Bonnie Decker, EdD - Chair
Lisa Chase, PhD
Cindy Mathena, PhD
Margaret Nonnemacher, PhD
Gregory Oxford, DDS, PhD, MS
Elwood Nelson, MS
Barbara Bower
Anthony Palazzo

The IRB meets monthly to review research proposals involving the use of human subjects. The purpose of the IRB is to protect the human rights of those subjects and keep them from harmful procedures.

Who needs IRB review?
All projects involving human subjects must receive IRB approval before research can begin. Some proposals will require full IRB review, while others may be granted expedited review. When in doubt, ask the IRB Chair for clarification.

How do I get IRB review?

Protocol For Presentation To The Institutional Review Board Of The University Of St. Augustine For Health Sciences

General Instructions
First, determine if your study should use the full or expedited protocol. If expedited, go to the page entitled "The Expedited Review Process".

While it is recognized that the research proposal will serve as a major resource for completing the requested information on the IRB protocol, it is important for the author of the report to provide only the information that is requested and not merely transfer information from the proposal. If the answers to the components of the IRB form are not addressed or vague it will result in rejection of the proposal by the IRB. The author should concentrate on providing clear and succinct answers with attention to the total length of the document submitted.

The document for IRB review is to be no longer than 4-5 pages. There should be standard margins on each page with single line spacing. The font size for use in the document is 12. The document must be paginated. The informed consent should be a separate document and come attached with the report prepared for the IRB review. The informed consent is not to be counted in the 4-5 pages prepared for the IRB. Tables, charts and pictures that add clarity to points raised in your document may be attached as Appendices. Again please remember that clarity and brevity are important issues to be addressed when you prepare your documentation for the IRB.

1. Project Title:
It is essential that the proposal has a clearly stated title and the title is used consistently. This assures proper filing and retrieval of all correspondence.

2. Investigator(s):

Student Research
Students identify themselves as the Primary Investigator and any co-investigators should be identified. In addition if they are master's students, they will clearly identify their Major Advisor and Second Reader and if they are doctoral students, they will identify their doctoral committee members. Student contact information must also be included. (Mailing address and email.)

Faculty Research
Any faculty member doing research on the University of St. Augustine campus will complete a protocol if human subjects are involved in their research. The faculty member is requested to identify the principal investigator for the study and co-investigators if they exist.

3. Abstract:
This should be a concise one or two paragraph summary of the study. You should summarize the problem, your hypothesis, and what you will do.

4. Significance and Specific Aims
Please explain in a succinct and clear manner why your project is a logical scientific next step and why that step is important to take. Explain what you expect to learn from your data.

5. Research Plan:
Please describe in a clear and succinct manner what you will do to your subjects, or have subjects do. If you are studying patients, explain how what you will do differs from the clinical care they would receive if they were not in the study. If you intend to conduct a longitudinal follow-up study on the research subjects after subject accruals have been closed and the research interventions are complete, you must explain this clearly when you describe and outline your protocol.

Describe clearly your inclusion and exclusion criteria.

6. Potential Health Risks:
Describe the physical and psychological risks that may result from participation in this research protocol. Explain how common or uncommon each risk is. Explain how these risks will be minimized.

7. Potential Financial Risks:
Describe any financial risks to the subject that may result from participation in this research protocol. If the exact dollar amount is unknown, estimate the cost of the additional procedures, medications, etc. that the subject may incur.

8. Potential Health and Financial Benefits:
Describe the potential health and financial benefits of the research to your subjects. If there are no direct benefits to the subject, then make that statement. Describe the potential benefits to society. Explain why the benefits outweigh the risks. When you address these criteria, please include any direct compensation, free service or medications, etc.

9. Conflict of Interest:
Describe any conflict of interest that exists or may appear to exist as it relates to any of the investigators and this protocol. A conflict of interest exists if there is potential benefit to the investigator(s) beyond professional benefit from academic publication or presentation of the results.

10. Signature Lines:
At the bottom of this document, provide lines for signatures of you and your Major Advisor and Second Reader as well as the date of preparation. Please remember to have this document signed before submission to the IRB.

