Movassagh, Mercedeh
Morton, Sarah U.
Hehnly, Christine
Smith, Jasmine
Doan, Trang T.
Irizarry, Rafael
Broach, James R.
Schiff, Steven J. https://orcid.org/0000-0003-2623-3614
Bailey, Jeffrey A.
Paulson, Joseph N. https://orcid.org/0000-0001-8221-7139
Funding for this research was provided by:
NIH Office of the Director (1DP1HD086071, 1R01AI145057)
Article History
Received: 30 November 2021
Accepted: 17 April 2022
First Online: 13 June 2022
Declarations
:
: New COVID-19 data was generated through the Penn state PRIDE program. Eligibility to Participate in the Research Tissue and/or Data Bank Inclusion criteria for the PRIDE project were as followed: 1) any age; and 2) ability of patient, child, and/or parent(s) to understand the consenting process. Exclusion criteria are: 1) opted out of research studies; and 2) unable to understand or complete the consent process. All patients who participate in the PRIDE Program have completed informed consent, parental permission, and/or assent processes. Parents of children less than 18 years of age provided parental permission.All participants who participate in the PRIDE Program first provided written informed consent and authorization. Only “extra” blood samples were obtained, primarily drawn during a clinically ordered phlebotomy after tubes for clinical care have been obtained, thus there were no blood draws scheduled exclusively for research purposes (i.e., a separate venipuncture will not be required). “Leftover” specimens (including blood) removed from patients during medically indicated surgeries and/or procedures that were not needed for any aspect of the patient’s care would have also be obtained for processing and storage. Volunteers contacting the PRIDE Program through PennState Studyfinder, were allowed to participate in the PRIDE Program as long as all inclusion/exclusion criteria are met. By signing the written consent/authorization form, patients agreed to donate extra blood (up to two tablespoons) collected when blood was drawn for their care, and, if undergoing surgery or a medical procedure, donate whatever leftover tissue, fluid, or cells that would otherwise be discarded during the course of their care. By signing the written consent/authorization form along with their child’s signature on the assent form, parents of pediatric patients permit the donation of extra blood (up to two teaspoonfuls) collected when blood is drawn for their child’s care, and, if undergoing surgery or a medical procedure, donate whatever leftover tissue, fluid, or cells that would otherwise be discarded during the course of their child’s care. They also agreed to provide some additional health information including smoking history, race, and family health history and to allow protected health information (PHI) to be matched with samples for processing and tracking, and de-identified health information to be matched with de-identified samples for research (IRB-40532).
: All authors have read and given consent for the publication of this article.
: The authors have no competing or conflict of interest.