Below are a list of entities to consider for your protocol approval. Please note that this is intended to be a guide to help you navigate through our internal research administrative processes.

Updated: October 30, 2018
The use of this tool is not required. It has been developed to assist the Penn research community in navigating our Human Research Protections Program. The tool should be used as early in the protocol development process as possible to maximize utility.

After completing the questionnaire below you will be provided with an output to help you plan and track your progress for gathering the required information and ancillary approvals before seeking IRB approval for your study. The information will detail which entities within Penn should be engaged, why they are important to your project as described and how to get in touch with them.

These are required questions within the HSERA application. Working with the questionnaire in advance will ensure you are fully prepared to submit your project and may reduce common regulatory roadblocks.

Please answer the following 7 questions as they pertain to your protocol.

1. Does the research involve ionizing radiation exposure that is specifically for research purposes? Yes
No
2. Does the research involve gene transfer?
 Yes
No
3. Does the research enroll subjects with relevance to cancer?
 Yes
No
4. Does the research require use of the Center for Human Phenomic Science (CHPS)? [formerly known as Clinical Translational Research Center (CTRC)] Yes
No
5. Does the research involve use of UPHS (Penn Medicine) services?
 Yes
No
6. Does the study involve investigational use of a Drug, Device or Biologic? Yes
No
6a. Does a Penn investigator require assistance with obtaining IND/IDE approval? Yes
No
7. Does the research involve use of PHI or access to medical records? Yes
No