Mercy Research is committed to improving the quality of health care for our patients by being a leader in innovative clinical and health services research.
Mercy Research offers trials for a wide range of medical conditions including diabetes, cancer, rheumatoid arthritis, pediatric care, ophthalmology, asthma, cardiology, high cholesterol, hypertension, gastroenterology, neurology, and stroke, as well as surgical subspecialties including orthopedics and pain management.
We provide patients access to clinical trials on new medical products and treatments, bringing them additional options and new hope. All trials are guided by our commitment to the highest standards of ethics.
Study participants are the most valued contributors to medical research. By volunteering for a clinical research study, you can be a part of helping to find new and improved treatments and better ways to provide care. Volunteering for a clinical study is a personal choice. The next steps include:
1. Contact Mercy Research – Complete our online contact form
2. Screening Process – You will be asked a series of questions to determine if you qualify to participate in a research study.
3. Schedule a Visit – After the screening process, you will have an appointment to learn more about the study and determine if becoming a research volunteer is right for you.
4. Provide Informed Consent – During your visit, you will be given a consent form to review and discuss. It is very important you read and understand this form. The consent form describes what activities will take place during the study and the risks involved.
5. Begin the Study – If you are eligible for a study and provide consent, you may have regular appointments during your participation in a clinical trial.
The Human Research Protections Program (HRPP) provides direction in protecting of the rights, welfare and wellbeing of human subjects involved in research supported by the Department of Health and Human Services (HHS).
Mercy Research’s HRPP policies and procedural guidelines support our commitment to the highest standards of ethics, honesty and integrity in pursuit of our mission. Guided by the HRPP, our policies and procedural guidelines address all regulatory requirements as well as offer clarification on standards of conduct, conflict of interest and commitment, sponsored research activities, data sharing and ownership and financial stewardship and accountability.
Mercy Research has a robust regulatory team to ensure compliance with federal regulations and the Catholic Ethical and Religious Directives and to support Institutional Review Board (IRB) submissions for ongoing study activities. This centralized team completes the submission process for Mercy IRB and external IRB submissions. Furthermore, the regulatory team is the primary intermediary between principal investigators, sponsors and IRBs to cover all related study reviews and reporting requirements.
Compliance is critical to uphold the ethics, integrity and mission of our work. Mercy’s corporate compliance function provides comprehensive onsite and virtual monitoring for Good Clinical Practice (GCP), study conduct and regulatory compliance and assists with external audits. In addition, this group consults on Investigational New Drugs (IND), Investigational Device Exemptions (IDE), education and training on regulatory requirements and oversight of policies and procedural guidelines.
Should I participate in a clinical trial at Mercy?
Mercy Research is dedicated to the evaluation of drug therapies and medical devices for diseases and conditions that commonly affect the lives of members of our community. People participate in clinical trials for a variety of reasons. People who volunteer for clinical trials may gain access to promising drugs or devices long before they are approved for the public. Participants continue to receive excellent care from their physicians during the trial.
Do I have to participate in a trial?
Participation in our clinical trials is always voluntary. Our expert panel of physicians provide the highest level of medical and scientific review, and the values and ethics of Mercy are present in everything we do. Deciding not to participate in a trial will not affect your care. Clinical trials are often treatment options that you may want to consider.
What should I expect during a clinical trial?
Before you begin a clinical trial, you will be asked to provide informed consent, which is a voluntary agreement to participate in the research. After you have read an informed consent document, you will be given the opportunity to ask questions and receive answers. This is not merely a form that is signed; informed consent is a process in which the subject understands the research and its risks, benefits, and alternatives. Informed consent is essential before enrolling in a study and ongoing once enrolled.
Many clinical trials research drugs or devices to determine safety and effectiveness. If you decide to participate in a clinical trial such as this, your health care will be monitored during required office visits by physicians and research staff. Throughout the clinical trial, you will have to take the study drug or device as instructed. You may be asked to have laboratory and diagnostic testing conducted, as well as modifying your diet and exercise habits. Upon completion of the trial, you will be instructed to follow up with your primary physician for continuation of your medical care.
Other clinical trials exist to observe and collect data about diseases and treatment. These trials tend to have less benefit for an individual patient, but do not require a patient to change their current treatment to participate. The results collected from these observational trials may improve our knowledge and understanding of these conditions in the future.
What questions should I ask?
Choosing to participate in a clinical trial is an important decision. When you take any drug or use a device, there may be the risk of uncommon or previously unknown side effects occurring. In a clinical study, there are no guarantees that a new treatment will work. You should think carefully about the potential risks and be sure all your questions are answered before deciding to participate. We encourage you to discuss your questions with family, friends, the research staff and your primary physician. Here are some questions you may want to ask the research staff:
Who is watching out for me and the safety of my health?
Before a study begins, the Mercy Institutional Review Board (IRB) reviews the study’s goals, treatments and procedures to ensure there are no unnecessary risks and your rights are fully protected. In addition, federal agencies and external review boards evaluate studies to ensure their safety and compliance with federal regulations.
The physician and study coordinator will review your medical history. Per study protocol, any tests, vital signs and physical examinations will be conducted to determine if you are eligible for the trial you are considering. If you choose, you may withdraw from the trial at any time.
Is there a cost?
If you decide to participate in a clinical trial, some of the associated costs may be paid for by the research study. Typically, you or your insurance would still be billed for costs of routine care, including co-pays or deductibles. The investigator or research coordinator will discuss the specific costs of a trial with you before you decide to participate.
What should I do if I am interested in participating in a research study?
If you are interested in participating in a clinical trial, please complete our online contact form.
For more information: http://clinicaltrials.gov