IRB Application Process Guide

General IRB Process Overview

The Internal Review Board (IRB) reviews all human subjects research at The University of Texas at Austin. The IRB is composed mainly of UT faculty and meets monthly to review research proposals. The IRB reviews full board research; exempt and expedited research are reviewed "in house" by the Office of Research Support and Compliance. When a study is approved an approval letter is sent to the PI by email.. Studies are typically approved for a one-year period. PIs wishing to continue research beyond their one-year approval time period must submit a continuing review. The IRB must approve any changes or amendments to an approved study before the researcher implements such changes. If a continuing review is not received by the study expiration date, the study is suspended. Research cannot proceed during the suspension period. However, a continuing review can be submitted during this time. After 30 days a suspended study is terminated or expired. A terminated study is permanently closed.

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What to submit for IRB approval?

New Study submissions must include:

  • IRB electronic application
  • Study proposal document
  • Consent forms
  • Recruitment materials
  • Data collection instruments (surveys, interview questions, stimuli, etc.)
  • Other forms or documents utilized with human subjects
  • Research personnel list for New Study

Continuing Review submissions must include all current IRB approved study documents, even if they have not changed since the last review:

  • Continuing review application
  • Study proposal document
  • Consent forms
  • Recruitment materials
  • Data collection instruments (surveys, interview questions, stimuli, etc.)
  • Other forms or documents utilized with human subjects
  • DSMB/DSMP Report (if applicable)
  • Research personnel list for Continuing Review

Amendment submissions must include:

  • Amendment application
  • Amendment summary form
  • Research personnel list (if applicable)
  • Revised IRB proposal or other documents impacted by the proposed research modification
  • Newly developed documents that support the proposed research modification

Forms, templates, and guidance documents are available at the IRB Forms page. Study-specific materials will need to be provided by the researcher.

Note: Processing for Exempt and Expedited Review typically takes 3 to 4 weeks. For Full Board Review,  allow up to four weeks from the day of the IRB meeting to receive a determination notice. Incomplete submissions may require additional time.

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The Proposal

The IRB research proposal is a description of your study plan and must be submitted in the required format (see template at the link below). The research proposal describes the protocol you will follow beginning with the purpose of the study, research questions, background, significance,  design, proposed statistical analyses, research methods, and human subject interactions. It is important to design your research protocol to account for risks to human subjects. The study proposal is supplemented by recruitment materials, consent forms, and data collection instruments. Once you have written your proposal and developed the supplemental materials, the next step is to get IRB approval. IRB approval is required before you begin conducting research. Visit the IRB Forms page for the proposal template.

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Site Letters

Research conducted upon private-premises other than the University of Texas at Austin requires approval of that site. You can get a template for site letter on our Forms page. The site letter must grant permission for the researcher to conduct research at that site. The letter should be as formal as possible (use letter head). The letter should be signed by a party responsible for research and/or the conduct of similar activity at the site. For example, school district letters are typically signed by the superintendent for schools in that district. Letters from private institutions should be signed by a director, executive, owner, or other appropriate official.

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Informed consent and confidentiality are critical to the process of collecting data from human participants. Except as described in "Waiver of Informed Consent" below, investigators may not enroll human subjects in research unless they have obtained the legally effective, written, informed consent/authorization of the subject or the subject's legally authorized representative. Investigators are responsible for insuring that the subjects, or their representatives, are given sufficient opportunity to consider whether or not to participate and must seek to avoid coercion or undue influence. Information given to potential subjects or their representatives must be in a language that is understandable to the subject or representative. No process of obtaining consent/authorization may include exculpatory language through which subjects waive any of their legal rights or releases or appear to release the investigator, sponsor, or institution or its agents from liability for negligence. The minimum elements necessary for informed consent are as follows:

  • A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
  • A description of any reasonably foreseeable risks or discomforts to the subject;
  • A description of any benefits to the subject or to others which may reasonably be expected from the research;
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  • For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
  • An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject;
  • A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Occasionally, the institutional setting in which the consent/authorization is sought will pose the possibility of coercion. Conducting research at institutions that provide services to subjects may be perceived as implying that continued service is dependent upon participation in the research. Students in the educational setting may be concerned that refusal to participate will affect their grades. These institutional pressures should be addressed in the research design. The protocol must adequately preserve the right to refuse participation. See Policies and Procedures Manual for more information and IRB Forms for informed consent template. You may also download a Consent Checklist.

