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  Name Size Creator Creation Date Labels Comment  
PDF File Assent Considerations for Subjects Lacking Consent Capacity-October 2024.pdf 449 kB Pauly, Kelly (NIH/OD) [E] Sept 26, 2024 11:24
 
Microsoft Word Document CEnR CBPR Points to Consider for IRB Final_v20210809_508f.docx 37 kB Marchi, Anthony (NIH/OD) [C] Aug 16, 2021 15:30
 
PDF File COI-What IRB Members Need to Know September 2022.pdf 138 kB Rasmussen, Kevin (NIH/OD) [C] Sept 12, 2022 11:42
 
PDF File Communicating New Information to Subjects-November 2023.pdf 176 kB Pauly, Kelly (NIH/OD) [E] Oct 30, 2023 10:34
 
PDF File Comparison of Consent Regulations Table.pdf 694 kB Marchi, Anthony (NIH/OD) [C] Jul 07, 2021 13:59
 
PDF File Consent form considerations for Early Phase research May 2022.pdf 177 kB Marchi, Anthony (NIH/OD) [C] May 12, 2022 15:27
 
PDF File Consent Readability Pre-review July-2023.pdf 199 kB Pauly, Kelly (NIH/OD) [E] Jun 20, 2023 07:47
 
PDF File Considerations for Research Involving Healthy Volunteers-November 2024.pdf 223 kB Pauly, Kelly (NIH/OD) [E] Nov 06, 2024 10:30
 
PDF File Data and Safety Monitoring Plans April 2022.pdf 229 kB Marchi, Anthony (NIH/OD) [C] Mar 22, 2022 09:39
 
PDF File Device Determinations March 2022.pdf 307 kB Marchi, Anthony (NIH/OD) [C] Mar 03, 2022 15:08
 
PDF File Device Software Functions and Mobile Medical Applications-August 2023.pdf 179 kB Pauly, Kelly (NIH/OD) [E] Jul 27, 2023 07:53
 
PDF File Equitable Selection February 2022.pdf 225 kB Marchi, Anthony (NIH/OD) [C] Mar 03, 2022 15:08
 
PDF File Guideline Sheet for Reviewing Return of Secondary Genomics Plans.pdf 153 kB Pauly, Kelly (NIH/OD) [E] Jun 09, 2023 08:21
 
Microsoft Word Document How to Receive Email Updates About FDA Drug Label Changes.docx 102 kB Marchi, Anthony (NIH/OD) [C] Mar 04, 2022 09:21
 
Microsoft Word Document Initial review checklist.docx 44 kB Vorwick, Windy (NIH/OD) [C] Sept 23, 2020 16:35
 
PDF File IRB Consideration of Possible Third-Party Research Risks-January 2024.pdf 206 kB Pauly, Kelly (NIH/OD) [E] Jan 18, 2024 08:05
 
Microsoft Powerpoint Slideshow IRB Criteria for Approval 4 and 5-informed consent - Part 1 of 2 - Narrated.ppsx 27.57 MB Vorwick, Windy (NIH/OD) [C] Oct 13, 2020 16:38
   
Microsoft Powerpoint Slideshow IRB Criteria for Approval 4 and 5-informed consent - Part 2 of 2 - Narrated.ppsx 30.82 MB Admin Oct 16, 2020 12:07
   
Microsoft Powerpoint Presentation IRB Criteria for Approval Criterion 1 and 2 - Narrated.pptx 27.26 MB Vorwick, Windy (NIH/OD) [C] Sept 23, 2020 16:37
 
Microsoft Powerpoint 97 Slideshow IRB Criterion for Approval #3-Equitable Subject Selection-Narrated.ppt 10.67 MB Vorwick, Windy (NIH/OD) [C] Sept 23, 2020 16:37
 
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