APA responds to the National Institutes of Health proposal on revised clinical trials application form

APA, in collaboration with the APA Committee on Human Research, recently provided feedback to the National Institutes of Health (NIH) request for information on its proposed Clinical Trial-Specific Application Form (PDF, 270KB)opens in new window, highlighting opportunities to ensure the form works equitably for biomedical and behavioral science research.

In its statement, APA commended NIH for modernizing and streamlining the clinical trials application process but pointed out implementation details that could unintentionally disadvantage nonbiomedical research. 

APA was pleased that the  proposed application form includes elements across disciplines and does not introduce explicit structural bias favoring biomedical research. The association welcomed the elimination of sections related to the Diagnostic and Statistical Manual of Mental Disorders Boards, study team structure, and enrollment procedures. APA also welcomed the introduction of page limits designed to reduce administrative burden.

However, the association cautioned that implicit bias could emerge during implementation, especially through instructions and technical design choices that have not yet been finalized. For instance, overly restrictive drop-down menus or controlled vocabularies, such as those based primarily on biomedical classifications, may fail to capture core social, behavioral or contextual constructs.

• Clarify the definition of “clinical trial” to better distinguish clinical trials from basic experimental studies involving humans.
• Ensure flexible terminology and descriptors, including open-text fields, to accurately reflect social and behavioral research.
• Provide concrete examples showing how social and behavioral clinical trials can be appropriately described in the form.
• Emphasize flexibility in instructions to accommodate qualitative, mixed-methods, and adaptive designs.

APA concluded that the proposed revised form represents a meaningful improvement and does not inherently disadvantage social and behavioral science. With targeted refinements, particularly around definitions, flexibility, and illustrative examples, the form can better support the full range of NIH-funded clinical research. APA stands ready to engage further with NIH to ensure that administrative processes reinforce federal health research priorities. 

For more information, email Angela L. Sharpe.