Now you're ready to start filling out the Protection of Human Subjects form! Be sure to fill this out completely--better to give too much information than not enough. If you don't give enough information about your project, your IRB form will come back to you requesting more information and you'll have to wait again. Stout's IRB tries hard to get IRB approvals back within ten days for most reviews.
Help on filling out the form:
1. The protocol form requests an abstract/overview of the project. Give a 250-word description of what you are planning to do. Assume you are writing for someone not in your field.
2. Fill out the human subjects/definition of research/exemption sections. Only request exemption for a category you know you fit.
3. You must have completed the IRB on-line training before you can get IRB approval. Every request for IRB approval is checked for completion of training.
4. Fill in the expected dates of the research. Be sure to give yourself time to get IRB approval (within ten days for quick approval of well-written protocol forms; up to a month for projects requiring full review).
5. If subjects can be identified, you need to note in question 7 how you will protect subjects' confidentiality. If your research doesn't depend upon getting identifying information, don't get it. It makes the whole project safer for subjects.
6. Any special populations or sensitive topics? If so, be prepared for a full board review.
7. Describe how you will choose subjects and assure voluntary participation. This is more than just "random selection of Menomonie business leaders"; how will you get their names and contact information? Phone book search? Web directory of some sort? Be precise in your description.
8. Procedures. Detailed information, please. Not just "survey of students in a class". Tell us what exactly will happen. Is it a paper or web survey, how will students get the survey and turn it in, what happens to those who don't want to participate, etc. If you are using a web-based survey, please answer the questions in #11 relating to confidentiality of electronic surveys.
9. Confidentiality. How will you ensure that no one besides the investigator(s) will have access to the data? How will you be sure that any reporting of the data will not identify a subject indirectly or directly (e.g. there may only be one Asian senior female in your sample).
10. Risks. There are always risks to everything we do; tell us what those are for your research. If your project involves no more than daily risk or minimal risk, tell us that. Never state "no risk" because there is no such project.
11. Benefits. What are the benefits to doing this? What are the benefits to participants (if any) and what benefits to the greater society? If there are no benefits, there isn't any point to doing the study. Risks will be balanced against benefits.
12. Attach whatever is necessary to the form: the survey/interview/instrument used; consent form (see good samples); copy of your training certificate from the online training website.
Consent form: All research needs to involve the consent of the study participant. This most commonly takes the form of a consent form. The consent form informs the participant of the purpose of the study, risks and benefits, expectations of what they will be asked to do, and verifies that participation is voluntary. There are good examples of consent forms available. If you are doing an anonymous survey, getting participants' signatures is not recommended. In this case, use implied consent language such as "by participating in this survey, you give your consent as a participant in this study...". For non-anonymous surveys and projects, consent forms with signatures are required and serve to protect both the participant and the investigator.
Signatures: The principal investigator(s) must sign, and if the investigator is a student, their research advisor must sign as well.
Bring the signed form and attachments to Research Services in 152 Voc Rehab. Someone will check it over briefly to make sure there isn't something obvious forgotten or missing, then it will get reviewed. You will receive an email with the results of the review (approved, need more info, make small modifications, etc.). You cannot start your research until you have received IRB approval. If Stout is found in violation of this Federal guideline, we are at risk of losing all Federal monies, including student aid and research grants. Please help us keep in compliance with the Federal guidelines for the protection of human subjects in research.
Approval statement: If your project involves a survey, test, or other instrument, you will receive in your approval letter a .jpg which you should copy and paste into your instrument. This way the subjects of the study know that the study has been approved by the Stout IRB. As a subject yourself, you should look for this statement on surveys you take.