Research in health care is at the core of all advances in treatments and cures. Volunteers help develop new knowledge through their participation in carefully controlled research protocols.
Researchers who work with Fairview actively seek a wide range of research volunteers, including men and women, children and the elderly, from a variety of ethnic backgrounds and geographic regions.
The purpose of the trial and your role will be explained to you. You should fully understand and be comfortable with the project and your role. You’ll have the opportunity to discuss all aspects of the trial to help you decide if you want to participate:
A number of federal and local organizations review research practices and protocols, including the National Institutes of Health (NIH), Food and Drug Administration (FDA), and the Office of Human Research Protection (OHRP).
All research is reviewed by a local committee called an Institutional Review Board (IRB), which includes health professionals as well as non-medical representatives. The IRB ensures there are appropriate protections for participants, and the research doesn’t create unnecessary risk. The IRB has the authority to require changes to the research or to sop the research if necessary.
You will receive the names and phone numbers for the researchers in charge of the trial. You can contact them any time with questions or concerns. In addition, you will receive contact information for the Patient Relations Department in the event you would like to talk to someone other than the researchers about your participation in the study.
Researchers generally keep study records for a minimum of two years and will explain exactly how they track your participation and how it is documented. Information about your research participation may be included in your medical record. Research records are kept confidential; however, there are circumstances when these records may be reviewed.
Research data that the researchers collect from you are coded to assure that no identifying information about you is part of the study. The research or research sponsor collects the data, analyzes it and often publishes the results. No research subjects are identified in any research publications.
After learning about a research study, you may choose to participate or to refuse. Signing a consent form for a research study does not commit you to participate. You are free to change your mind at any time and leave the study. Your relationship with your regular doctor, Fairview Health Services and its partners will not be affected by your decision to withdraw from a research study.