access to records relevant to their research projects. Furthermore, all records will be accessible for inspection and copying by authorized representatives of federal agencies at reasonable times and in a reasonable manner.

The following specifies the process of developing and initiating approval and implementation of changes to the current policies and procedures for KSU's HRPP and IRB.

When an HRPP policy or procedure requires modification, the IRB Chair in consultation with the HRPP specialist will draft a written proposal. Such proposal will include a statement of the need for the change, and a draft of the new policy or procedure. This proposal will be submitted to the IRB for consideration.

Minor procedural changes may not warrant this formal process and may be more appropriately termed IRB guidance or clarification. The IRB Chair will have discretion to determine what requires a formal policy or procedure change versus IRB guidance or clarification. Minor changes that the Chair determines fall into the IRB guidance or clarification category, and that do not contravene the policies and procedures herein, will be discussed and voted on at regularly scheduled IRB meetings.

Once the draft proposal of a revised policy or procedure has been reviewed by the HRPP specialist and/or the Director of Sponsored Programs (who may need to seek counsel from other staff/administrators to assure that the proposed policy and/or procedural change is consistent with KSU's policies and all relevant laws and regulations), it will be presented by email to the full Board for review and comments. The Board will be given one week ahead of a scheduled meeting to review the proposed change. IRB members should insert a comment into the document either indicating that they approve the proposed change as written or suggesting changes to the proposal.

After the review period, the Chair or the HRPP specialist will compile a final version of the policy or procedure. This version will be presented to the board at the IRB meeting. All active board members will be asked to vote to approve or disapprove or to abstain. A policy or procedure change will be recommended for adoption if more than 50 percent of active IRB members vote to approve the proposed change. The Chair and/or the HRPP specialist will then present the policy or procedure change to the Provost and/or President for guidance as to getting the change officially approved and adopted.

Once a policy or procedural change is officially approved by the Board of Regents, it will be added to an appendix to these policies and procedures. This entry will include the date the policy or procedure was adopted and include reference to the earlier sections of the policy and procedures that have been modified, clarified, or invalidated.