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Human Subjects site of Office of Research Support link to UT home link to Office of Research Support

The Office of Research Support (ORS) does not administer or oversee HOP policy 5-2011 or training related to the policy. ORS administers HOP policy 7-1210, “Promoting Objectivity in Research by Managing, Reducing or Eliminating Financial Conflicts of Interest” so if you conduct research and have:

  1. Not submitted a Financial Interest Disclosure (FID), you will need to complete mandatory training and file a FID. Instructions for completing these requirements are located at http://www.utexas.edu/research/rsc/coi/training.html.
  2. Previously submitted a FID, you are not required to complete additional training nor re-disclose the same information to comply with the UTS 180/HOP 5-2011 policy requirements.   However, you may have other responsibilities under that policy.

HOP policy 5-2011 QUESTIONS? Contact the Provost’s Office evpp_coi@austin.utexas.edu or call Mike Kerker, Associate Vice Provost at (512) 471-2694.

USER GUIDE

IRBaccess

About IRBaccess:

IRBaccess is built in the UT Direct portal. Users access UT Direct (and our system) with a high-assurance UT EID. UT Direct provides structure, color, some links, high-level navigation (across the top of each screen), a navigation area on left of the screen where IRBaccess links reside, and the main 'body' of the screen - which contains data relevant to our service.

Remember, a high-assurance UT EID is required to use IRBaccess.
Click here for UT EID information

Keys To Successful Study Management:

  1. High Assurance UT EID (Click for Upgrade instructions)
  2. IRBaccess URL: https://utdirect.utexas.edu/vr/IRBsignoff_actions.WBX or click the key image to enter
  3. Navigation

A word about logging in

In an effort to make IRBaccess as user friendly as possible you will find various "portals" into the database. All entrances first go through UTDIRECT - so you will need to enter your high assurance EID and password. However, from that point your destination will vary depending upon the link you followed. The default entrance is to your inbox and if your inbox is empty then you are automatically directed to your listings page. If for example you click on a link to the online amendment, continuing review, or closure forms the system will request the study number and take you directly to the form bypassing your inbox and listings page.

IRBaccess screens:

The Listing Page https://utdirect.utexas.edu/vr/list.WBX

The listing page is the "master" page for researchers. Here one can fill out the IRB application, view study details, request new actions (continuing review, amendment, closure etc.) verify training, view the status of various studies, verify participation for roles other than Principal Investigator, and more! Notice the orange links in the Navigation Menu on the left side of the screen.

listing page image

The Navigation Menu links to the major research pages: Vice-President for Research, Office of Research Support & Compliance, Office of Sponsored Projects, New Application,Training verification, Inbox, and Help. The listing page serves as home base. It defaults to a list of all studies where the user is the Principal Investigator. Also, note the screen lets the user know if he/she is listed as a Co-Investigator, Faculty Sponsor, Department Review Chair, or Other on any other studies. For example, this user by selecting the 2 Co-Investigator studies will display those studies. If there are any items in your inbox awaiting your digital signature the screen will display a message directly above the researcher EID stating the number of actions in the inbox awaiting your signature.

Using the "view study details or submit new action" link a user can view a study's details or take an action (continuing review, amendment, closure etc.) on an existing study. A user can also click to view the study summary for each study from this page. To do so simply click on the summary link. The study summary displays any errors or problems with a new study. Errors display at the top of the summary and also are highlighted in red. Also faculty sponsors and DRCs digitally sign their approval at the summary page. Other members of the research team confirm their participation at the summary page. Finally, at the bottom of the summary page users can submit new actions.

The user here has one study on file. We can see that its status is "approved" and the approval ends 10/22/2004. (Possible statuses include CREATED, SUBMITTED, RETURNED, APPROVED and others.)

Details Page & Update Page

listing page image

The detail and update page displays the current study's information. Before submitting a new action you should verify that the study you are viewing is the correct study you wish to amend, renew, close, or report an unanticipated problem. When you are ready to submit the action click "submit new action / view history." This will direct you to the history of actions page.

