Sanguine BioSciences's policies and procedures protect the subjects from whom we collect specimens and medical data. These policies and procedures comply with current regulations and guidelines from the entities below.
Office of Human Research Protections (OHRP) is an office within the U.S. Department of Health & Human Services (HHS), and provides guidance and leadership in the protection of the rights, welfare and wellbeing of human subjects involved in research. Sanguine operates according to HHS human subjects protection regulations 45 CFR 46. All Sanguine employees who are directly involved in research are required to complete human subjects protection certification.
Sanguine research studies are reviewed by Quorum Review IRB, an internationally and AAHRPP accredited ethical review board. An Institutional Review Board (IRB) is a regulatory committee that provides review and oversight to study procedures insuring all research is ethically sound and exposes participants to as little risk as possible. All divisions of Sanguine BioSciences operate under approved procedures in place to provide safety and privacy for all study participants.
Sanguine removes all identifying information from participant samples and medical data, and uses a study code to identify the participant, thereafter. This code cannot be used by third parties to connect participants with their health information. Therefore, all third parties (such as researchers) that receive samples with associated medical information from Sanguine's Cryo Core biorepository will receive coded data and are unable to associate the information with individual study participants. Each researcher requesting tissue from Sanguine's Cryo Core must be institutionally approved and be able to provide such documentation upon request. Every Sanguine employee directly involved with the biorepository has successfully completed privacy training and bound by law and company policy to protect participant privacy and confidentiality.
FDA Code of Federal Regulations 21 Part 11 (21 CFR 11) provides regulations and oversight for electronic records and signatures to insure they are as trustworthy, reliable and generally equivalent to paper records. In an effort to be environmentally cognizant and assure quality recordkeeping, Sanguine consents study participants electronically in accordance with the federal Electronic Signatures in National Commerce Act and collects and stores research data on a 21 CFR 11 compliant database.
Your participation in a research study is voluntary. You can change your mind and decide not to be in a research study at any time. There will be no penalty to you, and you won’t lose any benefits. If you decide to stop participating in a study or would like your name to be withdrawn from our contact list for future studies, please contact the study staff at (855) 836-4759. If possible, please make your request in writing.
Sanguine might contact you in the future about other research studies for which you might qualify. You can choose to be contacted about other research studies at any time by speaking with Sanguine study staff at (855) 836-4759.