Research Compliance

IRB

https://vpr.tamu.edu/division-resources/research-compliance-and-biosafety

Protection of human and animal subjects involved in research, the safety of our faculty, staff, and students involved in conducting research, and the welfare of the public.

It is the responsibility of the Principal Investigators (PIs) to carry out their research in compliance with all federal, state, and university requirements, with approval from the appropriate university committee, such as the:

  • Human Subject - Institutional Review Board (IRB): All individuals engaged in human subjects’ research that is sponsored by TAMU must submit an application to the IRB prior to commencement of any research activities.
  • Any faculty, staff, student, or agent of Texas A&M in connection with his or her institutional responsibilities.
  • Any employee or agent of Texas A&M using any property or facility of Texas A&M; or involved in the use of Texas A&M’s non-public information to identify or contact human research participants or prospective participants.

Modifications to the Protocol

The IRB must approve all modifications to the research activities and applications prior to implementation.

Minor changes proposed for previously approved research may be reviewed using the expedited review procedure. A minor modification is defined as a change that would not materially affect an assessment of the risks and benefits of the study or does not substantially change the specific aims or design of the study.

When a proposed change in a greater than minimal risk research study is not minor, the IRB must review and approve changes at a convened meeting before implementation. A major modification is defined as any change which materially affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study.

Promptly report all adverse events or deviations from the IRB-approved study. Investigators are responsible for reporting non-compliance.

Any change, divergence, or departure from the study design or procedures of a research protocol that affects the subject's rights, safety, or wellbeing and/or the completeness, accuracy, and reliability of the study data constitutes non-compliance. For example, enrollment of more subjects than the number approved by the IRB is non-compliance and must be reported promptly.

The IRB will consider how often continuing review will be required. Federal regulations (45 CFR 46) require review to occur on or before the 12-month anniversary date of the previous IRB approval.

When a human subjects research study has been completed. Researchers should inform the IRB that a study has ended by submitting an IRB completion report following the end of the study.

Roles and Responsibilities (IRB)

Institutional Official (IO) – VPR

IRB - has the authority to review, approve, require modifications in, or disapprove all human subject research activities that fall within its jurisdiction. The IRB is an administrative body within

Department Heads and Deans - Every IRB protocol includes a signature of the PI’s supervisor as a part of the process. Supervisors are responsible for ensuring that research involving the use of human subjects is appropriately reviewed and approved by the IRB prior to the initiation of any work.

Principal Investigators - The PI is the one individual researcher who is designated by the institution to direct a project or program and who is responsible to the institution for the scientific and technical direction of that project or program. The PI is the ultimate protector of the research participant’s rights and safety and is obligated to be personally certain that each participant is adequately informed and voluntarily consents to participate in the research. The PI must personally ensure that every reasonable precaution is taken to reduce to a minimum any risk to the participant. The PI also assumes responsibility for compliance with all federal, state, and institutional rules and regulations related to research involving humans and human subject-derived information and materials. Investigators may not initiate any research involving humans without prior IRB review and approval.

Resources for Human Subjects Research

  • Certificate of Confidentiality
  • Conflict of Interest Information
  • Consent Information
  • FAQ
  • Glossary of Terms
  • Investigator Self-Assessment Checklist for Human Subjects Research
  • IRB Classroom Guidance and Checklist
  • Payment of Survey and Research Participants SAP
  • Protection of Pupil Rights Amendment (PPRA)
  • Responsibilities for Investigators
  • Rules for FERPA in Research
  • Submission Deadlines for IRB Meetings
  • Guidance on Public Use Data Sets
  • IRB Contacts

Who Needs Approval

All research conducted by a member of the faculty or staff of Texas A&M University, or a Texas A&M System component with a signed Memorandum of Understanding (MOU) with Texas A&M, involving any of the agents/materials listed below must be approved by the Texas A&M Institutional Biosafety Committee (IBC) prior to initiation:

  • Pathogens and potential pathogens of humans, animals, or plants
  • Materials potentially containing human pathogens (including human blood, tissue, and cell lines; non-human primate blood, tissue, and cell lines)
  • Recombinant DNA (and RNA), including creation or use of transgenic plants and animals
  • Select agents and toxins (see http://www.selectagents.gov/) including strains and amounts exempted from the select agent regulations
  • Any material requiring a Center for disease control CDC import license or a USDA permit

IBC

Documentation Needed

  • The initial step for approval to work with biohazards is completing the Institutional Biosafety Committee permit application.
  • Principal investigators need to notify the IBC when information changes in the approved IBC permit, such as personnel, laboratory location, procedures, funding, etc. If such changes occur, the principal investigator will be required to fill out an amendment form.
  • Protocols are currently approved for the duration of three years with annual renewals and laboratory inspections.
  • Annual renewal forms must be submitted 60 days before the anniversary of the IBC permit approval.

