Common Problems with IRB Applications
Not Adhering to IRB Policies
Your application will automatically be rejected upon submission by the IRB if any of the following is missing and/or non-adherence to IRB policy:
- File Naming Policy: All documents within an IRB application packed (Application, Consent, Recruitment, surveys, etc.) except CITI trainings need to be named with the PI’s last name as per the File Naming Guidance Document (please see Guidance/Videos tab).
- Digital signatures by the PI and the Chair/Dean of the department must be on the application.
- CITI training documents must not be expired or incorrect.
- Using “see attached” will result in rejection, unless reference is made to a complete manuscript or test material.
- Application PDF must not be a scanned version.
Completeness/Comprehensiveness of Information
Remember, the job of the IRB is to review applications to determine the risks & benefits that exist in the proposed study. As such, it is vitally important for the PI to be thorough and complete when describing each section of the IRB application, as well as materials that are to be used. For example, attach a copy of any surveys, recruitment scripts, pre- and post-tests, and questionnaires; describe in detail the tasks that the participants will complete; describe the various parts of your study.
Any materials that you will use to recruit participants need to be included. This includes but is not limited to flyers, posters, announcements, telephone scripts, email scripts, and oral assent scripts. If this study is to be completed with participants who are non-English speaking, the materials must be approved first in English and then undergo an acceptable translation. An approval letter will not be awarded until all versions of the materials have been approved.
It is vital that if the researcher is in a position of authority over the participants, this relationship must be disclosed, and a complete description of how the risks associated with coercion will be mitigated in the research design (e.g. the use of a neutral third party) must be provided.
In addition to a thorough description of your research, it is important that all questions of the application be completed so that the IRB will know how to contact you and all members of the research team. The IRB can make an informed decision regarding your proposal. The more complete your proposal is, the less likely there will be delays in processing it.
- using “see attached“, unless reference is made to a complete manuscript or test material
- cutting and pasting from other documents as the material that you are moving will probably not answer the question in its entirety
Remember the easier it is for the reviewer to read your application, the more likely it is that the review process will proceed smoothly.
Consent Forms & Recruitment
Please see Utah Tech University’s informed consent template and checklist as well as recruitment checklist above.
Be sure that all elements of the consent form and recruitment are included in the documents. It is vital that the consent documents are written in language that is free of jargon and at an appropriate level for your participants. Avoid using the passive voice, and try to use short words and sentences.
Be sure that the reading level of the document is appropriate to the pool of potential subjects. This may require that you provide an approved translation of the consent/assent documents. The documents should first be approved in English. After they are approved, valid translations are required.
Include all consent/assent documents in the submission. If there are translations of documents required, please submit these after the English versions have been approved. An approval letter will not be awarded until all versions of the materials have been approved.
Please avoid using small font sizes, unusual fonts or any formatting in your documents that make them difficult for the reviewer to read. Use appropriate grammar and punctuation.
Privacy, Confidentiality, and Coercion
The problems of privacy, confidentiality and coercion can be especially difficult problems for the IRB to resolve because potential participants should be able to make an informed decision without undue pressure or coercion from the researcher. Therefore, potential participants should be solicited using a non-threatening approach (e.g., flyer or broadcast e-mail announcement) or by a neutral third party.
This is a significant problem when the researchers are in a position of authority over the participants. It is essential that the researcher explains in great detail the aspects of the research design that will be used to mitigate the possibility of coercion. In educational settings, this almost always involves the use of a neutral third party.
Confidentiality of the data is of utmost importance and should be taken very seriously by the researchers. All identifying information (e.g., name, telephone number, address) should be stripped from the dataset as quickly as possible. The researcher should include a thorough description of how the data will be stored and a description of all efforts to minimize the likelihood of release of confidential information. This should be included in the application and in any informed consent process and documents.
There are two important aspects to the timely review of applications. These are:
- The completeness of the application: a great deal of time is lost when an incomplete application is submitted and the IRB Coordinator or an IRB Board member must contact you to get the needed materials and forms or to get a more complete description of aspects of the project such as the:
1. instruments to be used
2. study design
3. consent/assent documents
4. steps taken to mitigate the risks of coercion
5. steps taken to mitigate the risks associated with violations of privacy or confidentiality
- The time it takes the investigator to respond to communication from the IRB. This is a significant area for time loss in the review process. Your prompt response to such communication is vital to keep the review process moving.
Use of Your Own Students in Research
If you plan to use your own students, please use these guidelines to facilitate the IRB Review Process:
NOTE: If one’s own students are used as subjects, the investigator must explain why he or she cannot use another instructor’s students, and he or she must follow one of the following procedures:
- Use a third party for recruiting subjects, obtaining consent and collecting data (including interviewing). The data must be held by the third party and not given to the instructor until the course is completed and grades are submitted.
- If the instructor is using as research data the assignments of students that would normally be given during the course, the instructor may request from each student permission to use the student’s work AFTER the course is completed and grades are submitted.
- If the study is anonymous, the instructor may perform the study. In such a study, no signatures or identifiers or any kind are obtained. The instructor passes out an informed consent document to the class. A survey is handed out to everyone. The instructor then tells the class that if anyone would like to complete the survey, they may do so outside of class time and leave the survey in a designated location other than the classroom.