Whether a provider told you about a research study or you found one on your own, you likely have questions about how to proceed. Our goal is to make it as easy as possible for you to take part in clinical research.
To help you make the best decisions possible for you and your loved ones, we encourage you to read through this list of frequently asked questions.
Are Clinical Research Studies Safe?
The U.S. Food and Drug Administration (FDA) requires that an Institutional Review Board (IRB) monitor all research activities involving human participants. They make sure that clinical trials meet ethical standards for human research and follow related safety policies and procedures.
To receive IRB approval, researchers must prove that their research is legitimate and safe. The IRB then regularly reviews every Penn Medicine Lancaster General Health research study to ensure safety and protocol (study plan) compliance.
The IRB is part of the Penn Medicine Lancaster General Health Human Research Protection Program (HRPP). It works closely with the HRPP to protect the safety, privacy, and rights of all study participants.
The compliance committee is another key part of the HRPP. It ensures that institutional and individual investigator financial conflicts of interest do not influence clinical research studies.
Who Is a Candidate for a Clinical Research Study?
Your provider may ask you to consider a clinical research study if it could benefit you and you meet the study’s eligibility criteria. The eligibility criteria are a list of qualifications you must meet to participate in the study. They are another layer to ensure you can safely participate in the study.
A study’s eligibility criteria often involve factors such as:
- Age
- Health status
- Treatment history
To learn more about a study’s eligibility criteria, you can:
- Ask our research team for assistance.
- Find and review the study on iConnect, our clinical research database.
- Find and review the study on ClinicalTrials.gov.
At the Research Institute, our research team can help you decide if a research study is appropriate for you.
What Is Informed Consent in Research?
The purpose of informed consent in research is protecting study participants and their well-being. During the informed consent process:
- A member of the study team introduces the study to you. They explain what’s involved in the research study, the potential benefits and risks, and your alternatives if you decide not to participate. The study Informed Consent Form (ICF) contains this information.
- If you are interested in participating, the study team provides you with the study ICF to review.
- The study team answers any questions you have about the ICF so you can make an informed decision.
- If you choose to participate once you have all your questions answered, you sign the ICF. At least one person from the study team signs the ICF as well.
Depending on what’s required, parts of the consent process may take place over the phone, over video, electronically, or in person. Several people, including your provider, could administer separate parts of the consent process.
What Happens When You Consent to Participate in a Research Study?
What happens next depends on the details of your study. Some studies, especially clinical trials, need you to fill out questionnaires or have lab tests or imaging tests. In some cases, the results of these tests may disqualify you from being in the study.
As a research participant, you continue to receive medical care under the direction of your regular provider. But you also benefit from other experts on the study team. They pay close attention to the details of your care while you are part of the study.
What Costs Are Involved in Study Participation?
In most cases, you and your insurer do not have to pay for study-related health care. Instead, the study sponsor usually covers these costs as part of the study budget. Some studies may even pay you for your time.
What Happens If You Choose Not to Take Part in Research?
Your involvement in research is completely voluntary. If you choose not to participate at any point, your decision won’t affect your regular medical care or your relationship with your providers. You will continue to receive the high-quality care Penn Medicine Lancaster General Health is known for.
Sometimes, we learn new information that may affect your desire to stay in a study after you have agreed to join it. We provide this information to you and your provider so you can discuss it together. Rest assured, you can withdraw from a clinical study any time after signing the consent form.
Participate in Research
If you’re interested in joining a study, email us at LGHResearch@pennmedicine.upenn.edu. You can also register to be contacted for studies you are interested in via iConnect, our clinical research database.
Questions?
For general questions about research at Penn Medicine Lancaster General Health, email LGHResearch@pennmedicine.upenn.edu or call 717-544-1777.