Brown's IRB has assured federal regulatory agencies that the institution will review all research that meets the federal definition of human subjects research. As such, the IRB follows the terms and definitions laid out in the Federal Policy for Protection of Human Research Subjects (45 CFR 46).
Research: A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. [45 CFR 46.102(l)]
Public Health Surveillance Activities: Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such 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). [45 CFR 46.102(l)(2)]
Public Health Authority: An agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate. [45 CFR 46.102(k)]
Do Public Health Surveillance Activities Need IRB Review?
The federal regulations specifically deem “public health surveillance activities” as not meeting the definition of research. Therefore, studies that qualify as a public health surveillance activity do not require IRB review.
If the proposed study activities do not meet the definition of a public health surveillance activity, and the study data will be used in whole or in part for research purposes, an IRB Application will be required.
Can Public Health Surveillance Activities Be Published?
Yes. A determination that an activity is “public health surveillance” and not human subjects research has no bearing on an investigator’s ability to publish their work.
Who Can Make A Public Health Surveillance Determination?
NIH-Funded Research: As a public health authority, the NIH, will solely make all determinations as to whether an NIH-supported / NIH-conducted study qualifies as a public health surveillance activity for purposes of the federal definition of research.
If an investigator with an NIH-sponsored study wants a determination of “public health surveillance,” they must get approval from the NIH.
The NIH will not grant a public health surveillance determination for:
- NIH-defined clinical trials,
- The intent to store biospecimens and/or data for future use,
- Any activity that does not meet the requirements of the exclusion.
All Other Funded Research / Unfunded Research: Investigators are able to make their own determination as to whether a study qualifies as a public health surveillance activity.
There are many resources available to assist investigators in determining if their study meets the federal definition of human subjects research.
The HRPP website offers guidance and resources with a decision chart, comprehensive comparison table, definitions, an educational video on human subjects research, and HRPP self-determination tools and checklists.
The NIH’s Office of Extramural Research and the Office for Human Research Protections (OHRP) have quick decision tools to assist with non-human subjects determinations.
The federal regulations for the protection of human subjects do not require a formal determination for studies that do not meet the definition of research.
If a study sponsor/funding source requires documentation that the study does not require IRB review, the investigator should submit to the Brown HRPP the:
- Completed Human Subjects Research Self-Determination Tool, and
- Sponsor/Funding requirement for documentation.
The HRPP will provide the investigator with a memo indicating that the self-determination has been received and accepted. This memo will not be a formal review.
Regulations & References
DHHS - Office for Human Research Protections (OHRP)
National Institutes of Health (NIH)
- Decision Tool: Am I Doing Human Subjects Research?
- NIH Implementation of the Revised Common Rule Provision Regarding Public Health Surveillance Activities Deemed Not to Be Research (NOT-OD-22-001)
U.S. Department of Health and Human Services (DHHS) Federal Regulations