To aid in determining whether a project is human subject research, such
as some Evidence Based Practice projects (EBPs), Action Research, etc., please
download to your computer this 2-page HSR Determination Form,
complete, save, and submit to IRB@UNF.EDU. If you don’t save the form to
your compute before you complete the form your work may not save.
- Exempt Studies: The review process for exempt projects has been revised (see pages 13-17 of the UNF IRB SOPs for details). Exempt projects will only be reviewed to the extent necessary to confirm exempt status (please refer to the Documents Checklist for Exempt Projects for more information about the required documents). Only the IRB Chair or the IRB Chair's designee can determine if a project is exempt. Projects determined to be exempt will receive a Declaration of Exempt Status Memo. Once a Declaration of Exempt Status memo has been received via IRBNet, the project can begin. If you are uncertain as to whether your project fits into one or more of the exempt review categories, please contact a research integrity administrator (904-620-2455 or firstname.lastname@example.org). You can also refer to the Decision Chart for Determining Exempt Status. If a study does not qualify for an exemption, the Principal Investigator will be notified and asked to submit additional documentation for expedited or full board review (please refer to the Documents Checklist for Expedited or Full Board Projects for details).
- Qualtrics Access:To Request access to Qualtrics for class projects that do not require IRB oversight, please complete this form and submit it to the Center for Instruction and Research Technology (CIRT) . To establish student access that requires IRB approval, please submit the form to email@example.com.
- Revisions Must be Submitted within 90 days: Based on a UNF
IRB decision, researchers will have up to 90 days to submit revisions
after receiving a review memo from the UNF IRB. If researchers will need
more than 90 days to revise protocol documents, they may email firstname.lastname@example.org to request additional time. This email must be received
at least 7 days prior to the 90 day deadline. The deadline
for revisions will be included on the review memo sent to the principal investigator. If revisions are not submitted within the 90 day time period and no additional time is requested, the project will be administratively withdrawn.
- IRB Contact Information for Consent: For best practice, please utilize the updated
IRB contact information as shown below in your consent/assent/permission documents:
you have questions about your rights as a research participant or if you would
like to contact someone about a research-related injury, please contact the UNF Institutional Review board by calling (904) 620-2498 or
- Extensions for older IRB projects should be submitted through IRBNet (updated 7/01/2014):
UNF IRB transitioned from a paper submission and review process to an
online submission and review process through the use of the online submission
software called IRBNet. Older IRB projects approved based on Expedited or Full Board review must now be transitioned to IRBNet at the time of continuing review. For information about how to do this, please refer to the Guide for Submitting Extensions for Old Projects in IRBNet. If you have questions, please feel free to contact a research
integrity administrator by calling (904) 620-2455 or emailing email@example.com.
- How to Make Data Anonymous in Qualtrics: Select "Anonymize
Response" in the Survey Options section of Qualtrics. If you will
send the survey via email, you will also need to use the "Anonymous
Link" option under Advanced Options in the Distribute Survey tab in
Qualtrics. For more information, please contact a research integrity
All covered research, training, and demonstration projects involving human subjects must undergo thorough review by the University of North Florida’s Institutional Review Board (IRB) for the Protection of Human Subjects prior to commencement of the project. The IRB is an administrative body established to protect the rights and welfare of human subjects recruited to participate in research activities conducted under the auspices of the University of North Florida. The IRB has full authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction and to conduct continuing reviews of the research activities at intervals appropriate to the degree of risk, but not less than once a year. The IRB meets on a monthly basis. Please see the schedule Spring 2018 which includes deadlines for submissions classified as "full board review." Projects that require full-board review (those that are not eligible for "exempt" or "expedited" review) need to be submitted at least 2 weeks prior to the monthly IRB meeting. If you have questions, please contact a research integrity administrator at IRB@unf.edu or x2455. For a listing of the current members of the IRB, see the committee roster.
Federal regulations regarding human research set forth a minimum standard for what must be reviewed by an IRB. Additionally, each institution is granted a Federalwide Assurance (FWA) with the Department of Health and Human Services which requires it to implement its own written operating procedures. Written procedures must, at a minimum, reflect the federal standards, but may also go above and beyond those standards as each institution determines necessary and appropriate.
