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.
|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.
Still have questions?
Email email@example.com or call 850-857-6378.
All investigators and co-investigators must complete the Protection of Human Research Participants computer-based training course from the National Institutes of Health (NIH) AND attest they have read the Belmont Report and UWF IRB Policies and Procedures. A copy of the training certificate must be submitted along with your IRB application.
UWF has provided an electronic IRB application. Please complete the application by making sure all applicable areas are completed and all questions are thoroughly answered.
|ARE YOU USING A MAC?|
|1.||Open the IRB application in Adobe.|
|2.||Save your application prior to clicking "Generate PDF."|
|A.||CTRL+A or right click mouse and choose Select All.|
|B.||CTRL+C or right click mouse and choose copy.|
|C.||Open word processing software.|
|D.||Press CTRL+V or right click mouse and choose paste.|
|E.||Save new document.|
Need some help completing the application? Check out additional tips for preparing an IRB application.
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.
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. 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.
See an example informed consent form for adults. (PDF)
When research involves young children, the parent assumes responsibility for consenting to the research. See a sample parental consent form. (PDF)
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 assent form. (Word)
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 statement in your informed consent form. (PDF)
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 (PDF).
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 informed consent addendum for use of recorded media. (Word)
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 HIPAA authorization form. (Word)
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.
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.
Is your informed consent form complete?
Checklist for Informed Consent Documents
Your application should include any written documents and/or surveys that will be used in your research. This includes, but is not limited to:
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.
Note: Florida public schools require 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.
All IRB applications should be submitted to Research and Sponsored Programs via e-mail (firstname.lastname@example.org) or in hard copy (Building 11, Room 110). If sent electronically, please send as PDF or Word documents.
Signatures are required on ALL applications before projects will be reviewed. Be sure to submit all of your supporting documents and training certification along with your application.
What happens to my application after it has been submitted?
Check out this IRB process flow chart.
Once the IRB members have reviewed your application and decided to approve the project, you will receive a formal approval notification letter via email. Receipt of this letter is an important part of your research project as it details your duties as a researcher.
Once you have completed the Project Amendment form, 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.
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. The request must be received prior to the project end date.