Frequently Asked Questions

IRB stands for "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 mission of Texas Tech University Health Sciences Center at El Paso is to improve the lives of people in our State and our community by focusing on the unique health care needs of socially and culturally diverse border populations through excellence in integrated education, research, and patient care. This mission includes conducting human subjects research in compliance with applicable laws and regulations, including but not limited to the U.S. Department of Health and Human Services (DHHS) regulations and TTUHSC El Paso policy. TTUHSC El Paso has signed an assurance with the DHHS. As set forth in this assurance, TTUHSC El Paso has two registered IRBs whose purpose is to protect the rights and welfare of human subjects participating in research activities conducted at TTUHSC El Paso and any other entity for which TTUHSC El Paso has been designated as the IRB of record in an assurance filed with the DHHS, Office of Research Resources (ORR) and by written agreement between the parties. These IRBs are located at the El Paso campus and provide initial and continuing review of research applications and protocols involving human subjects.

Each IRB shall uphold the TTUHSC Federal Wide Assurance (FWA) as filed with the DHHS and ORR. As set forth in the assurance, TTUHSC El Paso has two registered Institutional Review Boards:

TTUHSC El Paso IRB #1 – 00009945

TTUHSC El Paso IRB #2 - 00009946

Designation of additional IRBs under the assurance requires prior notification of and approval by ORR.

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 El Paso campus 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 46.102d). Human subjects are living individuals with whom an investigator conducting research obtains (1) data through intervention or interaction with the individuals, or (2) identifiable private information. 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 observations;
  • 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;
  • Tissue specimens 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.

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 and consults with the PI if 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 six specific categories listed in the Common Rule (45 CFR 46) exempt category of research, it can 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 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.

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.

Canceled: The study received IRB approval, but the PI has chosen not to continue or 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 El Paso policy and 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 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. A letter indicating that your project has been approved will be sent when approval has been granted.  Please review the letter for any additional approvals that may be necessary.

The principal investigator must submit a written report to the IRB of all unanticipated adverse events or problems, both serious and non-serious, involving risks to subjects that occur at TTUHSC El Paso 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 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.

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

In general, yes, 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.

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 ORR) 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 El Paso;
  • The research is conducted by, or under the direction, of any employee or agent of TTUHSC El Paso in connection with his or her responsibilities to TTUHSC El Paso;
  • The research is conducted by, or under the direction, of any employee or agent of TTUHSC El Paso using any property or facility of TTUHSC El Paso;
  • The research involves the use of non-public information maintained by TTUHSC El Paso;
  • The research is conducted in accordance with an assurance filed with the ORR in which a TTUHSC El Paso 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 El Paso, but not as PI;
  • The research takes place at any property or facility of TTUHSC.

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 El Paso-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.

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.

 

The informed consent document approved by the IRB 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.

If you have further questions, contact your local IRB office.