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 […]
Read MoreResearch Conducted in Elementary and Secondary Schools Introduction Guidance Documents and References Points to Consider ⏴back to Guidance Series Research Conducted in Elementary and Secondary Schools Version: September 22, 2020 Introduction This guidance focuses on research conducted in elementary and secondary schools. For more information on research conducted in post-secondary schools, please see the IGS: […]
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 MoreResearch Conducted in Post-Secondary Schools Introduction Guidance Documents and References Points to Consider ⏴back to Guidance Series Research Conducted in Post-Secondary Schools Version: September 10, 2020 Introduction This guidance focuses on research conducted in post-secondary schools with individuals 18 and older. For more information on research conducted in elementary and secondary schools, please see the […]
Read MoreAdvertisements Guidance Documents and References Points to Consider ⏴back to Guidance Series Advertisements Version: September 9, 2020 Guidance The IRB reviews recruitment methods, including advertisements, to ensure that they do not interfere with the equitable selection of participants. The IRB reviews proposed advertisements and solicitations for research participation to ensure that they do not violate […]
Read MoreRecruitment Methods Guidance Documents and References Points to Consider Appendices ⏴back to Guidance Series Recruitment Methods Version: September 4, 2020 Guidance The IRB reviews the process of screening, recruiting, and determining eligibility. The IRB reviews proposed recruitment procedures and advertisements to ensure that they do not violate the regulatory requirements of consent. For more information […]
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 MoreRisk Assessment Guidance Documents and References Points to Consider ⏴back to Guidance Series Risk Assessment Version: August 14, 2020 Guidance The IRB must conduct an assessment of the risks to participants in order to determine whether a study is approvable. In order to approve research, the IRB must find that: Risks to subjects are minimized […]
Read MoreHIPAA Privacy Rule & Authorization Definitions Guidance Documents and References Footnotes ⏴back to Guidance Series HIPAA Privacy Rule & Authorization Version: October 21, 2019 Definitions Breach. The term ‘breach’ means the unauthorized acquisition, access, use, or disclosure of protected health information which compromises the security or privacy of such information, except where an unauthorized person […]
Read MoreUtah 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. […]
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