Because research ideas often arise while caring for patients, our investigator-initiated studies are a unique resource for Penn Medicine Lancaster General Health clinicians. At the Research Institute, we provide support services for investigator-initiated studies, including study design, identification of funding sources, administrative support, and Institutional Review Board (IRB) preparation.
How to Conduct an Investigator-Initiated Study
All research studies at Penn Medicine Lancaster General Health follow an established study life cycle. The study life cycle follows these six steps:
- Proposal development
- Funding
- Study startup
- Study activation
- Participant enrollment
- Data analysis and dissemination
Step 1: Proposal Development
What Happens:
- You first need to complete the Research Support Request Form.
- A research project manager will follow up with you to schedule a meeting to discuss your research idea.
- We help you develop your study proposal and complete a feasibility assessment. This planning phase involves fine-tuning your:
- Research question
- Study design
- Hypothesis
- Methodology
- Timeline
- Budget
- We also help you find internal or external funding.
- You must also complete CITI (Collaborative Institutional Training Initiative) Program training before facilitating human subjects research. Learn how to register for CITI training in our resources for clinical research investigators.
Step 2: Funding
Once we complete the study proposal, we submit it for funding. At Penn Medicine Lancaster General Health, the Louise von Hess Research Grant awards funding for research projects that can be completed within two years for physician-directed research focused on:
- Education
- Advancement of the practice of medicine
- Application of research to medicine
- Health improvement in Lancaster and the surrounding community
For questions about funding, email:
Halle Becker, MPH
Research Project Manager
Halle.Becker@pennmedicine.upenn.edu
Step 3: Study Startup
If you receive funding, we begin preparing for study implementation. This process often takes three to four months and involves:
- Determining staffing
- Developing the IRB protocol and associated documents, such as consent forms and recruitment materials including posters and electronic messages sent through the electronic health record
- Obtaining IRB approval
- Developing and establishing contracts with outside vendors or institutions if needed
- Setting up the study’s logistics, such as recruitment strategies, enrollment workflows, data collection tools, and billing processes
Step 4: Study Activation
Once you have received IRB approval for your research study and we’ve received the completed contracts, we finish training the team. We also develop study manuals that detail the study’s methods and procedures.
Any study startup tasks that need to be completed prior to enrollment are completed during this phase. These tasks may include full execution of any contracts, final development of study workflows, and study team trainings.
Step 5: Participant Enrollment
Your study is officially active. The study team will now implement the activities outlined in your study protocol, including enrollment. Enrollment involves screening, consenting, and enrolling participants.
Step 6: Data Analysis and Dissemination
Our biostatisticians help you analyze the data to draw conclusions. If you are looking to publish or present your findings, we can help you with presentations, manuscript development, and mission development. You can publish your findings internally in The Journal of Lancaster General Hospital or externally in other journals.
Important Policies to Know When Conducting Investigator-Initiated Studies
The Human Research Protection Program Policy and Procedure Manual [PDF] outlines the policies and procedures you must follow when conducting human subjects research. It’s important to familiarize yourself with them as you engage in clinical research.
Policies That Apply to All Investigators
Find the policies in the PDF linked above:
- Policy 104 Responsibilities of Research Investigators: Policy 104 describes your responsibilities as a research investigator. It’s one of the first policies that you should review and understand.
- Policy 110 Institutional Conflict of Interest in Research and Policy 111: Conflicts of Interest Involving Researchers: Policies 110 and 111 explain the requirements involved with reporting conflicts of interest before getting IRB approval and during the study.
- Policy 203 Activities Requiring IRB Review and Policy 204: Exempt Research: Policies 203 and 204 explain the different kinds of research that require IRB review and approval.
- Policy 402 Initial Review of Research: Policy 402 outlines the minimum requirement for IRB approval for all research proposals involving human subjects.
- Policy 501 Assessment of Risks and Benefits: Policy 501 outlines how the IRB assesses the health and science risks and benefits of a study.
- Policy 502 Informed Consent and HIPAA Authorization Requirements and Policy 503: Documentation of Informed Consent: Policy 502 describes the general requirements for obtaining informed consent and HIPAA authorization. Policy 503 describes the requirements for documentation of informed consent and circumstances when the IRB may waive them.
Policies for Special Circumstances
- Policy 507 Vulnerable Populations: Policy 507 describes human subjects research guidelines for studies involving people who are potentially vulnerable to coercion, present conditions that may affect risk/benefit determinations, or bear an unequal burden in research.
- Policy 601 Research Involving Drugs or Biologics and Policy 602: Research Involving Devices: Policies 601 and 602 describe the IRB process for initial review of human subjects research involving drugs, biologics, and devices.
- Policy 603 Humanitarian Use Devices and Policy 604: Emergency Use of an Investigational or Unlicensed Test Article: Policies 603 and 604 describe what you must do if you have a humanitarian use device or need to engage in the emergency use of an investigational or unlicensed test article.
IRB Questions?
For more information on IRB requirements, submission processes, templates policies, and access to IRB Manager (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