Human Subject Research at CSM~

Information about Human Subject Research from the Colorado School of Mines Procedures Manual (Section 14.3)

As of November 16, 2005
Human Subject Research
Colorado School of Mines (CSM)

Appropriate Internal Steps That Need to be Taken Prior to Conducting Human Subject Research

(1) Faculty members must submit a summary of the research protocol to Vice President for Research (VPR) (or, in his/her absence, Nigel Middleton as the Executive Vice President for Academic Affairs (EVPAA)). To be able to ascertain whether a given project should be deemed exempt from IRB oversight (under the terms of the pertinent federal regulations), it will be important to know:

a) How the research will be conducted (e.g., through surveys, questionnaires, interviews, clinical trials, etc.)
b) What data is sought;
c) Specific characteristics of the subjects (noting, in particular, whether any will be minors, pregnant, disabled, or another population deemed particularly vulnerable by federal regulators); and
d) Whether individual subjects will be identified or identifiable, and, if so, how they will be identified or identifiable.

(2) The VPR (or, in his/her absence, Nigel Middleton as the EVPAA) must approve the project and determine whether it must be submitted to an outside IRB for approval and oversight.

(3) If the research is approved by the VPR or EVPAA and is deemed subject to IRB oversight, the faculty-PI will be so informed in writing and will not be permitted to commence the research at CSM until an IRB is engaged and its conditions and requirements of the researcher(s) are satisfied.

(4) If IRB oversight is needed, the PI must contact an outside agency. Western IRB [http://www.wirb.com/] is recommended as CSM has information on file and CSM faculty have worked with Western previously.

CSM has have no specific contact at the WIRB; that would be assigned once you make contact with them and engage them for review of a particular project or protocol. CSM does have a Federalwide Assurance ("FWA") number (No. FWA00006893), which was assigned to us by the Office for Human Research Protections in May 2004. This number will expire in May 2007. CSM's Human Subjects Administrator or designated Human Subjects Contact Person is Linn Havelick. Nigel Middleton is the Signatory Official responsible for assuring protections for human subjects required by federal law.

The fee schedule obtained on Sept 28, 2005 from WIRB states that the fee for an Initial Review is $1500. Annual review (for multi-year projects) is $700.

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