____________________________          ______________
Signature of Principal Investigator                               Date

____________________________          ______________
Signature of Major Advisor                                          Date

____________________________          ______________
Signature of Second Reader                                       Date

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1. University of St. Augustine Informed Consent Form
The University of St. Augustine for Health Sciences has a standardized informed consent form you are required to use for subjects involved in your clinical research project. You need to adapt this form to your research project and submit it with this report. It is also assumed the consent form will be used during the investigation. If you also have a consent form that has been approved by another facility and will be used in the completion of the investigation, you need to attach it to your report. Please note, it is requested that you compare this consent form with the consent form requested by the University of St. Augustine. If there are differences between the two consent forms, please attach this explanation to the front of the consent form that has been developed for the facility where you will complete this research. If you have any questions regarding this matter please consult with the Chair of the Institutional Review Board (1-904-826-0084 x232). The consent form developed at the request of the facility for your particular study will be the consent form of choice. In all other cases the consent form developed for the University of St. Augustine will be the consent form of choice.

2. Approval From The Facility Where The Research Is To Be Conducted
Please provide the IRB approval from the facility where the research will be carried out; as well as, documentation from the facility's highest-ranking operations officer noting approval and support of your investigation and an understanding of the liability attached to the research investigation.

In some cases when an IRB Committee does not exist in the facility where the research is being carried out, the letter from the highest-ranking officer will meet both needs. If this last case is the situation, please make note of the fact that both needs are being met with just one letter.

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Policy for Dual Institution IRB Review

1. Investigator confirms whether a dual institution review will be required.

2. If there is no IRB approval process at the institution where the research will take place, the investigator is required to have a letter of support from the highest- ranking administrative officer that the research can take place within the facility and is supported by the institution.

3. Upon confirmation that a dual review situation exists, the investigator addresses IRB requirements where research will take place first. The investigator submits the required paper application from the institution in which the research will take place, and receives written confirmation from the facility on the status of the application. If denial is the end result, the investigator will need to address deficiencies and resubmit.

4. With confirmation of approval from the site institution, the investigator will submit copies of the approval and the approved IRB application first to his/her advisors, if a student, and then to the U.S.A. IRB. If the individual is a faculty member they will submit their documentation directly to the U.S.A. IRB.

5. The investigator will also complete the full process for IRB approval as requested by the University of St. Augustine.

6. This documentation will be submitted in a timely manner to the IRB Committee at the University of St. Augustine. No research can be conducted until both IRB applications have been approved.

7. The primary and secondary reviewers will review all the documentation prior to submission to the USA IRB. They may make written request through the program director for an expedited review of the investigator's applications after a careful review of the two applications.

Institutional Review Board
Informed Consent Form

Instructions for Completion
Consent forms should contain the basic elements, or additional elements, as appropriate, included in the Sample Consent Form and follow the format outlined below:

