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Texas A&M UniversityDivision of Research
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About

The division is committed to a truly comprehensive university where students, researchers, and inventors bring scholarship and innovation to bear for the benefit of the community, the state, and the nation.

About the VPR STAFF DIRECTORY

About the Division

Mission Statement

Advancing and strengthening all aspects of the research enterprise.

Senior Administrative Leadership Team

Associate vice presidents, executive directors and directors

Faculty Research Organizations

Council of Principal Investigators and University Research Council

About the Research Enterprise

The Strategic Plan

Download the entire plan or the abbreviated version.

Themes and Sub-themes

Download a packet of fact sheets for details about each.

Highlights (2023)

Gathers and frames data into six foundational categories.

Quicklinks
  • Fact Sheets
  • Research Rankings
  • Feedback
Funding

Seek external funding from governments, non-profits or corporations. Apply for internal grants for interdisciplinary or multidisciplinary projects.

Funding Newsletters

Internal

Advancing Discovery to Market

Nurtures commercial potential of recent discoveries.

Arts & Humanities Fellows Program

Provides multi-year support for scholarship or creative works

Panther RISE Grant Program

Fosters collaboration with Prairie View A&M University.

 
Research Development Fund

Supports strategic investments across the research enterprise.

Research Leadership Fellowship

Develops junior faculty into the next research leaders.

Targeted Proposal Teams

Encourages collaboration across disciplines.

External

Search for Funding

Navigate databases to identify opportunities.

Federal Funding

Explore online access to departments and agencies.

Limited Submissions

Understand how the division identifies and manages these opportunities.

Private Foundations

Consider options for non-profit support.

Proposal Support

Generate applications that compete more effectively for research dollars.

Proposal Development

Research Development Services

Central office providing proposal support, resources, and professional development.

Multidisciplinary Proposal Development

For multidisciplinary funding opportunities.

Early Career Faculty

For researchers launching their portfolios.

Special Strategic Projects

For proposals that align with division priorities.

Proposal Submission

Sponsored Research Services – Getting Started

Master the steps for submitting a successful proposal.

Submission Guidelines

Follow the approve process for pursuing external funding.

Budget Development

Work with a proposal administrator.

Quicklinks
  • Proposal Forms
  • Tutorials
  • Find Your SRS Contact
  • Time and Effort
  • Institutional Letter of Support
  • Cost Rates
  • Limited Submission
  • Research Titles and Staffing
  • iThenticate
  • Hanover Research: Proposal Review
  • Bouvier Grant Group: NIH Proposal Training Courses
Awards & Projects

Get help with starting, managing or closing a project.

Starting a Project

SRS PI Guidebook

Delve into services offered throughout the project cycle.

Contract Negotiations

Protect your interests and Texas A&M’s.

Facilities and Administration

Learn your cost rates.

Project Set-Up

Ensure a project meets all requirements.

Managing a Project

Project Administration

Exercise best practices from establishment to closeout.

Maestro

Streamline project administration.

Informational Sessions

“Answers for You” videos address vital topics and issues.

Project Closeout

Meet the requirements for final technical reports.

Quicklinks
  • Research Compliance
  • Find Your SRS Contact
  • Commercialization
  • Administrative Forms
  • Agreement Forms
  • Developing a Budget
Research Compliance

Understand the laws, rules and regulations for conducting research that is safe, legal and ethical.

Report an Incident / Concern Research Misconduct

Research Compliance and Biosafety

Animal Welfare Program

Gain approval for animal research or teaching at Texas A&M.

Biosafety Program

Obtain consent before initiating research involving biohazards.

Human Research Protection Program

Protect the rights and welfare of participants.

Biosafety Occupational Health Program

Reduce the risk of exposing personnel.

Research Security and Export Controls

High Risk International Activity

Manage the transboundary aspects of your research.

Export Controls

Comply with all U.S. laws and regulations.

Conflict of Interest and Commitment

Disclose all activities outside of Texas A&M.

