The LifeBridge Health Institutional Review Board (IRB) ensures that the rights and welfare of human subjects participating in research are adequately protected, the risks to subjects are outweighed by the potential benefits of the research, the selection of subjects is not coercive or biased, informed consent will be obtained and documented where appropriate, and there is scientific merit to the proposal.
IRB Information
Federal-Wide Assurance Number - FWA00003667
FWA Expiration Date is 6/6/2017
Policies and Standard Operating Procedures
LBH Conflict of Interest Policy
LifeBridge Health Research Policy
Misconduct-in-Research Policy
IRB (A) Membership Roster
IRB (B) Membership Roster
Meeting Schedules and Submission Deadlines
2012 Deadlines and Meeting Dates for IRB A
2013 Deadlines and Meeting Dates for IRB A
2012 Deadlines and Meeting Dates for IRB B
2013 Deadlines and Meeting Dates for IRB B
Initial Submission Documents:
Expedited and Full Board Reviews:
Studies involving human research subjects may qualify for expedited review. The application documents for expedited and full board review are the same. However, studies that qualify for expedited review may be reviewed by the Chairman or his designee rather than by the full IRB board. Please review the Application for New Research to determine how many copies are needed.
When submitting an application for Medical Records Review the investigator must submit a Data Collection Form (created by the investigator) stating exactly what will be extracted from the medical record.
Exempt and NCI CIRB Initial Reviews:
Minimal risk research studies may qualify as exempt from full LBH IRB review. The Exemption Screening Questions Form will assist you in determining whether your study qualifies as exempt.
The LBH IRB is a participant in the National Cancer Institute (NCI) Central Institutional Review Board (CIRB initiative. Any study that has been reviewed by the NCI CIRB may be submitted to the LBH IRB for a facilitated review. The LBH IRB requires a letter requesting a Facilitated Review of the NCI CIRB protocol, the protocol and all documentation from the Participants Area downloaded from the CIRB website, and the documents listed below.
Humanitarian Use Device (HUD) Reviews:
A Humanitarian use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals per year in the United States. An investigator, or sponsor may submit a request for HUD designation to the FDA, and must include the following information: A statement that the applicant is requesting HUD designation for a rare disease or condition, the name and address of the applicant, a description of the rare disease or condition for which the device is to be used, a description of the device, and documentation with authoritative reference appended, to demonstrate that the device is designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 people in the United States per year. Once approved, this device must be stored separately from all other devices. Please review the Humanitarian Use Devices Guideline and the Humanitarian Use Devices (HUD) FDA Training Module.
Renewal Submission Documents:
All research studies require a continuing renewal (either annually or semi-annually depending on the level of risk to the subject). Studies that have been identified as exempt do not require a continuing renewal. As with initial reviews continuing renewals may be completed either by full board or in an expedited manner. The form to be used for these submissions is the Renewal Application. This form is used for all studies except the Humanitarian Use Device (HUD) and the National Cancer Institute Central Institutional Review Board (NCI CIRB) reviews. The HUD Renewal Application requires different information than that of the Renewal Application and therefore is a separate form. The HUD Renewal Application may be reviewed in an expedited manner. There isn't a Renewal Application for the NCI CIRB studies as the information is obtained through the NCI CIRB. All that the LBH IRB requires is a cover letter explaining what has occurred at a LifeBridge Health facility. All Renewal Submissions require that the SAE & SRs Annual Report (Serious Adverse Events and Safety Reports) be submitted at the time of the continuing renewal (annually or semi-annually) if any have been reported.
If there are any Adverse Events that occurred at a LifeBridge Health facility the Adverse Events Form is required to be completed at the time of the event and resubmitted when the continuing renewal is submitted.
