For both the Protocol and Informed Consent:
- Use a 12-point font.
Participants and committee members must be able to see it.
- Adapt the template to your own research.
Delete the parentheses, directions and italics from the final version. Adapt the template to present your own project information.
- Use everyday language.
This will allow the widest audience, including the IRB members, to understand the purpose of your research, and the procedures you have planned, and any risks or benefits involved.
- Separate your personal agenda from the research procedures.
The protocol is the place to tell the IRB how you plan to interact with your research participants to obtain the data. The informed consent tells the participants what will happen to them during the research project. The hypothesis is the place to state your research problem and proposed solution.
IRB committee members, from a wide variety of disciplines, must be able to understand the language used in protocols. Please do not use discipline-specific jargon or acronyms. If you must, please define them. Please use the template provided. Be clear and concise, and limit the scope of the document to the purpose and background of your research, the procedures you will use to elicit data from your human subjects, risk and benefits, and how you intend to analyze the data to answer your research question. If you are conducting a qualitative research project, please define your methodology clearly.
Informed Consent Guidelines
The informed consent must give prospective participants the information they need to make an informed decision whether to participate in a research project. Please use the template provided to make sure you include all the elements of informed consent. Remember to write the consent form in language which can be understood by your potential subjects. If you must use discipline-specific terms, define them clearly in everyday language.
- Write at a sixth- to eighth- grade reading level.
Lay people, as well as IRB committee members and staff from outside your own discipline, must understand your informed consent document. Please make this document simple and informative. Writing it at a sixth to eighth grade reading level will allow the widest audience to be eligible to participate in your project.
- Check the readability level of your consent form.
When you have finished writing your consent, go to the Word menu bar and choose “Tools/Options/Spelling and Grammar.” Check the “Check Grammar with Spelling” box and the “Show Readability Statistics” box. Then run a spell check, and the readability statistics will be displayed when the spell check is finished.
Human Subjects Research Training Course
All researchers doing non-exempt research using human subjects are required to pass the online research training course offered by CITI. This includes not only the principal investigator but also all co-investigators, research technicians, research assistants, or student assistant who have contact with the research subjects. Researchers doing exempt research are also strongly encouraged to complete the training.
Please refer to the Online Research Training Course page for more info.