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The IRB may waive the requirements for obtaining informed consent/authorization or approve a consent/authorization procedure which does not include, or which alters, some or all of the elements of informed consent/authorization listed above, provided that all of the following four conditions are met:

  • The research involves no more than minimal risk to the subjects;
  • The waiver or amendment will not adversely effect the rights and welfare of the subjects;
  • The research could not practicably be carried out without the waiver or amendment; and
  • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

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Informed consent/authorization must be documented by the use of a written consent/authorization form reviewed and approved by the IRB and signed by the subject or subject's legally authorized representative. A copy must be given to the subject or person signing the form. It is assumed that the consent/authorization form is only part of the total consent/authorization process in which the investigator, perhaps using the written consent/authorization form as an outline, describes all facets of the study and answers the subject's questions. The investigator is responsible for insuring that research subjects understand the research procedures and risks. Failure of the subjects to ask questions should not be construed as understanding on the part of the subject.

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If the informed consent and other documents are not professionally translated to the non-English language version, the following procedures must be performed when submitting non-English versions for the Informed Consent for IRB approval:

  • Create an original Informed Consent document in English (English version).
  • Translate the English version into the spoken language (non-English version) of the research participants.
  • The non-English version must then be translated back into English to ensure that all statements are accurate and reflect the statements made in the English version.
  • The PI will be required to respond to the following statement in the IRBaccess application: I certify that I will/have review(ed) the translation from the English version to the non-English version. To the best of my knowledge and belief the statements in the non-English version will be true and accurate, and have the same meanings as the statements in the English version.

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The IRB may waive the requirements for obtaining informed consent/authorization or approve a consent/authorization procedure which does not include, or which alters, some or all of the elements of informed consent/authorization listed above, provided that either of the following two sets of conditions are met:

  • The research presents no more than minimal risk AND
  • The research involves procedures that do not require written consent/authorization when performed outside of a research setting 45 CFR 46.117(c)(2)

OR

  • The principal risks are those associated with a breach of confidentiality concerning the subject's participation in the research
  • The consent/authorization document is the only record linking the subject with the research. 45 CFR 46.117(c)(1)
  • The IRB typically requires a cover letter providing informed consent to be given to the subjects but not signed and returned to the PI. The cover letter should include all necessary elements for full informed consent, but is not signed.

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Confidentiality and Anonymity

Frequently proposals confuse confidentiality and anonymity. Anonymity means "unknown." This means for subjects to be anonymous the researcher must not be able to identify them. Confidentiality occurs when the subjects are identifiable but the researcher does not reveal their identities. Whenever possible design human subjects research to be anonymous as this poses the minimal risk to research subjects.

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Timeline

Different types of studies have different timetables for review. For example, expedited and exempt studies are reviewed as received by RSC. Exempt studies, posing minimal risk to human subjects, take approximately 2-3 weeks to process from the date received by RSC. Expedited studies take approximately 3-4 weeks to process from the date received by RSC. It is important to remember that both exempt and expedited studies are reviewed "in house." Therefore, the full board meeting and agenda dates and deadlines are not applicable to exempt and expedited studies. Full board studies are reviewed monthly. Each meeting has a corresponding agenda deadline. A study must be submitted on or before the agenda deadline to be reviewed by the board at that month's meeting. Notification of determinations reached at the full board meetings are e-mailed to PIs within two weeks after the meeting date.

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DRC

Many academic areas have Departmental Review Committees (DRC). The DRC is responsible for reviewing studies within their respective departments. You must obtain DRC approval before submitting an application to the IRB. For a listing of DRC’s visit our DRC Listing page. Traditionally, the DRC has approved the study by physically signing the application, however, the DRC is now able to electronically approve studies. For approval instructions visit our Approval Instructions page. If you have questions about the rules and procedures for ethical review or the applicability of this information to your proposal, first contact your DRC.

