Stuchiner, Tamela
Lucas, Lindsay
Baraban, Elizabeth
Spinelli, Kateri J.
Chen, Chiayi
Smith, Alden
Hashemi, Lobat
Cohan, Stanley
Funding for this research was provided by:
Sanofi Genzyme
Article History
Received: 17 February 2020
Accepted: 26 November 2020
First Online: 4 December 2020
Ethics approval and consent to participate
: This study was approved by the Providence Health & Services Institutional Review Board. The registration form completed by participants includes language of consent that states by submitting the registration form, consent is given to participate in the study. In accordance with the Providence Health & Services Review Board, implied consent was reviewed and approved by the Privacy Board. As this is a regional, voluntary registry for which not all participants are patients of our healthcare system and therefore they register through the website, it is not practical to obtain written consent for all participants. After 2014, the registry became electronic (online only). Date of submission of the registration is documented in the registry as the consent date. Approved language by the Providence Privacy Board and Institutional Review Board and in accordance with all HIPAA regulations for implied consent is below: “If you agree to take part in this project, please fill out the online registration form. Once we receive your completed form as your consent to participate, we will send you surveys to learn about you, your disease, and the medicines or services you use to help manage your disease. Participation is voluntary and you will not receive payment for participating.”Taking part in the registry will have no effect on your relationship with your doctors. The information that you and other persons with MS provide will be used only for research purposes; for example, to compare the rate of MS between different regions, or to compare the health care available to MS patients living in rural versus urban areas.“We will make every effort to protect your privacy. A number will be assigned to represent your information. All information about you will be kept in secure, locked cabinets and password-protected computer files. Your personal identity will not be shown as part of any reports or made available to insurance or other companies. We may send you additional surveys from time to time, but your privacy will always be protected. Only the MS Registry researchers will have access to the information you provide for the registry. You are not required to answer all survey questions. Also, you may choose to stop your participation at any time. If you decide to stop taking part in the MS registry, please notify us by using the Pacific Northwest MS Registry contact information. Information that you have already provided will still be used in the registry, but no more information about you will be collected. If you have any questions about the registry please contact Dr. Stanley Cohan’s office at 503–216-1060. If you have any questions about the use of your information for research purposes, please call the Providence Health & Services Institutional Review Board at 503–215-6512, or the HIPAA privacy officer at 503–574-9123.”
: Not applicable.
: TS, LL, EB, KJS, and CC have no conflict of interest to report. SC has either served on advisory boards or steering committees for Biogen, Mallinckrodt, Novartis, and Sanofi Genzyme; has received research support from AbbVie, Adamas, Biogen, Mallinckrodt, MedDay, Novartis, Opexa, Roche Genentech, Sanofi Genzyme, and Teva; and has received speaker honoraria from Acorda, Biogen, Novartis, and Sanofi Genzyme. AS and LH were employed by Sanofi and owned Sanofi stock at the time of the analysis.