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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.

Faculty Research

IRBaccessIRBaccess is the human subjects research database. Click the key above or anywhere on our website to enter.   This system allows users to manage their research studies.  It interfaces with UTDIRECT allowing for smooth navigation. Use IRBaccess to apply online or to update your compliance training. Are you wondering if your amendment has been approved?   Save time and effort by checking online using IRBaccess. Now submit online amendments, continuing reviews, closures, and more! Click here for more information and direct links to online amendments, continuing reviews, closures, and more.

If you are beginning a research project for the first time at the University of Texas-Austin, we recommend you visit our Users Guide for information on application requirements and a process overview. This page will assist with what to include in the proposal, how to complete and submit an application to the IRB, how to make changes to an existing study, and how to file a continuing review.  For some classes with research components, it may not be necessary to apply for IRB review, as the research being conducted is to instruct and develop students' researching skills. Please visit our Student Class Project Guidelines page for more information. For more information on research proposals, applications, and answers to general questions see our FAQs page.

Types of Studies

lab scientist

Type of studies vary by risk, participant population, and data collection method. Most benign studies are considered to have "no more risk than everyday life." Typically, such studies are minimal risk, exclusively include non-vulnerable participants, and involve surveys, questionnaires, or analysis of existing data. Studies with minimal risk can go through an exempt or expedited review. However, although exempt means "free from federal regulatory oversight" it does not mean free of University IRB oversight, and although expedited means "faster," it does not mean less scrutiny in the review. Higher risk studies are those that include any invasive procedures (drawing blood) or studies concerned with vulnerable populations (including but not limited to prisoners, children, pregnant women, and age, health, cultural considerations), or sensitive topic areas (sexuality or alcohol use).

Policy Updates: (Updated February 21, 2007)

Training

Word FileConsent Check List

Questions, Concerns, and Suggestions

If you have questions, concerns, and suggestions or wish to provide input or feedback regarding IRB policies and procedures, you are encouraged to contact the IRB Office at (512) 471-8871. Alternatively, an email may be sent to orsc@uts.cc.utexas.edu.

Serving as Faculty Sponsor/ Supervisor

A faculty sponsor is required for all students conducting human subjects research.  The faculty sponsor is primarily responsible for human subjects protections. The faculty sponsor must approve the application prior to IRB submission. For instructions on how to approve an application visit our Approval Instructions page.

DRC

There are Departmental Review Committees (DRC) in a number of areas at UT.  To view a list of DRCs visit our DRC Listing page.  If you intend to do international research a list of experts in certain subjects and geopolitical areas has been compiled by the Office of Research Support. 

Use of Subject Pool & Student Participants

Students at UT-Austin have the same rights as any other potential subject to participate in a research project, irrespective of the degree of risk, provided all of the following conditions exist:

(1) The research must not bestow upon participating University of Texas at Austin subjects any competitive academic or occupational advantage over other University of Texas at Austin students who do not volunteer, and the researchers must not impose any academic or occupational penalty on those University of Texas at Austin students who do not volunteer.

(2) University of Texas at Austin students must not be systematically treated differently from non- University of Texas at Austin subjects as part of the project.

(3) Due to the potential for perceived or real coercion to participate, University of Texas at Austin students who desire to participate in the research must not be under the direct supervision of the principal investigator or listed research collaborators except as necessitated by scientific merit or overwhelming benefit to subject(s).

In accordance with 45 CFR 46 and 21 CFR 56, the UT-Austin IRB will review all studies (exempt, expedited, and full board) requesting the use of University of Texas at Austin students. The IRB may waive any and or all of the above conditions provided the study demonstrates either of the following:

(1) Overwhelming benefit to the subject;

(2) Reasonable scientific merit.

Subject pools are undergraduate students enrolled in particular departmental courses requiring participation in one or more research projects.  The Institutional Review Board provides guidance and oversight of departmental subject pools, and reviews all research requesting subject pool participation.  All student participation in subject pool research must be completely voluntary.  Departments provide students with incentives (usually extra credit) to participate in the subject pool. Reimbursement for participation must not jeopardize subject confidentiality or anonymity.  Any subject pools offering extra credit to participating students must provide alternative opportunities to earn extra credit to students declining to participate in research.  Subject pools including subjects under 18 years-of age are required to obtain parental consent prior to their involvement in research unless those individuals are emancipated.   It is up to the student to decide whether to participate in any study; instructors cannot mandate or require student participation. In accordance with our policies on recruitment, vulnerable populations, and subject pools instructors are strongly discouraged from recruiting subjects they directly supervise or selecting subjects on such basis.  Subject pool requirements and procedures vary by department so it is best to consult with your individual departments for specific guidelines and additional requirements.

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. For information regarding records and procedures involving reimbursement of subjects see the Office of Accounting.

Funding

Funding is an important topic for many faculty researchers. There are many resources available. For information on how to write a grant proposal contact the Regional Foundation Library at the Hogg Foundation. For Department of Health and Human Services grants see their website and the Office of Sponsored Projects.  For general information about research and funding on the web see http://www.hhs.gov/ohrp, http://www.primr.org, www.fda.gov, and www.aahrpp.org.