• Each page of the consent form should be on bond paper with the title University of St. Augustine for Health Sciences, IRB Consent Form, IRB Approval # centered at the top of the document. This heading should appear on all pages of the consent form.
• The pages of the consent form should be numbered.
• Once the proposal is approved by the IRB an identifying number will be posted on the consent form noting IRB approval.
• The consent form should be in language understandable to the subject or his or her legal representative.
• If the research is externally funded, the funding agency should be listed under funding source.
• The title of the study and the name, address and telephone number of the investigator(s) must follow immediately after funding source. The Principal Investigator's address and phone number, and the phone number of the University IRB Office (904) 826-0084 ext. 232 must appear on the consent form. If the Principal investigator is a student, the address and phone number of his/her advisor(s)/clinical supervisor(s) must also appear on the form.
• Section I - Description of the Study. This section should include a statement that the study involves research, the purpose of the study, the reason for selecting the subject, the procedures to be used and identification of any procedures which are experimental, and the expected duration of the subjects participation, including anticipated follow-up.
• Section II - Risks and Benefits to the Participant. Subjects should be informed about direct or indirect potential benefits to them or others or the absence of benefits. Potential or anticipated risks should also be specified. For research involving more than minimal risk, explanations at to whether compensation or medical treatments are available if injury occurs. The section must include the following: If you have any concerns about your participation in the study, you should discuss them with the Major investigator. If you continue to have concerns you may contact the Faculty Member. If either of these resources are not able to address your concerns and you still desire to participate in the study, you may contact the IRB Office at the University of St. Augustine for Health Sciences: (1-904-826-0084 ext-232).
• Section III - Costs and Payments to the Participant. This item should be addressed explicitly, including a statement that payments will not be given if that is the case. There is also to be a statement in bold print that reads as follows: "The University of St. Augustine is not liable for any cost or compensations incurred as a result of participating in this study."
• Section IV - Confidentiality. Confidentiality must be specified as well as a description of procedures for protecting privacy, including specific information regarding how data will be stored to ensure security and confidentiality. The confidentiality statement must include in the statement a clause that reads "all information obtained in this study is strictly confidential unless disclosure is required by law".
• Section V - Participant's Right to Withdraw from the Study. This item must include a statement that the subject understands he/she is free to refuse to participate in or withdraw from the study at anytime without penalty, and that, if the participant withdraws, the data will be destroyed.
• Section VI - Voluntary Consent by the Participant. The following voluntary consent paragraph must be used in all consent forms and must appear in boldface type: "I have read this consent form (or it has been read to me) and I fully understand the contents of this document and voluntarily consent to participate. All of my questions concerning this research have been answered. If I have any questions in the future about this study, the investigator listed above or his/her staff will answer them. A copy of this form has been given to me."

In addition, the following paragraph must appear in boldface type: "I have explained to __________ the purpose of the research study, the procedures required, and the possible risks and benefits to the best of my ability. Investigator: ________________ Date: ________."

• " Section VII - Other Considerations. Subject needs to be informed if significant new information relating to the study becomes available which may relate to his/her willingness to continue to participate. This information will be provided to him/her by the investigators.

" A closing statement is required on all consent forms and must appear at the end of the consent form in bold print. Please refer to the example of the consent form for clarity regarding this statement. Consent forms must provide a space for the subject's signature, the date and the signature of a witness, generally the member of the research staff obtaining the consent. Please refer to the example consent form to clearly understand this request.

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SAMPLE CONSENT FORM

University of St. Augustine for Health Sciences
IRB Consent Form
IRB Approval # _________

Funding Source (if externally funded):

Title:

Investigators (if student, name of research advisor or core faculty member must also appear):

Principal Investigator(s):

Advisor/Faculty Member(s) (if a student):

Institutional Review Board, University of St. Augustine for Health Sciences (904) 826-0084 ext. 232

I. Description of the Study: The purpose of this study is: (Add Applicable Information
-See Instructions for Completion)

II. Risk and Benefits to the Participant: If you have any concerns about your participation in the study, you should discuss them with the Major investigator. If you continue to have concerns you may contact the (Faculty Member). If either of these resources are not able to address your concerns and you still desire to participate in the study, you may contact the IRB Office at the University of St. Augustine for Health Sciences (1-904-826-0084 x-232)

III. Costs and Payments to the Participant: (add Applicable Information)
There is also to be a statement that reads as follows: "The University of St. Augustine is not liable for any cost or compensations incurred as a result of participating in this study."

IV. Confidentiality: Strict confidentiality will be maintained at all times throughout the course of the research project unless law requires disclosure. A random code number, rather than your name, will be used to identify information you give us. Only members of the immediate project staff will have direct access to this information. Reports at scientific meetings or in scientific journals will not include any information which identifies you as a participant in this study. Your research records, just like any hospital records, however, may be subpoenaed by court order or may be inspected by federal regulatory authorities (add Applicable Information).

V. Participant's Right to Withdraw from the Study: You may choose to not participate or to stop participation in the research program at any time without penalty. If you choose not to participate, the information collected about you will be destroyed.

VI. Voluntary Consent by Participant: Participation in this research project is totally voluntary, and your consent is required before you can participate in the research program. See signature statement below.

