If you or someone you know has contracted norovirus and are still showing symptoms (or have done so in the past three days) then University of Michigan scientists need your help. Yes, they need a sample for a new study. See the description starting below.
We are doing a study to learn more about human noroviruses. Human noroviruses are highly infectious viruses that cause diarrhea and/or vomiting. No specific vaccines or antivirals to limit or prevent infection are approved. Being in this study is voluntary. You don’t have to join if you don’t want to. Choosing not to be in this study won’t affect your medical care in any way.
To find out how noroviruses infect cells, we want to collect a fecal sample from people who had norovirus symptoms of diarrhea and/or vomiting within the last 3 days. If you are 18 or older and join this study, you will collect one bowel movement in an unlabeled, closed plastic container (e.g. old Tupperware container, empty ice cream container, empty yoghurt container). This usually takes one minute.
Please do NOT label your container. If applicable, please deface any reference to food, to avoid the contents being mistaken for food. For transport, please put container that is clean on the outside (e.g. wiped down with chlorox-wipes) into a sealable plastic bag (e.g. Ziploc bag) that includes absorbent material (e.g. paper towel). Please drop off the sample in the collection bin located at the door of Room 5737 Med Sci II. Please make sure to wash hands frequently with soap and water to prevent transmission of virus.
We’ll test your fecal sample in our lab for the presence of norovirus. If positive, we will use your sample as a source of norovirus in basic science studies. If negative, your sample will be destroyed. Thus, the fecal sample will be stored in the laboratory without identifying information for future research indefinitely or until used up. Participation in this study has a minimal risk of feeling uncomfortable in handling and collecting your own stool.
We will NOT label your sample, so there is no way someone could use it to identify you. We will also NOT collect any medical information, so there is no way to know your identity. Being in this study won’t benefit you directly. We hope what we will learn more about human noroviruses to help us develop effective anti-norovirus drugs or vaccines in the future. There is no charge to you or your health insurance for being in this study.
None of the information that we publish or discuss will enable others to figure out who took part in this study. The results of this study could be published in an article, but would not include any information that would let others know who you are.
Study ID: HUM00112726 IRB: IRBMED
Date Approved: 2/25/2016
Expiration Date: 2/18/2017
Contact and Legal
To find out more about the study, to ask a question or express a concern about the study, or to talk about any problems you may have as a study subject, you may contact one of the following:
- Principal Investigator: Christiane Wobus
Mailing Address: 1150 West Medical Center Dr.,
5622 Med Sci II, UofM
Ann Arbor MI
You may also express a concern about a study by contacting the Institutional Review Board:
- University of Michigan Medical School Institutional Review Board (IRBMED)
2800 Plymouth Road Building 520, Room 3214
Ann Arbor, MI 48109-2800
If you are concerned about a possible violation of your privacy or concerned about a study, you may contact the University of Michigan Health System Compliance Help Line at 1-866-990-0111.