Top ten issues that may slow down the IRB approval process.
1. Incomplete human subjects research training
If any UW-Madison affiliated member of the study team does not show current human subjects research training, approval of an ED/SBS IRB protocol application will be delayed until training completion has been completed/confirmed.
Use the View Study Team Training activity in ARROW to ensure all UW-Madison affiliated study team members have their CITI training appearing in ARROW.
2. Incomplete, unclear descriptions
Ensure the protocol application and supporting document(s) are written in plain English. No scientific jargon, no citations, no academic language pasted from a grant application. The application should be written so that non-scientists and researchers from other disciplines can easily understand the study aims, goals, and plans. The consent document(s) should be written to ensure they are appropriate for the proposed consent procedures and targeted subject population.
3. Missing study team members
All personnel engaged in any research activities (including recruitment, consenting, data collection, data analysis, answering questions, etc.) must be listed as either Principal Investigator, Point of Contact, study team member, or be listed as a non-UW collaborator.
For more information about collaborators at community sites, other institutions, etc. that are engaged in research activities, click here.
4. No risks
Outlining risks does not mean that the study cannot be approved as minimal risk. Nearly all of the research submitted to the IRB office has at least the risk of a breach of confidentiality. Be sure to clearly identify risks associated with participation in the study, outline the steps to mitigate any identified risks, and include this information in the consent document(s).
5. Missing documents
All documents to be used in the course of the study - such as recruitment materials, interview scripts/questions, survey tools, consent & assent documents, data use agreements and other contracts, IRB approval or site permission from collaborating sites, etc. - should be submitted for IRB review/approval.
Ensure all information throughout the protocol application, as well as supporting documents, present consistent information (ie. Risks in the application match those outlined on the consent(s)).
7. Consent missing required elements
The IRB strongly recommends using the Consent Form Wizard
to draft consent documents submitted with ED/SBS IRB applications to ensure all required elements are included (submissions to the HS or MR IRBs should be sure to use the consent templates provided on their website
). Documents drafted using the Consent Form Wizard
should be carefully reviewed for edits and applicability to the study and proposed consent process.
8. Confidential, not anonymous
Much of the research reviewed by the ED/SBS IRB maintains the confidentiality of participants, but very few studies have truly anonymous participants. If any identifiers are collected at any point in the study, if participants will be face-to-face with study team members, or if any information is collected/tracked for recruitment or compensation, the participants are not considered anonymous. Even three seemingly benign pieces of demographic information can easily identify an individual. Ensure the protocol application and consent document(s) address the confidentiality of participants, as opposed to identifying participants as anonymous.
The anonymity of participants very rarely has any impact on how a project is reviewed or approved.
9. No direct benefits
In minimal risk research, there is very rarely any direct benefit to participants that can be proven or guaranteed. Ensure the protocol application and consent document(s) clearly indicate "There are no direct benefits to participants in this study."
Please note that compensation (monetary, course credit, etc.) is NOT considered a benefit of research.
10. Delays from the study team
The IRB review process requires actions from both the IRB (staff and, sometimes, committee members), as well as the study team. Pay close attention to the application workspaces and email notifications from ARROW as they are designed to communicate changes to the protocol status as well as the current status of the protocol application to the study team. Timely response to the questions raised by the IRB and rapid resubmission by the PI will result in faster IRB approval.