Application Tips
Following the recommendations below can help reduce the time needed by the IRB to complete the review of your application and the number of action items that may require revisions to your protocol or informed consent prior to approval.
- Know your audience—IRB members and staff. The audience for IRB applications is doctoral-level reviewers and masters-level IRB staff. Most of the people who will be reviewing your application are not likely to be experts in your field and may have varying degrees of familiarity with your research methods.
- Download the latest versions of application forms and informed consent templates for each new application. These documents may have been revised since the last time you prepared an application.
- Review the IRB application form before you start filling it out. Understand where certain details belong and where the IRB reviewers expect to find them. This reduces the likelihood that you will be asked to provide clarification about details the reviewers could not easily find.
- Know your audience—research participants. Informed consent documents and research questionnaires should be written for a lay audience unless the study participants are all knowledgeable about the topic(s) being studied. For most studies, consent forms should be written at an 8th-grade reading level. If you are using Microsoft Word to draft your informed consent, you can check the readability level by following the instructions provided here.
- Avoid jargon. In your IRB application, informed consent, and surveys and questionnaires, define terms that are specific to your academic discipline and might not be familiar to your readers.
- Avoid passive voice and vague wording. Use active voice to clarify who will be responsible for accomplishing the various components of the study. Include relevant details.
- IRB application example:
- Passive voice, vague wording: “Informed consent will be obtained.”
- Active voice, specific wording: “The principal investigator will send a copy of the informed consent document to people who express interest in participating in the study. The PI will schedule a time to talk with potential enrollees by phone or Zoom to discuss any questions they may have before completing the study enrollment and informed consent process.”
- Informed consent document example:
- Passive voice, vague wording: “A sample of your blood will be taken.”
- Active voice, specific wording: “A trained member of the research team will use a sterile needle to stick your finger and obtain a few drops of blood for testing.”
- IRB application example:
- Avoid legal terminology in informed consent documents. Such phrasing can be intimidating and interfere with a participant’s comprehension of study information. Examples include “You hereby agree,” “You, the undersigned, do acknowledge that,” and “You understand your legal rights as a research participant.”
- Include appropriate details. In an IRB application, it is appropriate to include details about the analytical approaches you will use to test your hypothesis or answer your research question. This information is rarely relevant to study participants. Fewer details about data collection methods are typically appropriate in informed consent documents compared to IRB applications:
- Appropriate details, IRB protocol: “A research team member will measure the participant’s height and weight using a wall-mounted stadiometer and a calibrated balance-beam scale.”
- Appropriate details, informed consent: “We will measure your height and weight.”
- Proofread all documents for spelling and grammar before submitting them for review.