Pregnancy During Research Participation Guidance Documents and References Points to Consider ⏴back to Guidance Series Pregnancy During Research Participation Version: April 28, 2021 Guidance For some research protocols, women of childbearing age are advised to avoid pregnancy or nursing for a time during or following the research to protect the health and safety of the […]
Read MoreGenetic Research Introduction Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Series Genetic Research Version: February 2, 2021 Introduction Information developed during genetic studies may vary considerably with respect to its impact and value to subjects. When using the following guidance, it is acknowledged that there are many ways of responding to […]
Read MoreConsent During the COVID-19 Public Health Emergency Guidance Documents and References Points to Consider ⏴back to Guidance Series Consent During the COVID-19 Public Health Emergency Version: September 22, 2020 Guidance During the COVID-19 public health emergency, the IRB realizes that investigators must plan for adjustments to the consent process and documentation of consent. This guidance […]
Read MoreResearch Design Introduction Guidance Documents and References ⏴back to Guidance Series Research Design Version: September 10, 2020 Introduction “It is not unusual for institutional review board (IRB) members, institutional officials, and researchers to debate the role of the IRB in evaluating study design or other aspects that affect the fundamental quality of the science of […]
Read MorePlacebo Comparators Guidance Points to Consider ⏴back to Guidance Series Placebo Comparators Version: September 4, 2020 Guidance A protocol that involves removing participants from the standard medication for their disease or condition, and randomizing them to receive either an investigational agent or a placebo, may raise issues of participant safety. If some participants will receive […]
Read MoreGender Inclusive Language in Research Definitions Guidance Documents and References ⏴back to Guidance Series Gender Inclusive Language in Research Version: August 15, 2019 Definitions Gender or Gender Identity describes the internal/psychological sense of self, regardless of biology. Response options to questions categorizing gender would typically include woman, man, transgender, and non-binary. Sex is the biological […]
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 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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