Know When To Submit a Public Health Surveillance Request

Funding News Edition: December 01, 2021
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As announced in an October 12, 2021 Guide notice, eligible applicants, offerors, recipients, or investigators may submit a compelling justification as to why their NIH-funded activities should be considered public health surveillance activities, and thus not subject to certain requirements of the revised Common Rule.

To be clear, these types of activities are exceedingly rare among NIH-funded grants.

Exemptions to the Common Rule for activities categorized as not presenting safety or privacy risks to human subjects, e.g., studies of publicly available data or public health surveillance activities, are meant to remove administrative burdens like pre-award institutional review board approval of the Research Plan and informed consent documentation.

To qualify, the activities must meet three conditions:

  1. Be limited to those necessary for NIH to identify, monitor, assess, or investigate:
    1. Potential public health signals
    2. Onsets of disease outbreaks
    3. Conditions of public health importance (including trends, signals, risk factors, or patterns in diseases)
  2. Provide timely situational awareness and priority setting during the course of an event or crisis that threatens public health
  3. Directly inform NIH public health decision-making or action

The policy goes into effect for application due dates on or after January 25, 2022, and contract solicitations issued on or after January 25, 2022.

For new grant applications, you will submit the justification as to why your NIH-funded activities should be considered public health surveillance activities during the just-in-time period that follows peer review. This means that you will write your application, including the PHS Human Subjects and Clinical Trials Information Form and budget section, as though your research activities will be fully subject to the Common Rule.

If you believe your grant activities function as public health surveillance, we highly recommend you discuss this with the program officer listed in your Notice of Award before writing a justification.

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