"Impact of COVID-19 on People Living with Rare Diseases and Their Families."

Maurizio Macaluso, MD, DrPH, FACE

3333 Burnet Avenue, MLC 5041
Cincinnati, OH 45229-3039

We are asking you to take part in a survey to learn how the pandemic of coronavirus disease (COVID-19) impacts people who live with rare diseases and their families. We are looking for people with rare diseases living in the US and under 90 years of age. Parents of children under 18 years of age or a care giver can complete on behalf of the person with a rare disease. We want to find out how many people who have a rare disease have also become sick with COVID-19. This survey will help us better understand the symptoms of COVID-19 and how they affect someone who also has a rare disease. We want to figure out how the virus and people's symptoms change from the time symptoms begin to when they end. We also want to learn more about any treatments given to patients with a rare disease and how well they may have worked.

More specifically, we are interested in where patients with rare diseases live and how many have become infected with COVID-19 in a particular area. We will look at whether certain rare conditions are affected more often than others and if they experience more severe symptoms of the COVID-19 infection. We also want to determine if any specific treatments that patients are taking for their rare condition are making it more likely that they will become sick with COVID-19.

We also want to learn how the COVID-19 pandemic is affecting the lives of people with rare diseases who have NOT been sick with COVID-19. The pandemic may have caused stress, anxiety, and made access to care harder, especially in areas where COVID-19 is more common.

We want to figure out how the Rare Diseases Clinical Research Network (RDCRN) can respond to those concerns by perhaps providing information or advice through its consortia and patient advocacy groups. Lastly, we would like to follow-up with patients and families who would like additional information from our RDCRN research studies.

This research may generate helpful information for those with a rare disease. If you choose to participate in this study, you will not receive payment or any direct benefits. You will not be charged for participating in this survey. Please read this information carefully to decide if you want to participate.

Responding to this survey is completely voluntary. It should take you approximately 20 minutes to complete.

Participating in research always has some risk. The risk of participating in this study is a loss of confidentiality, meaning that the information you provide could identify you. We will also ask for your contact information for follow-up interviews and to make you aware of future RDCRN research. Any information that can identify you will be kept in a separate file apart from your survey responses. An identification (ID) number will be a link between your identifying information and your survey responses. Your contact information will be shared with RDCRN consortia that are interested in letting you know about their research, including those you are already connected to. Results from the survey will be combined and you will not be identified through our reports.

If you are not comfortable sharing identifying and contact information, you may complete the survey anonymously. However, if you choose to remain anonymous, we will have no way of tracking the impact of COVID-19 on your life as time goes on.

Completing the survey means that you consent to participate in this research study. No medical advice will be offered based on the information collected from the survey. If you have a concern, please contact your physician. The information collected from this survey may be kept by the investigators for potential future unspecified research.

To be in this research study you must also give your permission (or authorization) to use and disclose (or share) your "protected health information" (called PHI for short).

What protected health information will be used and shared during this study?
Cincinnati Children's Hospital Medical Center (Cincinnati Children's) will need to use and share your PHI as part of this study. This PHI will come from:
-Your medical records
-Your research records

The types of information that will be used and shared from these records include:
-Laboratory test results, diagnosis, and medications
-Reports and notes from clinical and research observations
-Imaging (like CT scans, MRI scans, x-rays, etc.) studies and reports
-If applicable, information concerning HIV testing or the treatment of AIDS or AIDS-related conditions, drug or alcohol abuse, drug-related conditions, alcoholism, and/or psychiatric/psychological conditions (but not psychotherapy notes)

Who will share, receive and/or use your protected health information in this study?
-Staff at all the research study sites (including Cincinnati Children's)
-Personnel who provide services to you as part of this study
-Other individuals and organizations that need to use your PHI in connection with the research, including people at the sponsor and organizations that the sponsor may use to oversee or conduct the study
-The members of the Cincinnati Children's Institutional Review Board and staff of the Office of Research Compliance and Regulatory Affairs

How will you know that your PHI is not misused?
People that receive your PHI as part of the research are generally limited in how they can use your PHI. In addition, most people who receive your PHI are also required by federal privacy laws to protect your PHI. However, some people that may receive your PHI may not be required to protect it and may share the information with others without your permission, if permitted by the laws that apply to them.

Can you change your mind?
You may choose to withdraw your permission at any time. A withdrawal of your permission to use and share your PHI would also include a withdrawal from participation in the research study. If you wish to withdraw your permission to use and share PHI, you will need to notify the study doctor, listed at the top of this page, in writing. Your request will be effective immediately and no new PHI about you will be used or shared. The only exceptions are (1) any use or sharing of PHI that has already occurred or was in process prior to you withdrawing your permission, and (2) any use or sharing that is needed to maintain the integrity of the research.

Will this permission expire?
Your permission will never expire because we want to keep the information you provide for future research.

Will your or your child's other medical care be impacted?
By completing this survey, you/your child agree to participate in this research study and give permission to Cincinnati Children's to use and share you/your child's PHI for the purpose of this research study. If you refuse to complete this survey you/your child will not be able to participate in the study. However, you/your child's rights concerning treatment not related to this study, payment for services, enrollment in a health plan, or eligibility of benefits will not be affected.

Certificate of Confidentiality
To further protect the privacy of study participants, a Certificate of Confidentiality will be obtained from the NIH. This certificate protects identifiable research information from forced disclosure. It allows the investigator and others who have access to research records to refuse to disclose identifying information on research participation in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. By protecting researchers and institutions from being compelled to disclose information that would identify research participants, Certificates of Confidentiality help achieve the research objectives and promote participation in studies by helping assure confidentiality and privacy to participants.

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