Neonates Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Neonates Version: January 21, 2019 Definitions Subpart B: This term refers to the regulations which apply to research involving neonates as subjects. Subpart B is found in 45 CFR 46 (DHHS). Neonate: Newborns from the time of delivery up until 28 days […]
Read MoreWards of State Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Wards of State Version: November 8, 2016 Definitions Ward: A ward is a child who is placed in the legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State, or local law. The term […]
Read MoreExercise Testing in Research Guidance Documents and References Points to Consider ⏴back to Guidance Series Exercise Testing in Research Version: June 17, 2016 Guidance When exercise testing is used as part of a research study, investigators must provide the IRB with information regarding the safety plan. Investigators should describe the process and mechanisms in place […]
Read MorePrivacy and Confidentiality Guidance Documents and References Points to Consider ⏴back to Guidance Series Privacy and Confidentiality Version: May 19, 2016 Guidance When thinking about privacy and confidentiality in the research context, distinctions should be made between the two issues. Privacy refers to persons and to their interest in controlling access of others to themselves. […]
Read MoreExemption Umbrella Protocol Help Sheet Guidance ⏴back to Guidance Topics Exemption Umbrella Protocol Help Sheet Version: October 14, 2014 Guidance When completing your IRB application for an Exemption Umbrella Protocol, you must include the following information as indicated below, replacing any instruction text in red with project-specific information. General Application Guidance You must answer all […]
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