STUDY INFORMATION

Title:                                Surveillance of COVID-19 in a Single Institution, a Registry

Institution:                       Lancaster General Health

                                         555 N Duke Street

                                         Lancaster, PA 17602

Principal Investigator:     Adam Lake, MD          

Protocol:                          Version 1, 4/3/2020

INTRODUCTION

Doctors may ask patients to take part in a research study.  Before a patient agrees, the doctor or research staff must give the patient information about the study and its risks and benefits.  The form you are about to read gives such detailed information. You will get a copy of this form by email.

We are asking you to take part this study because you are seeking care for an upper or lower respiratory infection or flu-like symptoms, or you are asking to be tested for COVID-19. This study plans to look at the link between patient data and who is tested, who has COVID-19, and outcomes of the disease. It involves a filling out a survey now, in 90 days and finally in 180 days. It also involves giving us permission to get data from your medical record at Lancaster General Health. It is your choice whether or not to take part in the study.

ABOUT THE STUDY

We plan to enroll up to 12,500 subjects in this registry. If you choose to take part in the study, you will next get an online survey to fill out. This survey will collect information about you and your symptoms. We will link your answers to your medical record. We will collect data from your Lancaster General Health medical record for 180 days. We also will send you a follow-up survey at 90 days, and again at 180 days, at the email address you provide. You do not have to do anything for this to happen. After 180 days, your study participation is finished.

There is no direct benefit to you for joining this study. The information we gather might help us learn about COVID-19 and who we should test for the disease.

There are no medical risks to this study. The only risk to you is the chance that your health information might be accidentally released. To prevent this from happening, we are collecting and storing the study data in REDCap. REDCap is a secure, encrypted database that meets privacy standards. (See the section below on medical records and study data.)

There are no costs for joining the study. You also will not be paid to join the study. You can choose not to join. It will not affect your medical care. You also may withdraw from this study at any time during the 180 days and we will not collect further data from your records. To withdraw, you need to contact the study doctor, Dr. Adam Lake, via email (adam.lake@pennmedicine.upenn.edu) or telephone (717-544-2644).

Also, if you have any questions or concerns about this study, you may contact Dr. Lake (see above).

The Human Research Protection Program (HRPP) oversees all research at Lancaster General Health. If you have any questions about your rights as a research participant, or if you have complaints or concerns, you may send an e-mail to the HRPP (SM‑HRPP@lghealth.org). You also may call the Chair of the Institutional Review Board at Lancaster General Hospital at 717-544-5091.

ABOUT MEDICAL RECORDS AND THE STUDY DATA

Federal law requires that we tell you what health information we will use and how. We can use your data only if you authorize it.

1.     The team may use health information in your medical records for this study:

·       Name and date of birth

·       COVID-19 test result

·       Medical history information that may affect your response to the virus

2.     The data collected in this research study and the data we get from your medical records will be kept confidential. It will be kept in a secure research database. Only people involved with the study will have access to the database. The study files will be kept for 6 years.

3.     Staff from the HRPP, who check to make sure that the study is being run properly, may see your study information. HRPP staff are held to strict professional standards for keeping research data confidential.

4.     We may publish the results from this study in a scientific journal. We also may share study data with other researchers in the future. In either case, we will not include any information that would identify you or anyone else in the study.

5.     Your authorization to use your data for this study does not expire.

6.     You may refuse to authorize us to use your data. Refusing means that you will not take part in the study.

7.     If you wish to withdraw your permission for us to continue collecting information about you, you must do this in writing, via e-mail, to Dr. Lake (see above). You cannot withdraw permission for us to use data that have already been collected.

Study title: Surveillance of COVID-19 in a Single Institution, a Registry

We are asking you to join a research study. It is for people with fever, cold, or flu-like symptoms, as well as for people asking to be tested for COVID-19. We want to learn about the link between patient symptoms and the results of the test. If you join the study, you will fill out a survey about your symptoms. (Your loved one who is responsible for you can help you if you need it.) Then we will collect more information about you from your medical record. We will collect your test results and information about your health over the next 180 days. You do not have to do anything for this to happen. We will send your loved one a survey by email about how you feel in 90 days and again in 180 days.

This study does not involve any medication. Because of that, the risk of the study is low. You may be concerned about your privacy. The study team will take care to keep your information safe and secure.

Please talk this over with your loved one. It is the choice of you and your loved one whether you join the study. You may refuse; it will not affect the care you receive for any symptoms you have. If you have any questions, please ask Dr. Lake (adam.lake@pennmedicine.upenn.edu).

You can check below if you are willing to join the study. Your loved one also will need to give permission on another form.