Human Research Protection Program

Tips for Composing your Initial Protocol

1. When composing your protocol, consider your readers. The IRB members are giving up their time to sit on the IRB and review research protocols – remember to respect their time and them.

2. Review the application in its entirety before you begin answering the questions. This will allow you to answer each question appropriately without duplicating your work. You can look through the electronic Initial Protocol or go to our Initial Protocol Sample Questions page for a preview of the main questions you will find on the application.

Note that when looking through the Initial Protocol, questions on the first page must be answered before you may continue. In addition, keep in mind that the application is “smart” – new questions may appear based on answers to initial questions.

3. Ensure you give yourself enough time for the entire protocol review process – assume you will be asked to make revisions to your protocol, just in case.

4. Take your time – read each question carefully and answer them fully. Many questions give examples of what they are specifically looking for – use these to guide your own answers.

5. Ensure you are using full sentences with correct spelling, punctuation, and grammar. Composing an IRB Protocol is similar to writing an academic paper, whether it be for a class or publication.

6. Write using lay language – remember, the reviewer might not be an expert in your exact area of research.

7. If using more than one research method (e.g., interviews and participant observation), ensure you include all methods in your answers to each question (e.g., describe your informed consent procedures for both the interviews and participant observation – use separate paragraphs for each method).

8. Be sure to include all relevant elements of informed consent in your consent documents. Note that elements 1-13 are required for all research – unless you are requesting an alteration or waiver of informed consent – while one or more of the additional elements may also be necessary (e.g., if your research includes the use of focus groups).

9. Ensure your consent documents are in an easily readable format – use our Informed Consent Template as a guide.

10. Ensure your consent documents contain no typos or errors of any kind (i.e., spelling, punctuation, or grammar).

11. Informed consent documents must be submitted in their final form – exactly as the subjects will see them.

12. Ensure all consent documents are at the appropriate reading level. If working with the general population, consent documents should be written at an eighth-grade reading level. (Our Informed Consent Template is written at the eight-grade reading level – use this as your guide.)

When working with a specific population whose reading level may be lower or is generally higher, the consent documents must/may be written for the appropriate reading level (e.g., at a fourth-grade reading level for nine-year-old subjects or at a twelfth-grade reading level for college students).

13. Ensure all recruitment materials include the required elements and are without typos or errors of any kind.

14. Proofread – and/or have someone else proofread – your final product to ensure the above tips are followed.

15. If revisions are required, read each request carefully and ensure you address each one completely.