August 2007 The Organization has granted in writing to the Institutional Official (IO) the authority to develop, implement and monitor the Human Research Protection Program (HRPP). The HRPP at the Organization will be conducted in accordance with federal, state and local law and regulations. The OHSR Regulatory and Compliance staff will meet on a regular basis with the General Counsels of the JHU and the JHHS. This meeting will focus on review of policies and procedures to assure compliance with federal, state, and local laws and regulations. New guidance and alerts from the OHRP and the FDA, and other information relevant to the HRPP, will also be discussed. The meeting will provide an opportunity to address any legal issues associated with the conduct of human subject research at the Organization, and develop new or amended guidance, policies and/or procedures as needed. The OHSR will keep the IO informed of IRB findings and actions by regular provision of IRB meeting minutes. The IO will meet with the Director of Operations and the Assistant Dean for Human Subject Research Compliance on a regular basis to discuss policies, procedures, and guidance. The IO will meet as needed with the General Counsels of the Organization. The IO will meet with the chairs of the JHM IRBs to obtain input on proposed new policy or modifications in existing policies and procedures. Such input shall be advisory in nature. The IO has the authority to issue policy, guidance, and procedures that govern the HRPP and the associated IRB review processes. Policies will be approved by the IO by signing and dating the hard copy, and will become effective the date signed. A copy of the signed and dated policy will be kept in the OHSR files. The IO may delegate authority to approve OHSR guidance and operating procedures to the Director of OHSR, the Assistant Dean for Human Subjects Research Compliance, or other senior administrative staff as determined appropriate. OHSR staff will track all changes to HRPP policies, procedures, and guidance using a date and version system. |
