Forms and Templates
*IRB Protocol
This form is used in conjunction with Zipline to submit an application to the IRB. If you anticipate that you will have no contact with subjects, such as with a medical records review, use the form: APPLICATION IRB Protocol, No Contact with Subjects.
The form must be submitted as a Word document (not PDF or other format).
Change Notes
Revise data sharing question for clarity and to add advisory point about UW Medicine security review for machine learning using UW Medicine PHI – 06.29.2023
Add references to GUIDANCE Designing the Consent Process; remove references to Standard Consent Template; remove taxonomy emphasis for all references – 06.01.2023
Remove COVID questions; minor revision to the way the research-related costs question is asked – 03.30.2023
Add link to reasonably foreseeable risks guidance – 01.26.2023
Update reference from GUIDANCE Electronic Consent Signatures to INSTRUCTIONS UW E-Signature Tools – 12.29.2022
Revision in response to NIH DMS policy; add consultant question; other minor changes – 11.30.2022
Update to records retention requirements for subject identifiers; typo fixes and other minor organizational updates – 08.04.2022
Note limitations of using UW Medicine’s “Care Everywhere” for research purposes; expand question 8.2f to allow researchers to describe the process/method for providing new/revised information to subjects – 03.03.2022
Add question about whether UW Medicine or UW Dentistry fellows or residents will be recruited – 12.28.2021
Update references to revised consent materials; add cannabis research question – 10.08.2021
Add information about what constitutes the UW Covered Entity; add note to review UW Financial Management website for subject payment; add link to ITHS DSMP webpage – 08.26.2021
Clarify that the REDCap Mobile application does not capture legally valid e-signature; add example of how to request an exception to particular data security protections – 07.22.2021
COVID questions revised/deleted – 07.08.2021
Minor revision to question about prisoner subjects – 04.29.2021
eSignatures updates in recruitment and HIPAA sections; add reference to new TEMPLATE Other eSignature Attestation Letter; clarify that cold contact recruitment materials must be submitted – 03.25.2021
Removed question regarding ITHS COVID research review – 02.25.2021
Minor revisions to questions on prisoners, MRI, and electronic consent – 01.21.2021
Revise UW Youth Office review question – 12.09.2020
Revised subject payment question – 11.02.2020
Addition of REDCap as option for e-consent; restructure COVID review question; addition of UW Youth Program ancillary review question – 10.15.2020
Clarifications on participants older than 85 – 08.14.2020
Updated COVID-19 questions – 08.12.2020
Remove “Zipline” from document title and from documents referenced within; other, minor wording updates to several questions – 06.26.2020
Added questions related to COVID-19 protections – 06.16.2020
Updated instructions and clarifications about how to fill out the form for multi-site and collaborative study designs; revised PHI question to get more detailed information about how it is accessed; updates to formatting, typos, links, and remove references to Zipline pages that are renamed-11.15.2019
Removed all references to Confidentiality Agreements and to state law RCW 42.48 – 07.28.2019
Instructions about accessibility issues; new set of questions about return of individual research results; revise deception question; remove questions (newborn blood spots; retrospective/prospective data); minor wording, link and numbering corrections – 04.12.2019
Updated consent questions to conform with revised Common Rule; other minor fixes and updates – 11.30.2019
Many minor updates related to Zipline upgrade, see release notes for details – 08.24.2018
Minor revisions to clarify the intent of various questions – 01.12.2018
Corrected question 8 directional and typos – 06.23.2017
Corrected formatting – 04.14.2017
Updated links and fixed typos, clarified deception question – 04.05.2017