VII. Other Considerations: (add Applicable Information)

I have explained to____________ the purpose of the research, the procedures required and the possible risks and benefits to the best of my ability.

________________________             _____________
Investigator                                            Date

I have read the preceding consent form, or it has been read to me, and I fully understand the contents of this document and voluntarily consent to participate. All of my questions concerning the research have been answered. I hereby agree to participate in this research study. If I have any questions in the future about this study, they will be answered by the investigators listed above or their staff. A copy of this form has been given to me.

________________________          _______________
Participant's Signature:                  Date:

_____________________
Print Participant's Name:

_____________________          _______________
Witness's Signature Date:

_____________________
Print Witness's Name:

University of St. Augustine for Health Sciences
IRB Consent Form
IRB Approval # _________

The above is the sample letterhead to be used for your Consent Form. The Approval # will be noted in your letter from the IRB after review of your proposal.

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CHECK LIST FOR IRB PRESENTATION
Full Review

Project Title (consistent use throughout and on the Informed Consent Form)
Principal Investigator, Major Advisor, and Second Reader - names listed and signatures on document
IRB and/or documentation of approval from facility where research will be carried out
Abstract: Concise summary of study (1-2 paragraphs). Summarize problem, hypothesis, and what you will do
Significance and specific aims: Explain why project is a logical scientific next step and why that next step is important to take, including what you expect to learn from your data
Research Plan including inclusion and exclusion criteria
Potential Health Risks
Potential Financial Risks
Potential Health and Financial Benefits
Conflict of Interest
Signatures on last page

Check List for Informed Consent Form

Proper heading on each page
Funding source (if externally funded)
Investigators (if student, name of research advisor or core faculty member must appear)
Advisor/Faculty member(s)
Principal Investigator(s) (For Faculty)
Institutional Review Board, USA for Health Sciences (904) 826-0084 ext. 232
I Description of the Study: purpose of the study
II Risk and Benefits to the Participant
III Costs and payments to the participant including statement in bold print "The University of St. Augustine is not liable for any cost or compensations incurred as a result of participating in this study."
IV Confidentiality
V Participant's right to withdraw from study w/o penalty
VI Voluntary consent by participant
VII Other considerations
Participant's claim "I have read the preceding consent form…."
Participant's signature and date line
Witness's signature and date line

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Expedited Review for Research Proposals
University of St. Augustine for Health Sciences
Institutional Review Board (IRB)

Expedited Review Process

The following steps should be completed to file for an Expedited Review for a research proposal:

1. Obtain documentation necessary for a review of an IRB proposal from the Secretary for the IRB. This person can be reached by contacting the Chairperson of the IRB committee.

2. Determine if your proposal qualifies for expedited review. You should be able to categorize your study as one of the following:

A. Research involving the collection of existing data, documents, records, or specimens if these sources are publicly available. The researcher must record the information in such a way that subjects are not identified. For example - A literature review of procedures used in physical therapy to improve balance or a chart review concerning treatment of spondylolithesis over the past 5 years at Flagler Hospital.

B. Research that does not involve human or living subjects in any way. For example - An analysis of compliance to ADA architectural codes in downtown St. Augustine.

C. Research involving the use of educational tests, survey procedures, interview or observation in which nothing is "done" to the participants.

For example - A survey of parent perceptions of the effectiveness of sensory integration therapy.

If you have questions as to whether or not your study qualifies for expedited review, get clarification from the Chairperson of IRB.

3. Follow the format for an expedited research proposal explaining what data will be collected and how it will be used. Carefully review the requirements for the informed consent form. Even though human subjects are not included in the research design, there is still a high probability that a consent form will need to be developed. If you have questions regarding the consent form, you may contact the Chairperson of the IRB Committee or the Secretary of the IRB for clarification.

Also note that if another facility is involved in the research project, there will need to be an indication of their IRB and/or administrative approval of the process involving your research proposal prior to an expedited review by the USA IRB.