Time and Effort

Certify for sponsored projects using TimeTraq or certification system.

Quicklinks
  • My IRB Contact
  • Send an email to IRB
  • iRIS Portal
  • Aggie Research Volunteers
  • COI Disclosure / Preapproval Request
  • IRB Submission System
  • Enroll in Biosafety Occupational Health Program
  • Responsible Conduct of Research
  • Visiting Scholars
Research Support

Offers cutting-edge resources, services and facilities to investigators and their teams.

Core Facilities

Provide state-of-the-art instrumentation, technologies and specialized scientific services.

Centers and Institutes

Organize collaborations to take on major challenges.

Comparative Medicine Program

Offers high quality animal care at affordable cost.

Postdoctoral Affairs

Serves postdocs and the faculty who train them.

Research Data Management

Organizes, stores, preserves and shares findings and results.

Resources on Generative AI in Research

Guidance from federal agencies on generative AI in research.

Division Centers, Institutes, and Facilities
  • High Performance Research Computing
  • Microscopy and Imaging Center
  • Materials Characterization Facility
Units

Through its units, the Division of Research delivers strategic support to further Texas A&M’s research mission.

Staff Directory
Research Compliance and Biosafety

Provides guidance in biosafety, animal welfare and human research protection.

Research Development Services

Offers no-cost consultation and training for developing proposals.

Research Security and Export Controls

Helps to safeguard integrity of research and scholarship.

Sponsored Research Services

Works with researchers in the administration of funded projects.

Strategic Initiatives

Coordinates cross-cutting initiatives to advance the research enterprise.

Postdoctoral Affairs

Advances postdoctoral research and career development through support and collaboration.

Quicklinks
  • Comparative Medicine Program
  • Special Strategic Projects
  • Research Misconduct
  • Research Enterprise Business Services (Intranet)
Texas A&M University
Texas A&M Logo
Texas A&M UniversityDivision of Research
  • Aggie Research Volunteers
  • Federal Administration Transition
About

The division is committed to a truly comprehensive university where students, researchers, and inventors bring scholarship and innovation to bear for the benefit of the community, the state, and the nation.

About the VPR STAFF DIRECTORY

About the Division

Mission Statement

Advancing and strengthening all aspects of the research enterprise.

Senior Administrative Leadership Team

Associate vice presidents, executive directors and directors

Faculty Research Organizations

Council of Principal Investigators and University Research Council

About the Research Enterprise

The Strategic Plan

Download the entire plan or the abbreviated version.

Themes and Sub-themes

Download a packet of fact sheets for details about each.

Highlights (2023)

Gathers and frames data into six foundational categories.

Quicklinks
    Fact Sheets
    Research Rankings
    Feedback
Funding

Seek external funding from governments, non-profits or corporations. Apply for internal grants for interdisciplinary or multidisciplinary projects.

Funding Newsletters

Internal

Advancing Discovery to Market

Nurtures commercial potential of recent discoveries.

Arts & Humanities Fellows Program

Provides multi-year support for scholarship or creative works

Panther RISE Grant Program

Fosters collaboration with Prairie View A&M University.

Research Development Fund

Supports strategic investments across the research enterprise.

Research Leadership Fellowship

Develops junior faculty into the next research leaders.

Targeted Proposal Teams

Encourages collaboration across disciplines.

External

Search for Funding

Navigate databases to identify opportunities.

Federal Funding

Explore online access to departments and agencies.

Limited Submissions

Understand how the division identifies and manages these opportunities.

Private Foundations

Consider options for non-profit support.

Proposal Support

Generate applications that compete more effectively for research dollars.

Proposal Development

Research Development Services

Central office providing proposal support, resources, and professional development.

Multidisciplinary Proposal Development

For multidisciplinary funding opportunities.

Early Career Faculty

For researchers launching their portfolios.

Special Strategic Projects

For proposals that align with division priorities.

