The Penn Medicine Lancaster General Health Human Research Protection Program (HRPP) and Lancaster General Hospital Institutional Review Board (IRB) are integral partners of our Research Institute. They ensure compliance and provide oversight of all research activities involving human subjects at 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 Penn Medicine Lancaster General Health HRPP Helps Researchers
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.
The HRPP has been accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) since 2015. This accreditation signifies that the HRPP meets rigorous standards for maintaining the safety of research participants.
Lancaster General Hospital IRB
The IRB is responsible for approving or disapproving each proposed clinical research project. It also determines whether a proposal constitutes human subjects research. IRB approval is required before work can begin on human subjects research.
More than a dozen scientific and nonscientific members from LG Health and our community form the IRB. They monitor compliance with established policies and procedures around application, review, and reporting processes. This responsibility involves reviewing research protocols, informed consent forms and processes, and adverse events.
IRB Questions?
For more information on IRB requirements, submission processes, templates policies, and access to IRBManager (online protocol submission and management tool), please contact:
Kia Ultz, MA
Human Research Protection Program and IRB Manager
717-544-5091
Kia.Ultz@pennmedicine.upenn.edu
Guidance for Researchers: What You Should Know About IRB Approval
All research projects involving human subjects must have IRB approval before they can begin. The Human Research Protection Program Policy and Procedure Manual [PDF] outlines the required standards.
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 Jill Rebuck and copy the general Research Institute email (LGHResearch@pennmedicine.upenn.edu):
Jill Rebuck, PharmD, MBA, BCPS, FCCM, FCCP
Director of Research Operations
Jill.Rebuck2@pennmedicine.upenn.edu
When starting a sponsored research project:
- Your industry partner provides the needed study protocol, consent forms, and budget proposal.
- 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.
- Our Research Regulatory and Outreach Manager 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.
- 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 Compliance Issues
To obtain IRB approval, you must disclose any financial conflicts of interest at the start of and throughout your research project. Here's how:
- At the start of your study, you will receive a form to report financial conflicts of interest. This form will be entered into an electronic database.
- Once in the database, you will receive a link via email to complete your research financial disclosure statement annually.
- 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, use our Conflict Of Interest Reporting Form.
For more information, review the Human Research Protection Program Policy and Procedure Manual [PDF]:
- Policy 110: Institutional Conflict of Interest in Research
- Policy 111: Conflicts of Interest Involving Researchers
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 at Penn Medicine Lancaster General Health, please contact an HRPP representative by emailing SM-HRPP@lghealth.org.