Study participant rights
Informed consent is the process of giving information about the research study’s purpose, procedures, risks, benefits and alternatives to potential subjects so they can decide if they want to take part. Before signing up for a research study, you have the right to:
- Learn about everything the study involves
- Hear and read information in a language you understand
You can ask questions at any time. Participation in a research study is always voluntary.
Clinical trial phases
Each study phase answers different questions about the new treatment.
- Phase I research studies are the first step in testing a new treatment in humans. In these studies, researchers look for the best and safest way to give a new treatment. They also watch for any harmful side effects.
- Phase II research studies continue to test the safety and effectiveness of the new treatment. Unpredictable side effects can occur.
- Phase III research studies compare a new treatment with standard treatment. Participants are randomly assigned to receive either the new treatment or standard treatment.
- Phase IV research studies are used to further learn about a treatment’s long-term safety and effectiveness. These studies usually occur after the new treatment is approved for standard use.
Clinical services given during a trial are related to either the research study or usual medical care. The study may pay for services related to research but not for usual medical care.
Usual care includes services medically necessary for your disease. It includes tests that would be done whether or not you were in a research study. You and/or your insurance plan are responsible for the cost of usual care, including deductibles and copayments.
Before a study opens, the research team conducts a coverage analysis to identify research-related services and to ensure that the study will cover them.
When the study ends
After a study ends, the results are often published in medical journals. If the results are interesting, they may appear in news media and be discussed at scientific meetings. The new approach may also become the standard of care.
Ask the research team if the study results have been or will be published or search for the study’s official name or protocol number in the National Library of Medicine’s PubMed database.
The Institute’s Research Subjects Protection Program manages two institutional review boards (IRBs). Each board reviews research with human subjects per the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration regulations.
The IRBs advocate for research subjects and conduct ethical reviews so that:
- Participants’ rights and welfare are protected
- The potential benefits of the research are maximized, and the potential harms are minimized
- The research results in important knowledge gained
The HealthPartners Research Subjects Protection Program is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). This group promotes high-quality, ethical research. This informs study participants, researchers, funders, regulators and the public that our program is focused on excellence and protecting the rights of study participants.