Proposal Submission

Sponsored Research Services – Getting Started

Master the steps for submitting a successful proposal.

Submission Guidelines

Follow the approve process for pursuing external funding.

Budget Development

Work with a proposal administrator.

Quicklinks
    Proposal Forms
    Tutorials
    Find Your SRS Contact
    Time and Effort
    Institutional Letter of Support
    Cost Rates
    Limited Submission
    Research Titles and Staffing
    iThenticate
    Hanover Research: Proposal Review
    Bouvier Grant Group: NIH Proposal Training Courses
Awards & Projects

Get help with starting, managing or closing a project.

Starting a Project

SRS PI Guidebook

Delve into services offered throughout the project cycle.

Contract Negotiations

Protect your interests and Texas A&M’s.

Facilities and Administration

Learn your cost rates.

Project Set-Up

Ensure a project meets all requirements.

Managing a Project

Project Administration

Exercise best practices from establishment to closeout.

Maestro

Streamline project administration.

Informational Sessions

“Answers for You” videos address vital topics and issues.

Project Closeout

Meet the requirements for final technical reports.

Quicklinks
    Research Compliance
    Find Your SRS Contact
    Commercialization
    Administrative Forms
    Agreement Forms
    Developing a Budget
Research Compliance

Understand the laws, rules and regulations for conducting research that is safe, legal and ethical.

Report an Incident / Concern Research Misconduct

Research Compliance and Biosafety

Animal Welfare Program

Gain approval for animal research or teaching at Texas A&M.

Biosafety Program

Obtain consent before initiating research involving biohazards.

Human Research Protection Program

Protect the rights and welfare of participants.

Biosafety Occupational Health Program

Reduce the risk of exposing personnel.

Research Security and Export Controls

High Risk International Activity

Manage the transboundary aspects of your research.

Export Controls

Comply with all U.S. laws and regulations.

Conflict of Interest and Commitment

Disclose all activities outside of Texas A&M.

Time and Effort

Certify for sponsored projects using TimeTraq or certification system.

Quicklinks
    My IRB Contact
    Send an email to IRB
    iRIS Portal
    Aggie Research Volunteers
    COI Disclosure / Preapproval Request
    IRB Submission System
    Enroll in Biosafety Occupational Health Program
    Responsible Conduct of Research
    Visiting Scholars
Research Support

Offers cutting-edge resources, services and facilities to investigators and their teams.

Core Facilities

Provide state-of-the-art instrumentation, technologies and specialized scientific services.

Centers and Institutes

Organize collaborations to take on major challenges.

Comparative Medicine Program

Offers high quality animal care at affordable cost.

Postdoctoral Affairs

Serves postdocs and the faculty who train them.

Research Data Management

Organizes, stores, preserves and shares findings and results.

Resources on Generative AI in Research

Guidance from federal agencies on generative AI in research.

Division Centers, Institutes, and Facilities
    High Performance Research Computing
    Microscopy and Imaging Center
    Materials Characterization Facility
Units

Through its units, the Division of Research delivers strategic support to further Texas A&M’s research mission.

Staff Directory
Research Compliance and Biosafety

Provides guidance in biosafety, animal welfare and human research protection.

Research Development Services

Offers no-cost consultation and training for developing proposals.

Research Security and Export Controls

Helps to safeguard integrity of research and scholarship.

Sponsored Research Services

Works with researchers in the administration of funded projects.

Strategic Initiatives

Coordinates cross-cutting initiatives to advance the research enterprise.

Postdoctoral Affairs

Advances postdoctoral research and career development through support and collaboration.

Quicklinks
    Comparative Medicine Program
    Special Strategic Projects
    Research Misconduct
    Research Enterprise Business Services (Intranet)
Search
Key Documents
    Memos from the VPR
    iRIS Help Documentation
    Huron IRB Knowledge Center
    My IRB Contact
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    News
    Federal Administration Transition
    Events Calendar

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Reporting to the IRB

  1. Home
  2. Research Compliance
  3. Human Research Protection Program
  4. Reporting to the IRB

What to Report to the IRB

Report any of the events listed below to the IRB within five (5) working days of the research staff having knowledge of the event. Reportable New Information must be submitted via the electronic system.

