Please note the following:
HRP-090 SOP – Informed Consent Process for Research has been updated to incorporate the following changes:
Removal of prior requirement that only a US licensed medical doctor or a US licensed nurse practitioner may request to finalize informed consent when a protocol involves an investigational drug, device or surgical procedure. The IRB will contine to review the education, experience and training from each investigator to determine if the individual is suitable to finalize informed consent. Principal Investigators (PIs) are reminded to provide sufficient information on the qualifications and proposed roles of each member of the research team.
Additional requirement for greater than minimal risk research that involves the application of an investigational drug, device, or surgical procedure. The protocol must include an individual authorized by the institution to independently prescribe the drug, device or perform the surgical procedure on the protocol. This individual, as approved by the IRB, must also be listed on the consent form and available to finalize consent. The PI is responsible for determining whom (in addition to themselves, if appliable) on their study team meets this definition.
The biomedical consent template has incorporated the following changes:
A new section added to the consent template titled OTHER RESEARCHERS PROVIDING MEDICAL MANAGEMENT OF SUBJETS will provide a space to specify those investigators providing medical care of subjects, as required by the protocol and aligned with the above.
Updated text added to the COMPENSATION section in accordance with the One Big Beautiful Bill Act increasing the IRS reporting threshhold from $600 to $2000 per calendar year.
Updated text added to the WHAT ARE THE COSTS OF TAKING PART IN THIS STUDY? section, Option 1. PIs are reminded to review this section, along with the complete consent document to ensure text reads accurately and consistently. The PI must ensure that the consent process is comprehensive and subjects are sufficiently informed. For more information on this topic visit the relevant HRP webpage.
Any questions? Review HRP webpages or contact the HRP directly.
As always, a BIG THANK YOU to our Research Community for ongoing flexibility and continued efforts to protect human research subjects!
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