The UNF IRB's jurisdiction includes all human subject research as follows:
- by UNF faculty, staff, students, agents, affiliates, or outside researchers, and occurs on the property of the University of North Florida;
- by UNF faculty, staff, students, agents, affiliates, or associated outside researchers, and occurs elsewhere;
- elsewhere by an outside researcher involving UNF faculty, staff, students, agents, or affiliates;
- by UNF faculty, staff, students, agents, affiliates, or outside researchers, and involves the use of UNF's non-public information to identify and/or recruit human research subjects or prospective subjects;
- by UNF faculty, staff, students, agents, affiliates, or outside researchers and receives funds through UNF or receives support by internal resources; and
- by UNF faculty, staff, students, agents, or affiliates that is supported by federal funds or any other external resource(s).
ALL investigators conducting research falling into any of the categories listed above are required to submit a protocol to the IRB for review. If you have any doubts about whether or not your project falls into one of these categories, you may contact IRB administrative staff at IRB@unf.edu. As of February 6, 2012, all new protocols must be submitted through IRBNet.
In compliance with federal regulations (45 CFR 46) and the University's OHRP-issued Federal-wide Assurance, the University of North Florida's Institutional Review Board must review all projects involving human subjects. Only the chairperson or one or more IRB members designated by the chairperson may determine the appropriate review type: exempt, expedited review or full board review. All projects that do not qualify for exempt or expedited review will undergo full board review.
Categories of Projects which may be considered exempt:
- Research conducted in established or commonly
accepted educational settings, involving normal educational practices such
- research on regular
and special education instructional strategies, or
- research on the
effectiveness of or the comparison among instructional techniques,
curricula or classroom management methods.
- Research involving the use of educational
tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
interview procedures or observation of public behavior unless:
- information obtained
is recorded in such a manner that human subjects can be identified
directly or through identifiers linked to the subjects; and
- any disclosure of the
human subject's responses outside the research could reasonably place the
subject at risk of criminal or civil liability or be damaging to the
subject's financial standing, employability, or reputation.
Note: This spring, after clarification from the Office for Human Research
Protections (OHRP), the UNF ORSP learned that Exempt Category 2 projects cannot
involve manipulation of any kind, e.g. Implicit Association Tests (IATs),
Educational Interventions, Games, etc. If a project entails any of the aforementioned
manipulations, or similar researcher interventions, it will require, at
minimum, an Expedited Review.
- Research involving the use of educational
tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
interview procedures, or observation of public behavior if:
- the human subjects
are elected or appointed public officials or candidates for public office
- Federal statute(s)
require(s) without exception that the confidentiality of the personally
identifiable information will be maintained throughout the research and
- Research involving the collection or study of
existing data, documents, records, pathological specimens or diagnostic
specimens. If these sources are publicly available or if the investigator
in such a manner records the information that subjects cannot be
identified directly or through identifiers linked to the subjects.
- Research and demonstration projects which are
conducted by or subject to the approval of Department or Agency heads, and
which are designed to study, evaluate, or otherwise examine:
- public benefit or
- procedures for
obtaining benefits or services under those programs;
- possible changes in
or alternatives to those programs or procedures; or
- possible changes in
methods or levels of payment for benefits or services under those
- Taste and food quality evaluation and consumer
- if wholesome foods
without additives are consumed or
- if a food is consumed that contains a food
ingredient at or below the level and for a use found to be safe or agricultural
chemical or environmental contaminants at or below the level found to be safe,
by the Food and Drug Administration or approved by the Environmental Protection
Agency or the Food Safety and Inspection Service of the U.S. Department of
Expedited review requires review by the Chairperson of the IRB or one or more IRB members designated by the Chairperson. Expedited review may require informed consent and safeguards as required by Federal law. Reviewers may approve but not disapprove a project. Only the full IRB may disapprove a project.
Categories of Projects which may be handled through Expedited Review:
- Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, nonpregnant adults who weight at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently than 2 times per week; or (b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more frequently than 2 times per week.
- Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. NOTE: (Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt).
- Continuing review of research previously approved by the convened IRB as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.
- Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
In order to implement changes to a previously approved protocol, you must submit an Amendment Request to the IRB. To complete this request you will need to forward the following documents to ORSP:
- Amendment Request (revised 7/16/12)
- Revised documents (updated application for IRB protocol review, informed consent forms, instruments, etc.), where applicable.
- Additional documents as necessary
All documents must be submitted electronically. If you are amending a project that was approved via IRBNet, it will be necessary to submit any amendment documents via a new package in IRBNet.
longer are Instructors, who require students to conduct research methods
projects involving human participants, required to submit class project
information to the IRB for review and consideration. Please consult the Class
Project flow chart to learn whether a project on which a student is working
requires IRB review and approval or whether that fits within the Class Project
designation. As always, if you have questions about a class project utilizing
human participants, please feel free to contact IRB staff at 904.620.2455 to
As you complete the forms below, do not leave sections blank. If a question or section is not applicable to your research project indicate such with a "not applicable" response. In some circumstances you might also need to explain why you are stating that a section is not applicable to your project. Forms older than those included below will not be accepted.
If Attachment A or B are not working for you, first make sure that you have Adobe Acrobat Reader or another Adobe Acrobat program downloaded on your computer. You can download Adobe Acrobat Reader for free online. Then, try right clicking the document link above (if using a Mac, hold down the Ctrl button and then click the link), then select the option for "Save link as..." or "Save target as..." and save the document to your computer. Then, open the Adobe Acrobat Reader program (or Adobe Acrobat Standard or Adobe Acrobat Pro if you have those programs rather than reader). Within the Adobe Acrobat program, open up the file you previously saved to your computer (click file, then select open, select the form from where you saved it previously and then click open). If you are still having technical difficulties, please contact the UNF ITS department (904-620-4357 or firstname.lastname@example.org). For the most accurate service, ITS suggests that you title your email to ITS as "PDF Form Issue on the UNF Website."
After you have completed the required forms, new submissions must be submitted for review within IRBNet. Please see the Read Me First! document for more information. IRBNet submissions that are incomplete will be returned to the PI for completion.
The principal investigator must maintain a file of human subjects research project documents. This file must include the following items:
- A copy of the original documentation sent to the IRB for review
- A copy of all correspondence to and from the IRB regarding the project
- A copy of the IRB stamped approved project documents
- A copy of the IRB stamped approved consent form(s)
- A copy of the IRB stamped approved data collection instruments (e.g., surveys, tests, questionnaires)
- A copy of the IRB stamped approved (e.g., recruitment flyers, notices, advertisements)
- A copy of all IRB stamped approval of amendments/modifications to any part of the research (e.g., proposal, consent form, instruments)
- The original signed consent form for each participant
- A copy of all data derived from the study
In accordance with the University of North Florida's assurance agreement with the Office of Human Research Protections (OHRP) and 45 CFR 46 of the Code of Federal Regulations for the Protection of Human Subjects in Research, the IRB may perform random and for-cause audits of research projects conducted by UNF researchers.
For more information about IRB meetings, please view the minutes below:
- January 9, 2012
- January 23, 2012
- February 6, 2012
- February 20, 2012
- March 5, 2012
- March 19, 2012
- April 2, 2012
- April 16, 2012
- May 16, 2012
- June 20, 2012
- July 25, 2012
- September 12, 2012
- September 26, 2012
- October 17, 2012
- October 31, 2012
- November 14, 2012
- November 28, 2012
- January 15, 2013
- February 05, 2013
- February 19, 2013
- March 05, 2013
- March 26, 2013
- April 16, 2013
- April 30, 2013
- May 13, 2013
- September 06, 2013
- November 01, 2013
- December 11, 2013
- January 14, 2015
- February 04, 2015
- March 25, 2015
- April 22, 2015
- May 06, 2015
- May 29, 2015
- June 29, 2015
- September 21, 2015
- October 19, 2015
- November 02, 2015
- November 19, 2015
- December 07, 2015