Guidelines
IRB Fees
| Initial Review, Full Board |
$2,000 |
| Initial Review, Expedited |
$1,000 |
| Continuing Review |
$ 500 |
| Review for Exempt Status |
$ 500 |
| Review of Amendments, Revisions, or Modifications: |
$ 500 |
| Payable to: |
LifeBridge Health IRB |
HIPAA Policy
LifeBridge Health HIPAA Policy #4 - Use of Protected Health Information for Research (PDF)
Education Requirements
To ensure that clinical research within the LifeBridge Health system adheres to the highest ethical standards and is in full compliance with applicable regulations, the following educational requirements must be followed:
| a. All Clinical Investigators and Staff who participate in clinical research within LifeBridge Health for: |
| i. |
certification of clinical competence to perform research studies, and |
| ii. |
continuing education to keep pace with changing requirements. |
| b. All Institutional Review Board members, designated alternates and staff, for |
| i. |
education in the requirements of review of research studies, and |
| ii. |
continuing education to keep pace with changing requirements.
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This policy applies to all members of the medical staff, medical residents and fellows in training who are responsible for recruitment, enrollment, treatment and/or follow-up of subjects in clinical research within the institution. This includes research projects deemed "exempt" from LBH IRB oversight. Department Chiefs, administrators and others who oversee staff who conduct clinical research studies within the institution are also encouraged to avail themselves of the resources detailed herein.
The Collaborative IRB Training Initiative (CITI)
The CITI human subjects research educational program consists of a basic course of 17 training modules for Biomedical investigators and a similar number of modules specifically prepared for investigators conducting Social/Behavioral research. Each module was developed by experts in the "IRB community", focuses on different aspects of bio-ethics and human subjects research, and has an associated quiz. Software maintained at the University of Miami compiles the quiz scores. When the user completes the required materials (which takes ~20 minutes/module), the learner can print/download a Completion Report that details the learner's accomplishments. A copy of the report is e-mailed to the institutional LBH IRB administrator. Click here for more detailed instructions.
Requirements:
| a. Principal Investigators and Clinical Research Coordinators |
| i. |
Individuals involved in biomedical research are required to complete the CITI Program "Group 1" training |
| |
consisting of 12 modules prior to initiating any research activity. |
| ii. |
Individuals involved in Social and Behavioral Research training are required to complete The CITI Program "Group 3"
|
| |
consisting of 12 modules prior to initiating any research activity. |
| b. Co-Investigators and Research Staff |
| i. |
Individuals involved in biomedical research are required to complete The CITI Program "Group 2" training consisting of 8 |
| |
modules prior to initiating any research activity. |
| ii. |
Individuals involved in Social and Behavioral Research training are required to complete The CITI Program "Group 4" |
| |
consisting of 8 modules prior to initiating any research activity. |
| c. LBH IRB Members, Designated Alternates, and IRB Staff |
| i. |
For new appointments |
| |
The CITI Program "Group 1" training consisting of 12 modules is required within 120 days of appointment |
| ii. |
For current appointments |
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The CITI Program "Group 1" training is required to be maintained by completing The CITI Program |
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within three (3) years of their last completed training session. |
Alternatives and Additional Resources:
For "Group 1 and Group 3 Training Requirements"
The CITI Program completed at another institution may satisfy LBH IRB training requirements within three (3) years from the date of the documented completed training session. Alternate coursework provided by appropriately certified educational, regulatory or governmental entities or professional societies may be substituted for The CITI Program, subject to approval by the Research Office.
Failure to complete required certification as outlined above by the indicated dates will result in the following actions:
Consequences for Failure to Comply with the Education and Training Policy
| i. |
Refusal to accept new research applications from the non-compliant Investigator and staff by the LBH IRB office, and
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| ii. |
Suspension of the non-compliant Investigator and staff from participation in further research until the requirements are met. |
| iii. |
LBH IRB Members who do not comply with deadlines imposed will have their status changed to a non-voting member with a
|
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one-(1) month extension to fulfill the requirements unless the LBH IRB chairperson allows the member additional time |
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to complete training.If the requirements are not met, the member will be removed from the LBH IRB committee. |
HIPAA Appendices
Instructions for Individual Authorization Form for Use or Disclosure of Protected Health Information (PHI) for Research Purposes (Word format)
Application for Waiver of Individual Authorization for Use or Disclosure of Protected Health Information (PHI) in a Research Study (Word format)
Request for Use or Disclosure of Protected Health Information (PHI) Preparatory to Research (Word format)
Request for Use or Disclosure of Protected Health Information (PHI) of Decedents (Word format)
Guidance and Regulatory Links