Research Integrity Office - FAQs

IRB stands for an "Institutional Review Board."  It is a specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.  The TTUHSC mission includes conducting human subjects research in compliance with applicable laws and regulations, including but not limited to U.S. Department of Health and Human Services (“DHHS”) regulations and TTUHSC policy.  TTUHSC has signed an Assurance with DHHS.  As set forth in this Assurance, TTUHSC has two (2) registered Institutional Review Boards (IRBs).  Their purpose is to protect the rights and welfare of human subjects participating in research activities conducted at TTUHSC and any other entity for which TTUHSC has been designated as the IRB of record in an Assurance filed with DHHS, Research Integrity Office (“RIO”) and/or by written agreement between the parties.  These Institutional Review Boards are located at Lubbock and Amarillo campuses, and provide initial and continuing review of research applications and protocols involving human subjects.

Each IRB shall uphold the TTUHSC Federal Wide Assurance as filed with the U.S. Department of Health and Human Services (DHHS), Research Integrity Office (RIO).  As set forth in the Assurance, TTUHSC has two registered Institutional Review Boards:

• TTUHSC IRB #1 - 00000096 (LUBBOCK)
• TTUHSC IRB #2 - 00000097 (AMARILLO)

Designation of additional IRBs under the Assurance requires prior notification of and approval by RIO.  (see the IRB Policies and Procedures section 2.1 or the Resources Document Titled “Procedure for Determining the Use of an External IRB”).

iRIS is an electronic web-based research software that facilitates IRB submissions and management of human subjects research protocols. Use of iRIS is mandated on the TTUHSC Lubbock, Permian Basin (Odessa and Midland), Amarillo, Abilene, and Dallas campuses for all IRB submissions.

Research, as defined by federal regulations, means "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" (45 CFR 46.102).  Human subjects are living individuals about whom an investigator (whether professional or student) conducting research (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Regulatory requirements to protect human research participants apply to a much broader range of research than investigators sometimes realize, and researchers obtaining new data or using existing data are often unsure about how regulations apply to their research.  Regulatory and ethical obligations to protect research participants apply, for example, to research that uses:

• Data from varied research methods including surveys, interviews, and observation;
• Private information, such as medical, family, or employment information, or residual administrative records including earnings, and treatment histories that can be readily identified with individuals, even if the information was not specifically collected for the study in question;
• Biospecimens, obtained for routine medical care that would have been discarded if not used for research, or DNA samples, where samples or specimens can be linked to a living individual.

If you are uncertain, whether your planned activities constitute research with human subjects requiring IRB approval, CALL YOUR LOCAL IRB OFFICE PRIOR TO BEGINNING THE ACTIVITY.  Lubbock 806-743-4753   Amarillo 806-414-9935.

Organizations should define, in writing, the roles and responsibilities of each collaborating organization when working with other organizations for oversight of research, including, defining an emergency contact. 

• Role of the Relying IRB
  When relying on an external IRB, the relying organization shall have policies and procedures that are applicable to the organization’s reliance on an external IRB. Written documents shall be used for oversight of research conducted by the relying organization. 
• Role of the Reviewing IRB
  When providing IRB review services to other organizations, written materials shall describe the responsibilities of the relying organization, including expectations for relying organizations to follow reporting policies of the reviewing IRB. 
  • • • Selection of the Reviewing IRB  Any IRB with a federal wide assurance (FWA), or registration filed with the Office for Human Research Protections (OHRP), and is accredited by AAHRPP, can serve as a Reviewing IRB. In accordance with OHRP guidance, an IRB Authorization Agreement/Reliance Agreement must state the responsibilities of both parties.
      • Will TTUHSC Serve as a Reviewing IRB?  Decisions will be made on a case-by-case basis. If the lead PI decides to use TTUHSC IRB or we are the prime awardee for the NIH funds will be significant factors in the determination.
• References and Regulations
  • • • DHHS
        • • • 45 CFR 46.114
            • 45 CFR 46.101(b)
      • NIH
        • • • NIH single IRB (sIRB) mandate
            • NIH FAQs – Single IRB Policy for Multi-Site Research
            • Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
            • Guidance on Exceptions to the NIH Single IRB Policy
            • NIH requests for exception to the sIRB mandate 
      • OHRPP
        • • IRB Reliance

Full-Board Review
Submissions to the IRB are reviewed by the fully-convened Board.  Committee members have access to documents related to the research, and are invited to discuss the proposal.  After the discussion, the Board can make a recommendation to approve, request changes, disapprove, or table a study.  The Board will also indicate the level of risk assigned to the study, and the frequency with which the study will require ongoing review.