History of Actions Page


listing page image
The history of actions page displays a study's past actions taken and current actions pending approval. This study has had 5 amendments approved and has a continuing review pending approval. The lack of an action taken and approval date for the continuing review indicates that it is pending approval. The drop down menu has four options for new action submission: amendment, unanticipated problem report, closure, and continuing review. By clicking on your selection you are directed to the appropriate form.

Inbox https://utdirect.utexas.edu/vr/IRBsignoff_actions.WBX

Your inbox contains all study actions requesting your digital signature. The database automatically emails DRCs, faculty sponsors, and CO-PIs that a digital signature is required. Users are routed through their inbox if it contains signature requests when logging on. To digitally sign an action click on the link for the type of action (amendment, continuing review, etc.) or click "Go to application and approve new study." In either case you are directed to the study summary page. Before signing off on the request action you should review the summary and any pertinent uploaded documentation. To view uploaded documentation simply click on the "upload" links in orange. DRCs and faculty sponsors can also disapprove a requested action. To do so simply click the "do not approve" tab. A new window will open to confirm this choice. Once confirmed, the database prompts the reviewer to send the PI an email indicating the rationale for disapproval.

listing page image

Training Verification Page https://utdirect.utexas.edu/vr/trngVerify.WBX

This page is vital! To get to this page - click on the navigation bar link from the listing page above to "Verify Training". Again, this page requires a high-assurance UT EID. Here your UT EID serves as an electronic signature. Training is valid for three years from the training date. The benefit to the researcher is that he/she no longer has to show proof of training with each IRB submission since the documentation is now kept in a database! All key personnel on a given study will be required to verify training using this page.

Researcher with no training on file:
researcher training verification page image

 

Researcher with training on file:
research training verification page image

To verify training other than the choices listed, a user should select 'OTHER' and wait for additional fields to appear. The additional fields allow the user to specify whether training was a college course or some other type of training. The user will need to specify the date for the training, as well as, either course information or details about/description of the training. A user may verify multiple training types (up to 20).

Once a user has verified training, it will appear in a list above the select menu for adding training. The user can update the date of training if a data entry mistake occurred. Or, if the entry is just plain incorrect, the user may delete it. If training is deleted, it is GONE - with no record - so use this function with care! Click here for additional training information.

IRBaccess Application Pages

The online IRB application is divided up into two parts: the six step application and the collections of digital signatures. The user can access this application from the 'Create New IRB Application' link in the left navigation area. Only asterisk (*) marked items with a highlighted background color require responses. Steps 1 and 2 of the application request: title, type of research, key personnel (co-investigators), the faculty sponsor (if the PI is a student), Department Review Chair (if the PI's department has one), research assistant or project coordinator, and conflict of interest.

Throughout the application, and again on step six, references are made to "uploading additional documentation" in support of the application. Examples of such documentation are a research proposal, consent forms, permission letter to do research at an "off-campus" site, and other IRB review approval letters. The upload function works just like an email attachment. The user may upload an electronic copy of these documents with the IRB application - allowing the entire process to be completely paperless!

The user may fill out all six steps of the application at once, or complete one or two steps at a time and return later. The user must save each page as he/she goes through the application. Upon returning, the user would go to the LIST page and see which pages of the application still need to be completed. The listing page displays the completed steps of the application under "status." Click here for step by step tips and help.

Routing


New Study Submission Routing Map
New Study Routing Map

All online forms and the online application are automatically routed for electronic signature collection to necessary parties. If the user lists key personnel, a faculty sponsor, or a DRC on the study application, the application cannot be SUBMITTED to the Office of Research Support for approval until all involved parties have "signed off," indicating their approval of the study. The Principal Investigator will always be able to track who has not yet signed off by checking the summary page for details. Once a study can be submitted, a "SUBMIT" button will appear on the listing page and on step six of the IRB application. This final "submit" step is necessary only for new applications, PIs do not have to "submit" (step 6 above) amendments, continuing reviews, closures, or unanticipated problems. Instead, these actions are directly routed to ORS after all faculty and DRC have signed-off.

