u6063341 – Page 8 – Institutional Review Board

Writing a Review Summary – Facilitated Review of Community Consultation Plans for Studies Using an Exception from Informed Consent (EFIC)

Categories: Board Members Guidance Series

Writing a Review Summary – Facilitated Review of Community Consultation Plans for Studies Using an Exception from Informed Consent (EFIC) Introduction Guidance Documents and References ⏴back to Board Member Guidance Board Member Guidance Series Writing a Review Summary – Facilitated Review of Community Consultation Plans for Studies Using an Exception from Informed Consent (EFIC) Version: […]

October 8, 2020

Consent During the COVID-19 Public Health Emergency

Categories: guidance-series

Consent 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 […]

September 22, 2020

Research Design

Categories: guidance-series

Research 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 […]

September 10, 2020

Placebo Comparators

Categories: guidance-series

Placebo 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 […]

September 4, 2020

Utah Population Database(UPDB) Consent and Authorization Requirements

Categories: guidance-series

Utah Population Database(UPDB) Consent and Authorization Requirements Guidance ⏴back to Guidance Series Utah Population Database(UPDB) Consent and Authorization Requirements Version: October 2, 2019 Guidance The Utah Population Database (UPDB) is a resource that is housed and operated at Huntsman Cancer Institute; however, the UPDB is not considered part of the University of Utah Covered Entity. […]

October 2, 2019

IRB Authority: Observation of Consent and Conduct of the Research

Categories: Board Members Guidance Series

IRB Authority: Observation of Consent and Conduct of the Research Guidance Documents and References Points to Consider ⏴back to Board Member Guidance Series Board Member Guidance Series Version: August 25, 2019 Guidance The IRB has authority to observe or have a third party observe the consent process, and the conduct of the research. See SOP […]

August 25, 2019

Gender Inclusive Language in Research

Categories: guidance-series

Gender 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 […]

August 15, 2019

Verification From Other Sources

Categories: Board Members Guidance Series

Verification From Other Sources Guidance Documents and References Points to Consider ⏴back to Board Member Guidance Series Board Member Guidance Series Version: April 30, 2019 Guidance The IRB determines which clinical investigations need verification from sources other than the clinical investigator that no material changes in the research have occurred since the previous IRB review. […]

April 30, 2019

Expedited Category 9 Decision Chart

Categories: Board Members Guidance Series

Expedited Category 9 Decision Chart Guidance Documents and References ⏴back to Board Member Guidance Series Board Member Guidance Series Version: February 6, 2019 Guidance Decision Chart Use this chart to determine whether a study being discussed at a convened board meeting may be expedited under Category 9. After using the decision chart above to determine […]

February 6, 2019

Exercise Testing in Research

Categories: guidance-series

Exercise 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 […]

June 17, 2016