What is the purpose of this investigation?
The purpose of this investigation is to see if Oropouche virus can be spread through sex. Several viruses are known to be sexually transmitted, but it is unknown if Oropouche virus can be. However, Oropouche virus has been found in semen. This will help us guide people on how to protect themselves and others from getting sick.
What do you want me to do if I decide to take part in this investigation?
If you take part, we will interview you about recent travel history. We will also ask you about any symptoms you might have had. If you had any symptoms that suggest you had Oropouche, we would ask you to have a small blood sample taken by a healthcare provider. Your blood sample would be sent to a laboratory at the CDC to be tested for Oropouche virus. We would tell you the results of your tests and help you understand what they mean.
After this study is over, we would like to store your blood sample if you tested positive. We might use your sample in other studies to better understand Oropouche. Your sample will not be used for human genetic testing. You can still take part in this study even if you do not want us to store your samples. At the end of this form, we will ask you to tell us whether or not you agree to let us store your samples. If you agree now and then change your mind, you can contact us at any time to have your sample removed from storage.
Are there any risks to me if I decide to be in the investigation?
The risks of being a part of this study are very small and most have to do with getting the blood sample. When we take blood from the arm with a sterile needle, you may feel some pain or get dizzy. You may also get a bruise or red mark where the needle goes into the skin. Very few people also get an infection. Receiving results of Oropouche testing might be stressful to you.
Only project staff will have access to your personal information. All efforts will be made to keep your personal information confidential. However, there is a small risk that information we collect could become available to staff who are not involved in the investigation.
Are there any benefits to me if I decide to participate in the investigation?
You might not benefit directly from the investigation. Information from this investigation will help us learn about how to prevent Oropouche from spreading in the future. You will not be paid for taking part.
If you had symptoms and take part, you can see if you were infected with Oropouche virus. You will be told about your test results and can ask any questions.
Will the information I give to you be kept private?
Anything you share with us will be kept private to the extent allowed by law. We will not put your name or address on the information you provide. We will keep track of your name and contact details only to get in touch with you about the investigation. Your information will be stored digitally in a secure place. No one other than investigation staff should see this material. Your name will not be used in any reports that are written about the investigation’s results.
Will I be contacted in the future?
If your blood samples test positive for Oropouche, your state or local health department might reach out with additional questions. Additionally, we may contact you about other projects about this virus, but only if you agree.
Do I have to participate in this investigation?
Taking part in the investigation is voluntary. You may decide not to take part or to quit the investigation at any time. If you refuse to be in the investigation or drop out of the investigation, you may do so without any negative effect to you.
Who should I contact if I have questions or think I may have been harmed by this investigation?
Please feel free to ask any questions you may have about the investigation at any time. If you have questions later, you may contact [name and phone number of staff member from CDC or state health department, TBD]
Do you have any additional questions?
[Flesch-Kincaid Grade Level 7.7]
Once all questions have been answered:
We will now ask you to verbally agree or disagree to participate in this part of the investigation. We will send you a copy of this form for your records.
o Yes |
o No |
I have been told about the investigation. I have been allowed to ask questions and have had all of my questions answered. If no, address additional questions. |
o Yes |
o No |
I agree to be interviewed |
o Yes |
o No |
I agree to have samples of my blood collected for Oropouche virus testing if I had symptoms that might be Oropouche |
o Yes |
o No |
I agree to allow my samples to be stored for future possible work on Oropouche virus or related viruses |
o Yes |
o No |
I agree to being contacted again in the future |
Name of person giving verbal consent: ____________________________________________________
Name of person obtaining verbal consent: _________________________________________________
Date/time: __________________________________________________________________________
Address or email address participant would like consent forms sent to: ___________________________
_____________________________________________________________________________________
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Drehoff, Cara R. (CDC/PHIC/DWD) |
| File Modified | 0000-00-00 |
| File Created | 2024-10-29 |