IRB Application & Reporting Process
Researchers should follow these 8 steps for submitting a proposal and managing an IRB-approved project.
STEP 1: Confirm that your project requires you to submit an application to the IRB.
The IRB only has jurisdiction over research involving human participants. If both of the definitions below apply to your project, you must seek IRB approval prior to beginning your project.
"Research" means a systematic investigation designed to develop or contribute to generalizable knowledge.
"Human participant" means a living individual about whom an investigator conducting research obtains: (a) data through intervention or interaction with the individual, or (b) identifiable private information.
Examples of research that do not involve human participants: literature reviews, publicly available data, and online aggregate data.
Are you still confused about whether your project is human subject research? Use this decision chart to decide if your project requires IRB approval.
Types of IRB Applications
New Projects: For applicants preparing to begin new research. New applicants must complete the entire application process.
Project Modifications: For applicants wishing to change details of a project that had previously been approved by the IRB. A completed IRB Project Amendment Request Form (Word) must be submitted to the IRB in order for changes to be made to an IRB-approved research project.
Project Extensions: For applicants wishing to extend the dates of their IRB approval in order to complete their research. Requests for extension must be submitted to the IRB along with a complete Continuing Review Form (PDF).
Special Project Types
External Research Projects: Researchers from institutions outside of UWF wishing to recruit UWF faculty, staff, or students to participate in their research must follow the procedures outlined in UWF's External Research Request Policy (PDF).
Projects as part of a research methodology course: Instructor Guidelines for Classroom Research Projects (PDF)
Still have questions?
Email email@example.com or call 850-857-6378.
STEP 2: Complete mandatory online training.
All investigators and co-investigators must complete an training course on the protection of human research participants.
There are two options for completing the training requirement. The content and format of these two training courses are similar.
First time users must register to complete the training. These instructions will guide you through the registration process.
The CITI training program contains many educational modules. You will only be required to complete the modules that correspond with your IRB application. Use this chart (PDF) to decide which training module is appropriate for you. ** CITI Training must be updated every 3 years in order for your certificate of completion to remain active. You will receive notification from CITI program and/or the UWF IRB Office regarding your need to participate in online refresher courses when the time nears. **
2. NIH Office of Extramural Research: Protecting Human Research Participants Training Course
First time users must register to complete the training. Access the course through the NIH Office of Extramural Research.
All investigators and co-investigators are also required to complete the following mandatory readings:
STEP 3: Complete the IRB Application.
When composing your IRB application, make sure that all applicable areas are completed and all questions are thoroughly answered. You will need to provide details about:
- Research Objectives
- Participants Recruitment
- Confidentiality of Data
- Methods and Procedures
- Risks to Participants
It may be helpful to use these general tips when completing your IRB application.
STEP 4: Get the necessary signatures.
All IRB applications require the signature of the primary investigator, all co-investigators (if applicable), and the investigator's department head. Students submitting an IRB application are also required to get the signature of their faculty advisor.
STEP 5: Create and attach Informed Consent Forms.
Research involving human participants requires that all participants be provided with certain information regarding the study prior to their participation. Your informed consent form must be submitted with your application.
Things to remember about informed consent documents:
There are several sections of information that must be included in your informed consent. These sections are detailed in UWF's IRB Policies and Procedures.
Informed consent forms must be easy to read and easily understood by your participants. The IRB will examine your informed consent to ensure the form is appropriate for your study's participants. You can test the clarity of your consent/assent (PDF).
Questions to consider when creating informed consent forms:
1. Are all of your participants adults?
See an example Adult Consent Form Model (PDF).
2. Does your research involve young children (less than 7 years old)?
When research involves young children, the parent assumes responsibility for consenting to the research. See a sample Parental Consent Form Model (PDF).
3. Does your research involve children and/or adolescents (7-17 years old)?
When research involves minors within this age range, the child must agree to participate in the research by signing an assent form. It is important that assent forms be tailored to the age range and abilities of the children involved in the study. Generally, written assent should be obtained from children with an intellectual age above 7 years. NOTE: In this type of research, the parent must sign a parental informed consent as well.
You can use this template to create an Child Assent Form Model (Word).
4. Could participation in your research potentially cause the participant to experience emotional disturbances?
Having to deal with negative emotions (e.g. anger, sadness, stress) may be one of the risks to which participants in your study are exposed. In this case, you should inform your participants that counseling is available. Here is an example of how to include a Counseling Statements in Informed Consent Forms (PDF) in your informed consent form.
