University Pennsylvania Consent Form
Protocol Information
Attached to Protocol: IRB-843454
Principal Investigator: Christopher M. Perrone
IRB Protocol Title: Multiple Sclerosis Patient Response to COVID19 Outbreak
Research Purpose: Currently, we still have little information on whether this virus affects patients with multiple sclerosis (MS), neuromyelitis optica (NMO), transverse myelitis, optic neuritis, anti-MOG syndrome, or another inflammatory disease of the brain or spinal cord. We need your help to collect valuable information on COVID-19; this information will help us to guide you and the patient community through this challenge
Contacts
- Christopher Perrone, Principal Investigator, Phone: 215-662-3606 , Email: christopher.perrone@pennmedicine.upenn.edu
- Mary Spencer, Coordinator, Phone: 267-588-9099, Email: Mary.Spencer@pennmedicine.upenn.edu
- Ashley Reiter, Coordinator, Phone 267-521-2377, Email: ashley.reiter@pennmedicine.upenn.edu
Information on Research
Welcome to the COVID-19 response survey research study. We are using this online questionnaire to both minimize any risk of virus transmission and to rapidly gather information on large number of patients so that we can get
scientifically rigorous results with which to inform the management of our patients. The information you input into the questionnaire will be kept private, but we will make the results from the entire study available to other scientists and
physicians as quickly as possible, and we will update you on these results through an electronic newsletter. We will collect this data through online questionnaires via REDCap, a secure online database. The study team may access your medical records to confirm your diagnosis.
General Information
Research Study Summary for Potential Subjects
You are being invited to participate in a research study. Your participation is voluntary, and you should only participate if you completely understand what the study requires and what the risks of participation are. You should ask the study team any questions you have related to participating before agreeing to join the study. If you have any questions about your rights as a human research participant at any time before, during or after participation, please contact the Institutional Review Board (IRB) at (215) 898-2614 for assistance.
We are asking you to take part in a research study because you have been diagnosed with multiple sclerosis or another neuro-immune disease, or because you are a healthy individual who lives with someone who has one of these diseases. We are looking for about 500 participants at the University of Pennsylvania to be part of this research study. Several other centers around the country are also participating, and at the end of the study, information from all the centers will be pooled together.
This study will employ prospective data collection and review of medical records. It is an observational, non-interventional study. Participants will be provided with a longitudinal set of online questionnaires to assess response to the COVID-19 outbreak. Information surrounding their neurologic diagnosis will be verified from their medical records. A set of surveys will be sent out every 2-4 weeks, and each set of surveys will require approximately 10-30 minutes to complete. There will be 16 total sets of surveys over 52 weeks. No in-person visits or testing are required. Your participation will last for approximately 2 years.
If you are interested in participating, a member of the study team will review the full information with you. You are free to decline or stop participation at any time during or after the initial consenting process.
Why am I being asked to volunteer?
We are asking you to take part in a research study because you have been diagnosed with multiple sclerosis or another neuro-immune disease, or because you are a healthy individual who lives with someone who has one of these diseases. We are looking for about 2000 participants at Yale to be part of this research study. Several other centers around the country are also participating, and at the end of the study, information from all the centers will be pooled together.
Your doctor may be an investigator in this research study. You do not have to participate in any research study offered by your doctor. If you choose not to participate, there will be no loss of benefits to which you are otherwise entitled. You may also decide to discuss the study with your family, friends, or family doctor. Being in a research study is different from being a patient. As an investigator, your doctor is interested both in your clinical welfare and in the conduct of this study.
If you decide to participate, you will be asked to sign this form. A copy of this form will be provided to you for your records.
What is the purpose of this research study?
The purpose of this research study is to understand how our patients with MS and other neuroimmune disorders are being affected by the COVID-19 outbreak. We want to understand how susceptible our patients are to COVID-19. We also want to evaluate the longer-term social and psychological consequences of the pandemic for individuals who have chronic neuroimmune diseases. We are also inviting healthy individuals to participate in this study as controls.
How long will I be in the study?
Your participation will last for approximately 2 years.
What am I being asked to do?
If you agree to take part in this study, this is what will happen:
We will send you a number of electronic surveys over the course of one year. A set of surveys will be sent out every 2-4 weeks, and each set of surveys will require approximately 10-30 minutes to complete. There will be 16 total sets of surveys over 52 weeks. No in-person visits or testing are required.
The surveys will focus on any symptoms of COVID19, how the pandemic has affected your MS/MS treatment, and also on your emotional health and availability of social support.
The schedule for the surveys is as follows:
Week | 0 | 2 | 4 | 6 | 8 | 12 | 16 | 20 | 24 | 28 | 32 | 36 | 40 | 44 | 48 | 52 |
Estimated time (min) | 25-30 | 15-20 | 10-15 | 25-30 | 10-15 | 20-25 | 10-15 | 10-15 | 20-25 | 10-15 | 10-15 | 20-25 | 10-15 | 10-15 | 20-25 | 10-15 |
If you carry a diagnosis of MS or another neuroimmune disease, the study team will access your medical record (e.g. doctor's notes, lab results, imaging results) to verify the diagnosis. We will not access health records for healthy participants.