Expedited Review
Submissions are reviewed by the IRB Chairperson or another qualified IRB member.  This reviewer evaluates all of the appropriate materials necessary to come to a decision about the approval of the study.  This type of review may be carried out for studies that involve minimal risk to subjects and fit into an expedited category of research.  A reviewer may exercise all of the authorities of the full Board, except that they may not disapprove the research.  The reviewer may also refer the submission for Full-Board review.

Exempt review
If a study fits into one of the Common Rule (45 CFR 46.104) exempt categories of research, it may be classified as “exempt research”.  The IRB (not the investigator) decides whether a particular study can be classified as “exempt.”  Therefore, even if an investigator is certain that a research project qualifies as an exempt study; it must be submitted to the IRB for review.  If the research is determined to be exempt, written acknowledgement will be provided to the PI, and the specific category of exemption will be included in the letter.  Remember, TTUHSC investigators do not have authority to make an independent determination that research involving human subjects is exempt.

Open - Participants may be enrolled.
Draft - Proposal has not yet been submitted to the IRB.
Pending - Proposal has been submitted to the IRB, but has not yet received final approval.
Cancelled - The study received IRB approval, but the PI has chosen not to continue/complete the study.
Completed - The study received IRB approval and has been conducted as approved by the IRB. All subjects have finished treatment; there is no further participation/intervention; data collection and analyses are finished.
Declined - The IRB will not be conducting any further review of this study.
Follow-up - Enrollment is closed and no subjects are receiving study drugs or active intervention; research staff continue to monitor participants’ condition
Closed to accrual - Enrollment is closed but at least one subject continues to receive study drugs or active intervention
Suspended - Study is temporarily closed by the IRB because of OHRP–reportable problems in the conduct of the research.
Terminated - Study is permanently closed by the IRB because of OHRP–reportable problems in the conduct of the research.
Administratively Closed - Study is permanently closed by the IRB—often for non-response to requests by the IRB.
Withdrawn - Proposal has been submitted to the IRB, but the investigator requests that no further review take place.
Exempt - Proposal fits into one or more categories designated by DHHS as "exempt" from ongoing IRB review. Note that the IRB (not the investigator) makes the determination of exemption.
Temporary Closure - Study is temporarily closed by the investigator or sponsor.
Not Human Research - The study does not fit the DHHS definition of human research

No.  TTUHSC policy and the Federal Regulations are clear that it is not up to the investigator alone to determine if a project is exempt. "Exempt," as used here, does not mean that a project is exempt from review of any kind, nor does it mean exempt from ethical responsibility. The IRB (not the investigator) decides whether a particular study can be classified as “exempt.” Therefore, even if an investigator is certain that a research project is exempt, it must be submitted to the IRB for review prior to the initiation of any research activities. If the research is determined to be exempt, written approval will be provided to the PI and the specific category of exemption will be included in the approval letter. Remember, investigators do not have authority to make an independent determination that research involving human subjects is exempt. 

No.  You must receive written approval from the IRB before beginning participant recruitment, data collection, or data analysis. The IRB approval letter may identify the need for additional institutional approvals.  ALL approval letters are required prior to beginning participant recruitment, data collection or data analysis.

The Principal Investigator must submit a written report to the IRB in writing (or to IRB office in Amarillo) of all unanticipated adverse events or problems (both serious and non-serious) involving risks to subjects that occur at TTUHSC or an affiliated entity that are known to be related or may possibly be related to the research activities within two (2) business days after becoming aware of the event.

The Principal Investigator is responsible for the accurate documentation, investigation and follow up of all possible study related adverse events and unanticipated problems involving risks to subjects. Reports of all adverse events or unanticipated problems must be retained in the Principal Investigator files.

The IRB may conduct an expedited review of the event if there is no change in the risk/benefit ratio, the research proposal, or the consent form; otherwise, full Board review is required. The Chair or designee, at the time of expedited review, may refer any adverse event to the full Board for review.

Serious Adverse Event (SAE): Regardless of whether the event was related to the research activities, all serious adverse events must be reported to the IRB via iRIS (or to the IRB office in Amarillo) as soon as possible, but in any event, no later than two (2) business days after the Principal Investigator becomes aware of the event. SAE includes death; a life threatening experience; hospitalization (for a person not already hospitalized); prolongation of hospitalization (for a patient already hospitalized); persistent or significant disability or incapacity; congenital anomaly and/or birth defects; or an event that jeopardizes the subject and may require medical or surgical treatment to prevent one of the preceding outcomes. (see the IRB Policies and Procedures for more information). 

