How do you determine if research is ‘human subjects research?’

How do you determine if research is ‘human subjects research?’

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Whether research focuses on the disease process within cells or drug discovery for more effective treatments, remnant clinical specimens or their associated data both play pivotal roles in these studies.

Data show that patients agree. Specifically, 87 percent of patients believe that the donation of human biospecimens is essential, while 75 percent are willing to donate their own biospecimens.

However, even when human subjects are open to the idea of donating their samples, scientists still have the responsibility to make sure they comply with the Human Subject Protection Regulations enforced by the U.S Department of Health and Human Services. In making this determination, it is important for researchers to figure out whether the remnant clinical specimens or associated data they are working with are actually covered by these regulations.

Ultimately, these products do not qualify as human subject research if they were obtained while the patient was dead; the biospecimens were deidentified and came from a provider who is not allowed to release identifiable information; or the recipient of the products will not be receiving any identifiable information. Additionally, the products are exempt from Human Subject Protection Regulations if the sources of the specimens and data are publicly available, or if the patients donating the products provided information in a deidentifiable fashion without being able to be reidentified.

In all other cases, remnant clinical specimens and associated data fall under the Human Subject Regulations. These include products obtained through personal interaction with the donors, or products that did not exist at the time the research was first proposed.

By themselves, researchers may have difficulty keeping these regulations in mind, which is why working with a knowledgeable and compliant biospecimen procurement service can be valuable.