HFES 2024 – IRB Poster References

¹ Commissioner, O. of the. (2023). Informed consent guidance for IRBs, clinical investigators, and sponsors. U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent

² Commissioner, O. of the. (1998). Institutional review boards frequently asked questions: guidance for institutional review boards and clinical investigators. U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions#IRBOrg

Office for Human Research Protections (OHRP). (2021). Lesson 3: What are IRBs? HHS.gov. https://www.hhs.gov/ohrp/education-and-outreach/online-education/human-research-protection-training/lesson-3-what-are-irbs/index.html

Office for Human Research Protections (OHRP). (2023). 2018 requirements (2018 common rule). HHS.gov. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html

³ The Federal Register. Code of Federal Regulations. (n.d.). 21 CFR 56.103. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56/subpart-A/section-56.103

⁴ U.S. Department of Health and Human Services. (n.d.). Step 1: Do you need to submit to the IRB? National Institutes of Health. https://irbo.nih.gov/confluence/display/ohsrp/Step+1

Office for Human Research Protections (OHRP). (2022). Human subject regulations decision charts: 2018 requirements. HHS.gov. https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts-2018/index.html

Office for Human Research Protections (OHRP). (2022). 45 CFR 46. HHS.gov. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

⁵ U.S. Department of Health and Human Services. (2017). Does your human subjects research study meet the NIH definition of a clinical trial? National Institutes of Health. https://grants.nih.gov/ct-decision/index.htm

⁶ National Institute of Health (NIH). (2020). NIH exempt human subjects research. https://grants.nih.gov/sites/default/files/exemption_infographic_v8_508c_1-15-2020.pdf

⁷ Office for Human Research Protections (OHRP). (2023). 2018 requirements (2018 common rule). HHS.gov. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102

The Federal Register. Code of Federal Regulations. (n.d.). 45 CFR 46.102. https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102

⁸ The Federal Register. Code of Federal Regulations. (n.d.). 21 CFR 56.101. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56

The Federal Register. Code of Federal Regulations. (n.d.). 21 CFR 56.103. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56/subpart-A/section-56.103

The Federal Register. Code of Federal Regulations. (n.d.). 21 CFR 50. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50

⁹ The Federal Register. Code of Federal Regulations. (n.d). 21 CFR 50.3. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50

¹⁰ U.S. Department of Health and Human Services. (n.d.). Chapter 3 – obtaining and preparing required documents for IRB initial review. National Institutes of Health. https://ohsrp.nih.gov/confluence/display/ohsrp/Chapter+3+-+Obtaining+and+Preparing+Required+Documents+for+IRB+Initial+Review?desktop=true&macroName=use-skin

Brigham Young University (BYU). (n.d.). Completing the iRIS application. https://irb.byu.edu/completing-the-iris-application

¹¹ Office for Human Research Protections (OHRP). (n.d.). Exempt research determination FAQs. HHS.gov. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/exempt-research-determination/index.html#:~:text=When%20an%20exemption%20determination%20is,responsible%20for%20making%20exemption%20decisions

¹² The Federal Register. Code of Federal Regulations. (n.d). 21 CFR 56.104. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56/subpart-A/section-56.104

¹³ Jones Day. (2024). FDA Final Rule: IRB waiver of informed consent for minimal-risk investigations. Insights | Jones Day. https://www.jonesday.com/en/insights/2024/01/fda-final-rule-irb-waiver-of-informed-consent-for-minimalrisk-investigations#:~:text=Share-,FDA%20Final%20Rule%3A%20IRB%20Waiver%20of%20Informed%20Consent%20for%20Minimal,regulated%20minimal%2Drisk%20clinical%20investigations.

¹⁴ Office for Human Research Protections (OHRP). (2016). OHRP expedited review categories (1998). HHS.gov. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html

¹⁵ U.S. Department of Health and Human Services. (2022). National Institutes of Health. 3014-204 – Levels of IRB review and criteria for IRB approval of research. https://policymanual.nih.gov/3014-204

¹⁶ FDA. (1998). Categories of research that may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure. U.S. Food and Drug Administration. https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/categories-research-may-be-reviewed-institutional-review-board-irb-through-expedited-review