Following the approval of changes to a protocol either through the change in research activity approval process or continuing review, OHRP recommends that the investigator incorporate the revision into the written protocol and provide the OSP a copy of the revised protocol. This practice ensures that there is only one complete and up-to-date protocol. The revision dates should be noted on each revised page and the first page of the protocol itself. This procedure should also be used for revised and approved informed consent documents, which supersede previous one(s).
As stated in 45 CFR S 46.115(b), OSP will retain the IRB records described in section 15.1 for at least 3 years. Records relating to research reviewed by the IRB will be retained for at least 3 years after completion of the research. Records will be accessible to OSP staff, IRB members, and the designated Institutional Official. Investigators may request 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 HRPPSpecialist 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