Common Barriers to Protocol Approval

1. Using your own students as research subjects
   Given the subtle coercion that exists in the teacher/student relationship, the IRB recommends that study participants be recruited from classes other than the researcher’s own. In instances where this is unavoidable, the IRB recommends that the following measures be taken:

• Recruit another person to obtain consent, collect the questionnaires and seal them in an envelope until the end of the semester.
• Include the following sentences in the written statement which you distribute to the students; “Your participation is voluntary. Volunteering, declining to volunteer, or withdrawing after volunteering will not affect your grade; the envelope will not be opened until the grades have been submitted.”
• Provide students with an appropriate method for not participating, such as not completing but handing in the questionnaire with a cover page making the answers

2. Not allowing enough time for IRB approval before you must begin your project

Projects scheduled to begin in the spring semester, should seek approval early in the preceding fall semester. Projects scheduled to begin in the fall semester should seek approval early in the preceding spring semester.

3. Consent forms

• Must bewritten at an 8th-grade reading level. To determine the reading level of your consent form, click on the Tools menu in MS Word and click on the first option, Spelling & Grammar, and activate the readability option.
• Must include both the researcher’s and the IRB Administrator’s contact information
• Must include the name and status of the investigator, as well as the University, school and department identifiers
• Must indicate who has access to the files, where files are kept, and how anonymity is protected. Include a statement in the consent form indicating that all files must be kept in a locked file cabinet for a period of three years.
• Must inform participants that the study is confidential but not anonymous if the researchers and/or key personnel will have access to participants’ personal information.
• Must indicate that “there are no known risks” in studies where the risk of harm to participants is relatively low. It is unacceptable to state in a consent form that there are no risks to subjects, as the potential for harm can not be predicted.
• When students are involved, a statement indicating that non-participation will in no way affect academic standing or access to project services must be included.
• When children are involved, both parental permission and children's consent or assent are required.
• When video/audio-taping is involved, an opportunity to review the completed tape must be given so that subjects may ask that it not be used (either in whole or in part).

4. Some Helpful Tips

Provide detailed descriptions of study methodologies & procedures throughout your application

If there are multiple personnel working on the project, outline exactly what their roles are and make sure they have completed their CITI training program

If you are handing out surveys/consent forms, explain how you will do this and who will be responsible for distributing and collecting this information

Thoroughly explain your subject recruitment procedures

Be consistent
If you refer to a particular study procedure in your consent forms/surveys, you must also describe the procedure in your response to the application questions and in your proposal.

For example, if you plan on audio-taping your study participants and you inform them of this in your consent form, you must also provide the committee with a detailed description of who will conduct the audio taping, how you will conduct the taping and what procedures you have put in place to allow students to withdraw from the audio-taping session and/or the study should they experience discomfort.

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