Checklist to Avoid Delays in the IRB Approval Process
This checklist is intended to help researchers create and submit applications, avoiding common errors and other issues that slow down review and time to approval.
- Ensure all members of the study team have current training
- For ED/SBS IRB studies, a UW-specific human subjects research course in CITI is required for all UW-Madison faculty, staff and student study team members. If a collaborative study includes study team members that are not
affiliated with UW-Madison, they must have completed comparable
human subjects research training elsewhere. See IRB Guidance: UW-Madison Acting as IRB of Record and ARROW FAQ: Non-UW Collaborators for more detail.
- Use the Record a Human Subjects Training Snapshot activity in ARROW to ensure all UW-Madison affiliated study team members have their CITI training appearing in ARROW.
- For ED/SBS IRB studies, a UW-specific human subjects research course in CITI is required for all UW-Madison faculty, staff and student study team members. If a collaborative study includes study team members that are not affiliated with UW-Madison, they must have completed comparable human subjects research training elsewhere. See IRB Guidance: UW-Madison Acting as IRB of Record and ARROW FAQ: Non-UW Collaborators for more detail.
Initial Review Application
- Ensure all UW-Madison affiliated personnel engaged in research activities are listed as study team members
- The Principal Investigator (PI) should hold a faculty appointment at UW-Madison;
- The PI is ultimately responsible for the study and submitting for review;
- Point(s) of Contact will receive emails about the study, can start new related applications (Continuing Review, Changes, etc.) for the study, and can edit open applications;
- Study Team Members should only list those not already identified as PI or POC;
- Any non UW-Madison personnel should be listed as non-UW collaborators in the ARROW application. See ARROW FAQ: Non-UW Collaborators for more information on how to list external personnel in the application.
- Provide a complete description of the study
- Include research questions or a hypothesis to clearly define a project as research;
- Write all responses and supporting study documents (recruitment, consent, instruments, etc.) in plain English; do not include academic jargon, citations, etc.
- Include a clear description of all potential risks to subjects
- Nearly all research submitted to the ED/SBS IRB has a risk of a breach of confidentiality;
- Other common risks including discomfort with sensitive questions; revealing personal, sensitive, or identifiable information in response to open-ended questions; embarrassment;
- Include all risks in the application and consent documents.
- Clearly state that there are no direct benefits to subjects
- In minimal risk research (all ED/SBS IRB studies), direct benefits to subjects are very rare as they cannot be proven or guaranteed;
- Compensation is not a benefit of research.
- Understand confidentiality versus anonymity
- Very few studies submitted to the ED/SBS IRB are truly anonymous;
- Most projects offer to protect the confidentiality of subjects through the use of pseudonyms, data projections, etc.;
- The anonymity of participants very rarely has any impact on how a project is reviewed or approved;
- If any identifiers are collected at any point in the study (contact with a study team member, consent documents, tracking recruitment, offering compensation), participants are not considered anonymous;
- Even three seemingly benign pieces of demographic information can easily identify an individual.
- Address data storage, access, and protection
- Long term data storage (7 years) should be on UW-Madison servers, UW Box or in secure campus locations;
- Short term storage of minimal risk data may be stored on laptops or other portable devices with appropriate protection measures (encryption, etc.).
- Address consent and provide complete consent documents appropriate for the proposed consent process and subjects
- Consent must be addressed for all studies, even if the request is to waive the informed consent process completely;
- Use the Consent Form Wizard to draft consent documents submitted with ED/SBS IRB application, to help ensure all required elements of consent are included (for HR or MR IRB applications, please be sure use consent templates provided on their website);
- Carefully review draft documents for edits & readability, appropriate language/reading level, and appropriate for the proposed consent process (signed/written document, information sheet/screen, oral script, etc.).
- Sample IRB Application Text
- Review the application and supporting documents to ensure complete
- Ensure all documents are finalized (no draft documents) and ready for review;
- Clearly explain if any site permissions, finalized MOUs/DUAs, or translated documents are forthcoming before final approval;
- Click the Hide/Show Errors link at the top of the application.
- Review the application and supporting documents to ensure consistent
- Ensure numbers (time commitment, number of subjects, age of subjects, compensation, etc.) are consistent across all sections of the application and all documents;
- Ensure risks and benefits are consistent in the application and consent, etc.
- Preview Final Documents
- Execute this activity in the study workspace on all signed consent forms that will be stamped by the IRB when approved.
- Request the PI review and submit the application
- Only the PI listed on the application can submit the application each time for review;
- The IRB cannot review an application until it is submitted;
- Any required information that is missing will block submission;
- When successfully submitted, an activity will be logged on the History tab and the Current State will change.
- Promptly address and respond to issues sent back by reviewer(s)
- Do not include questions in Reviewer Note responses;
- Do not make additional revisions, beyond those requested by the Staff Reviewer;
- Contact the assigned Staff Reviewer with questions.
- Any study team member without current training will block final approval.
- PI should resubmit issues response in a timely manner
- Only the PI can resubmit the application after issues are address;
- The IRB cannot review modifications until it is resubmitted;
- Any Reviewer Notes without a response will block submission;
- When successfully resubmitted, an activity will be logged on the History tab and the Current State will change.
- Carefully review the workspaces in ARROW
- History tab: Logs all activities including (re)submission and when each took place;
- Current State: Details where in the review process the application is;
- Documents tab: Includes stamped, approved consent documents.
- Begin your project, only after final IRB approval has been provided
- Only activities and documents included in your approved application can be conducted/used;
- If participants are providing signed, written consent, use only documents with the IRB approval stamp;
- Retain documents and data in accordance with the approved application and campus polices;
- Create and submit Change applications – which have two parts – to propose updates or modifications to the study as needed;
- Create and submit Continuing Review applications well in advance of expiration dates, if research activities are continuing;
- Request the PI submit a Completion Report when all research activities – including data analysis – are complete.