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Office of Research and 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))

 

Do I need an IRB Protocol?

The easiest way to determine if you need an IRB is for the PI on the projects (students cannot be PIs) to click the link below and fill in the online form so our office can review what is being done and get a determination.  This review may require time for us to send this to the IRB Chair to confirm an answer, so please account for this in your project planning stage.  

"Do I need an IRB" Online Form Questionnaire

 

***For May Graduation, it's advisable to have your IRB fully approved no later than Spring Break/Midterms. Review times vary based on the proposed project and the state of the submission.***

The Research Compliance PDF forms here are dynamic PDFs, and don't behave quite the same as other PDFs.  Please right-click on the link to 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 just 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.


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 meeting dates and times.

Exempt IRBs do not require documentation of consent.  The subjects still need to have a consent document presented to them, with all the required information, but no signature is needed. 
This is one reason we work to keep online surveys at the Exempt review level - since no signature is needed, the problematic logistics of meeting to obtain it can be avoided.  
 
Digital signatures are not accepted at this time by the A&M System for Documentation of Consent regarding IRB subjects unless we can meet the validation requirements.  
 
These requirements mean adherence to FDA level rules for digital signatures, and include some cumbersome practices, like entering a password to sign for each clause in a consent template.  As far as we know, the A&M system does not have any of those add-ons for any of our software packages.  After a conversation with the Chief Research Compliance Officer (CRCO) at System, as well as the representative for DocuSign, we were told it is not something we can do as far as Documentation of Consent for Human Subjects Research.
 
We can accept digital or scanned signatures for internal forms, for IRB (and other protocol) submissions, but for a participant in research, we cannot accept their signature on an Informed Consent document.
 
Expedited and Full Board reviews usually DO require documentation of consent:
 
In these instances, the PI can request a waiver for documentation of consent if the reviewers both agree it meets the criteria in 45 CFR 46 (below).

(1) An IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following:

(i) That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;

(ii) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or

(iii) If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

(2) In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.

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:

  • If you are using pre-existing data for your research protocol, log into CITI and also complete the “Data or Specimens Only Research”
  • If your protocol is to involve Children Under 17 years and younger please email Research Compliance requesting the “Child Protection Training” provided on the TAMU Single Sign On, via TrainTraq.  If you cannot find the training, we can assist.

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.

 

Instructions for CITI Training for Undergraduates and Master(s) Candidates:

Please log onto the CITI website by clicking on the link below.

https://www.citiprogram.org/Default.asp

New CITI members:

  1. Please register as a new user.
  2. CITI will ask you for a User ID and Password.
  3. Then you will be asked to affiliate with an institution.
  4. Go to U.S. Institutions and pick “Texas A&M Kingsville” from the drop down list.
  5. On the next page, you will be prompted to fill in your personal information.
  6. Be sure to enter your Full Legal Name as Research Compliance will see it on the IRB protocol, so that we may recognize you when checking training (no nicknames, please).

 Current CITI members / Following New CITI member registration:    

  1. Click on “Add a Course or Update Learner Group.”
  2. You will be launched into a menu asking you to select a course.
  3. Pick “Human Subjects Research.”
  4. Select “NO, I have NOT completed the Basic Course in the Protection of Human Research Subjects in the past,” click next.
  5. On the next page, select “Students conducting no more than minimal risk research,” click next.
  6. Then the main page will appear giving you the course option: “Students course.”
  7. Enter the “Students course”.
  8. Complete the “Integrity Assurance Statement” before beginning the course.

 Go through the Course(s) and take all the quizzes and when you are finished, you will be able to save or print your completion report. 

If you need to take any other courses, just select the Add a Course or Update Your Learner Groups and it will send you back to the curriculum menu to take more courses.

Instructions for CITI Training for Investigators, Staff, and Doctoral Degree Candidates

Please log onto the CITI website by clicking on the link below.

https://www.citiprogram.org/Default.asp

New CITI members:

  1. Please register as a new user.
  2. CITI will ask you for a User ID and Password.
  3. Then you will be asked to affiliate with an institution.
  4. Go to U.S. Institutions and pick “Texas A&M Kingsville” from the drop-down list.
  5. On the next page, you will be prompted to fill in your personal information.
  6. Be sure to enter your Full Legal Name as Research Compliance will see it on the IRB protocol, so that we may recognize you when checking training (no nicknames, please).

 Current CITI members / Following New CITI member registration:  

  1. Click on “Add a Course or Update Learner Group”.
  2. You will be launched into a menu asking you to select a course.
  3. Pick “Human Subjects Research.”
  4. Select “NO, I have NOT completed the Basic Course in the Protection of Human Research Subjects in the past,” click next.
  5. On the next page, select “Social & Behavioral Researchers,” click next.
  6. Then the main page will appear giving you the course option: “Social & Behavioral Researchers.”
  7. Enter the “Social & Behavioral Researchers.”
  8. Complete the “Integrity Assurance Statement” before beginning the course.

Instructions for CITI Training for IRB Members – Basic / Refresher:

Please log onto the CITI website by clicking on the link below.

https://www.citiprogram.org/Default.asp

New CITI members:

  1. Please register as a new user.
  2. CITI will ask you for a User ID and Password.
  3. Then you will be asked to affiliate with an institution.
  4. Go to U.S. Institutions and pick “Texas A&M Kingsville” from the drop down list.
  5. On the next page, you will be prompted to fill in your personal information.
  6. Be sure to enter your Full Legal Name as Research Compliance will see it on the IRB protocol, so that we may recognize you when checking training (no nicknames, please).

 Current CITI members / Following New CITI member registration:  

  1. Click on Add a Course or Update Learner Group.
  2. You will be launched into a menu asking you to select a course.
  3. Pick Human Subjects Research.
  4. Select “NO, I have NOT completed the Basic Course in the Protection of Human Research Subjects in the past,” click next.
  5. On the next page, select “IRB Members,” click next.
  6. Then the main page will appear giving you the course option: “IRB Members – Basic / Refresher”
  7. Enter the “IRB Members – Basic / Refresher”
  8. Complete the “Integrity Assurance Statement” before beginning the course.

 Go through the Course(s) and take all the quizzes and when you are finished, you will be able to save or print your completion report.

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