FULL BOARD RESEARCH PROTOCOLS

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Human subjects research that is not Exempt or eligible for review by the Expedited procedure must be reviewed at a convened meeting of the IRB. Full Board review usually involves research that is greater than minimal risk but also includes minimal risk research that does not meet one or more of the Expedited Review Categories.
 

Examples of Full Board Research

Common examples include research involving greater than minimal risk procedures and:

• clinical procedures with drugs, devices, or biologics, or innovative research into new medical or surgery procedures
   
• disclosure of information that could require mandatory legal reporting (e.g., child/elder abuse, etc.)
   
• deception
   
• vulnerable populations (Children, prisoner, pregnant women and neonates, per federal regulation)
   
• taking place internationally (particularly countries with little or no provisions for protection of human subjects) where subjects may be at physical, psychological or legal risk
   

How to Submit

The quality and clarity of any proposed research materials submitted to the IRB will affect the Board's ability to assess risks to participants and to make a determination in a timely manner.  Researchers who are developing study protocols that may involve greater than minimal risk to participants, or are unsure of the risk level of the research, are encouraged to actively seek guidance and information from the IRB Office (IRBOffice@lsuhsc.edu) prior to submission to avoid unnecessary delays in the review process. Whether a proposed research protocol will require Full Board review depends on the nature and context of the particular study.  The level of review is ultimately determined by the IRB/IRB Office, not by the investigator.

All research applications for IRB review are submitted through the Kuali Research (KR) electronic submission platform.  In KR, applications are referred to as “protocols” and instructions for preparing and submitting protocols are available in Kuali Quickguides. If your research involves greater than minimal risk to subjects, select Full Board Research under Protocol Type, complete the resulting form and submit it for IRB review.
 

When to Submit

Committee meetings are typically held on the 3rd Wednesday of each month. A Full Board study will be assigned to the next available meeting by the Chair.  IRB applications for full committee review must be received by the last working Wednesday of the month prior to the meeting date. In general, researchers should allow sufficient time for the pre-review process to ensure that submission materials are adequate for IRB review. Only complete and consistent submission materials will be assigned to a meeting agenda for review.
 

Possible Outcomes of a Full Board Review

There are several possible outcomes that may be made for proposed research that is reviewed by the convened IRB:

• The Board may vote to approve the proposed research when all criteria for approval are met.
   
• The Board may determine that modifications are required to secure approval (MRSA) of the proposed research protocol and will outline those specific modifications for the investigators.  Individual IRB members and/or HRPP staff are designated to review the modifications, when received, to determine whether the researchers have made the required changes.
   
• The Board can decide to defer the proposed research when the study does not qualify for approval or minor modifications and will make recommendations that might make the protocol approvable.  Once further information and/or revised research materials are received from the researchers, the study is assigned to the next available IRB meeting for subsequent review.
   
• The Board may vote to disapprove proposed research and will provide the Principal Investigator with their reasoning for this decision.  If a study is disapproved, the investigators may appeal this decision or modify their protocol and submit for a new IRB review.  Please be aware that no one at the institution, including the administration, deans, or department chairs, can override an IRB decision to disapprove a proposed study.

IRB Office staff will help facilitate the IRB review process and send appropriate correspondence to the Principal Investigator via Kuali of any determination made by the IRB.
 

Post-approval Requirements

When the Board approves a research study, it must also determine an interval for continuing review.  Most approvals are granted for one year at a time.  The investigators are responsible for submitting for continuing or final review of the research to ensure that this IRB approval does not lapse. In general, continuing reviews and amendments to studies originally approved by a convened IRB must also be reviewed and approved in the same manner.  However, depending on the risks to participants and the current status of the research, the IRB may determine at some point that a specific study may be handled through the expedited process.

Resources

Use the following resources (as applicable) to submit an initial application for a greater than minimal risk research study:

• Kuali Quick Guide - Expedited / Full Board Research
   
• Joint Consent Form & HIPAA Authorization Templates
   
  • Main Consent/HIPAA Template - Complete Instructions
     
  • Main Consent/HIPAA Template - Minimal Instructions
     
• Short Consent Form Templates
   
  • Instructions for obtaining and documenting informed consent of non-English-speaking subjects
     
  • English Version - use in conjunction with one of the translated versions
     
  • French Version
     
  • Spanish Version
     
  • Vietnamese Version
     
• Other Consent Form Templates
   
  • Biorepository Consent Template
     
  • Pregnant Partner Consent Template
     
• Other HIPAA-Related Forms
   
  • Notice of Privacy Practices (only required for treatment studies)
     
  • Privacy Notice Acknowledgement (only required for treatment studies)
     
  • Request for Review of Protected Health Information Preparatory to Research
     
  • Additional Forms, Policies & Guidance
     
• Supplemental Application for International Research - Complete and submit this form if your project involves conduct of research outside the United States.