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Faculty Sponsor

A faculty sponsor is required for all students conducting human subjects research. You and your faculty sponsor are responsible for human subjects protections. Your faculty sponsor must approve your application prior to IRB submission. For instructions on how a faculty sponsor approves an application visit our Approval Instructions page.

The faculty sponsor is typically your dissertation or thesis chair, however, this is not always the case. It is important to remember to choose a faculty sponsor which works well with you. Your sponsor will provide valuable recommendations about experimental designs aimed at reducing the risk to human subjects. Your faculty sponsor is your primary contact for human subject concerns and questions.

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Compensating Research Subjects

The guidelines outlined below are meant to assist investigators in determining a reasonable amount of compensation that can be given to research participants and also place some boundaries on what is and is not “reasonable.” The “reasonableness” of a particular sum of money or other form of payment should be based upon the time involved, the inconvenience to the subject, reimbursement for expenses incurred while participating, and should not be so large as to constitute a form of coercion.

During the initial review of a research protocol, the IRB is required to review both the amount of compensation proposed and the method and timing of disbursement to assure that neither are coercive or present undue influence. The following are some additional guidelines:

  1. Any compensation should not be contingent upon the subject completing the study, but should accrue as the study progresses.
  2. Unless it creates undue inconvenience or a coercive practice, compensation to subjects who withdraw from the study should be made at the time they would have completed the study, had they not withdrawn.
  3. Compensation given as a “bonus” or incentive for completing the study is acceptable to the FDA, providing that the amount is not coercive. The IRB is responsible for determining if the incentive amount is not so large as to be coercive or represent undue influence.
  4. The amount of compensation should be clearly set forth in the informed consent/authorization document.

Also note: The University of Texas at Austin Institutional Review Board discourages the payment of finder’s fees (monetary or in kind) in any form, due to the potential that such a practice could be perceived as coercive and bordering on unethical research subject recruitment. In addition, several professional associations and groups have stated that this practice is unethical.

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Email Notices

The Office of Research Support and Compliance & Compliance notifies PIs 90, 60, and 30 days prior to the study expiration date. The IRBaccess database runs a program monthly generating these notices and emailing them. These emails are automated and only warnings about the upcoming expiration date. Suspension and termination emails are also generated and emailed by IRBaccess. All emails are sent to the email address on file in the UT directory.

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Closing a Study

A PI closes their study on or before the study expiration date. All studies which approval has lapsed are expired and then terminated. Lapsed studies cannot be closed. Closing a study requires PIs to submit a closure report. This is a very short form that summarizes your research project; the PI and (if one exists) faculty sponsor sign the closure report. A study should be closed when human subject interactions have ended and subjects are not identifiable. If a risk to confidentiality remains despite all research being concluded (i.e. subjects can be identified in your data as you analyze and write) then you should not close the study.

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Non-Compliance with IRB Policies, Procedures,or Decisions

THE IRB CANNOT RETROSPECTIVELY APPROVE RESEARCH. DO NOT BEGIN RESEARCH WITHOUT IRB APPROVAL.

Human subjects research that deviates from the policies, procedures, stipulations, or decisions of the IRB is subject to further inquiry by the IRB.   Initially, RSC may send the investigator(s) in question a notice requesting the suspension of all research activities while the issue of non-compliance is reviewed, consistent with Federal Mandate 45 CRF Part 46.113. This initial notice will also include a statement detailing the rationale for the IRB’s action. Finally, RSC will investigate allegations of non-compliance.

Areas reviewed during a non-compliance inquiry include: the category of original review (e.g. Exempt, Expedited, Full Board), the type (e.g. general, serious, continuing) and nature of the non-compliance, how investigators deviated from approved protocol, or failed to follow IRB procedure. They also include the history of non-compliance for the PI, CO-PI, and/or faculty sponsors, how the event was reported to the IRB, what steps if any the investigator took to rectify the non-compliance, and finally the implications for participants and the informed consent process.

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Complaints

PIs may bring forward to the Advisory Committee, IRB Chair, Director of RSC, or Human Subject’s Program Coordinator concerns or recommendations regarding the human research protection program, including the IRB review process. To voice a complaint, concern, or problem, email orsc@uts.cc.utexas.edu or call 471-8871.

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