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Research Integrity Office

Frequently Asked Questions

What is an IRB?
What is iRIS and does it affect me?
How do I know if my research project requires IRB review?
What is the difference between full, expedited and exempt review?
What are the study status definitions?
I've heard that the Federal regulations consider certain categories of research to be exempt. If my research fits into one of these categories, does this mean that I don't have to have it reviewed by the IRB?
May I begin data collection upon department approval?
What are adverse events and when do I have to report them?
Does student research require review?
Do I always have to obtain the informed consent of the research participants?
What should I do with the informed consent documents once the participants have signed them? Does the IRB need to see them?
Do I need IRB approval if my research is not externally funded?
Who should be present when the informed consent interview is conducted?
Must a witness observe the entire consent interview or only the signature of the subject?
Who must sign the consent form?

What is an IRB?

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 three (3) registered Institutional Review Boards (IRBs) whose 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 by written agreement between the parties. These Institutional Review Boards are located at the Lubbock-Odessa, 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/ODESSA)
  • TTUHSC IRB #2 - 00000097 (AMARILLO)

TTUHSC at El Paso also has two registered Institutional Review Boards:

  • TTUHSC at El Paso IRB #1 - 00000098
  • TTUHSC at El Paso IRB #2 - 00007656

Designation of additional IRBs under the Assurance requires prior notification of and approval by RIO. (see the IRB Policies and Procedures section 2.1).

What is iRIS and does it affect me?

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/Odessa, Amarillo, and TTUHSC at El Paso campuses for all IRB submissions.

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

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 about 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 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;
  • 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.

What is the difference between full, expedited and exempt review?

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 which involve minimal risk 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.

I've heard that the Federal regulations consider certain categories of research to be exempt. If my research fits into one of these categories, does this mean that I don't have to have it reviewed by the IRB?

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.

May I begin data collection upon department approval?

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.

What are adverse events and when do I have to report them?

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).

Does student research require review?

In accordance with federal regulations, TTUHSC 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.

Do I always have to obtain the informed consent of the research participants?

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)

What should I do with the informed consent documents once the participants have signed them? Does the IRB need to see them?

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.

Do I need IRB approval if my research is not externally funded?

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.

Who should be present when the informed consent interview is conducted?

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).

Must a witness observe the entire consent interview or only the signature of the subject?

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).

Who must sign the consent form?

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.

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