Jefferson Office of Human Research Protection
Leadership
- Director, Jefferson Office of Human Research Protection
- Director, Clinical Research Unit
- Professor, SKMC Department of Pharmacology & Experimental Therapeutics
* Secure links
For Research Activities
- Senior Associate Provost, Research Integrity, Conduct & Compliance
- Professor, SKMC Department of Pathology & Genomic Medicine
Policies, Regulations, Resources
Jefferson Office of Human Research Protection (JOHRP) policies for the conduct of human research are contained in the Policy & Procedures Manual (PDF). After opening the document, use "Find" to search the policies for a particular term. Additionally, the Table of Contents is linked to take you directly to the policy of your choice within the document.
Additional Policies
Federalwide Assurance
Institutions receiving federal funding to conduct human research must enter into an agreement with the federal Office of Human Research Protection (OHRP) in DHHS. This agreement is called a Federalwide Assurance, or FWA. In entering into this agreement, the institution affirms that all human research it conducts adheres to certain ethical standards as embodied in federal regulations governing human research.
Please use the link below to view FWAs maintained by JOHRP within the Jefferson Enterprise, along with affiliate locations. Contact JOHRP Staff with any questions or concerns.
Several Federalwide Assurances are maintained by JOHRP
Federal Guidance & Resources
A list of resources for more information on federal guidance.
- Office for Human Research Protections
Department of Health & Human Services
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, MD 20852
301-496-7005
- Food and Drug Administration (FDA)
- FDA Guidance for Researchers - Guidance for Institutional Review Boards and Clinical Investigators
- Office of Research Integrity
- National Institutes of Health (NIH)
Sidney Kimmel Comprehensive Cancer Center Guidance
The information provided covers the fundamental elements of initiating any oncology-related study at the SKCCC, from concept to activation. This will include the required committees and the sequence of committee reviews, key events that need to occur, and helpful checklists that will assist in making sure that all necessary activities have been completed prior to activation. The purpose of the study start-up process is to make sure that all oncology-related studies are being properly presented and discussed at all the required committees, and that the process of activating these studies is being done in an efficient and timely manner.