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Institutional Review Board

   

General Information

 

IRB Announcements

On behalf of Thomas University, the primary role of the Thomas University Institutional Review Board (IRB) is to advise on the ethical standards of those conducting research using humans or vertebrate animals, and biological or biomedical research involving Recombinant DNA. The IRB is responsible for safeguarding the rights and welfare of human subjects in any research, development, or related activity, and for assuring proper laboratory practices and the proper care of laboratory or other vertebrate animals used in research conducted by Thomas University faculty and students, or research conducted on behalf of Thomas University in partnership with other university or external entities and independent researchers.
 
Starting January 1, 2010 the Thomas University Institutional Review Board (IRB) requires that all students conducting research involving human subjects complete the online Human Subjects Education Training available at the OHRP website, or the Collaborative IRB Training Initiative (CITI) available at the CITI website.

 


Does My Research Require Review?

In compliance with Federal law and institutional policy, all research projects involving human subjects or human material and research involving vertebrate animals must be reviewed and approved by the IRB. All biomedical, social and behavioral research including class projects conducted by the Thomas University faculty, staff and students are subject to the Policies and Procedures of the Institutional Review Board and subject to review.

For more information, please reference the Thomas University Institutional Review Board Policies (Thomas University Policy Manual Volume IV, Section 4.15) and the Guidance for Class Projects Manual.
 
Application Quick Links

IRB Applications for Research Involving Human Subjects

IRB Applications for Research Involving Vertebrate Animals

IRB Applications for Research Involving Recombinant DNA

Instructions for Application Submission and Review

The researcher should first complete either the CITI or Human Subjects Education Training (according to the type of research proposed) prior to submission of their IRB application. A copy of a certificate of completion must accompany the IRB application and will not be reviewed without a certificate of completion for one of these trainings.

Following the completion of the CITI or Human Subjects Education Training, a researcher should download and fill out one of three IRB application submission forms which correspond to the nature of their particular proposed study. A hard copy of the submission form should be sent to the attention of the IRB Chairperson (Forbes Building Office #203), after a signature has been obtained from the researcher’s Division Chairperson or Assigned Faculty Sponsor. Please fill out all questions completely in order to expedite your application. Study methodology and consent processes must be clear to the review board.

Note: If the principal researcher is a Thomas University Faculty or an external researcher, they should submit their application directly to the IRB Chairperson.

IRB Response Timeframe

Though the IRB employs a state of rigor when reviewing all applications, we do so in a timely and expedient fashion, regardless of the type of research proposed and in accordance to IRB policy and procedures. To that end, all researchers are asked to please allow up to two weeks (10 business days) for Exempt and Expedited IRB application reviews, and up to 4 weeks (20 business days) for a Full IRB Committee review of proposed research. All decisions of the IRB will be returned to the principal investigator in writing in accordance to IRB policy and procedures.

Key Terms of the IRB to Remember

Research

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of these regulations, whether or not they are supported or funded under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.(45 CFR 46.102 d).

Human Subject

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual; and/or identifiable private information (45 CFR 46.102f).

Vulnerable Populations

Vulnerable populations include minors, pregnant women, human fetuses, human neonates, prisoners (detainees, parolees), institutionalized persons, mentally disabled or handicapped persons.

Minimal Risk

Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons. That is, the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (45 CFR 46.102 (i) and 46.303 (d)

IRB Approval

IRB approval means the determination of the Thomas University Institutional Review Board that the research that has been proposed and reviewed may be conducted at the institution or within the proposed venue external to Thomas University as described in the proposal, (as subject to the approval of the usage of the proposed external venue by the external venue’s governing body), within the constraints set forth by the Thomas University Institutional Review Board and by other institutional or federal, state, or local regulations or requirements as they relate specifically to the research under scrutiny. All approved research will receive IRB Certification (see definition) of that approval.

Full Committee Review

A full committee review is a procedure for research that does not qualify for an expedited review (see definition) that occurs during convened Institutional Review Board meetings at which the majority of IRB members (a quorum) are present, including at least one member whose primary concerns are in non-scientific areas. In order for the research to be approved, it will receive the approval of the majority of those members present at the meeting. (45 CFR 46.108 a-b)

Expedited Review Defined

An expedited review is a procedure for certain kinds of research involving no more than minimal risk to subjects that participate in the research study or project under scrutiny. The expedited review procedure is used to review one or both of the following types of research or similar activities:

  • Minor changes in previously approved research during the period (of one year or less) for which approval is authorized (See Addendum and Amendment form for IRB Research Proposal and Application) (Appendix K); or
  • Some or all of the research appearing on the US Department of Health and Human Services Federal Register list of categories of research that may be reviewed by the IRB through an expedited review procedure.

For complete details about the Thomas University Policy and Procedures, please refer to the Thomas University Policy Manual Volume IV, Section 4.15.
 
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