VCU Human Research Protection Program (HRPP) Blog

The VCU HRPP is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

Institutional Review Board (IRB) Submission Guidance

by Jennifer Rice

Introduction

This guidance document provides precise information on the requirements for submitting research proposals to the Institutional Review Board (IRB) using the Research Administration Management System (RAMs IRB system) at https://research.vcu.edu/rams-systems/. The RAMs IRB system streamlines the submission process for studies involving human participants at Virginia Commonwealth University (VCU) and ensures compliance with federal regulations, including the Common Rule (45 CFR 46 subpart A) and the Health Insurance Portability and Accountability Act (HIPAA) where applicable.

The “study application” is a smart form within RAMS IRB.  The smart form utilizes branching logic, opening various paths depending on your answers.

The templates referenced below can be found here: https://research.vcu.edu/forms/

Essential Submission Documents:

Study Protocol:

  • All human subject research study applications must include a separate study protocol using the applicable VCU protocol template:
    • HRP-503 – This template is suitable for biomedical studies and clinical trials. It offers a structured format for detailing a study’s objectives, methods, and procedures
    • HRP-503a – This template is suitable for Social and Behavioral Science studies and studies that do not involve an investigational agent; OR
    • HRP-508  — This template is a site-specific protocol addendum. It is submitted along with a separate sponsor/consortium protocol.  HRP-508 is a tool to document the required site-specific protocol information, such as local recruitment strategies and local enrollment targets. 

The study protocol must be comprehensive and transparent, providing detailed information about the research study’s objectives, methods, procedures, and data collection processes. These specific templates are designed to align with the necessary regulatory and ethical standards. By utilizing these templates appropriately, you help streamline the submission process and enhance the clarity and completeness of your research proposal.

HRP-503, HRP-503a, or HRP-508 (whichever is applicable) must be uploaded to the “Protocol Upload” section of the IRB Smart Form.

Informed Consent Form (ICF) or Script for Oral Consent:

  • Ensure a Microsoft Word version of the ICF is uploaded to the “Protocol Upload” section of the study application. (This section includes the protocol and all supporting documentation). The ICF must adhere to regulatory standards and clearly convey the research study’s purpose, potential risks, benefits, and the voluntary nature of participation. Use HRP-502, the VCU consent template, or customize a consent provided by a sponsor/consortium.

VCU HRPP applies the Revised Common Rule to all studies.  This rule requires that all consent forms include the “Key Information” section. As such, all VCU consent forms must have a “Key Information” section, per the revised common rule. 

The VCU informed consent template includes site-specific language for the consent subject injury language section and participant payment section. If appropriate, refer to HPR-502 to update a sponsor/consortium consent with the required VCU language. Note, for industry studies, the Sponsored Program office will provide a “subject injury language” (SIL) memo, which will stipulate the specific injury language to include in your consent. 

  • If your study involves oral consent instead of a written ICF, ensure the verbal consent script is uploaded to the “Protocol Upload” section of the study application. The script must follow the same regulatory standards as the written ICF, conveying all necessary information to potential participants clearly and comprehensively.

By including the script for oral consent, you provide a transparent and standardized way of obtaining consent from participants when written consent is not practical or preferred.

To write your script, use the HRP-502 consent template, removing the signature line.

  • An Information Sheet template is also available. This template is suitable for exempt studies.

HIPAA:

  • Health Insurance Portability and Accountability Act of 1996 (HIPAA) Authorization (if applicable): If your research involves the use or disclosure of protected health information (PHI) under HIPAA, upload the separate HIPAA authorization form to the “Protocol Upload” section of the study application.  This form should outline how PHI will be used and protected in the study.  The regulations also allow HIPAA information to be included in the consent form as a combined ICF/HIPAA document.  

Drug Management Plan (if applicable):

  • For studies involving drugs or investigational products, ensure the “Study Intervention/Investigational Agent” section of the protocol template is completed (Section 5.0 in HRP-503 or Section 2.0 in HRP-508). This section should detail drug procurement, storage, dispensation, and monitoring protocols. Investigators are strongly encouraged to utilize VCU’s Investigation Drug Services (IDS) to develop a comprehensive drug management plan.

