University of Pennsylvania Human Research Protection Program

The University of Pennsylvania Human Research Protection Program (HRPP) and Institutional Review Board (IRB) are integral partners of the Research Institute. They ensure compliance and provide oversight of all research activities involving participants at Penn Medicine LG Health.

The Ann B. Barshinger Cancer Institute is involved with National Cancer Institute (NCI) cooperative group research studies, as well as some industry-sponsored research.  

The Research Institute also conducts research in many other specialties including: 

  • Cardiology
  • Diabetes
  • Infectious diseases
  • Nephrology
  • Neurosciences
  • Vascular surgery 

Most research is industry-sponsored research. Lancaster General Hospital or The Heart Group of Lancaster General Health often serve as study sites. These research studies involve investigational devices, pharmaceuticals, post-market approval studies, and more. 

How the University of Pennsylvania HRPP Helps Researchers at Penn Medicine LG Health

The HRPP oversees all research activities involving human subjects. It helps researchers comply with federal and state laws and regulations as well as ethical standards for human research. It also educates researchers and staff and provides public outreach.

Penn’s HRPP (including the IRBs) was awarded full accreditation by the Association for the Accreditation of Human Research Protection Programs. Accreditation standards establish the highest expectations for the conduct and oversight of human research.  

University of Pennsylvania IRB 

The IRB is responsible for approving or disapproving each proposed human research project. It also determines whether a proposal constitutes human subjects research. IRB approval is required before work can begin on human subjects research. 

The University of Pennsylvania IRB has multiple boards to review research studies across all of the University of Pennsylvania Health System. 

IRB Questions?

For the most up to date information on IRB requirements, submission processes, templates, and policies, please refer to the IRB website: https://irb.upenn.edu

For questions on any of the above, please utilize the Penn IRB Staff Directory: https://irb.upenn.edu/homepage/staff-directory. Penn has three general help desks which are monitored daily. 

General Questions

For general IRB inquiries, including questions about where to find forms and guidance, IRB review considerations, status of review progress, Not Human Subjects’ Research Determinations, or other general concerns, contact the IRB PO Box.

Technical Issues

Contact the HSERA Help Desk about technical issues with the online HSERA submission system.

CITI Training Questions

If you have questions about CITI training curriculum or issues obtaining or documenting your CITI training, please contact the CITI Training Help Desk.

If you have more complex questions, consider signing up for Penn IRB Office Hours: https://zcal.co/pennirb/officehrs OR reach out to Kia Ultz, Senior Regulatory Analyst.

HSERA Access

If access to HSERA (the online IRB application system) is needed, please complete this form.

If you are a Penn Medicine LG Health researcher and would like support with submitting to / interacting with the Penn IRB office or other regulatory requirements for research, please contact:

Heather Madara, BA
Supervisor Research Regulatory and Outreach
Penn Medicine Lancaster General Health Research Institute Heather.madara@pennmedicine.upenn.edu

Guidance for Researchers: What You Should Know About IRB Approval

All research projects involving human subjects must have IRB and other institutional committee approval before they can begin. 

Our Research Institute team guides and assists you at every step of your project. We provide the knowledge, tools, and resources needed to develop and navigate research studies, remain compliant, and secure funding. Our robust support enables you to focus on your research while we handle the logistics and administrative work.

New and experienced researchers can engage in both investigator-initiated and government-, foundation-, and industry-sponsored research. All are great opportunities for professional development. See our clinical research investigator resources to learn how to get started.

Sponsored Research Guidance

If you are interested in participating in sponsored research, email Swapnil Shewale and copy the general Research Institute email (LGHResearch@pennmedicine.upenn.edu):

Swapnil Shewale, B.Pharm, MS, PhD
Director of Research Operations
Swapnil.Shewale@pennmedicine.upenn.edu

When starting a sponsored research project:

  1. Your industry partner provides the needed study protocol, consent forms, and budget proposal.
  2. Our team works in conjunction with finance and legal staff within the University of Pennsylvania’s Office of Clinical Research and/or Office of Research Services. Together, we negotiate the budget and execute any required study agreements.
  3. Our Supervisor Research Regulatory and Outreach takes the lead on securing IRB approval, including preparing documentation for IRB submission. During this step, they will have you review and approve materials when needed. For studies funded through grants or federal contracts, our grants department gets involved as well.
  4. After your initial IRB approval, any changes to the protocol or other aspects of the study require IRB approval as amendments. You will also have to submit periodic reports for IRB review as the study progresses. These reports include updates on enrollment, adverse events, and findings from internal or external study monitors. The study team works with you throughout the study to help you meet these requirements.

Investigator-Initiated Research Projects Guidance

Investigator-initiated research projects, often referred to as investigator-initiated studies (IIS), are tremendously beneficial to the communities we serve. They are inspired by questions that arise during routine patient care in our own patient populations. They also arise from gaps identified during review of medical literature.

While investigator-initiated research projects tend to require more local resources than studies that are initiated and sponsored by industry, we are committed to your success. Our team includes a project manager, regulatory manager, and budget analyst. These experienced professionals help you secure funding, obtain IRB approval, and remain compliant with research regulations. You also have access to ancillary staff, such as research coordinators, research assistants, and a statistician.

See our investigator-initiated studies guidance to learn the policies and steps involved in conducting investigator-led research projects.

Reporting Financial Interests

To obtain IRB approval, you must disclose any Significant Financial Interests (SFIs) or Intellectual Property (IP) Interests at the start of and throughout your research project.

  • Once your study has been submitted to the IRB, you will receive an email from the Research, Interests, and Activities (RIA) system to report any SFI's or IP Interests.
  • You must also report any changes in this area to the IRB within 30 days to remain compliant. To report a financial conflict of interest outside of the annual reporting process, you can do so on in the RIA system.

For Patients: Volunteer for Research

We have one of the most active clinical research programs among community hospitals in the U.S. Our active clinical research studies span a wide range of areas, including research on heart diseases, stroke, brain diseases, and cancer. Find clinical research studies at Penn Medicine Lancaster General Health.

If you’re interested in participating in a study, you can:

Contact Us

If you have questions, would like to file a complaint, or have a suggestion about research please contact an HRPP representative by calling the Research Participant Hotline: 215-898-2614.