Know before you submit! Here is a list of the top ten issues that may slow down the IRB review and approval process. Avoid these items and the process will be much quicker!
1. Incomplete, unclear descriptions
Ensure the application and other study document(s) are written in plain English and complete sentences. Using the “cut and paste” function is highly discouraged, as it almost always requires grammatical and formatting corrections. 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. Generally, consent form(s) should be written at a 6th – 8th grade reading level.
Ensure all information throughout the application and other study document(s) present consistent information. For example, risks listed in the application must match those outlined in the consent form(s).
3. Incomplete human subjects research training
Before IRB approval can be granted, all individuals engaged in research activities are required to complete human subjects training. Prior to submission, ensure all study personnel have actually completed their CITI and other required trainings. The IRB reviewers confirm training completion status during their review.
4. Missing study team members
All personnel engaged in any research activities including, but not limited to, recruitment, consenting, data collection, identifiable data analysis and answering questions, must be listed on the List of Research Personnel form. If the PI is a student or resident, the PI’s advisor must also be listed on this form. If the PI is not medically certified to perform study procedures, the responsible physician must also be listed on this form.
5. Missing documents
All documents that will be used during the study, such as recruitment materials, interview scripts/questions, survey tools, participant materials, and consent documents, must be included in your submission email to the IRB.
6. No risks
Like most things in life, there are risks. In human subjects research, there are also risks, even if they are minimal. Nearly all human research submitted to the IRB has at least the risk of a breach of confidentiality, especially if identifiable data is collected. Be sure to clearly identify risks associated with participation in the study, outline the steps to minimize and mitigate any identified risks, and include this information in the consent form(s). Here is an example of preferred language for a project that includes a survey that asks sensitive questions. (Remember, the language should be revised according to your target audience: the subject or IRB.):
Completing the survey may cause feelings of discomfort or emotional distress. The subject will be informed that they can stop the study at any time. If a subject expresses discomfort or emotional distress, the subject will be informed to stop the survey. Before leaving the research center, the subject will be provided with a list of resources of local counselling services.
7. No direct benefits
Most research rarely presents any direct benefit to participants (except for some clinical trials). The application and consent form(s) should clearly indicate, “There are no direct benefits to participants in this study.” Please note, compensation (i.e., money, course credit, etc.) is NOT considered a benefit of participating in research.
8. Unclear data classification
Ensure the application and other study document(s) are consistent with the state of identifiability in which the data will be collected and stored. For example, if you will be issuing a survey that will collect only de-identified data, the application and consent form(s) should NOT indicate that you will, for example, record the names of participants. Please remember that coded data is NOT de-identified data.
The University of Arizona offers Research Data Management Services. This is a free service for navigating data management requirements, tools, and best-practices.
9. Consent form(s) missing required elements
To ensure a clean, concise consent form(s), the HSPP highly recommends using the consent form templates published by the HSPP. These are drafted to include the appropriate required elements of informed consent based on the type of research. Not only does this make the IRB review process easier, it also presents research participants with a well-designed and accurate consent form(s). Please remember that if you are using Banner Health resources, the UA Medical Informed Consent Form (ICF) is REQUIRED.
10. Delays from the study team
The IRB review process requires action from both the IRB and study team. Pay close attention to correspondence, including pre-review emails, from the IRB reviewer and ensure all questions are addressed in each study document returned during the pre-review process. Timely responses to questions and rapid replies will result in faster IRB approval.