Completeness of information
Remember the job of the IRB is to review applications to determine the risks and benefits that exist in the proposed study. As such, it is vitally important to be thorough and complete when describing the test materials that are to be used. For example, attach a copy of any surveys, pre- and post-tests, and questionnaires; describe in detail the tasks that the participants will complete; describe what parts of your study are research and what parts are typical clinical or educational practice. For example, in the simplest case, if you are going to test students using pre- and post-educational techniques and the educational technique is standard educational practice, then the research is only the pre- and post-test scores.
Any materials that you will use to recruit participants should be included in the application as well. This includes but is not limited to flyers, posters, announcements, telephone scripts, e-mail 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 Administrator 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
Please see Montclair State University’s informed consent templates.
Be sure that all elements of the consent form are included in the document. 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 (see the readability guide (PDF)). 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.
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:
- instruments to be used
- study design
- consent/assent documents
- steps taken to mitigate the risks of coercion
- 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 Analyst or the Board. 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.
- Failure to respond to comments in Cayuse IRB. In addition to making any changes requested, please reply to the comment that you addressed the concern and made the necessary revisions.
- Forgetting to certify the submission in Cayuse IRB. IRB staff will not receive any submission until it has been certified by the PI.
The use of non-English speaking participants requires special care on the part of the investigator. If you intend to use translations, please indicate in the application the languages (other than English) that you will use.
All materials should be presented to the IRB in English so that a thoughtful review of the risks associated with the materials can be made. Because changes may need to be made to the materials, it is unwise to have the materials translated before final approval of the materials is obtained. After the materials have been translated, the investigator is responsible for providing the IRB with verification of the veracity of the translations.
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.