Although the details may vary somewhat from institution to institution, an application for IRB approval usually requires the following information:
- Goals and objectives of the research study;
- Description of the methods including any written materials that will be used to recruit human subjects to the study. Note that special considerations may come into play if you plan to use minors, prisoners, incompetent patients, or other vulnerable populations as research subjects. Important issues include a discussion of any criteria that will be used either to include or exclude potential subjects such as age, gender, race or ethnicity;
- Thoughtful analysis of the potential risks and discomforts that might arise from participation in the study. This is particularly important when working with vulnerable populations such as younger children or mentally-disabled persons. Be sure to clearly describe the special safeguards that you will use in order to protect the rights and safety of vulnerable human subjects. These risks should be weighed against the potential benefits that are anticipated to result from the study and you should be prepared to demonstrate that your work will not harm your subjects or that it mill minimize the possible harm and maximize the possible benefits;
- Identification of the experimental procedures, including examples of all forms, scripts, etc. that will be used to obtain and demonstrate informed consent; and
- Discussion of the research methods that you will use to acquire your human subjects’ data and to safeguard it (privacy).