Consent for Medical and Social Information

APPENDIX B. CONSENT FOR MEDICAL AND SOCIAL INFORMATION

What is the purpose of this investigation?

We would like to know more about a relative new virus, Oropouche virus, and its potential impact on people’s health. This includes what makes people more likely to be infected with the virus, what illness looks like, and how symptoms come and go over time. We also want to learn who may be at risk for severe symptoms and disease. This information will be used to better understand how we can prevent infections and help people who do get sick with Oropouche virus.

We would also like to know if there is any evidence that Oropouche virus can be spread through sex because it was found the semen of one person. There are some similar viruses that can be sexually transmitted, but it is unknown if Oropouche virus can be. 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?

We would like to ask you some questions about your illness and how you’re feeling now. First, we will ask about your symptoms, travel activities, and medical history over the phone. This should take about 30 minutes. Then, we will ask you to complete a symptom diary to keep track of when you feel unwell. We will follow-up with a short phone call every one or two weeks where you can share your symptom diary. This should take less than 15 minutes. We hope to keep in touch with you until you have been feeling better for four weeks.

Then, if you agree, we would interview you about any sexual partners you had between when you returned from travel and 6 weeks after you first felt sick. We would ask some details about your sexual contact. We would ask your permission to reach out to your sexual partners so we can interview them. We would tell sexual partners that they might have been exposed to someone with Oropouche through sex, but we would not identify you by name. We will ask the partners if they have had any symptoms that suggest they might have gotten sick with Oropouche. If they did have symptoms, we would ask them if they would be willing to get tested for Oropouche.

Are there any risks to me if I decide to be in the investigation?

There are very few risks to taking part in this investigation. 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.

It may be uncomfortable or embarrassing to discuss your sexual history around the time you traveled and got sick. All interviewers will be trained to collect sensitive information. All information you provide us will be kept private and we would only contact your sexual partners with your permission.

Are there any benefits to me if I decide to participate in the investigation?

You might not benefit directly from the investigation. However, information from this investigation may help people who become sick in the future. You will not be paid for participating.

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. The surveys you complete will not have your name or address. We will keep track of your name and contact information only to contact 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?

Only if you agree, we may contact you about other projects about this virus.

Do I have to take part 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 effects 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 8] 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 my questions answered. If no, answer additional questions.
o Yes	o No	I agree to be interviewed about my illness, travel history, and medical history
o Yes	o No	I agree to be interviewed about my sexual partners following my Oropouche illness
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: ___________________________

_____________________________________________________________________________________

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