ADMINISTRATIVE OPERATING PROCEDURES
Kansas State University Confidential/Sensitive Research Committee
1. Purpose: To provide written guidelines for the operation and administration of the KSU Confidential /Sensitive Research Committee (CSRC).
a. Committee: The KSU Confidential /Sensitive Research Committee (CSRC).
b. Institutional Official (IO): The individual who appoints CSRC members. At KSU, the Vice Provost for Research is the IO.
c. CSRC Members: Appointed as appropriate by the IO, representing select university administrative or academic units.
d. University Research Compliance Office (URCO): Responsible for administrative operation and oversight of the CSRC.
e. Chair: Chairperson of the CSRC.
f. Stipulations: During proposal review by the CSRC, the committee may have questions, or clarifications from the PI may be needed. Stipulations are formal requests to the PI to address questions or issues raised by the CSRC. Stipulations must be adequately addressed and if appropriate, changes made to the proposal, prior to final proposal approval.
g. Modifications/addenda: Modifications are changes to an approved CSRC protocol. All modifications must be reviewed and approved by the CSRC prior to implementation by the PI.
h. Home Page/Website: The URCO has developed and maintains a CSRC website http://www.urco.ksu.edu, that contains the CSRC online application, and pertinent links to other appropriate materials.
CSRC Composition: The CSRC is composed of at least one representative from each major administrative unit (college) of the University that performs research.
The Institutional Official (Vice Provost for Research) appoints committee members, and they serve at his pleasure for an indefinite period, but usually three years. The IO may appoint additional members based upon statutory requirements, programmatic emphasis, or desired expertise needs. Since the CSRC is a Presidential Committee, the Faculty Senate annually reviews and approves committee appointments by the IO.
Committee membership and specialty participation is subject to adjustment at the discretion of the IO. (Ex officio members are non-voting).
4. CSRC Meetings: The CSRC will meet as necessary to review and approve proposed activities that involve confidential / sensitive materials. The committee must have a quorum present to hold a formal meeting. At the discretion of the Chair, the CSRC may appoint a subcommittee from regularly appointed members to review and/or recommend approval of activities. The Chair may choose to have CSRC members review proposed activities and vote electronically if appropriate. If electronic means are used to review proposals, a vote of a quorum of appointed members is necessary to approve or disapprove a proposal. If a committee member(s) has concerns about the proposal, they may recommend full committee review, in which case, the Chair may schedule a formal meeting of the committee. No member will be purposefully excluded from review of a proposal.
5. CRSC Review: CRSC members will receive the written proposal for preliminary review prior to the scheduled meeting.
7. CRSC Reports and Records: (maintained by URCO)
a. Minutes of CSRC Meetings
b. Protocol Records and Changes to Protocols
d. Membership Records and Qualifications
e. CSRC Correspondence Records
8. Protocol Application: Researchers must complete the Application for approval form available on the URCO website. The URCO will distribute the application to the CSRC and assist the Chair in arranging the meeting for formal committee review.
9. Changes to Protocols/Activities: If changes to an approved activity are needed, the PI must submit a change/modification request in writing to the Chair. The Chair makes the determination whether a proposed change is a major or minor change.
a. Major Modifications: The proposed change is a significant departure from the CSRC approved protocol or activity, and the full committee must approve the modification or change.
b. Minor Modifications: The proposed change is a minor or relatively insignificant departure from the CSRC approved protocol or activity. If so, the Chair can approve the minor change without full committee review. The committee must be informed of the minor modification, and the approval by the Chair must be documented in the minutes at the next full committee meeting.
10. Annual Review of Activities: The CSRC / URCO will perform a formal review of ongoing activities at least annually. The review will be coordinated by the URCO and will use a formal annual review form that will be maintained by the URCO.
11. Meetings: The full committee will meet at the request of the Chair. If appropriate, the Chair may request that the PI attend the committee meeting to help facilitate understanding and review of the proposed activity. Order of business for convened meetings will generally proceed as follows:
a. The Chair will convene the meeting
b. Administrative announcements.
c. Review of minutes
d. Review of proposals
e. New Business
f. Old Business
12. Special Subcommittees: In some instances, it may be appropriate to utilize special subcommittees of the CSRC. Examples where subcommittees might be useful include evaluation of complex or problematic proposals or issues, or review of proposed activities that need expedited review because of unusual time constraints or circumstances, etc. The use of subcommittees for CSRC business will be at the discretion of the Chair, and the Chair will subsequently convey all activities and/or findings to the full committee. If appropriate, the Chair may use a consultant to assist the subcommittee (or full committee) in technical or specialized review, deliberations or investigations. Consultants cannot vote on an activity unless the IO has formally appointed them a voting member of the committee. No CSRC member will be purposely excluded from special subcommittees, and when feasible all members will be invited to participate in activities of special subcommittees.
Prepared by University Research Compliance Office
4 August 2004