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Hello,

We are establishing a new core laboratory that houses clinical chemistry instruments and need to obtain freshly collected blood samples to validate and calibrate the instruments.

We are wondering how other core laboratories have handled this with their university IRB committees. We do not think that the collection of the blood samples constitutes "research" as we are not conducting a "systematic investigation designed to develop or contribute to generalizable knowledge." Additionally, there is no hypothesis or research question, and no data analysis protocol intended to test scientific aims.

We will be collecting the samples from volunteers and informed consent will be obtained but no demographic data will be collected and all blood samples will be de-identified before storage or use.

The activities are only to support instrument performance and quality assurance.

Does anyone have any experience in how they have proceeded with the IRB committees at their institution?

Thanks for any guidance or insight!

Hi Janet,

One way a lab overcame this issue was to purchase low volumes of normal blood from a neighboring blood donation institute. I do not know if you need an IRB for this kind of arrangement, where everything is anonymous!

Hope that works, good luck!

Warm regards,

Murali.

Hello,

We are establishing a new core laboratory that houses clinical chemistry instruments and need to obtain freshly collected blood samples to validate and calibrate the instruments.

We are wondering how other core laboratories have handled this with their university IRB committees. We do not think that the collection of the blood samples constitutes "research" as we are not conducting a "systematic investigation designed to develop or contribute to generalizable knowledge." Additionally, there is no hypothesis or research question, and no data analysis protocol intended to test scientific aims.

We will be collecting the samples from volunteers and informed consent will be obtained but no demographic data will be collected and all blood samples will be de-identified before storage or use.

The activities are only to support instrument performance and quality assurance.

Does anyone have any experience in how they have proceeded with the IRB committees at their institution?

Thanks for any guidance or insight!

Hello,

We are establishing a new core laboratory that houses clinical chemistry instruments and need to obtain freshly collected blood samples to validate and calibrate the instruments.

We are wondering how other core laboratories have handled this with their university IRB committees. We do not think that the collection of the blood samples constitutes "research" as we are not conducting a "systematic investigation designed to develop or contribute to generalizable knowledge." Additionally, there is no hypothesis or research question, and no data analysis protocol intended to test scientific aims.

We will be collecting the samples from volunteers and informed consent will be obtained but no demographic data will be collected and all blood samples will be de-identified before storage or use.

The activities are only to support instrument performance and quality assurance.

Does anyone have any experience in how they have proceeded with the IRB committees at their institution?

Thanks for any guidance or insight!

------------------------------
Janet Williams
COBRE Nutrition Analytics Core Laboratory Director / Sr Research Scientist
University of Idaho
Moscow, ID
208-885-6351
------------------------------

Hi Janet! Our experience on this end is with tissues versus blood. Our IRB office will do Not Human Subject Research (NHSR) approvals for similar uses.

This means that we can retrieve archival human samples and use them for IHC control as long as we are not privy to the PHI details. 

Maybe your IRB office has a similar mechanism? Might be good to shoot them an email to ask how to process on their end. Since you are not doing any research with the samples, it should fall under the NHSR category. 

Best of luck! 

------------------------------
Gaby De la Cruz
University of North Carolina- Chapel Hill
Chapel Hill NC

Original Message:
Sent: 10-02-2025 12:35
From: Janet Williams
Subject: IRB approval for core's collection of biospecimens for quality assurance/quality improvement?

Hello,

We are establishing a new core laboratory that houses clinical chemistry instruments and need to obtain freshly collected blood samples to validate and calibrate the instruments.

We are wondering how other core laboratories have handled this with their university IRB committees. We do not think that the collection of the blood samples constitutes "research" as we are not conducting a "systematic investigation designed to develop or contribute to generalizable knowledge." Additionally, there is no hypothesis or research question, and no data analysis protocol intended to test scientific aims.

We will be collecting the samples from volunteers and informed consent will be obtained but no demographic data will be collected and all blood samples will be de-identified before storage or use.

The activities are only to support instrument performance and quality assurance.

Does anyone have any experience in how they have proceeded with the IRB committees at their institution?

Thanks for any guidance or insight!

------------------------------
Janet Williams
COBRE Nutrition Analytics Core Laboratory Director / Sr Research Scientist
University of Idaho
Moscow, ID
208-885-6351
------------------------------

Hi Janet! Our experience on this end is with tissues versus blood. Our IRB office will do Not Human Subject Research (NHSR) approvals for similar uses.

This means that we can retrieve archival human samples and use them for IHC control as long as we are not privy to the PHI details. 

Maybe your IRB office has a similar mechanism? Might be good to shoot them an email to ask how to process on their end. Since you are not doing any research with the samples, it should fall under the NHSR category. 

Best of luck! 

------------------------------
Gaby De la Cruz
University of North Carolina- Chapel Hill
Chapel Hill NC

Original Message:
Sent: 10-02-2025 12:35
From: Janet Williams
Subject: IRB approval for core's collection of biospecimens for quality assurance/quality improvement?

Hello,

We are establishing a new core laboratory that houses clinical chemistry instruments and need to obtain freshly collected blood samples to validate and calibrate the instruments.

We are wondering how other core laboratories have handled this with their university IRB committees. We do not think that the collection of the blood samples constitutes "research" as we are not conducting a "systematic investigation designed to develop or contribute to generalizable knowledge." Additionally, there is no hypothesis or research question, and no data analysis protocol intended to test scientific aims.

We will be collecting the samples from volunteers and informed consent will be obtained but no demographic data will be collected and all blood samples will be de-identified before storage or use.

The activities are only to support instrument performance and quality assurance.

Does anyone have any experience in how they have proceeded with the IRB committees at their institution?

Thanks for any guidance or insight!

