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Kevin Gibbs, IT Operations Manager at CSTEAmanda Masters, Director of Workforce Development at CSTEAl DemariaJennifer Lemmings, CSTEErica Runningdeer, ILJessica Arrazola, Director of Educational Strategy at CSTEJeff Engel, Senior Advisor for COVID-19 at CSTERita Altamore, EpidemiologistLesliann HelmusRachel StricofAmanda Payne, Senior Consultant at J Michael ConsultingKatie BrownAnne KjemtrupJen FiddnerJulius Tonzel, Epidemiologist at LA DOH, OPH, IDEPI +112 others
Posted by Joni Koenig ·

No longer HSR

A project was designated as "human subjects research" under the Pre-2018 Requirements (aka Old Rule), but was transitioned to comply with the 2018 Requirements and now does not meet the definition of "human subjects research". It more accurately meets the definition of "public health surveillance activities".  Do you simply close the study with the IRB and the documentation is not held to 45 CFR 46.115?  OR is the documentation that was dated before the "closed date" held to 45 CFR 46.115?

Comments & Events

Robin Krause Robin Krause
In order for a study to qualify for public health surveillance it must meet the definition of Public Health Surveillance per the Federal Regulations and the three criteria that are required for a project to be determined a Public Health Surveillance Activity.  The three criteria are: 
  • The activity must be a public health surveillance activity per 45 CFR 46.102(l)(2);

  • The activity must be conducted, supported, requested, ordered, required, or authorized by a public health authority (45 CFR 46.102(k) and 46.102(l)(2)); and

  • The activity must be limited to that 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) (45 CFR 46.102(l)(2)).
Most projects do not qualify for Public Health Surveillance because it does not meet the following criteria:
The activity must be conducted, supported, requested, ordered, required, or authorized by a public health authority (45 CFR 46.102(k) and 46.102(l)(2)).
As this is generally a mandate, law or formal authorization from Commissioner of Health, state or federal governments.  When i went to the PRIM&R conference in November this was a hot topic due to the Revised Common Rule and the misidentification of what constitutes Public Health Surveillance.  Just because CDC is asking for data from a health department does not make it Public Health Surveillance.

There is Public Health non-research that does not require the review of IRB.  Which yes, you can then make a note in the file and close it.  You will need to keep the file on hand for however, long your mandate is for research files to be maintained before it can be destroyed. 

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Joni Koenig Joni Koenig
Robin - Do you have any conference materials that you'd be willing to share?  
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Craig Conover, Medical advisor, Chicago DPH, IRB Chair IL DPH Craig Conover, Medical advisor, Chicago DPH, IRB Chair IL DPH
Were the projects discussed at the PRIM&R conference that were considered to not be public health surveillance ones that were being carried out by entities other than public health agencies? 
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Robin Krause Robin Krause

There weren't specific projects discussed.  The presentation was on what is  considered Public Health Surveillance per the Federal Regulations.  I know here people throw out Public Health Surveillance for everything, but in reality it is Public Health Non-Research because it very rarely meets the criteria of being authorized by a Public Health Official or Mandate/Law.   
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Robin Krause Robin Krause
Joni Koenig - There were no handouts provided at the individual presentations.  However, if you are a PRIM&R Member, I believe you can access the presentations through their website.  You can also look up the definition of Public Health Surveillance (45 CFR 46.102(k) and 46.102(l)(2)). 
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Joni Koenig Joni Koenig
Our state public health statutes and Board of Health rules are written pretty broadly, and our state health department is a public health authority so we actually have several projects that meet the criteria of "conducted, supported, requested, ordered, required, or authorized by a public health authority".  I believe the attached is the PRIM&R presentation.
CDC Surveillance versus Research.pdf 6.33 MB • Download
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Robin Krause Robin Krause

Ours are different.  Public Health Authority within our Health Department is the Commissioner of Health.  So if it does not come from the Commissioner's Office or is mandated by federal or state law it is not Public Health Surveillance which coincides with the federal definition.
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