Institutional Review Board for the Protection of Human Subjects (IRB)

 


Standard Operating Procedures of the Institutional Review Board 

 

Available in printable pdf


 Announcements (recently updated August 2014)

 Meeting Schedule and Roster

 Categories of Review

 Changes to Existing Protocols

 Class Projects

 Forms and Guidelines (updated September 2014)

 IRBNet Resources

 Principal Investigator Responsibilities

 Quality Assurance Audits

 Minutes

 Compliance Links

 

 Announcements 

    • IRB Workshops: The UNF IRB will be hosting several workshops in the fall, please email IRB@unf.edu if you are interested in attending one or more of the following workshops:
      1. IRBNet Demo Workshops (staff will give a demonstration of IRBNet features)
        • September 9th (Tuesday) from 1:30pm - 3:00pm
        • September 22nd (Monday) from 11:00am - 12:30pm
        • October 9th (Thursday) from 10:30am - 12:00pm
        • October 20th (Monday) from 1:00pm - 2:30pm
        • November 12th (Wednesday) from 3:00pm - 4:30pm 
         
      2. IRB Strategy Workshops (staff will provide tips and discuss common pitfalls relating to IRB review. Researchers will also have opportunities to ask questions about the IRB process)
        • September 29th (Monday) from 1:30pm - 3:00pm
        • October 14th (Tuesday) from 10:00am - 11:30am
        • November 17th (Monday) from 11:00am - 12:30pm

Additional workshops will be scheduled as needed. If you have a group of four or more and you would like research integrity administrators to hold a workshop for your group, please email IRB@unf.edu with the names of the individuals who will attend and several possible days and times for the workshop. 

    •  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 irb@unf.edu). 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: If you would like to request student access to Qualtrics, please complete this form to request an account. Your request will be processed within three business days. Faculty and staff already have access to Qualtrics automatically. For more information about Qualtrics, please refer to the Qualtrics information site .
    • 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 irb@unf.edu 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:

     

    If 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 chair of the UNF Institutional Review board by calling (904) 620-2498 or emailing irb@unf.edu.

     

    •  Extensions for older IRB projects should be submitted through IRBNet (updated 7/01/2014):

    The 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  irb@unf.edu.

    • 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 administrator.

 Meeting Schedule and Roster 

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 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.

 New Protocol Submission 

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.

 Categories of Review 

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.  

Exempt Projects

Categories of Projects which may be considered exempt:  

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices such as: 
    • 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. 
     
  2. 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.  
     
  3. 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 or  
    • Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
     
  4. 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.  
  5. 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 service programs;  
    • 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 programs  
     
  6. Taste and food quality evaluation and consumer acceptance studies 
    • 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 Agriculture.  

Expedited Review

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:

  1. 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.
  2. 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. 
  3. 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.
  4. 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.
  5. 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.
  6. Collection of data from voice, video, digital, or image recordings made for research purposes.
  7. 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.)
  8. 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.
  9. 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. 

Special Circumstances

Are you:

 Changes to Existing Protocols 

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. 

 Class Projects 

 Instructors who plan to require their students to conduct projects involving human participants in order to help those students develop knowledge and research skills may be required to submit documentation to the UNF IRB before engaging in those activities. Please review the procedure for class projects to determine if your proposed activities meet the definition for class projects at UNF.

 Forms and Guidelines 

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.

Forms

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. If you are still having technical difficulties, please contact the UNF ITS department (904-620-4357 or its-help@unf.edu). For the most accurate service, ITS suggests that you title your email to ITS as "PDF Form Issue on the UNF Website." 

Guidelines

 IRBNet Resources 

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.

 Principal Investigator Responsibilities

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

 Quality Assurance Audits 

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.

 Minutes 

For more information about IRB meetings, please view the minutes below:

 

 2010:

 2011:

 2012:

2013:  

2014:

 Compliance Links