IRB Policies

I.  STATEMENT OF PRINCIPLES AND POLICIES

(a) The University of Texas at Arlington is committed to the principle that research, teaching, and public service activities should contribute to the acquisition of knowledge and should benefit humanity. It is within the role and scope of the faculty of the University to utilize human subjects from time to time in carrying out activities contributing to the advancement of knowledge.

(b) Safeguarding the rights and welfare of human subjects in research, development and related activities is of prime concern to The University of Texas at Arlington and shall be a responsibility of persons at all levels, including, staff, faculty, and students. All personnel engaged in a study will be held accountable for actions or lack of actions that might contribute to the injury of persons placed at risk.  It is the policy of this University to maintain such reviews as necessary to minimize the risks of injury to human subjects and to insure maximum protection for the rights and welfare of subjects. 

(c) The broad responsibilities outlined above should involve a preventive attitude with respect to potential injury, physical or psychological, to human subjects at risk. However, to better insure that the rights and welfare of human subjects are adequately protected, authority is delegated and responsibilities fixed as indicated below to bring into focus competent professional judgment for the purpose of reducing the risk of injury to human subjects to the lowest level possible.

(d) To determine if this policy applies to a particular project, consideration must be given to the two following questions. For this policy to apply to a research project, the answer to both of the following questions must be yes.

1. Does the activity involves research?

Research is defined by the regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

2. Does the activity involves human subjects?

 Human subjects are defined by the regulations as "living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information

II.  POLICIES REGARDING COMPLIANCE WITH FEDERAL REGULATIONS ON PROTECTION OF HUMAN SUBJECTS

(a)  The University of Texas at Arlington will comply with the Department of Health and Human Services
Regulations on Protection of Human Subjects (45 CFR Part 46, as amended), accordingly:

1. An Institutional Review Board for the Protection of Human Subjects will be maintained to review research projects and activities that involve human subjects. The Institutional Review Board for the Protection of Human Subjects shall consist of qualified representatives charged with the major responsibility of assuring the protection of human subjects against undue risk.

2. No  research activity involving human subjects shall be undertaken unless the Institutional Review Board has reviewed and approved such activity.  Although federal guidelines require Institutional Review Board approval specifically for activities funded by federal grants, the University’s Assurance with OHRP extends the review procedure to all such projects whether privately or publicly funded. Since the participation of human subjects in research and related activities may raise fundamental ethical and civil rights questions, no distinctions in the monitoring of projects will be drawn between funded and unfunded projects, sponsored and unsponsored projects, or between projects carried out by students, faculty or other University employees, on‑campus or off‑campus.

3. The basis for determining risk for human subjects concerns whether: 

4. Reviews by the Institutional Review Board for the Protection of Human Subjects will be conducted with objectivity and in a manner to ensure the exercise of independent judgment of the members. Members will be excluded from review of projects or activities in which they have an active role or conflict of interest.

5. The Institutional Review Board for the Protection of Human Subjects will promote continuing constructive communication between Board members and the principal investigator(s) as a means of safeguarding the rights and welfare of the human subjects.

6. The University of Texas at Arlington acknowledges that it has responsibility for the proper performance of work and services including the use of human subjects under any grant or contract covered by this assurance, including continuing compliance with pertinent state or local laws, particularly those concerned with informed consent.

7. The Institutional Review Board for the Protection of Human Subjects will accept responsibility for maintaining appropriate and informative records of the Board's review of other documentation that may pertain to the selection, participation, and protection of subjects and to the review of circumstances that affect the rights or welfare of individual subjects.

8. The University of Texas at Arlington Institutional Review Board for the Protection of Human Subjects will at least annually evaluate the practices and procedures designed for the protection of the rights of human subjects.

9. Cooperative research projects are those projects normally supported through grants, contracts, or similar arrangements, which involve institutions in addition to UTA.  Each Institution is responsible for safeguarding the rights and welfare of human subjects and for complying with the DHHS Regulations on Protection of Human Subjects (45 CFR Part 46, as amended).  When research is conducted at or in cooperation with another entity,  the investigator must obtain approval from the UTA IRB, or written acknowledgement from the UTA IRB of its acceptance of a collaborating IRB of record for the project involving human subeject research.  The letter of approval from the IRB of the cooperating institution must be submitted to the UTA IRB for approval or acknolwedgement.  If the cooperating institution does not have an IRB, a letter of acceptance of the UTA-IRB review and  approval for the research to be conducted must be submitted by the CEO/signatory official of the cooperating institution. 

In instantaces where UT Arlington’s IRB acknowledges approval of a cooperating institution’s IRB approval in accordance to 45 CFR 46.114 the protocol of the IRB of record must have a Principal Investigator that is employed by the cooperating institution.