Research and Clinical Trials

The federal government has strict regulations to protect clinical trials participants. An Institutional Review Board (IRB) is an independent committee of physicians, health care professionals, and community members responsible for ensuring that clinical trials are both scientifically and ethically sound.

If you have additional questions about human subjects’ research protections, please contact the ProMedica IRB at 419-291-5362 or phsirb@promedica.org.

We adhere to the most stringent medical and ethical standards to ensure safety and quality of care for our patients. Some potential risks of participating may include:

• The treatment may not be effective and health status may not improve.
• Participating in the clinical trial may be demanding and time consuming.
• There may be minor or serious side effects resulting from the treatment.

Clinical trials are important because they help to determine if a medical treatment even works and which treatments work better than others. Your health and safety are always a priority. Clinical trials undergo rigorous scrutiny and are monitored regularly to ensure patients are safe and protected.

If you have questions about the protections in place for patients in a clinical trial, please contact the ProMedica IRB at 419-291-5362 or email phsirb@promedica.org.

Informed consent is the process where the study team explains the key facts about a clinical trial before the participant decides to enroll in the study. This process continues throughout the study to provide updated information to participants. Risks and potential benefits are explained in the informed consent document and will be discussed thoroughly with the participant. The participant then decides whether to enroll in the clinical trial. By signing the document, the participant agrees to join the clinical trial; however, they may withdraw from the trial at any time.

Here are some questions to consider if you are interested in participating:

• Who is conducting the clinical trial? Who is sponsoring (funding and managing) the clinical trial?
• Who will be responsible for my care? What is the purpose of the clinical trial?
• What are the potentials benefits/risks of participating in the clinical?
• What are the clinical trial-related costs? Will this be covered by insurance?
• What is the overall time commitment that is expected of me? What are my other treatment options?
• How does the clinical trial therapy compare to other treatment options?
• How often are clinical trial-related visits performed?
• How long will the clinical trial last?
• How do I end my participation if I change my mind?
• How many people will be in this study and will I be compensated for my participation in the study?

For more information about participating in a clinical trial, view these videos from the U.S. Department of Health and Human Services

ProMedica strives to protect health information of all its patients which includes information intended for research purposes. An important aspect of research is data management and the protection of data acquired for study purposes. The research department at ProMedica has several safeguards in place to reduce the risk of loss of confidentiality. The following are some core practices that researchers at ProMedica implement to ensure that data is protected and secure.

1. Minimum necessary rule: The HIPAA Privacy Rule requires that covered entities make reasonable effort to limit use, disclosure of, and requests for protected health information to the minimum necessary to accomplish the intended purpose. Researchers at ProMedica are held to and abide by this rule when conducting research, collecting only the data agreed to and approved by the Institutional Review Board.
2. De-Identification: This involves removing personally identifiable information (PHI) like names, addresses, and dates of birth from medical data, ensuring that individuals cannot be recognized within the dataset, thereby safeguarding their privacy while allowing researchers to utilize the information for analysis and study purposes. Study IDs are often assigned to patients instead of using PHI, such as names and medical record numbers, to ensure confidentiality of data when managing databases.
3. Regulatory agencies: There are several regulatory bodies that govern researchers at ProMedica and help safeguard patient privacy. These include local and central Institutional Review Boards as well as the U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), and the Office for Human Research Protections (OHRP). As it pertains to patient privacy, the Institutional Review board’s role is to ensure that researchers are conducting studies in an ethical manner, reducing risk for patients and ensuring all safeguards are being properly utilized to do so.
4. Publications: Medical research is essential for understanding the underlying pathophysiology of disease and to advancing treatment options. A major component of this includes publication of data acquired from research studies. It is important to note that all information included in the publication of information obtained from research trials is always de-identified and most often is only a summary of the research groups. Therefore, published information cannot be linked back to individual patients, protecting the individual’s anonymity.

Institutional Biosafety Committees (IBC) play a key role in promoting safe and responsible research. They oversee studies involving recombinant or other potentially hazardous biological materials to ensure that all work is conducted in accordance with the established biosafety standards and National Institutes of Health (NIH) Guidelines.

Institutions engaged in this type of research, such as ProMedica, are required to utilize an IBC and promote transparency by making meeting minutes publicly available. The committee meets regularly to evaluate research activities, assess potential risks, and support a culture of safety in the research community. Minutes from the IBC meetings are provided below.

• July 2, 2025