Research with Penn Patients
This page is a central resource to guidance on conducting research with Penn patients.
General Resources for Conducting Research with Penn Patients
HIPAA in Research
The Health Insurance Portability and Accountability Act established a Security and Privacy Rule for the protection of protected health information (PHI). How is PHI defined? How may PHI be used in Research? Click below for the answers to these questions and more.
Release of Research Information to the Electronic Medical Record
Participants must be informed when research related information will be released to their medical records. The 21st Century Cures Act established increased patient access to their electronic medical records in 2021. Click below for more information about required language in the informed consent, and the Cures Act.
Sharing Data & Specimens
Investigators are responsible for informing the IRB of any disclosures of participant data or samples outside the institution. Likewise, the protocol and consent must be consistent with any associated agreements or contracts in place for the sharing of data and/or specimens. Click below to learn more about what agreements may be required.
Other Penn Reviewing Entities
The IRB is one component of the Human Research Protections Program (HRPP) at the University of Pennsylvania. Click below for a resource of Penn Medicine Offices and Committees that work together under the HRPP to ensure research is well-designed and meets regulatory requirements.
Penn Medicine Social Media Guidelines
This guidance is intended for Centers, Institutes, Department, Divisions or other groups – not individual faculty members or staff – aiming to create social media accounts representing the activities and interests of their group as part of Penn Medicine.
Penn Medicine Guidance on Remote Consent and Use of e-Signatures
The Penn IRB supports the use of remote consent and remote study procedures, when appropriate. However, the use of remote methods must be outlined for IRB review to ensure that risks to subjects continue to be minimized and the data integrity of the study can be maintained. This guidance is meant to serve as a resource to guide research teams considering the use of remote procedures for research.
Research Collecting Blood
IRB Review procedures for research involving blood sampling require careful assessment of sample collection methods and volume of collection. Click to learn more about blood collection in research and risk mitigation strategies.
Drugs and Devices Resources
Treatment of Patients with Investigational Agents
Click for guidance and instructions on submitting a Treatment Use request to the IRB and FDA to treat a patient with an investigational drug or device outside of a clinical trial.
Treatment of Patients with Humanitarian Use Devices
Click for IRB submission guidance on submitting a request to treat a patient who has an Orphan Disease with a Humanitarian Use Device (HUD).
Research with Drug Products
Any use of a drug product is considered to be an experiment, excepting the use of a marketed drug in the course of standard medical practice. Click to learn more regarding what products are defined as drugs by the FDA and when a protocol may be subject to FDA IND regulations.
Research with Device Products
Research involving the use of devices is complex and varied. Click below for information about non-medical and medical devices as well as FDA IDE regulations.