Guidelines & Forms

HUMAN SUBJECTS APPLICATION GUIDELINES FOR INVESTIGATORS

I.     Responsible Conduct in Research
       1.  Principal Investigator Responsibilities
       2.  Student Investigator Responsibilities
       3.  Faculty Advisor Responsibilities
       4.  Educational Responsibilities

II.    General Guidelines
       1.  Determine if IRB Review is Applicable
       2.  Application Preparation
       3.  Application Submission
       4.  Application Review
       5.  IRB Action Descriptions
       6.  Approval
       7.  Approval Term & Requirements
       8.  Annual or Continuing Review
       9.  Modifications/Amendments
     10.  Adverse Events 
     11.  Project Completion

III.   Preparing & Submitting a Complete IRB Application

IV.  Additional Information
       1.  Important Reminders for Expedient Review and Approval
       2.  Submission to Fulfill UGS Thesis and Dissertation Requirements
       3.  Annual Renewal for Projects Initially Reviewed by Full Board
       4.  Waiver of Written Consent
       5.  Funded Projects

V.   Contact Information

---

I.       RESPONSIBLE CONDUCT IN RESEARCH

1 .   A Principal Investigator must possess skills adequate to their proposed research, design research that meets quality assurance standards   and whose benefit to subjects or society justifies the risks to subjects. PI's are also required to:

1. Submit fully detailed research plans,

2. Ensure that no human subject be enlisted without prior informed consent,

3. Take all necessary safeguards to minimize risks and to protect the interests of vulnerable populations,  and PROMPTLY report, in writing and verbally to IRB Chairperson, Coordinator or VP for research, any injuries or other unanticipated problems.

4. Assure the adequate training of their personnel including Human Subjects Training and Adverse Event procedures,

5. Adhere to high ethical standards, and

6. Read, sign, and comply with the Affirmation of Compliance on the applicable IRB Form.

2.     Student Investigators are responsible for the acquisition of prospective IRB approval.  Data that is obtained without approval may be deemed unusable for a Master's thesis or Dissertation.  The IRB can not give retrospective approval to any project.  In addition, students are responsible for the submission of completion reports.  Remember that failure to do so will affect the timely review and approval of students under the supervision of the same faculty advisor.

3 .    Faculty Advisors are responsible for providing students that they supervise with:

1. Timely information and guidance regarding proposal preparation, conduct and responsibilities.  This is most important because the IRB CAN NOT give retrospective approval nor can it approve a research study that does not protect the rights of the potential subjects;

2. Information to foster responsible research conduct and independence.    

In this light, it is imperative that faculty advisors:

1. Complete the Human Subject training required by FIU and federal regulations,

2. Remain up-to-date with IRB procedures and policies as well as those of the Graduate School.  It is important to note that delinquency in the submission of requested information and forms by a particular faculty advisor and his/her students will delay the review of subsequent submission: and,

3. Have the necessary expertise to advise and supervise students performing humans subject research.

4 .   Educational Responsibilities 

Federal regulations require that ALL Principal Investigators and Key Personnel fulfill the Responsible Conduct of Research Educational Requirements to improve research subject safety. FIU currently uses the NIH web-based training procedure that will allow you to download and print a certificate with your name upon successful completion. A copy of the certificates for all members of the research team must be kept for your records and must accompany the IRB Application. Before new members can be added to the research project, they must also complete the web-based training and provide their IRB training certificate along with the Form B-1 Amendment Application.

[ TOP ]

II .  GENERAL GUIDELINES FOR OBTAINING IRB APPROVAL

The application process involves the following steps:

1.    Determine if IRB Review is Applicable. IRB approval is only applicable if the project involves “human subjects” and it meets the definition of “research.” To further assist with the determination of "human subjects research,” please review the Human Subjects Decision Charts.  An investigator may also complete Form A-1 and submit it to an IRB representative if he/she is unable to determine that IRB review is applicable.

The application process requires that investigators are aware of their responsibilities and understand how the proposed research project should be conducted within the federal, state, local and university policies and procedures (i.e. how to protect the human subjects, human subject training, and renewal of studies). Investigators and faculty advisors are ultimately responsible for requesting additional information or training in order to be best prepared to conduct research at FIU. Applications are located on the Guidelines and Forms web page for the Institutional Review Board.

2.   Application Preparation (Determined by Review Category). IRB applications are prepared based on three (3) review categories: Exempt, Expedited, and Full Board Review. A basic determination of review category is accomplished by comparing the research idea to the Exempt and Expedited Categories provided in the Federal Regulations [45 CFR 46.101] and online. These categories are not written to be all-inclusive, however the concepts of participant protection and minimization of risks can be applied to varying types and constructs of research. Guidelines for submission of a complete application are later provided in this manual. If additional assistance is required during the preparation of an application investigators may contact the IRB Coordinator, or an IRB representative (See a list of representatives online).

