Skip to main content

Office of Research & Graduate Studies

Research Compliance

Institutional Review Board (IRB)


The Institutional Review Board (IRB) is charged with ensuring that research involving human subjects is conducted in a manner that is in compliance with federal, state, and local regulations. Any human subject research conducted at TAMUK must be reviewed and approved prior to initiation. Research and human subject are defined as follows:

Research:

a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. (Code of Federal Regulations Title 45 Part 46.102 (d))

Human subject:

a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information. (Code of Federal Regulations Title 45 Part 46.102 (f))

Determining if you need an IRB protocol in place before you start your research depends on a few things: From whom are you collecting data, what type of data is to be collected, how you are doing the collection, and what is to be the final use of the data?  If you are doing any of the following, it's good to send us an abstract including the answers to those questions so we can see if your project falls under OHRP's definition of Human Subjects' research.

  • Surveys and Interviews
  • Taking blood from living individuals for research
  • The use of specimens or data from a repository or database
  • Program evaluation, program assessment or demonstration project conducted for research
  • Pilot studies, preliminary studies, or other preliminary research with human subjects
  • Some types of classroom research
  • Observing or recording private behavior
  • Obtaining private identifiable information that has been collected about or provided by individual

Remember that grant funding is not required for a project to need an IRB.  Many research projects do not receive external funding but do require an IRB to be in place for the life of the project.  


TAMUK Faculty and Staff can serve as PIs on IRB protocols.  

Students at all levels, undergraduate, graduate, and Ph.D. candidate require a Supervising Faculty Mentor to oversee and assist with the preparation of their IRB protocols.  This faculty mentor signs off on the protocol as acceptable and certifies they will be the responsible party to the student as needed with the research design and proper execution of the protocol.   


  1. See the section for IRB Forms Resources below, download the IRB Protocol application, Informed Consent Template and fill in both to best describe whom you want to study, how you plan to collect the data, from how many, and how you will protect and store the data.
  2. Complete the required CITI training, and email your application, along with your CITI certificates, your data collection instrument, consent template documents, and any recruitment materials to researchcompliance@tamuk.edu.
  3. Research Compliance will screen your application and if it's complete, a review path will be selected. You will be notified when we receive your IRB, when it is sent for review, and once your reviewer has revisions or comments to address prior to approval. If you fail to get receipt confirmation from Research Compliance within (3) three business days, call 361-593-2677 / 361-593-4764 to ask if your IRB was received.
  4. Once all comments and revisions are stated to be complete by your reviewer(s), a Notice to Proceed email will be sent to you while the final approval letter is being drafted. You may begin once you receive the Notice to Proceed.  The IRB review paths are explained in the section below.
  5. Notify Research Compliance of any changes you make to your protocol during the life of your project. IRB Amendments are required before certain changes can be enacted.

NOTE - For time-dependent studies (graduating students, faculty on grants), please contact Research Compliance as soon as you send your IRB, to determine the review path and assist in meeting your deadlines.

It is not recommended for students in the graduating semester to submit an IRB protocol for a thesis or dissertation later than the mid-semester point in their graduating semester. IRB review can take a few days to a few months, based on the speed of revisions returned.


IRB has (3) review paths.  Your final approval time is contingent on the promptness of returned revisions.

  • Exempt review
    • This does not mean an IRB is not needed, it means you are required to do one but the project qualifies as minimal risk and can be reviewed by a single reviewer via email communication
    • Examples - emailed surveys where no identifying data will be requested, analysis of preexisting de-identified data.
  • Expedited
    • This still is considered a minimal risk project, but requires 2 reviewers and documentation of consent (signed consent forms), and can be reviewed via email communication.  Note: The TAMU System does not allow digital signatures for documentation of consent.
    • Examples - studies where a pre-and-post test will be administered, to see if subjects gain knowledge following a class or presentation; any low-risk study that will make use of video, audio, or any other biometric type of identification.
  • Full Board
    • The TAMUK IRB reviews anything over minimal risk, projects that involve minors, vulnerable populations, at the Full Board level.  These protocols must be reviewed at a convened meeting, where a quorum of IRB members can discuss the risks and benefits of the study, and determine if it can be approved as is, if it can be approved with minor modifications, or if it needs to be tabled for later review after heavy revision, and finally, if the study simply cannot be approved.
    • Examples - studies collecting data from minors, ages 0-17; studies that ask potentially incriminating or potentially stressful questions, involved deception, extreme human performance studies, studies using the collection of biological samples from humans (these will also require a companion IBC protocol)

The TAMUK IRB holds convened meetings on the second Tuesday of each month during the Fall and Spring semesters, and as needed during the Summer Sessions.  Quorum is required for the IRB to officially review and vote on protocol actions, so be aware the meeting dates may change based on holidays, campus closures, and over events to allow members to attend. 

If you have a time-sensitive IRB Protocol due to class requirements, graduation plans, or grant submission, please call Research Compliance to verify review paths and meetings dates and times.


 

The PDF forms here are dynamic PDFs, and don't behave quite the same as other PDFs.  Please save these files to your computer, open your PDF software application, and in the application, go to File->Open, and navigate to where the form is saved, and select it.  If you double click on it, your computer will likely give you an error message like this one:

PDF Error

There is nothing wrong with your computer.  It just thinks this form is a webpage.  Following the instructions above will help it function properly.

If you have difficulty with these forms or need additional assistance, please call 391-593-2677 or email researchcompliance@tamuk.edu to set up an appointment so we can help.


Every individual working on an IRB protocol is required to be listed on the protocol, and have certification of the required training before they can perform any protocol tasks.  They cannot interact with the subjects or the data until their placement on the protocol, either at the initial approval or via an amendment, is approved.

All Investigators are required to take at least one Social and behavioral Researchers Course via CITI Program.  Please see ORGS/Research-Compliance/RC-CITI to locate the correct training instructions.  Undergraduate and Graduate students are able to take the Basic Students Course, while Faculty, Staff, and Ph.D. candidate student are required to take a more intensive Social and Behavioral course.

Some projects will require additional training for instance, those working with minor children are asked to take a TranTraq course for Child Protections.

Also, some projects cross into multiple areas of Research Compliance and might require companion protocols to be reviewed by the IACUC or IBC committees.  These protocols will also require at least one appropriate CITI course and may require additional supplemental training.  Research Compliance can assist in making sure you know your minimum training requirements.

 


FWA00001427