What are the possible risks or discomforts?
A risk of taking part in this study is the possibility of a loss of confidentiality or privacy. Loss of privacy means having subjects' personal information shared with someone who is not on the study team and was not supposed to see or know about subjects' information. The study team plans to protect subjects' privacy through the use of a secure log in with username and passwords. Only the personnel involved in this study will have access to the study data.
What if new information becomes available about the study?
During the course of this study, we may find more information that could be important to you. This includes information that, once learned, might cause you to change your mind about being in the study. We will notify you as soon as possible if such information becomes available.
What are the possible benefits of the study?
You will not benefit from taking part in this study, but your participation may help people who have multiple sclerosis, neuromyelitis optica, and other less common neuroinflammatory conditions in the future.
What other choices do I have if I do not participate?
You may choose not to participate in the study at any time.
Will I be paid for being in this study?
You will be not be paid for taking part in this study.
Will I have to pay for anything?
Since this is a survey based study, there is no payments needed. You are still responsible for any deductibles or applicable co-pays for routine office visits, scans and blood work. Please talk to your doctor and study team about putting you in touch with a financial counselor to determine exactly what the deductible and co-pay will be for you; this is highly variable depending on your type of insurance.
When is the Study over? Can I leave the Study before it ends?
This study is expected to end after all participants have completed all visits, and all information has been collected. This study may also be stopped at any time by your physician, the study Sponsor, or the Food and Drug Administration (FDA) without your consent because:
- The Primary Investigator feels it is necessary for your health or safety. Such an action would not require your consent, but you will be informed if such a decision is made and the reason for this decision.
- You have not followed study instructions.
- The Sponsor, the study Principal Investigator, or the Food and Drug Administration (FDA) has decided to stop the study.
If you decide to participate, you are free to leave the study at anytime. Withdrawal will not interfere with your future care.
How will my personal information be protected during the study?
We will do our best to make sure that the personal information obtained during the course of this research study will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. The Institutional Review Board (IRB) at the University of Pennsylvania will have access to your records. If this study is being overseen by the Food and Drug Administration (FDA), they may review your research records.
We will also share information about you with other researchers for future studies, but
we will not use your name or any other identifiers. We will not ask you for any
additional permissions. The research information that is shared with people outside of the University of Pennsylvania will not include your name, address, telephone number or any other direct identifiers unless disclosure of the information is required by law or you have authorized the disclosure.
Your questionnaire responses will be assigned a code number and will be separated from your name or any other information that could identify you. The research file that links your name to the code number will be kept in a locked file cabinet or an encrypted data file and only the investigator and authorized study staff will have access to the file.
Electronic Medical Records and Research Results
What is an Electronic Medical Record and/or a Clinical Trial Management System?
An Electronic Medical Record (EMR) is an electronic version of the record of your care within a health system. An EMR is simply a computerized version of a paper medical record.
A clinical trial management system (CTMS) is used to register your information as a participant in a study and to allow for your research data to be entered/stored for the purposes of data analysis and any other required activity for the purpose of the conduct of the research.
If you are receiving care or have received care within the University of Pennsylvania Health System (UPHS) (outpatient or inpatient) and are participating in a University of Pennsylvania research study, information related to your participation in the research (i.e. laboratory tests, imaging studies and clinical procedures) may be placed in your existing EMR maintained by UPHS. Information related to your participation in clinical research will also be contained in the CTMS.
If you have never received care within UPHS and are participating in a University of Pennsylvania research study that uses UPHS services, an EMR will be created for you for the purpose of maintaining any information produced from your participation in this research study. The creation of this EMR is required for your participation in this study. In order to create your EMR, the study team will need to obtain basic information about you that would be similar to the information you would provide the first time you visit a hospital or medical facility (i.e. your name, the name of your primary doctor, the type of insurance you have). Information related to your participation in the study (i.e. laboratory tests, imaging studies and clinical procedures) may be placed in this EMR.
Once placed in your EMR or in the CTMS, your information may be accessible to appropriate UPHS workforce members that are not part of the research team. Information within your EMR may also be shared with others who are determined by UPHS to be appropriate to have access to your EMR (e.g. Health Insurance Company, disability provider, etc.).
What information about me may be collected, used or shared with others?
This may include, for example, information in the medical record, results of physical examinations, medical history, lab tests, or PHI identifiers such as name and dates. All PHI will be removed when sharing with others outside the University of Pennsylvania.
Why is my information being used?
Your information is used by the research team to contact you during the study. Your information and results of tests and procedures are used to: