Preparing your IRB proposal submission: Helpful hints and special cases.

SCROLL DOWN FOR FAQ’s:

Step 1. Before submitting your research project to the IRB, determine if it meets the requirements of human subject research.

If yes, go to Step 2. If no, then the project does not have to be reviewed by the IRB. Ethical research practices should still be followed.

Step 2. Note submission deadlines for IRB committee reviews. See Timeline page for due dates and IRB meeting dates.

Step 3. Complete the required CITI training. Certificates are active for three years, after that a new or refresher course is required. Everyone that will be involved with human subjects as part of the study must complete the required training before the study can be reviewed.

Step 4. Read over the IRB initial submission form. This asks for details about your study. This is so the IRB can determine the level of review required, and the potential risks and benefits to human subjects.

Overview of what the IRB needs to know

Short version:  your METHODS (proposed participants, materials (including informed consent/assent document, procedures)

Long version: who is your target population and how will people be sampled, is sampling equitable, do you have any needed research permissions (i.e. K-12 superintendent for children research), what will the people be asked to do (in detail, including any surveys or protocols), what are the benefits and risks beyond normal everyday life, what (if anything) do the people get out of participating, and how will the data be handled, stored, and used. The IRB wants to make sure that people can understand what is being asked of them, and that their safety and confidentiality (if applicable) is put first and foremost.

Overview of what the IRB does NOT need to know

Typically the IRB does not need any background literature review information, unless it pertains to supporting why certain materials or questionnaires are being used. The IRB does NOT review your application for  spelling, grammar, or other non human subject safety content errors. The IRB is here to assist regarding the protection of human subjects, however, we will not write or revise your proposal for you.

Step 5. Make sure you have all the research study proposal information available BEFORE completing the application. Getting a study ready for IRB review can take a significant amount of time and effort. All study methodology including recruiting, sampling, and procedural details have to be determined BEFORE submitting your application. Missing or unclear information can lengthen the review process. Students should work closely with their faculty sponsors and have them review all materials before submission.

Step 6. Submit proposal to the IRB.

Step 7. Check your email for any communications from the IRB. They may request additional information or clarification. Please respond to the IRB in an appropriate and timely manner. The IRB may request for you to attend the meeting to discuss your project.

Step 8. Notification of decisions. See due dates and IRB committee meeting times. The IRB meets one week after each submission due date. Typically you will get a response from the IRB within one week from that meeting date.

Step 9. Conduct your research as planned. Contact the IRB in a timely manner for any unanticipated aversive events related to human subjects. If you have ANY changes related to human subjects (i.e. have to add in a survey question), you must submit an Amendment form and receive approval BEFORE implementing any changes.

Why do we need an IRB?

Common question from students: “Why do I have to submit my research to the IRB? It seems like a lot of work, especially since all I want to do is ask a few anonymous survey questions”

Answer: As discussed in the CITI training, there was a need to ensure and provide guidance for the protection of human subjects. Although some research may be simplistic in nature, all human subjects research is still research and needs to adhere to the same guidelines. Ultimately this is to protect people, so when thinking about your research, take the perspective of a person who does not know anything about your project and may have little to no knowledge about university research.

Recruiting participants

Question: How do I recruit WLU people to participate in my study?

Answer: We want to avoid multiple mass emails to everyone at WLU. Each IRB proposal is required to include intended recruitment and sampling techniques. We are suggesting that people use “Hilltopper Headlines” to recruit people to participate in research studies. Include your contact information and deadlines for participating. Flyers can also be used, however, they should be removed at the end of the recruitment period.

Note that electronic recruiting and data collection pose some additional challenges to human protections, especially in the area of confidentiality.

Classroom projects & Program assessment – WHEN IN DOUBT…. ASK!

Question: Do classroom projects or program assessment require IRB review?

Certain activities have the characteristics of research but do not meet the regulatory definition of research needing IRB review. It is about the purpose and INTENT of the project. If the purpose is to teach about research and NOT contribute to generalizable knowledge then it is not considered research (for the IRB).

Examples of activities that may not need IRB review are:

• Data collection for internal departmental, school, or other college administrative purposes (e.g. teaching evaluations, course evaluations)
• If your research is a class project or term paper and will not be published in any form at any time.
• Reviews and searches of existing literature and research involving a living individual, such as a biography, that is not generalizable beyond that individual.

Use the following guidelines to determine if your activities in the classroom are subject to IRB review. IRB review is NOT required if all of the following are true:

1. The project is limited to surveys/questionnaires/interviews/observations of public behavior directly related to topics being studied in an official college course and will not be professionally published or presented outside the requirements of the course.

2. The above surveys/questionnaires/activities, etc. contain no sensitive personal questions (e.g., no questions about drug use, sexual behavior or attitudes, criminal activity, grades, medical history) or other personal information that could stigmatize an individual.

3. No identifying information is recorded to link a person with the data such that it could reasonably harm the individual’s reputation, employability, financial standing, or place them at risk for criminal or civil liability.

4. The participants in the project are not from a vulnerable or special population (e.g., pregnant women, prisoners, minors, cognitively impaired individuals).

5. The collected data does not leave the classroom setting, or if the project involves collecting data on an organization, agency or company, the data are shared only with that entity.

6. No WLU employee or student is receiving financial compensation for collecting, organizing, analyzing, or reporting the data.

If not all of these conditions are met, or if your project does not fall into any of these categories, your project will require IRB notification and may require formal IRB approval before you can start with your project.

When in doubt – email the irb and ask!