The NIH has designed a four-part test to help determine if a protocol might be considered a clinical trial (answering “Yes” to all means clinical trial):
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect being evaluated a health-related biomedical or behavioral outcome?
“Some important features that distinguish a clinical trial from a clinical study are whether there is prospective assignment of an intervention, a study design that evaluates the effect of the intervention on the participants, and a health-related biomedical or behavioral outcome,” says Lynda Wolter, executive director of Sponsored Research. “This new application of the definition will affect research in Chicago and Evanston, and so it is critically important that investigators who have questions reach out to the IRB or OSR offices.”
Research that now comes under the clinical trial definition has new requirements for Funding Opportunity Announcement eligibility, as well as other existing requirements, such as Good Clinical Practice Training requirements, Clinicaltrials.gov registration, and reporting. Ahead of the next NIH funding deadline (February 5), Wolter suggests principal investigators allow extra time to develop funding proposals.
“Understanding what a clinical trial is and determining if your project fits within the new definition is the start of a process that could involve aggregating a select set of data elements ahead of submission,” says Wolter. “Additionally, due to the new single-IRB policy, the IRB Office will need to be involved in the determination if Northwestern will serve as the single IRB of record for multisite studies using the same protocol. Principal investigators should discuss their needs with the IRB early in the proposal development.”
NIH also implemented a new application package, FORMS-E (previously FORMS-D), which includes a new Public Health Service Human Subjects and Clinical Trials Information form. The Office for Sponsored Research suggests that principal investigators or a designated person with full knowledgeable of a study completes the form, since Northwestern’s InfoEd system does not validate the quality of the data elements.
Sponsored Research has developed a webpage on NIH Clinical Trial requirements for grants and contracts that contains links to NIH policy updates, new requirements, FAQs, and other NIH resources.
Research News will further explore NIH policy changes in February.