Institutional Review Board (IRB)
Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, and IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of rights and welfare of human research subjects.
The purpose of the IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. FDA guidelines can be found here: www.fda.gov/oc/ohrt/irbs/default.htm.
Confidentiality
All records and other information we obtain will be kept strictly confidential. Any records with your name on them are kept in secured files. All samples are labeled only with a number code. Only authorized people in health research will use these records. Insurance companies and employers will not have access to this information. No names will be released or published in reports. Genetic studies sometimes show that family relationships among family members are different than reported to us (most commonly non-paternity). If this is discovered, we will not report this back to you or your family members.
