#  Key Checklists and Worksheets 

 



Many checklists and worksheets for reviewers are available in the IRB Library to provide reminders, guide decisions, and help document decision criteria.

**Important!** Checklist information is required by regulations to document the findings that justify your determinations. Fill out the pertinent checklists and attach them when you submit the review form. For committee reviews, attach your individual checklists as described in [Preparing Comments for a Meeting](/reviewer-meeting-prep).

Worksheets also provide important guidance, but regulations do not require them to be retained.

The following table summarizes some of the key pertinent checklists and worksheets, organized by the types of review decisions you must make. Consult with your IRB policies and procedures for a complete list of Checklists, Worksheets and requirements.

Sort**Topic****Checklists**  
**(use and attach)****Worksheets**  
**(for reviewer's use)****Approval criteria**

 

- [Criteria for Approval](https://irb.harvard.edu/IRB/sd/Doc/0/A3QTNQAVIS74DB77QLE6523245/HRP-314-WORKSHEET-Criteria%20for%20Approval.docx)



**Level of review**

 

- [Engagement](https://irb.harvard.edu/IRB/sd/Doc/0/PMUK6ROBKP1KF6U3L13UGSMT00/HRP-311-WORKSHEET-Engagement.docx)
- [Exemption](https://irb.harvard.edu/IRB/sd/Doc/0/HJI7K351US3KN6UMKKN8O7C750/HRP-312-WORKSHEET-Exemption.docx)
- [Expedited](https://irb.harvard.edu/IRB/sd/Doc/0/KVN9DISSJGLKRD5GGB2KP1CNDC/HRP-313-WORKSHEET-Expedited%20Review.docx)



**Consent / recruitment**

- [Waiver or Alteration of Consent](https://irb.harvard.edu/IRB/sd/Doc/0/C755M3M2FEUKB0BE85N0K3HL8C/HRP-410-CHECKLIST-Waiver%20or%20Alteration%20of%20Consent%20Process.docx)
- [Waiver of Written Documentation of Consent](https://irb.harvard.edu/IRB/sd/Doc/0/J0EGFMPHS00499DUTJA9E5OV6F/HRP-411-CHECKLIST-Waiver%20of%20Written%20Documentation%20of%20Consent.docx)
- [HIPAA Waiver of Authorization](https://irb.harvard.edu/IRB/sd/Doc/0/TUK1PPOVT2P4LFF0QVG4B7AS9D/HRP-441-CHECKLIST-HIPAA%20Waiver%20of%20Authorization.docx)



 

**Special populations**

- [Pregnant Women](https://irb.harvard.edu/IRB/sd/Doc/0/S12EJO6DK88UKMK195IPCLIG00/HRP-412-CHECKLIST-Pregnant%20Women.docx)
- [Non-Viable Neonates](https://irb.harvard.edu/IRB/sd/Doc/0/GTDCM416D8MK1BDJBI4Q1AKU75/HRP-413-CHECKLIST-Non-Viable%20Neonates.docx)
- [Neonates of Uncertain Viability](https://irb.harvard.edu/IRB/sd/Doc/0/GN2ASTK2CBB4FD0R115GIGFB49/HRP-414-CHECKLIST-Neonates%20of%20Uncertain%20Viability.docx)
- [Use of Fresh Human Fetal Tissue in Research](https://irb.harvard.edu/IRB/sd/Doc/0/K3MG7P1I4534T3CPHBO416I5A8/HRP-445-CHECKLIST-Use%20of%20Fresh%20Human%20Fetal%20Tissue%20in%20Research.docx)
- [Prisoners](https://irb.harvard.edu/IRB/sd/Doc/0/IBMIT9JJ7UOKB7SO60MB7GONF2/HRP-415-CHECKLIST-Prisoners.docx)
- [Children](https://irb.harvard.edu/IRB/sd/Doc/0/6DMLATBK8OFKB9GQ7498HHSID3/HRP-416-CHECKLIST-Children.docx)
- [Cognitively Impaired Adults](https://irb.harvard.edu/IRB/sd/Doc/0/J06C3S9IMH3KVAJP9JD1EB7G5D/HRP-417-CHECKLIST-Cognitively%20Impaired%20Adults.docx)



 

**Devices / drugs**

- [Non-Significant Risk Device (FDA)](https://irb.harvard.edu/IRB/sd/Doc/0/E9H4FGFSK6A417OMDLKPVG8AA5/HRP-418-CHECKLIST-Non-Significant%20Risk%20Device.docx)



 

**Federal agencies / laws**

- [HIPAA Waiver of Authorization](https://irb.harvard.edu/IRB/sd/Doc/0/TUK1PPOVT2P4LFF0QVG4B7AS9D/HRP-441-CHECKLIST-HIPAA%20Waiver%20of%20Authorization.docx)



- [NIH GDS Institutional Certification](https://irb.harvard.edu/IRB/sd/Doc/0/FNO0JTQLP0H494SR0SH1SO5L13/HRP-332-WORKSHEET-NIH%20GDS%20Institutional%20Certification%20.docx)
- [Additional Federal Agency Criteria](https://irb.harvard.edu/IRB/sd/Doc/0/QQ08TIL3UMDK5APSV426KL0MB0/HRP-318-WORKSHEET-Additional%20Federal%20Agency%20Criteria.docx)









 

- [Logging In](/logging-in "Logging In")
- [Locating the Reviewer To-Do List](/locate-reviewer-todo "Locating the Reviewer To-Do List")
- [Accessing a Submission](/accessing-submission "Accessing a Submission")
- [Locating the Meeting Agenda](/locating-meeting-agenda "Locating Meeting Agenda Items")
- [Locating Reviewer Checklists](/locating-checklists "Locating Checklists for Reviewers")
    - [Key Checklists and Worksheets](/key-checklists "Key Checklists and Worksheets")
- [Reviewing a Submission](/view-submission-details "Reviewing a Submission")
- [Requesting Clarifications](/requesting-clarifications "Requesting Clarifications to a Submission")
- [Viewing Study Changes](/view-changes "Viewing Changes to a Study")
- [Creating a Printable Attachments](/creating-printable-packet "Creating a Printable Attachments")
- [Preparing Comments for a Meeting](/reviewer-meeting-prep "Preparing Comments for a Meeting")
- [Submitting a Review Decision](/review-decision "Submitting a Review Decision")