|
Research protocols and subjects are classified, under NIH regulations, into one of three
types:
| "A" |
Pure research subjects: studies initiated by the investigator, usually funded by NIH
or foundation, but may have support from an industry; |
| "B" |
Subjects who are hospitalized for a medical problem supported by third-party payments
participating in a research study (medically necessary admission); |
| "D" |
Subjects who participate in industry-initiated studies such as clinical drug trials. |
At times, non-research subjects (classified as "C" subjects) are admitted to the GCRC
solely for the purpose of diagnosis or treatment according to established study protocols,
providing space and staffing are available. Because it is essential that the presence of "C"
and "D" subjects not compromise other research activities (e.g., "A" subjects), admission of
all "C" subjects will be at the discretion of the GCRC Program Director. In addition, according
to NIH regulation, subjects who require extraordinary paramedical and nursing care, such as
dialysis, post-operative care, or intensive care, should not be admitted as "C" subjects.
For investigator-initiated studies ("A" patients), the GCRC will support the full
cost of admission to the outpatient clinic. Specifically, there will be no charges
for the room, nursing care, or nutritional services. Specialized tests must be approved by the SAC to
ensure equitable distribution of limited funds.
When there is industry support for "A" studies, the GCRC will not provide duplicate
support. Clear documentation of investigator-initiated studies with industry support
is required for the GCRC records.
There will be charges for all "D" (industry-initiated) services provided by the GCRC.
You will need to contact Mary Dang, the Boulder-satellite GCRC Administrator
(303-735-2521 or email her at Mary.Dang@Colorado.edu)
before submitting the budget to the biopharmaceutical or medical device company to
ensure that all necessary charges have been included.
For "C" (non-research) patients, all charges must be billed to the patient’s insurance.
Wardenburg Health Center is responsible for all billings and collections on category "C"
patients. |