5. Are you using an internet survey in your research (e.g. Survey Monkey)?
For research conducted via the internet, the online survey should include an informed consent form. The participant must agree to participate in the research by clicking an "agree" button on the informed consent page. The participant should also certify that they are at least 18 years of age or older.
On your IRB application, briefly describe the web site and who administers it, as well as how data security will be maintained. See the sample wording to be used with an Online Survey Consent Form Model (PDF).
6. Are you planning to take photographs of the participants and/or make video or audio recordings of the participants?
If you are planning to photograph or record your participants in any way during the research, the participants must be told that they will be recorded and must be well informed about the potential loss of anonymity. Participants who agree to be recorded must sign a recorded media addendum. If the participant does not wish to be recorded and does not sign a recorded media consent form, no recording may take place.
You can use this template to create the Recorded Media Consent Form Addendum Model (Word).
7. Does your research involve gathering Protected Health Information (PHI)? What is PHI?
PHI refers to private health information that can be traced back to the individual. If your research is collecting information about the health of your participants and is also collecting information (e.g. name, date of birth, address, zip code) that could be used to connect the health information to an individual participant, you must have each participant sign a Health Information Portability and Accountability Act (HIPAA) authorization form. See a sample Health Insurance Portability and Accountability Act (HIPAA) Authorization Form (Word).
8. Are you planning to recruit participants who are not proficient in the English language?
If you plan to recruit subjects who do not speak English, you will need to translate your consent documents to obtain true "informed" consent. Please wait until after the IRB has approved the English version of the consent document before you submit a translated version for approval.
9. Are you planning to provide incentives (money, gift cards, etc.) to attract participants?
If you will be providing incentives to your participants, you will need to disclose this information in your consent form. This information should also be noted in your application (in the recruitment section).
Due to Florida Statutes, the use of lotteries, drawings and/or raffles as incentives for research participants are NOT allowed; instead, consider incentives that can be given to every participant.
In a few cases, informed consent may not need to be documented. In these cases, you must specify why your project does not require written consent when completing your IRB application and the IRB must approve the use of verbal consent. See a sample Verbal Consent Model (Word).
Is your informed consent form complete?
STEP 6: Include all necessary attachments.
Your application should include any written documents and/or surveys that will be used in your research.
This includes, but is not limited to:
- recruitment flyers,
- recruitment scripts,
- interview questions.
If you are collecting data from persons at an institution outside of UWF, or an outside institution is helping you with recruitment, the IRB requires a letter of cooperation from the outside site's authorized institutional official. Preferably, the letter should be on institution letterhead and signed; however, an email is sometimes acceptable if sufficient detail is provided.
If you are working in coordination with a Florida public school, the IRB requires documentation of permission from the County Superintendent of Schools.
Researchers working in collaboration with agencies and individuals outside of UWF may be required to submit an application to multiple IRBs. If you have received a letter of approval from an IRB at another institution, you must submit the letter as an attachment to your UWF IRB application.
STEP 7: Submit your IRB application.
You can submit the basic IRB application through the online system.
However, you will still be required to submit a copy of the signed IRB applications to Research and Sponsored Programs via e-mail (firstname.lastname@example.org) or in hard copy (Building 11, Room 110). Your application will be not be reviewed until all signatures and attachments have been received by the IRB office.
If sent electronically, please send as a PDF document.
What happens to my application after it has been submitted?
Check out this IRB process flow chart (PDF).
STEP 8: Know Your Responsibilities as a Primary Investigator.
You are required to have IRB approval before making any changes to your research protocol.
If you want to change your project after you have received IRB approval, you must complete a IRB Project Amendment Request Form (Word). Examples of protocol changes requiring IRB approval include:
- adding or removing a co-investigator from the project;
- adding or removing a research site;
- changing the survey, test, or data collection instrument;
- changing any part of the informed consent document;
- changing any part of your recruitment procedures;
- changing your targeted study population; or
- changing any other of the project methods or procedures.
Once completed, you must submit the form to the IRB for approval. No changes may be made in your research protocol until you have received IRB approval.
You are required to stop all data collection on or before your project end date.
The approval letter you received from the IRB will provide your approved project end date. Once you have reached the end of the project period, you must stop all data collection. Continuation of data collection past the IRB approved period violates federal regulations.
If you require additional time to collect data, you may request a project extension. Requests for extension must be submitted to the IRB along with a complete Continuing Review Form (PDF). The request must be received prior to the project end date.
You are required to report the conclusion of your project to the IRB.
When you have reached the end of the approved project period and have completed data collection, you are required to provide the IRB with your responses to the Final Report Questions (PDF). You must submit your responses to these questions in order to fulfill your duties as a researcher.