Amendment and Continuing Review Routing Map Amendment Routing Map

Please note: Amendments and Continuing reviews must be submitted with necessary additional documentation - Please be sure to upload your revised research proposal and consent forms!

The Summary Page

This page provides the user with a summary of the entire six-step application. It is condensed and lists out all of the current study information. When the user links to this page as the Faculty Sponsor, Department Review Chair, or Co-Investigator on a study, he/she will be able to confirm involvement from this page. Note: at the top of the page there is a button for the Faculty Sponsor (in this case) to approve of this study. New actions can be submitted using the drop down menu at the page's bottom.

irb application summary page image

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. 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.

photo of eyeWhat is Human Subjects Research?

It can be very difficult to determine what constitutes human subjects research. The Common Rule offers the following definitions as guidance for determining human subjects research. The definitions are intentionally broad to include a wide range of research in hopes of capturing both the biomedical and humanities spectrums. These definitions are the starting point for anyone attempting to determine whether their research requires IRB review or not. The official determination of what is human subjects research is made by the Office of Research Support.

The first question to ask is if your project involves human subjects:

Human Subject means a living individual about whom the investigator conducting research obtains (a) data through intervention or interaction with the individual or (b) identifiable private information (45 CFR 46.102F)

The second question is if your project is actually research as defined by the Common Rule:

Research means asystematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities (45 CFR 46.102d). For more information see the Office for Human Research Protections.

If the answer to both questions is "yes," then you need IRB approval to conduct research. If the answer to one of the questions is "no," then ask yourself these questions:

  • Does the activity involve a new drug or a new use for an approved drug (including over-the-counter drugs)?
  • Does the activity involve a new medical device or a new use for an approved medical device?  (Note that medical devices generally include devices intended for the use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals, and devices intended to affect the structure or any function of the body of humans or other animals.)
  • Will data be submitted to the FDA or held for their inspection?

If the answer to one of the above questions is "yes," then you will need IRB approval to proceed.

In making such a determination it is best to consult your faculty supervisor or advisor, DRC, department head, or consult with our office. However, before contacting ORS please review our addressing past determinations of what is human subjects research and our UT IRB Policies and Procedures manual.

Click here for exempt categories (note exempt research must be submitted for approval)

Click here for expedited categories

PDF FileHuman Subject Regulations Decision Charts

The Proposal

The IRB proposal consists of your application, research proposal, consent forms, and supporting documents. The research proposal must be submitted in the required format (see template at the link below). It is important in designing your research proposal to account for risks to human subjects. Once you have a proposal and it fits the definition of human subjects research, the next step is to get IRB approval. IRB approval is required before you begin conducting research. If you are a graduate or undergraduate student you must have a faculty sponsor assigned to your study. Your study should include information about the Investigators (co-investigators), hypothesis, research questions, project goals, background, significance, research method, design, proposed statistical analyses, and human subject interactions. Your proposal should also include all questionnaires, measures and interview questions you plan to administer to subjects. Click here for Application Forms and Templates

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 from a 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.

Informed Consent

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. Please see Policies and Procedures Manual for more information and Application and Form Templates for letters of informed consent. You may also download a Word DocumentConsent Checklist.

Waiver of Informed Consent

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.

Documenting Informed Consent

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.

Non-English Language Informed Consent and other Documents

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 reflex 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.

Waiver of Documentation of Informed Consent

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.

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.

Timeline

Different types of studies have different timetables for review. For example, expedited and exempt studies are reviewed as received by ORS. Exempt studies, posing minimal risk to human subjects, take approximately 2-3 weeks to approve from the date received by ORS. Expedited studies take approximately 2-4 weeks to approve from the date received by ORS. 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 mailed to PIs within two weeks after the meeting date.

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.

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.

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 please 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.

Email Notices:

The Office of Research Support & 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.

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.

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, ORS 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, ORS 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.

Complaints:

PIs may bring forward to the Advisory Committee, IRB Chair, Director of ORS, 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, please email orsc@uts.cc.utexas.edu or call 471-8871.