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Information for Study Participants

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Last update
08.10.07

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1) What is research?

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. 45CFR46.102

What does this mean? Basically, if an MU employee (or some other type of representative from MU) interacts or intervenes with the public to do some kind of study on a certain characteristic, then they are engaging in research. For example, it may be a clinical trial, where a large pharmaceutical company testing a new drug all over the U.S., or an MU faculty member working a small questionnaire to be used locally.

For more information about being a research volunteer, click here. (PDF, 2 pages, 3.4MB)

2) What is a Clinical Trial?

A Clinical Trial is a specific kind of research in healthcare. More information can be found at http://www.clinicaltrials.gov/ct/info/resources.

Additionally, you may find local information on research by contacting the Office of Clinical Research. Contact information can be found at: http://www.hsc.missouri.edu/~research/ocrinfo.shtml.

For a list of some of the clinical trials at the University of Missouri please go to https://apps.muhealth.org/clinical_research/.

3) If I participate in a research study, what are my rights?

Participation in a study is voluntary. You do not have to participate in a study. A person's present or future health care, benefits, or any other relations with MU will not change in any way should you choose not to participate in a study. If you decide to participate, you can change your mind and drop out of the study at any time without affecting your present or future care at the University of Missouri Health Care or MU in general. Leaving the study will not result in any penalty or loss of benefits to which you are entitled. If you decide to stop participating in a healthcare-related study, you are encouraged to discuss your decision with your doctor.

Study investigators will inform you of any new information relating to the study that might affect your health, welfare, or willingness to continue participation in this study. This may include the discovery of side effects that were previously unknown, or other unforeseen consequences or risks of participating. However, it is the role of the Health Sciences IRB in conjunction with the study investigators to minimize all such risks to the greatest extent possible.

4) Whom Do I Call if I Have Questions or Problems?

If you have questions regarding the study, the study investigators will have provided you a way to contact them. You may contact them at any time during the study. During the enrollment process, the investigators will describe what happens during the study, and ask if you want to participate. This is the most important time to ask questions!

If you have any questions regarding your rights as a participant in a research study, have concerns about the study, or if you feel you are under any pressure to enroll or to continue to participate in a study, you may contact us, the University of Missouri Health Sciences Institutional Review Board (we are a group of people that reviews research studies to protect participants' rights) at (573) 882-3181.

You may ask questions about the study at any time. For questions about the study or a research-related injury, contact the study coordinator or your physician.

You should keep a copy of the consent form for your records.

5) If I participate, how is my confidentiality protected?

Many people want to participate in research. However, many people also want their participation to be kept confidential. Methods to protect confidentiality vary depending on what information is being collected about you. We have developed strict guidelines to protect the privacy of medical and personal information. Part of the HS IRB's role is to ensure there are adequate methods for maintaining confidentiality. HIPAA regulations provide strict rules for how medical information can be used.

It is possible that your medical and/or research record, including sensitive information and/or identifying information, may be inspected and/or copied by the study sponsor (and/or its agent), the Food and Drug Administration (FDA), federal or state government agencies, the Institutional Review Board, or hospital accrediting agencies, in the course of carrying out their duties. If your record is inspected or copied by the study sponsor (and/or its agents), or by any of these agencies, the appropriate institutions will use reasonable efforts to protect your privacy and the confidentiality of your medical information.

Specific information on methods of protection may be found from the study investigators during your enrollment process into a study. This is where the investigators describe what will happen during the study, and then ask if you want to participate.

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