Roles and Responsibilities

Heads and Deans - approves of all the information as presented; research is appropriately reviewed and approved by the IBC prior to the initiation of any work; and ensuring the facilities and infrastructure are adequate for the proposed work

Principal Investigators (PIs) - The PI is designated to direct a project and who is responsible to the institution for the scientific and technical direction of that project. It is the responsibility of the PI to carry out their research in compliance with all federal, state, and University requirements with approval from the IBC. Principal Investigators must be trained and knowledgeable in appropriate laboratory techniques, safety procedures, and hazards associated with handling infectious agents and are responsible for the conduct of work with any infectious agents or materials. The PI is responsible for the proper training of laboratory staff and for enforcement of IBC rulings pertaining to lab specific research. The PI is also responsible for lab manuals, SOPs, licenses, and permits for transport and use of biological agents and recombinant DNA.

When working with infectious materials, the proper degree of protection is of utmost importance. Protection for laboratory personnel, the environment and the local community must be considered and ensured.

The protections required by these types of activities are defined as biosafety levels. Biological safety levels are ranked from one to four and are selected based on the agents or organisms on which the research or work is being conducted. Each level up builds on the previous level, adding constraints and barriers.

  • BS Level 1 - usually pose a minimal potential threat to laboratory workers and the environment. Research with these agents is generally performed on standard open laboratory benches without the use of special containment equipment. Training on the specific procedures is given to the lab personnel, who are supervised by a trained microbiologist or scientist.
  • BS Level 2 - work with agents associated with human disease, (example – HIV) great care is used to prevent percutaneous injury
  • BS Level 3 – examples: Yellow fever, St. Louis encephalitis and West Nile virus. Work with these agents is strictly controlled and must be registered with all appropriate government
  • BS Level 4 - high risk of life-threatening disease. Examples are the Ebola virus

Resources

http://rcb.tamu.edu/biohazards/resources
  • Biosafety Guidance sheets
  • BL2 Laboratory Inspections
  • Laboratory Coat Laundry Guidelines
  • Working with Pregnant Sheep Inside Facilities
  • Biosafety Cabinet certification information
  • Biosafety Inspection Checklist Examples
  • ABSL1 Inspection Checklist
  • ABSL2 Inspection Checklist
  • BL1 Inspection Checklist
  • BL1 Inspection Checklist with Drosophila work
  • BL1-P Inspection Checklist
  • BL2 Inspection Checklist
  • Biosafety Occupational Health Program
  • BL2 Biosafety Laboratory Manual Checklist and Suggested Table of Contents
  • Checklist for New Researchers

Biosafety Training

All personnel listed on a biosafety level two (BL2) IBC permit must complete BL2 training, provided by the Office of Biosafety, before being permitted to enter and work in the BL2 lab. BL2 training is offered weekly and upon special request.

Principal Investigators conducting research involving recombinant DNA molecules must complete NIH Guidelines This training is offered online via the CITI program.

All personnel listed on a biosafety level three (BL3) permit must complete BL3 training, provided by the Office of Biosafety, before being permitted to enter and work in the BL3 lab.  BL3 training is available upon request, as needed.

Documentation of Lab-Specific Training: The Principal Investigator is responsible for providing lab-specific training. Each employee working in BSL2 and above laboratories must receive and document the receipt of lab-specific training.

Responsible Conduct of Research

  • Commitment to conducting research responsibly and ethically.
  • Research Misconduct, Data Management, Conflict of Interest, Collaborative Science, Responsible Authorship, Mentoring, Peer Review, Animals Research, and Human Subjects Research.
  • Training is offered by the Collaborative Institutional Training Initiative
  • This training meets the NSF requirements for RCR training for student and postdoctoral researchers working on an NSF-sponsored project.
  • Group: Social and Behavioral Responsible Conduct of Research
  • Introduction to the Responsible Conduct of Research
  • Research Misconduct
  • Data Acquisition, Management, Sharing and Ownership
  • Publication Practices and Responsible Authorship
  • Peer Review
  • Numerous others (https://www.citiprogram.org/)

Export Controls

https://vpr.tamu.edu/resources/export-controls

  • Regulate the conditions under which certain information, technologies, and commodities can be transmitted to foreign persons or entities in the United States or abroad.
  • Restrict or prohibit the transaction of business with certain countries, persons, and entities that have been sanctioned by federal agencies as a threat to 05.01important U.S. interests.
  • Restrict the shipment, transmission or transfer of certain items, software, technology, pathogens and services from the United States to foreign countries.
  • Restrict as “deemed exports” release of controlled physical items or controlled information to foreign nationals located in the United States.

Roles and Responsibilities

Texas A&M University: comply with US export control laws and regulations while maintaining an open research environment that welcomes the participation of researchers from around the world.