Yes.  In accordance with federal regulations, TTUHSC requires that all human research be prospectively reviewed by the IRB.  Accordingly, student and resident research projects, theses, research practical, and Master’s or Doctoral theses involving human subjects must be submitted for IRB review. 

In general, yes, you do, but there are some limited exceptions. The IRB has the authority to waive some or all of the Federal requirements for informed consent in certain extenuating circumstances.

(For more information refer to the IRB Policies and Procedures) 

The Principal Investigator is responsible for retaining the signed informed consent documents obtained from the participants in a secure location for a minimum of three years after the study is concluded. The IRB or its designee (personnel in the Research Integrity Office) has the authority to conduct an audit of human research studies under its jurisdiction at any time, including a review of all signed informed consent documents. 

Yes.  IRB approval must be obtained regardless of funding source. Research involving human subjects and all other activities that involve such research in any way must be reviewed and approved by the IRB if one or more of the following apply:

• The research is sponsored by TTUHSC;
• The research is conducted by or under the direction of any employee or agent of TTUHSC in connection with his or her responsibilities to TTUHSC;
• The research is conducted by or under the direction of any employee or agent of TTUHSC using any property or facility of TTUHSC;
• The research involves the use of non-public information maintained by TTUHSC;
• The research is conducted in accordance with an assurance filed with the Research Integrity Office in which a TTUHSC IRB is designated as the IRB of record;
• Any employee of TTUHSC is engaged in research in connection with his or her responsibilities to TTUHSC, but not as PI.

The IRB requires disclosure of the process of obtaining informed consent during the application process. This disclosure includes specifying the names of the research personnel designated by the Principal Investigator to discuss the study with the potential subjects and obtained informed consent. Designated personnel must receive the TTUHSC-required training on the protection of human subjects in research prior to conducting any research-related activity, including obtaining informed consent. After IRB approval is granted, only authorized personnel may discuss the study and obtain informed consent from subjects.

If the subject or their legally authorized representative is unable to read, an impartial witness must also be present during the entire informed consent discussion. The witness should sign and date the informed consent document only after the subject or their legally authorized representative has consented to participate (see the IRB Policies and Procedures section 7.0 and Good Clinical Practice section 4.8 for more information). 

If the subject or their legally authorized representative is unable to read, an impartial witness must be present during the entire informed consent discussion. The witness should sign and date the informed consent document only after the subject or their legally authorized representative has consented to participate (see the IRB Policies and Procedures section 7.0 and Good Clinical Practice section 4.8 for more information). 

The informed consent document approved by the IRB must be signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy shall be given to the person signing the form. The person obtaining consent (either the Principal Investigator or their authorized designee), will also sign and date the form, attesting to the informed consent conversation. The Principal Investigator should sign the form only if he or she was present for the consent discussion. 

You must receive written approval from the IRB before beginning participant recruitment, data collection, or data analysis. A letter indicating that your project has been approved will be sent when approval has been granted.

The written approval letter will identify all approved materials (protocol, consent document(s), assent document(s), recruitment flyers, questionnaires, etc.).

A Data Use Agreement (DUA) is an agreement between TTUHSC and an outside party (e.g., contractor, private industry, academic institution, federal or state agency), when the outside party requests the use or disclosure of a limited data set. A limited data set is a data set that is stripped of certain direct identifiers specified in the HIPAA Privacy Rule. Please see policy HPP 6.2 Data Use Agreements for the list of identifiers. A limited data set may be disclosed to an outside party without a patient’s authorization only if the purpose of the disclosure is for research, public health, or health care operations purposes and the outside party (data recipient) signs a DUA with TTUHSC. A DUA must be entered into before there is any use or disclosure of a limited data set to an outside party. 

The TTUHSC department/researcher requesting to share data with an outside party is responsible for identifying when a DUA is needed. The HIPAA DUA Decision Tree is a useful tool to determine if a DUA is required. If a DUA is needed, the requesting department will fill out TTUHSC’s DUA template and send it to the data recipient for review and signature. Then the DUA should be submitted to the TTUHSC Contracting System for review/revision/approval. Only those individuals with authority delegated in accordance with TTUS Regents’ Rules have authority to sign a DUA or other written contracts. 

Note: If a TTUHSC researcher is the recipient of a limited data set from a non-TTUHSC source, the TTUHSC researcher may be asked to sign the other party's DUA. In such an event, the researcher should contact the TTUHSC Compliance Office for guidance. In some occasions, researchers are asked to sign a Data Sharing Agreement when obtaining data from an external database. Please follow the same steps of submitting a DUA.

For questions related to DUA, please contact the Privacy Director at the TTUHSC Compliance Office: Shen Wang, 806-743-2307, shen.wang@ttuhsc.edu