October 12, 2021
NOT-OD-18-211 - NIH Implementation of the Burden-Reducing Provisions of the 2018 Common Rule
NOT-OD-19-055 - Removal of the Requirement for Institutional Review Board Review of NIH Grant Applications and Contract Proposals Related to Research
NOT-OD-19-110 - Guidance on Posting Informed Consent Forms for NIH-Funded Clinical Trials
Office of The Director, National Institutes of Health (OD)
The National Institutes of Health (NIH) is informing the research community of its implementation of a provision in the 2018 Requirements for the Federal Policy for the Protection of Human Subjects (“the revised Common Rule”) under which public health surveillance activities may be deemed not to be research for the purposes of the regulation (45 CFR 46.102(I)(2)).
The revised Common Rule identifies certain public health surveillance activities as being excluded from applicability of the Common Rule, “including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.” In November 2018, the Office for Human Research Protections (OHRP) provided draft guidance on this exclusion, Activities Deemed Not to Be Research: Public Health Surveillance 2018 Requirements, which identifies NIH as a public health authority (45 CFR Part 46.102(k)) for the purposes of this provision. On October 20, 2020, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) recommended the exclusion be interpreted narrowly to avoid the inappropriate application of the exclusion to research that should be subject to the Common Rule in its Interpretation of Public Health Authority and Public Health Surveillance Activities, 45 CFR Part 46.102(k), 46.102(l)(2).
Given the importance of the protections provided by the revised Common Rule for research participants and acknowledging that exclusions from these requirements and protections should be made cautiously, NIH, as a public health authority, will solely make all determinations as to whether an NIH-supported or -conducted study qualifies as a public health surveillance activity for purposes of the Common Rule definition of research.
All requests for NIH-funded research - whether conducted or supported - including competing applications submitted for due dates on or after January 25, 2022, contract solicitations issued on or after January 25, 2022, applications for awards issued under Other Transactions Authorities (OTAs) on or after January 25, 2022, and NIH Intramural Research Program (IRP) studies in which the first participant is intended to be enrolled on or after that date - must receive approval by NIH to be considered as a public health surveillance activity deemed not to be research under 45 CFR Part 46.102(k), 46.102(l)(2).
NIH expects that NIH-supported or -conducted research will only be determined to be a public health surveillance activity in extremely rare cases. Please note that NIH will not consider NIH-defined clinical trials for a public health surveillance determination request. In addition, NIH will not consider studies for a public health surveillance determination that contain any activity that does not meet the requirements of the exclusion. This includes the intent to store specimens and/or data for future use.
Requesting a Determination that NIH-Funded or -Conducted Activities be Considered Public Health Surveillance Activities
Requests submitted by eligible applicants, offerors, recipients, or investigators must contain a compelling justification as to why their NIH-funded or -conducted activities should be considered public health surveillance activities deemed not to be research for the purposes of the revised Common Rule. All activities for which approval of use of the exclusion will be sought should be described.
The justification must include information that demonstrates all three of the following:
1) The proposed activity is limited to that necessary for NIH to identify, monitor, assess, or investigate:
a. potential public health signals; or
b. onsets of disease outbreaks; or
c. conditions of public health importance (including trends, signals, risk factors, or patterns in diseases).
2) The activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
3) the activities will directly inform NIH public health decision making or action.
Applicants for NIH grants will request a public health surveillance determination approval per the process outlined below. Recipients of ongoing, non-competing awards will also be expected to submit a public health surveillance determination request to use or continue to use this exclusion using the process below when the recipient submits a competing renewal application. Recipients are reminded to seek prior approval for certain changes involving human subjects in active awards in accordance with the NIH Grants Policy Statement 8.1.3 and the terms and conditions of award.
Grant applicants should submit the request and justification during the Just-in-Time period following Just-in-Time procedures as described in Section 2.5.1 of the NIH Grants Policy Statement. Applicants should notify their NIH Program Official/Program Director (PO/PD) of their intention to submit the request.
For submitting a determination request and justification, offerors for contracts shall follow instructions in the Request for Proposal (RFP); applicants for awards issued under Other Transactions Authorities (OTAs) shall follow instructions in the Research Opportunity Announcement (ROA); and NIH Intramural Research Program (IRP) studies shall submit a request to the Office of Human Subjects Research Protections (OHSRP). IRP investigators should contact OHSRP for additional instructions.
Applicants, offerors, and recipients must complete the PHS Human Subjects and Clinical Trials Information Form following instructions in the Application Guide, solicitation or opportunity announcement. Applicants, offerors, and recipients should not assume approval of use of the exclusion will be granted when completing the PHS Human Subjects and Clinical Trials Information Form.
Note that the proposed budget in the application or proposal must reflect all necessary costs for conducting research involving human subjects without approval of the exclusion. Applicants and offerors should not assume that approval will be granted when considering what costs to include in the budget.
Notice of Approval or Disapproval of Request
NIH applicants, offerors, and recipients will be notified of the final decision by the NIH grants specialist, agreements officer, or contracting officer prior to award. NIH IRP researchers will be notified by the OHSRP. Applicants, offerors, recipients, and NIH IRP researchers should not assume approval is granted unless notified of approval. For all extramural funding, the award budget may need to be adjusted if approval is granted.