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SPECIALTY PURCHASES

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SUBJECT PAYMENTS

 

Subject payments and reimbursements to patients and volunteers for their participation in a study must be issued in accordance with the Human Subjects Committee and the R&D Committee approvals for the project.

 

For all such participation payments or reimbursements, appropriate language must be in the human subjects consent form or Health Insurance Portability and Accountability Act (HIPAA) addendum to notify the participant that the individual's Protected Health Information (PHI) will be released to SIBCR in order to process such payments. If the study will require release of PHI to SIBCR in order to pay for diagnostic tests not available at VAPSHCS and obtained from outside vendors for the participant, the consent form should also include this information.

 

Subject participation payments of $600 or more in a given calendar year are taxable income and SIBCR is required to report the payment to the IRS and send an IRS 1099-MISC form to each such recipient. SIBCR will request the Social Security Number and permanent mailing address of each individual to whom subject payments are made if the $600 threshold will be reached.

 

NOTE: The $600 threshold does not include reimbursement of costs (e.g., travel) incurred by study participants as approved by the IRB.


LABORATORY ANIMALS

 

To order laboratory animals from an SIBCR account the VA process described below must be followed.

 

For SIBCR to pay for these purchases 3 items are needed: 1) a completed PO form from the PI or designee; 2) the packing slip forwarded to SIBCR from the ARF; and 3) the invoice from the vendor. 

 

The Animal Research Facility (ARF) supervisor or the Veterinary Medical Officer (VMO) must approve in advance any animal orders that are to be delivered to the VA. Approval must be obtained before the order is placed with the vendor. This policy is to assure that only animals for which there is an Institutional Animal Care and Use Committee (IACUC) approved protocol are ordered; that an acceptable vendor is used; that space and caging are available; and that, should an expected order not arrive, it can be immediately investigated.

To obtain approval, you may send an email message to the VMO or ARF supervisor. An approval response will be sent back to you. An email message and response will provide confirmation that the order is approved. You may also contact the VMO or ARF supervisor by phone for approval. However, leaving a voice mail message is not sufficient.

The request must include the following information:

  •     Principal Investigator Protocol Number (IACUC Number)
  •     Species of Animal Strain
  •     Quantity Age or Weight
  •     Sex
  •     Vendor
  •     Source of Funds (SIBCR)
  •     Any Special Housing or Care Instructions    
  •     Date of Arrival
  •     Contact Person/Phone Number

Please contact the VMO if you have questions about this policy.

 

RADIOACTIVE MATERIALS

The preferred method for purchasing radioactive substances is to order through VAPSHCS. In those cases where SIBCR is used, the following should be done:

  • The Radiation Safety Officer (RSO) must be notified prior to ordering any radioactive material. Notification must include the PI’s name, isotope, quantity and expected delivery date.
  • The radioactive material must be covered under the site license, have the member’s authorization and be approved by the RSO.
  • Every order must clearly specify that delivery should be to the RSO.
  • The investigator name should appear as user so the RSO will know where to send the supplies after the material is checked.

 

DONATION OF ANIMAL PURCHASES AND EXPENDABLE SUPPLIES TO VAPSHCS

The VAPSHCS Institutional Animal Care and Use Committee, established in accordance with Federal law, reviews all studies involving the use of animal subjects. Only studies approved by this committee and its parent VAPSHCS R&D Committee are conducted at VAPSHCS facilities. The animal research program and facilities are accredited by the American Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). The program is appropriately registered with the US Department of Agriculture and a current assurance is on file with the NIH Office for Laboratory Animal Welfare. SIBCR is included within this assurance.

Within the requirements of the law, and in order to eliminate duplication of registration, review and reporting activities, it is SIBCR policy that any animals purchased by SIBCR for the purposes of research are immediately upon receipt donated to, and become the property of, VAPSHCS.

SIBCR also utilizes VAPSHCS resources for such activities as handling and removal of medical and laboratory waste, including radioactive materials and other hazardous or controlled materials. In order to ensure conformance with requirements of the law and to eliminate duplication of activities, it is SIBCR policy that all expendable supplies purchased by SIBCR that are to be used in VA research laboratories for approved research and educational activities are immediately upon receipt donated to, and become the property of, VAPSHCS.

 

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