If you are unsure whether an event needs to be reported to the IRB or not, please contact your IRB coordinator for a consultation.

  1.  Harm: Any harm experienced by a subject or other individual, which in the opinion of the investigator is unexpected and probably related to the research procedures. Example: Serious adverse event or unanticipated problem
  2. Risk: Information that indicates a new or increased risk or a new safety issue. For example: safety monitoring report, drug or device changes, interim analysis, or investigator finding.
  3. Non-compliance: Non-compliance with the federal regulations governing human research or with the requirements or determinations of the IRB, or an allegation of such non-compliance.
  4. Audit: Audit, inspection, or inquiry by a federal agency or government agency.
  5. Report: Written reports of study monitors or DSMB Reports.
  6. Deviation (researcher error): Failure to follow the protocol due to the action or inaction of the investigator or research staff.
  7. Confidentiality: Breach of confidentiality.
  8. Unreviewed change: Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a subject.
  9. Incarceration: Incarceration of a subject in a study not approved by the IRB to involve prisoners.
  10. Complaint: Complaint of a subject that cannot be resolved by the research team.
  11. Suspension: Premature suspension or termination of the research by the sponsor, investigator, or institution.
  12. Unanticipated adverse device effect: Any serious adverse effect on health or safety or any life-threatening problem or death caused by or associated with a device.

Unanticipated Problems

Unanticipated problems, in general, include any incident, experience, or outcome that meets all of the following criteria:

1. unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; (b) the characteristics of the subject population being studied; and

2. is related or possibly related to the research (this means that it is more likely than not, the incident, experience, or outcome was caused by the procedures involved in the research); and

3. suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

There are other types of incidents, experiences, and outcomes that occur during the conduct of human subjects research that represent unanticipated problems but are not considered adverse events.  For example, some unanticipated problems involve social or economic harm instead of the physical or psychological harm associated with adverse events.  In other cases, unanticipated problems place subjects or others at increased risk of harm, but no harm occurs.

The following flowchart is designed to help investigators determine when an adverse event needs to be reported as an unanticipated problem to the IRB.

Unanticipated Problem Flow Chart

Ask all three questions

[box 1]: An adverse event occurs in one or more subject

[yes arrow connects box 1 to box 2]

[box 2]: 1. Is the adverse event unexpected in nature, severity, or frequency?

[yes arrow connects box 2 to box 3]

[box 3]: 2. Is the adverse event related or possibly related to participation in the research?

[yes arrow connects box 3 to box 4]

[box 4]: 3. Does the adverse event suggest that the research places subjects or others at greater risk of harm than was previously known or recognized? Note: if the adverse event is serious, the answer is always YES.

[yes arrow connects box 4 to box 5]

[box 5]: Report the adverse event as an unanticipated problem

[all no arrows connect from boxes 2, 3, and 4 to box 6]

[box 6]: Stop. The adverse event is not an unanticipated problem.

Reporting New Information to the IRB

All reportable new information (RNI) must be submitted to the IRB via the electronic system. An RNI must be submitted under the applicable study. The RNI consists of a simple online form that asks you to provide the date the research staff first became aware of the event and a description of the event. Additionally, you will be prompted to identify if the new information indicates a new or increased risk or safety issue, if the study and/or consent document need to be revised, and a corrective action plan.

Resources
  • HRP-024 SOP: New Information Process
  • HRP-029 SOP: Reportable New Information Items 
On This Page
  • What to Report to the IRB
  • Unanticipated Problems
  • Reporting New Information to the IRB
  • What to Report to the IRB
  • Unanticipated Problems
  • Reporting New Information to the IRB
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