General Application Help
Initial Review Application
Checklist and Tips
Informed Consent Development
Informed Consent Requirements (video)
Effective Consent Forms and the Process (video)
Strategies for Improving the Process (video)
OHRP: General Informed Consent Requirements (video)
Combined Consent HIPAA Wizard (Includes HIPAA Authorization)
Research with Vulnerable and Underrepresented Populations (panel discussion)
Modifying approved studies
Review of ongoing studies, required at least annually when applicable.
Screening and Recruitment
Studies must remain active in ARROW until all research activities are complete.
Data analysis is considered a research activity, which does require an active study so DO NOT close the study until after data analysis has been completed. If the study has been given an expiration date/annual review, you must submit a continuing review, in advance of the expiration date, to ensure the study remains active.
Information about Continuing Review can be found in Ongoing Activities.
Closing a Study with the IRB
When data analysis is complete - as determined by the study PI (See Study Closure Policy) - a Study Closure Report should be submitted in ARROW. Please refer to the "Study Closure" link on the ARROW FAQs page for a step-by-step guidance on submitting the Study Closure Report.
Ensure the Closure Report is consistent with IRB approved activities and the previous Continuing Review application.
When a Closure Report is confirmed by the IRB, the PI will then be able to Archive the study. When a study is Archived, no further email notifications will be sent and the study cannot be reopened.
Though not currently required, study teams will benefit from closing and archiving completed studies since:
- Campus policy requires research data be maintained by the PI for seven years after “the final project close-out”;
submitting the Closure Report marks the beginning of this data retention period;
- Currently, closed studies will not be subject to post approval monitoring.
Further information about study closure can be found below in the Study Closure and Data Retention section.