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Human Subjects Policy
Policy Number NCNR-3.11:
NCNR Policy for Procurement of Materials of Human Origin
Effective Date: 8/17/2015
Amended: 10/30/24
SECTION 1. PURPOSE
The purpose of this policy is to document the requirements for the procurement of materials of human origin.
SECTION 2. SCOPE
This policy applies to all NCNR staff, unless otherwise stated.
SECTION 3. DEFINITIONS
“Materials of human origin” means those materials that were obtained from human tissue or fluids.
“RPO” refers to the NIST Research Protections Office “ERL” refers to Enzyme Research Laboratories “Sigma” refers to Sigma-Aldrich
“PI” is the Principal Investigator procuring the material.
SECTION 4. RESPONSIBILITIES
The NCNR Senior Management Advisor is responsible for establishing and maintaining the content of this policy.
SECTION 5. POLICY
All procurements of materials of human origin by NCNR staff shall be reviewed by RPO prior to placing the order.
SECTION 6. REQUIREMENTS
The Director of the NIST RPO has reviewed the use of materials of human origin in intramural research at the NCNR. ERL and Sigma, the two primary commercial vendors that are used by the NCNR for the procurement of such products, were researched to determine whether the samples are being collected in a legal and ethical manner. It was determined that stock samples from these two vendors may be procured without further review by RPO, subject to reporting requirements as described in Procedures 1) and 2) below. All other procurements of materials of human origin must be reviewed by RPO per Procedure 3) below.
Specific Procedures:
- Stock samples that are being ordered from ERL may be procured without further review by RPO. A summary of materials procured from this vendor shall be provided to the RPO on an annual basis.
Stock samples that are being ordered from Sigma may be procured without further review by RPO. However, the PI shall request documentation of the sample source for inclusion in the annual report to the RPO.
Reporting: To facilitate the annual reporting of procurements under Procedures 1) and 2), the PI shall provide a copy of the procurement request and documentation of sample source, if applicable, to David Hoogerheide either via hardcopy (E101 or mailbox near A100) or email (david.hoogerheide [at] nist.gov). David Hoogerheide will retain this information and provide it to the RPO on an annual basis.
Orders for all samples other than those covered under procedures 1) and 2) above shall be reviewed by RPO prior to placing the order. This includes non-stock samples from ERL and Sigma that involve custom collections.
Obtaining Approval: Prior to placing an order covered under Procedure 3), the PI shall provide a copy of the purchase request to David Hoogerheide either via hardcopy (E101 or mailbox near A100) or email (david.hoogerheide [at] nist.gov). David Hoogerheide will facilitate the RPO approval and notify the PI when such approval has been received. In the event that David Hoogerheide is away from the office on leave or travel, Susana Teixeira will begin the RPO approval process on his behalf. In this case, the PI shall provide a copy of the purchase request directly to Susana Teixeira either via hardcopy (E103 or mailbox near A100) or email (scm5 [at] nist.gov).
SECTION 7. DELEGATIONS OF AUTHORITY
Not applicable.
SECTION 8. EFFECT ON OTHER POLICIES
Not applicable.