------------------------------
Janet Williams
COBRE Nutrition Analytics Core Laboratory Director / Sr Research Scientist
University of Idaho
Moscow, ID
208-885-6351
------------------------------

Hello,

We are establishing a new core laboratory that houses clinical chemistry instruments and need to obtain freshly collected blood samples to validate and calibrate the instruments.

We are wondering how other core laboratories have handled this with their university IRB committees. We do not think that the collection of the blood samples constitutes "research" as we are not conducting a "systematic investigation designed to develop or contribute to generalizable knowledge." Additionally, there is no hypothesis or research question, and no data analysis protocol intended to test scientific aims.

We will be collecting the samples from volunteers and informed consent will be obtained but no demographic data will be collected and all blood samples will be de-identified before storage or use.

The activities are only to support instrument performance and quality assurance.

Does anyone have any experience in how they have proceeded with the IRB committees at their institution?

Thanks for any guidance or insight!

Hi Janet,

My group holds the institutional oncology repositories at UNC, and we see this sort of thing from time to time. To echo Gaby, the UNC IRB would consider what you are proposing to be non-human subjects research, and would only require an IRB if there would be a desire to publish results. In general, healthy normal control blood is typically acquired through our blood donation center, and is covered under their consent. Happy to chat if helpful.

Best,

Ryan

Hello,

We are establishing a new core laboratory that houses clinical chemistry instruments and need to obtain freshly collected blood samples to validate and calibrate the instruments.

We are wondering how other core laboratories have handled this with their university IRB committees. We do not think that the collection of the blood samples constitutes "research" as we are not conducting a "systematic investigation designed to develop or contribute to generalizable knowledge." Additionally, there is no hypothesis or research question, and no data analysis protocol intended to test scientific aims.

We will be collecting the samples from volunteers and informed consent will be obtained but no demographic data will be collected and all blood samples will be de-identified before storage or use.

The activities are only to support instrument performance and quality assurance.

Does anyone have any experience in how they have proceeded with the IRB committees at their institution?

Thanks for any guidance or insight!

Hello,

We are establishing a new core laboratory that houses clinical chemistry instruments and need to obtain freshly collected blood samples to validate and calibrate the instruments.

We are wondering how other core laboratories have handled this with their university IRB committees. We do not think that the collection of the blood samples constitutes "research" as we are not conducting a "systematic investigation designed to develop or contribute to generalizable knowledge." Additionally, there is no hypothesis or research question, and no data analysis protocol intended to test scientific aims.

We will be collecting the samples from volunteers and informed consent will be obtained but no demographic data will be collected and all blood samples will be de-identified before storage or use.

The activities are only to support instrument performance and quality assurance.

Does anyone have any experience in how they have proceeded with the IRB committees at their institution?

Thanks for any guidance or insight!

Hello,

We have an IRB for the biorepository that lets us collect blood from donors for research projects, as controls for clinical validation studies, or other research only studies that wont publish results.  We also have other dept that will write their own IRB to collect the samples for validations and reference our IRB study.  They technically do not need one but some do for peace of mind.   Those usually go through an expedited process for approvals.  I think for us anyway, anytime you are getting anything from a subject you need the consent and IRB approval.  Our IRB approves the consent and we can only use IRB approved consents.

Hello,

We are establishing a new core laboratory that houses clinical chemistry instruments and need to obtain freshly collected blood samples to validate and calibrate the instruments.

We are wondering how other core laboratories have handled this with their university IRB committees. We do not think that the collection of the blood samples constitutes "research" as we are not conducting a "systematic investigation designed to develop or contribute to generalizable knowledge." Additionally, there is no hypothesis or research question, and no data analysis protocol intended to test scientific aims.

We will be collecting the samples from volunteers and informed consent will be obtained but no demographic data will be collected and all blood samples will be de-identified before storage or use.

The activities are only to support instrument performance and quality assurance.

Does anyone have any experience in how they have proceeded with the IRB committees at their institution?

Thanks for any guidance or insight!

Hello,

We are establishing a new core laboratory that houses clinical chemistry instruments and need to obtain freshly collected blood samples to validate and calibrate the instruments.

We are wondering how other core laboratories have handled this with their university IRB committees. We do not think that the collection of the blood samples constitutes "research" as we are not conducting a "systematic investigation designed to develop or contribute to generalizable knowledge." Additionally, there is no hypothesis or research question, and no data analysis protocol intended to test scientific aims.

We will be collecting the samples from volunteers and informed consent will be obtained but no demographic data will be collected and all blood samples will be de-identified before storage or use.

The activities are only to support instrument performance and quality assurance.

Does anyone have any experience in how they have proceeded with the IRB committees at their institution?

Thanks for any guidance or insight!

Hi Janet,

We had to get IRB approval for our protocol for blood from healthy donors. We are approved to use this blood for QA/QC, assay development, and basic research. It was an expedited review as a blood draw is seen as minimal risk.

As others have written it is possible you could get some de-identified excess blood from a local blood donation program and that may qualify as "Not Human Subjects Research." We obtain leukocyte reduction system cones for PBMC isolations and they are classified in this way.

-Dan

Hello,

We are establishing a new core laboratory that houses clinical chemistry instruments and need to obtain freshly collected blood samples to validate and calibrate the instruments.

We are wondering how other core laboratories have handled this with their university IRB committees. We do not think that the collection of the blood samples constitutes "research" as we are not conducting a "systematic investigation designed to develop or contribute to generalizable knowledge." Additionally, there is no hypothesis or research question, and no data analysis protocol intended to test scientific aims.

We will be collecting the samples from volunteers and informed consent will be obtained but no demographic data will be collected and all blood samples will be de-identified before storage or use.

The activities are only to support instrument performance and quality assurance.

Does anyone have any experience in how they have proceeded with the IRB committees at their institution?

Thanks for any guidance or insight!