3.   Application Submission (Determined by Review Type). All applications regardless of review category are submitted directly to an IRB representative for primary review. Representatives review and approve applications (for Exempt and Expedited categories) throughout the month. Applications for Full Board Review need to follow the Submission Schedule provided online.

Applications are submitted based on what the investigator is requesting or reporting. Types of IRB review are: 1) Initial, 2) Modification/Amendment, 3) Continuing or Annual Review, and 4) Completion. Each of these review types requires a different application (i.e. Form A, B-1, B-2). These forms can be accessed from the guidelines and forms page.

4.    Application Review. FIU utilizes a primary and secondary process for the review of IRB applications. Individual IRB representatives have the authority to review and approve IRB applications that meet the criteria for Exempt or Expedited review as determined by federal regulations. All other studies involving human subjects will be referred to the Full Board for review (if not already requested as the review category by the investigator).

5.    IRB Action. After reviewing the project, the representative recommends one of the following actions:

a. Approved,

b. Conditionally approved: approved pending minor modifications,

c. Tabled: requires modifications/ revisions and resubmission, or

d. Requires Full Board review.

Requested modifications/revisions are sent to the principal investigator as an email attachment. The memorandum provides information regarding the status of the review and approval process. It is important that investigators address any inquiries, perform modifications and provide such documentation to the person indicated on the memorandum. The PI may not commence the research study until full approval is received.

6.    Approval. IRB approval is granted when all requirements are met based on the federal regulations and FIU IRB policies; and, a representative signature is provided on the form indicating approval. Upon approval, the PI is sent written notification inclusive of the IRB approval number and annual review date. The written notification of approval will be provided directly to the faculty advisor if the principal investigator is a student. This memo from the IRB coordinator is the PI's record of approval and is to be used to provide official documentation to university departments and funding agencies. Upon receipt of the IRB approval number the PI may commence the research project.

7.    Approval Term & Requirements.  IRB approval for Exempt and Full Board is given for a maximum period of one year. After receipt of initial approval, investigators are required to:

a .    Submit for Annual or Continuing IRB Review and receive approval (Form B-2) ;

b .    Receive approval of PI initiated Modifications or Amendments (Form B-1) ;

c .    Report Adverse Events as the occur (Form C) ;

d.     Renew Consent Documentation (information letters, consent, assent etc) ;

e.     Submit Project Completion Report at conclusion of study (after data analysis) (Form B-2)

Investigators affirm their understanding of their responsibilities when they sign the "Affirmation" section of the IRB form. Information regarding investigator responsibilities and IRB requirements is also provided on the approval memorandum for the convenience of the investigator.

8.    Annual or Continuing Review.  Federal policy requires all studies approved in an expedited category or by full board review be renewed at minimum annually even if the investigator has not commenced recruitment of subjects. Annual renewal shall occur until all the data has been analyzed and all activity related to the project has ceased.

9.    Modifications/Amendments.  Any additions or changes in the procedures involving human subjects must be submitted to the IRB on Form B-1 for approval.

Modifications, whether new or approved during the term of approval, should be integrated into the documents being submitted for annual review. A PI need not submit Form B-1 along with Form B-2; however, all modifications should be evident to the reviewer by boldface type, underlined, or italicization.

The IRB must approve these changes PRIOR to implementing them in the study.

10.    Adverse Events.  The PI is responsible for reporting serious unanticipated events within 5 days, and non-serious events within 10 days of the occurrence. Said documentation should be faxed and/or hand-deliver to the IRB office (MARC 430) in order to assure receipt in a timely manner.

All key personnel are familiarized with AE procedures and are aware of the appropriate contact persons in case of an event.  At minimum the Adverse Event Table (AE Table) must be used with projects required to have a DSM system or plan.

The adverse event policies and forms can be accessed from Adverse Events Reporting Page.

11.    Project Completion. The PI (or Faculty Advisor of a student investigator) is required to submit a completion report when the study is no longer recruiting subjects, all the data has been analyzed and all activity related to this project has ceased. Studies completed prior to the end of the approval term may submit their completion report to the IRB Office (Form B-2).
 

[ TOP ]

III.   SUBMITTING A COMPLETE IRB APPLICATION

A complete IRB Packet includes:

Please note that the IRB may require additional documentation in order to protect human subject participants in all proposed research studies. 

[ TOP ]

IV. ADDITIONAL INFORMATION 

1.    Important Reminders for Expedient Application Review and Approval

1. You must submit your complete application to an IRB Representative prior to delivering the application to the IRB Office.  IRB Membership

2. The PI signature, and Faculty Advisor, if applicable, signature must be on the application prior to submitting to an IRB representative.

