Human Research Protection Program

Ten Common IRB Protocol Mistakes

1. Investigators have not completed required CITI training courses/ modules.

See the HRPP Required Training webpage for guidance.

Note that if you have taken a CITI course elsewhere, you must affiliate yourself with Brandeis University and complete any additional modules required for the requisite Brandeis course.

2. Not all required elements of informed consent are included in the informed consent form/ information sheet (necessary unless a waiver or permission for an alteration is requested).

See the Elements of Informed Consent sheet for guidance. Note that elements 1-13 are required for all research.

3. The informed consent form/information sheet is not in an acceptable format or reading level (typically 8th grade).

See the Informed Consent Template for guidance.

4. There is confusion between the concepts of a “waiver of informed consent” and a “waiver of documented informed consent.”

See the HRPP Informed Consent webpage for guidance.

5. The informed consent form/information sheet contains grammatical, spelling, or punctuation errors or typos.
Have someone proofread your protocol prior to submitting it to the HRPP office.
6. The protocol is difficult to follow.

Keep in mind that the reviewers are not familiar with your project – the protocol is the only information they have to go on when completing their review. Ensure your answers are complete and in layman’s terms.

7. There are discrepancies throughout the protocol with things like the time it will take to complete a survey or the amount of money subjects will be compensated for their time.
8. The data management plan is not thought through in sufficient detail.
See the Guide to Data Management and Protection for guidance.
9. There is confusion between the concepts of anonymity and confidentiality.

See the HRPP Anonymous vs Confidential webpage for guidance.

10. Questions on the application are not answered adequately.

Take your time to read the questions fully and answer them thoroughly.