EGRP News Flash - August 27, 2012

New NIH Guidance on Applications for Research Involving Human Subjects

On August 2, the National Institutes of Health (NIH) released new information on the types of changes in human subjects research awards that will require prior NIH approval (NOT-OD-12-129), and guidelines for submitting human subjects plans in delayed onset human subjects research (NOT-OD-12-130).

Going forward, prior NIH approval will be required for any changes in active human subjects research awards that would result in an increased risk to human subjects. These changes include the following:

  1. An addition or change to the study design/protocol that would result in the need to change the overall human subjects designation or clinical trial designation of the grant. For example:
    • A change from non-human subjects research to human subjects research (exempt or non-exempt)
    • A change from exempt to non-exempt human subjects research
    • A change from "No Clinical Trial" to "Includes a Clinical Trial"
  2. The new inclusion of subject populations that are covered by additional regulatory protections (pregnant women, human fetuses, and neonates; prisoners; or children).
  3. Any change to the study protocol that would result in an overall increase in risk level for subjects, including physical, psychological, financial, legal or other risks. This could include the addition of a new study population that would be at higher risk from existing research procedures, the addition of new study procedures that are greater than minimal risk, any modification of existing study procedures that would increase overall risk, or the addition of a new clinical study or a new clinical trial intervention arm not originally proposed that is greater than minimal risk.
  4. New information that comes to light after a study is underway which indicates a higher level of risk to participants than previously recognized for a study intervention, procedure, or pharmacological treatment.

In addition, NIH now offers clarified guidance regarding studies where definite plans for the involvement of human research subjects cannot be delineated at the time the research application is submitted. This situation is referred to as "delayed onset human subjects research." After award and prior to the involvement of human subjects, the grantee must submit to the NIH awarding Institute/Center (IC) for approval, a detailed human subjects section that follows the NIH competing application instructions.

More details on submitting this information can be found in the NIH Guide for Grants and Contracts notices:

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