4. Once you have completed your paperwork for IRB review, carefully review the checklist for IRB presentation for expedited review. Turn your completed proposal in to the Secretary for the IRB. The secretary for the IRB will inform the Chairperson of the IRB about the expedited review request and the Chairperson will assign the review to a member of the IRB committee.

5. The Chairperson of the IRB will provide the results of the expedited review to the individual requesting it.

This review is not subject to a full IRB discussion, but a report will be provided to the IRB about the number of expedited reviews that have been completed and the titles of each research proposal.

6. While the term "expedited" implies a fast turnaround, it can only be completed quickly if the individual submitting the documentation follows all directions carefully. A poor and incomplete submission will be rejected.

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Project Title: clearly stated and consistently used

Investigator(s): Add the names of all investigators and advisors/readers (when applicable):

Location of the Study: Attach a letter of facility approval if applicable

Abstract: Describe why the study is important. In your concise summary of the study, include the hypothesis or research questions and methodology. In a separate paragraph at the end of the abstract, describe why the study should be considered for expedited status. .

Conflict of Interest: Describe any conflict of interest that exists as it relates to the study or the investigators involved in this study. If there are none, state that there are no conflicts of interest that exist pertaining to this study. Do not simply state the word "none".

Signature Line: At the bottom of the document, provide lines for all investigators' names and signatures, and for advisors and readers when applicable. Put a line for the date next to each signature.

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CHECK LIST FOR IRB PRESENTATION
EXPEDITED REVIEW

Project Title (Consistent use throughout and on the Informed Consent Form, if applicable)
Principal Investigator, Major Advisor, and Second Reader - names listed and signatures on bottom of document
IRB and/or documentation of approval from Facility where research will be carried out, if applicable
Abstract: Concise summary of study (1 - 2 paragraphs). Summarize problem, hypothesis or research question, and what you will do.
Explain why project is a logical scientific next step and why that next step is important to take. Describe why the study is being considered for expedited status
Conflict of Interest

Check List for Informed Consent Form

Proper heading on each page
Funding source (if externally funded)
Investigators (if student, name of research advisor or core faculty member must appear)
Principal Investigator(s)
Advisor/Faculty member(s)
Institutional Review Board, USA for Health Sciences (904) 826-0084 ext. 232
I. Description of the Study: Purpose of the study
II. Risk and Benefits to the Participant
III. Costs and payments to the participant including statement in bold print "The University of St. Augustine is not liable for any cost or compensations incurred as a result of participating in this study."
IV. Confidentiality
V. Participant's right to withdraw from study w/o penalty
VI. Voluntary consent by participant
VII. Other considerations
Participant's claim "I have read the preceding consent form"
Participant's signature and date line
Witness's signature and date line

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HELPFUL HINTS FOR A SUCCESSFUL IRB PROPOSAL

• Is your Title descriptive and easy for a layman to understand? Do you use it consistently throughout?
• Are the names of the Principal Investigator, the Primary Advisor and the Secondary Reader listed in the Proposal? Have they all signed? How about the Informed Consent form?
• Do you have approval from the facility where you will carry out the research project? Have you attached that documentation? Did you take them into consideration under Costs and Benefits?
• Is your abstract a brief and to-the-point summary of what you intend to do? Will your subjects understand?
• Have you explained why your project is a logical scientific next step, and why it's important to take that step? What do you expect to learn from your data?
• Do you have Inclusion and Exclusion criteria in your Research Plan?
• What are the potential health risks to your subjects? Are they clearly stated?
• What are the potential financial risks to your subjects? What costs will they be expected to absorb?
• What are the potential health benefits to your subjects? Potential financial benefits?
• Is there conflict of interest between any of the parties involved with this project?
• How do you intend to maintain confidentiality and the privacy of the subjects? Should you have any statements concerning modesty?

INFORMED CONSENT FORM

• Will a poor reader understand? Have you used "jargon," or ordinary words?
• Is each page properly headed?
• Have you stated your funding source?
• Have you identified the IRB (Institutional Review Board, U.S.A. for Health Sciences (904) 826-0084, Ext. 232)?
• Do the subjects understand that their consent is purely voluntary? They can withdraw at any time without penalty?