Individual Responsibility: Note that it is College Policy that all college employees and students must complete every two years the on-line export control online training - 2111212: Export Controls & Embargo offered by TAMU. See the following site for further TAMU information   https://vpr.tamu.edu/initiate-research/export-controls

All University employees and students, visiting scientists, postdoctoral fellows, and other persons retained by or working at or for the university must conduct their affairs in accordance with United States export control laws and regulations. There are severe institutional and individual sanctions for violations of export controls laws including the loss of research funding, loss of export privileges, as well as civil and criminal penalties including imprisonment. Faculty, staff and students must be aware of and are responsible for the export control implications of their work and must ensure that their activities conform to export control rules and regulations. Any required license/approval must be in place before exporting anything that is deemed controlled.

University Administrators: All University employees with managerial or supervisory authority over foreign persons or projects involving controlled information or controlled physical items should view export control compliance as an important part of their day-to-day responsibilities. University employees with managerial or supervisory authority over foreign persons or projects involving controlled information or controlled physical items are required to take the Export Controls Office's basic export control online training course at least once every two years.

Technology Control Plans

Texas A&M University (TAMU) is committed to export control compliance. It is the policy of TAMU to comply with United States export control laws and regulations. All employees and students must be aware of and are responsible for the export control implications of their work and must ensure that their activities conform to export control laws and regulations. Individuals and the university may be subject to severe penalties for violations of export control laws and regulations, including the loss of research funding, loss of export privileges, as well as criminal and civil penalties.

Current TCPs

  • Robert Reece: Microeel by Geometrics, Geode Seismic recorder by Geometrics, MultiGeode Operating Software.
  • John Walpert (GERG): Autonomous Underwater Buoyancy Gliders - Glider, and COTS (glider) Software (EAR 99)
  • Bradley D. Julson (IODP): Magnetometer on the JOIDES Resolution
  • Ayal Anis (Galveston): Autonomous Underwater Vehicle ("Slocum glider") - Glider, COTS (glider) Software: EAR 99

Texas A&M Export Controls Resources

Federal Resources

Additional Resources

Laboratory Safety

  • It is the responsibility of all who work or study in laboratories to do so in a safe and environmentally responsible manner.
  • It is the policy of Texas A&M University to provide and maintain a safe environment for its faculty, staff, students, and visitors. The Laboratory and Chemical Safety Group of Environmental Health & Safety provides the. EHS has established the Laboratory Safety Manual as a resource for faculty and laboratory personnel, as well as anyone interested in laboratory safety. This manual is intended to comply with federal, state, and local regulations, as well as industry best practices. The Laboratory Safety Manual is a compilation of suggested work practices, protocols, and procedures to work safely in TAMU laboratories. The document is not exhaustive and should not be considered the only reference for health and safety concerns. The manual is available at: https://ehs.tamu.edu/programs/laboratory-safety/

Research Conduct

http://rcb.tamu.edu/responsible-conduct-of-research

The responsible and ethical conduct of research (RCR) is critical for excellence, as well as public trust, in science and engineering. Consequently, education in RCR is considered essential in the preparation of future scientists and engineers. Section 7009 of the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act (42 U.S.C. 1862) requires that each institution that applies for financial assistance from the Foundation for science and engineering research or education describe in its grant proposal a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project. http://edocket.access.gpo.gov/2009/E9-19930.htm.

Institutional Research Responsibilities

An institution must have a plan in place to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduates, graduate students, and postdoctoral researchers who will be supported by NSF to conduct research. As noted in GPG Chapter II.C.1e, institutional certification to this effect is required for each proposal.

While training plans are not required to be included in proposals submitted to NSF, institutions are advised that they are subject to review, upon request.

An institution must designate one or more persons to oversee compliance with the RCR training requirement.

Institutions are responsible for verifying that undergraduate students, graduate students, and postdoctoral researchers who receive NSF funds (support from salary and/or stipends) to conduct research on NSF grants have received training in the responsible and ethical conduct of research.

Conflict of Interest

The Department of Health and Human Services enacted has established rules regarding financial conflicts of interest in research.

The new requirements for disclosure of investigator financial conflicts of interest at the university, regardless of job title, who are responsible for the design, conduct, or reporting of research or research activities.

Certify annually through MAESTRO pursuant to the Texas A&M System Regulation 15.01.03 Financial Conflicts of Interest in Sponsored Research.

Professional Development Skill Sets

  • Communication skills (written, oral, cultural, legislative)
  • Mentoring (career management, personnel growth)
  • Knowledge Base
  • Supervision
  • Team building (working with others)
  • Management (personnel, project, laboratory, financial)
  • Internationalization
  • Wellness
  • Proposal writing (“Think Big”; interdisciplinary, Impact)
  • Conflict management
  • Administration