Required Documents and Forms for IRB Applications Guidance ⏴back to Guidance Topics Required Documents and Forms for IRB Applications Version: December 4, 2025 Guidance The IRB reviews and approves supporting documents to the IRB application for the following purposes: Information included in the document is necessary for the IRB to determine if the study meets the Criteria for […]
Read MoreRecruitment Methods Guidance Documents and References Points to Consider Appendices ⏴back to Guidance Topics Recruitment Methods Version: December 4, 2025 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. Advertising Advertising is […]
Read MoreSuicide Risks Guidance Documents and References Appendices Footnotes ⏴back to Guidance Topics Suicide Risks Version: December 1, 2025 Guidance Some studies may involve research with participants at heightened risk of suicide, while other studies may only include a standard survey asking about a participant’s mental health (questions about depression or suicide) as part of a […]
Read MoreResearch Conducted in Higher Education Introduction Guidance Documents and References Points to Consider ⏴back to Guidance Topics Research Conducted in Higher Education Version: November 26, 2025 Introduction This guidance focuses on research conducted in higher education (i.e., post-secondary schools) with individuals 18 and older. For more information on research conducted in elementary and secondary schools, […]
Read MoreResearch Conducted in Elementary and Secondary Schools Introduction Guidance Documents and References Points to Consider ⏴back to Guidance Topics Research Conducted in Elementary and Secondary Schools Version: November 26, 2025 Introduction This guidance focuses on research conducted in elementary and secondary schools. For more information on research conducted in higher education, please see the IRB […]
Read MoreRisk Assessment Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Risk Assessment Version: November 21, 2025 Definitions Standard of Care: In this guidance, the term standard of care is used to refer to medically recognized standards of care. Medically recognized standards of care are treatments or procedures that have been accepted […]
Read MoreEthical Considerations for Surrogate Consent Definitions Guidance Documents and References Footnotes ⏴back to Board Member Guidance Board Member Guidance Series Ethical Considerations for Surrogate Consent Version: November 17, 2025 Definitions Assent: Assent is a term used to express willingness to participate in research who are too young to give informed consent or do not have […]
Read MoreLegally Authorized Representative (LAR) and Surrogate Consent Definitions Guidance Documents and References Points to Consider Appendices Footnotes ⏴back to Guidance Topics Legally Authorized Representative (LAR) and Surrogate Consent Version: November 17, 2025 Definitions Assent: Assent is a term used to express willingness to participate in research who are too young to give informed consent or […]
Read MoreModernizing Biosafety (IBC) Regulations On September 9, the NIH announced plans to modernize their biosafety regulatory framework. You can see details here: https://www.nih.gov/about-nih/nih-director/statements/nih-launches-initiative-modernize-strengthen-biosafety-oversight and here: https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy/#tab2/ The NIH has indicated the new regulations will align with risk, lower regulatory burden for low-risk research, expand oversight beyond work with recombinant and synthetic nucleic acids, and empower IBCs. […]
Read MorePlease plan for a little extra time during the upcoming holiday season for application approvals, as some of our meetings will be canceled; see schedule below. November 26, 2025 (day before Thanksgiving): Regular IRB board meeting December 24, 2025 (Christmas Eve): Canceled board meeting December 31, 2025 (New Year’s Eve): Canceled board meeting January 7, […]
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