Procedures for Grants & Other Committee Submissions
Institutional Review Board Approval
Before doing any research study that involves human subjects, investigators must first determine if Institutional Review Board ( IRB) approval is needed. Investigators must also determine which IRBs need to review their protocols. There are TTUHSC IRBs in Amarillo, Lubbock, and El Paso, and many external entities also have IRBs. If in doubt regarding the need for IRB approval or the specific TTUHSC IRB's requirements, researchers should contact each TTUHSC IRB office directly.
Special note to Dallas researchers:
The TTUHSC Amarillo IRB serves as the IRB of record for all TTUHSC Dallas researchers. All studies must receive approval from the Amarillo IRB, even if approval has already been obtained from another entity’s IRB. (For example, the Dallas VA has a separate IRB, from which many TTUHSC researchers must secure study approval, but this approval does not stand alone; BOTH the Dallas VA and the Amarillo IRB must approve all studies prior to beginning them.)
IRB and iRIS Assistance
The SOP Department of Pharmacy Practice is available to assist applicants with the IRB submission process, from preparing the initial study materials to submitting the review through the iRIS system. (All TTUHSC IRBs now require submission through the iRIS system online.)
Please contact the Deaprtment Coordinator for assistance and refer to the following checklist/guide manual for additional help with IRB/iRIS submissions: IRB Checklist/Guide Manual . For guidance in determining whether or not projects are research (requiring IRB review/approval) and if informed consent can be waived, the Office for Human Research Protections has created decision charts. These charts take investigators step by step through the decision-making process and may be found at: http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm.
Education Requirements (CITI, HIPAA)
Those investigators and personnel involved in approved human subjects research will have to become trained and certified in such research. The required CITI and HIPAA training may be completed online. While formerly separate courses, CITI and HIPAA have now been combined into one course. To begin the training course, please go to: http://www.ttuhsc.edu/research/hrpo/irb/edurequirements.aspx
Please note: Even if investigators have previously completed other, similar training progams at other institutions, the TTUHSC-approved course must still be completed in order to remain in compliance.
Institutional Animal Care and Usage Committee (IACUC, or ACUC)
Prior to starting any animal research, researchers must submit a completed animal use protocol to the IACUC for review and approval. The protocol must be submitted on the current version of the protocol application form and completed in its entirety. For additional information about the IACUC and to access the forms, please visit: http://www.ttuhsc.edu/sponsoredPrograms/acuc/
Additional Committees and Information Regarding Research Experimentation
Institutional Biohazards Committee (IBC)
Prior to beginning any research involving hazardous materials and animals, researchers must first submit a registration application to use such materials to the IBC for review. IBC approval must be obtained prior to sending the protocol to external granting agencies. For additional information about the IBC and to access the forms, please visit: http://www..ttuhsc.edu/sponsoredPrograms/ibc/.
Recombinant DNA Biosafety Committee (RDBC)
Studies involving recombinant DNA must receive approval from the RDBC prior to initiation. For additional information about the RDBC and to access the forms, please visit: http://www.ttuhsc.edu/sponsoredPrograms/rdbc/.
Radiation Safety Services at TTUHSC is tasked with protecting individuals from unnecessary exposure to sources of radiation, preventing the spread of contamination, and assisting in the fulfillment of the responsibilities of the institution to its students, staff, and the general public, and to the associated regulatory agencies. The Office provides necessary laboratory training and approves the purchase of radioactive materials. For forms and additional information, please visit: http://www.ttuhsc.edu/admin/safety/rad.aspx
Material Transfer Agreements
Material Transfer Agreements (MTAs) are required whenever a TTUHSC employee sends out or receives proprietary materials, i.e., biologicals. The MTA protects the employee and TTUHSC against improper use of materials and protects materials as confidential. For additional information, please contact the appropriate staff person in the Office of Sponsored Programs.
Education/Training Requirements for Laboratory Work
For information regarding training necessary to working in research laboratories, please visit: http://www.ttuhsc.edu/Admin/safety/lab.aspx. For a more complete listing of all TTUHSC employee required training programs, visit: http://www.ttuhsc.edu/Admin/safety/training.aspx.