Recruitment Materials:

  • Upload all recruitment materials, such as flyers, advertisements, emails, and social media posts, into the “Protocol Upload” section of the study application. Ensure these materials accurately represent the study without making promises or misrepresentations of the study’s outcomes.

Advertising Materials:

  • If your study requires advertising beyond recruitment materials, upload copies of advertisements used in public forums, websites, or media outlets into the “Protocol Upload” section of the study application.

Investigator’s Curriculum Vitae (CV):

  • Attach the CV of the Principal Investigator (and Medically or Psychologically Responsible Investigator and Lead Student/Trainee Investigator, if applicable).  Highlight their qualifications and expertise in the relevant field.

CITI Training Certificates:

  •  Attach the certificates of completion for the Collaborative Institutional Training Initiative (CITI) human subjects research training course for the Principal Investigator (and Medically or Psychologically Responsible Investigator, and Lead Student/Trainee Investigator, if applicable).  The CITI site can be accessed at http://www.citiprogram.org/.

Partnering Sites and Community Partners:

  • Upload letters of support from partnering sites, community-based recruitment sites and community partners.  When conducting school-based research, use the HRP 504 Template Letter – School permission to conduct research.

VCU Ancillary Reviews:

HRP-309 – WORKSHEET – Ancillary review matrix 

VCU has institutional requirements that must be in place before a study can be reviewed:

  • Massey Cancer Center Protocol Review and Monitoring Committee (PRMC) or Protocol Review and Oversight Committee Approval (PROC) Letter/Email (if applicable): If PROC or PRMC approval is a prerequisite for your study, attach the committee’s approval letter to the application.
  • Data Management Plan (DMS Review): Studies that involve Category 1 data must have the Data Management Plan linked to the application.  Your plan must include the IRB study number to link to the application.  Additional information can be found here:  https://dms.vcu.edu.  
  • Scientific Review Committee (SRC) Letter (if applicable): If your study requires scientific review before IRB submission, attach the committee’s approval letter to the application.  VCU’s SRC only reviews studies that have not previously undergone a scientific review or peer review. More information can be found here:  https://cctr.vcu.edu/support/consultation/scientific-review-committee/

  • Training Certificates for Honest Brokers (if applicable): If honest brokers are involved in the study, attach the honest broker’s training certificate(s) to the application. 

Additional institutional review may be required if your study involves European data, student data, or external technology, amongst other things. The IRB smart form (study application) provides additional guidance.  Refer to the HRP 309 WORKSHEET – Ancillary Review Matrix for all ancillary review requirements.

Submission Process via RAMs IRB System

  • Log in with your credentials.
  • Navigate to the IRB submission section and select the relevant study type.
  • Complete the RAMs smart form by providing all requested information and uploading the essential submission documents mentioned above.
  • Review the completed submission for accuracy and compliance with VCU’s IRB guidelines.
  • Submit the application and documents through the RAMs system.
  • Participate in any required IRB meetings or respond promptly to queries and revision requests from the IRB.
  • Await IRB approval or exemption determination through the RAMs system before initiating research activities involving human participants.

Utilizing the RAMs IRB system at Virginia Commonwealth University simplifies the submission process for research involving human participants. It is imperative to adhere to VCU’s specific IRB guidelines and requirements when preparing and submitting research proposals. Compliance with these guidelines ensures ethical research conduct and regulatory compliance with federal and institutional standards. 

VCU HRPP documents and guidance can be found under the HRPP Toolkit: https://research.vcu.edu/human-research/hrppirb/hrpp-policies-and-guidance/

For any questions or clarification regarding the RAMs IRB system or the submission process, consult the VCU Human Research Protection Program office for guidance at hrpp@vcu.edu.

Effective date: October 19, 2023

Categories Education and Training, HRPP Transformation Project, New Guidance Document
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