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 (OR) 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 OR. 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 OR.

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.

How do I know if my research project requires IRB Review?

All research and other activities, which even in part involve human subject research, regardless of sponsorship, must be reviewed and approved, or acknowledged as Exempt, by the TTUHSC El Paso IRB, prior to initiation. This includes all interventions and interactions with human subjects for research, including advertising, recruitment and/or screening of potential subjects.

Please review the information in this section to understand what activities meet the definition of human subjects research.

Definition of Human Subjects Research

Human subjects research is any research or clinical investigation that involves human subjects.

Investigators conducting human subjects research must satisfy DHHS regulations [45 CFR Part 46] and FDA regulations [21 CFR Part 50 and 56] regarding the protection of human subjects research, as applicable.

Human subject

A living individual 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.

Research

Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

A "systematic investigation" is an activity that involves a plan that incorporates data collection in an organized/consistent way, and data analysis to answer a question (for example, a hypothesis).

Examples of systematic investigations include:

  • Surveys and questionnaires
  • Interviews and focus groups
  • Analyses of existing data or biological specimens
  • Epidemiological studies
  • Evaluations of social or educational programs
  • Cognitive and perceptual experiments
  • Medical chart review studies

Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations). However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to "generalizable (scholarly) knowledge" makes an experiment or data collection research, regardless of publication. Research that is never published is still research. Participants in research studies deserve protection whether or not the research is published. Note Thesis or dissertation projects involving human subjects conducted to meet the requirement of a graduate degree are usually considered generalizable, and require IRB review and approval.

Examples of activities that typically are not generalizable (not research) include:

  • Biographies
  • Oral histories that are designed solely to create a record of specific historical events
  • Service or course evaluations, unless they can be generalized to other individuals
  • Services, courses, or concepts where it is not the intention to share the results beyond the TTUHSC El Paso community
  • Classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices
  • Quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the TTUHSC El Paso community.

Per federal regulations, the following activities are deemed not to be research:

  • Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
  • Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
  • Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
  • Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Clinical Investigation

FDA regulations define a clinical investigation as any experiment that involves a test article and one or more human subjects and that either is:

Subject to requirements for prior submission to the FDA, or

Not subject to requirements for prior submission to the FDA under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit.

A test article is any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act.

Intervention

Includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction

Includes communication or interpersonal contact between investigator and subject.

Private information

Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Identifiable biospecimen 

A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

FDA regulations

Define a human subject as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. Examples of clinical investigations include:

Investigational drug clinical trials

  • Research testing the safety and effectiveness of an investigational device
  • Medical outcomes study comparing approved drugs/devices

Note:

Research testing the safety and effectiveness of an In Vitro Diagnostic (IVD) device using human tissue specimens (identifiable or unidentifiable) requires IRB review per FDA 21 CFR Parts 50 and 56, even though under DHHS regulations research involving unidentified tissue specimens would not be considered human subjects research.

To download a copy of this form, please click here.

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.

 

No. Research records, data, and specimens are the property of TTUHSC El Paso and shall not be transferred to another entity without prior approval of the VPR.

At TTUHSC El Paso, a single IRB will be required for the following types of non-exempt cooperative (multisite) research carried out within the United States:

  • New studies approved on or after January 20, 2020 supported by an agency that has signed on to the Common Rule. For a full list of HHS Departments and Agencies that follow the Common Rule, please click here.
  • Research supported by NIH.  Click here for the official notice from NIH: NOT-OD-16-094. There are some exceptions.  For more about the NIH exceptions and additional information on the single IRB requirement for NIH supported research (in effect since January 25, 2018) click here.

For additional information, please visit this page Single IRB Process.