3. The IRB Representative signature must be obtained before a memorandum of approval will be issued.

4. Consent documents must be in required format and on University Letterhead (generic university letterhead)

5. Follow the submission checklist on the 4th page of Form A.

2.    Submission to Fulfill UGS Thesis/Dissertation Requirements

Student investigators who intend to use humans subjects in research projects as fulfillment of the University Graduate School (UGS) requirements for thesis or dissertation must:

1. Submit IRB Form A for initial review of a human subject research project and receive approval prior to beginning research activity and,

2. Submit the IRB approval memorandum as a part of the M-2 or D-3 submission to UGS.  

Form M-2 or D-3 submissions to the Graduate School require the inclusion of an approval memorandum from the IRB Coordinator for research involving human subjects. Form M-2 is used for thesis proposals. Form D-3 is used for dissertation proposals.

Deadlines are associated with submissions to the IRB and the Graduate School. Timely submissions will prevent the return and delay of acceptance of Form M-2 or D-3 submissions.

The Calendar of the Graduate School deadlines can be found at: http://gradschool.fiu.edu/calendars.html 

Thesis/dissertation submissions are flagged if the proposed research involves humans. Provide adequate information in your research proposal to assist with the determination of involvement of human subjects.

Form M-2 or D-3 submissions will not be accepted if you suggest the use of human subjects and there is no memorandum of IRB approval or a memorandum indicating that the project does not meet the criteria for “research involving human subjects”. These memorandums are generated by the IRB Coordinator.

Data collected without prior approval will not be accepted for use with a thesis or dissertation.
UGS submission requirements regarding research involving human subjects are located in Chapter IV of the UGS Thesis/Dissertation Preparation Manual. (http://www.fiu.edu/ugs/thesis_dissertation_manual.html)

UGS does not waive requirements of rules or deadlines.

The investigator is required to submit a complete IRB application packet and comply with regulations for annual renewal, modifications/amendments and adverse events. All questions regarding the submission of forms or requirements for graduation must be directed to the University Graduate School. The IRB office only handles issues regarding human subjects.

3.    Annual Renewal for projects initially reviewed by Full Board

All projects that were reviewed by the convened board for its' initial review must be reviewed annual by the full board based on the Federal Regulations.  There are only three (3) exceptions, listed in the Expedited Research Criteria, by which a project initially reviewed by the convened board may subsequently be reviewed by an expedited process.  Therefore, PI's who have  projects initially approved by the full board should submit their request for annual renewal in a timely manner in order to be have a project reviewed and approved by the convened board prior to the end of the approval period.

4.    Request for Waiver of Written Consent

You may request a waiver of written consent for all proposals that are submitted for Expedited, and Full Board Review. 

In order to request waiver of signed consent, the investigator must:

1. Complete the appropriate section of the IRB Application and provide written justification in the IRB proposal being submitted to the IRB for review.  Applications will not be approved without the written justification.  Although written consent may be waived verbal consent must still be acquired.  You may use examples of modified consent forms as a guide for required document content.  

2. A copy of said document MUST be included with the IRB application for review. Upon approval of the entire proposal, the consent document will be date stamped and returned to the PI.

3. Copies of the date stamped consent document are to be provided to the participant for information but NO signature is required.  

4. Any modifications to a consent document MUST be reviewed by the IRB and MUST receive a date stamp.

5.    Funded Projects

In the review of IRB applications, Investigators should be reminded to initiate their applications in order to meet the following requirements:

1. Federal, State, and most local funding agencies require documentation of approval of human or animal subject involvement. Requirements regarding the time of submission (i.e. during proposal or prior to award) differ.

2. Agencies that require documentation of approval for the use of human or animal subjects will not release funding until they have received the appropriate documentation.

3. Some agencies will release funding for research identified as “Exempt”.

4. FIU requires the following regarding funding and IRB approval: a)  Submission to the IRB according to the agency requirements for submission of approval documentation (i.e. FIU does not require submission and approval prior to a proposal being submitted if the agency does not require prior approval);  b) IRB approval must be obtained prior to the release of funds regardless of the review category;  c) An IRB approval must remain current in order for subsequent funds to be released for use by a PI.

[ TOP ]

V. CONTACT INFORMATION

If there are any questions, please contact:

Correspondence to the IRB Coordinator may be directed to:

Institutional Review Board Coordinator

Office of Research Integrity -  MARC 430

E-mail:  irbiacuc@fiu.edu

Phone:  305-348-2494

Note:  Incomplete submissions will be returned to the PI for resubmission and will delay the commencement of the research study.