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Institutional Review Board
 

The Institutional Review Board (IRB) was established to assist researchers in the protection of the rights and welfare of human subjects involved in research. The purpose of this page is to relay information concerning the IRB and its policies. The original documentation, from which the information on this page is nearly verbatim taken, can be downloaded as a pdf.

There are three ways to have a course or project approved by the IRB. For full documentation concerning the IRB policies on research involving human subjects, please see below.

  1.  Exempt registration: Certain basic research projects (such as surveys) do not require approval by the IRB, but still must be registered.
  2. Non-exempt research approval: Research projects which fall under the jurisdiction of the IRB and cannot be exempt need to be fully approved by the IRB prior to their inception.
  3. Expedited approval: Research that is not clearly exempt from prior approval can be submitted to the IRB using the standard approval form, and may be expedited towards approval by the committee. A decision will be given by the end of the second business day after the calendar day of the request being made.

Please avail yourself of a free training module designed for researchers who will be using human subjects in their studies. Some universities require all researchers who submit a full review proposal to complete the module.

 

 


Policies and Procedures

Related to the Use of Human Subjects in Research

 

Contents

 


 

1. What are the policies?
 

Note: the policies set forth in this section are in addition to, and not prejudicial to, any other policies and regulations of the University.

The policies of the Institutional Review Board (IRB) are intended to protect the rights and well-being of persons who are subjects of research that is sponsored, funded, conducted, or supervised by the University of Dallas and its faculty. These policies seek:

No researcher may include in the publication of the results of a survey or other observational technique such data or other information by which the identity of an individual participant in the survey, or the identity of an individual observational subject, may be directly discovered, unless the participant or subject has given express, informed, and deliberate consent to such identification.

The researcher is responsible for maintaining written records of any such consent, in such form that the consent is not merely implied but reasonably demonstrated. Such records shall be maintained for a period of seven years from the date of publication of the research results and shall be open to inspection at any time within that period by the Institutional Review Board.


2. What type of research needs prior approval?
 

Any of the above shall require prior review and approval by the IRB without regard to the source of sponsorship or funding of the research.


3. Which project types are exempt from needing prior approval?
 

Research involving human subjects is specifically exempt from the prior approval of the IRB if any of the following conditions apply:


4. What is the procedure for class projects which are exempt?
 

A faculty member who requires students to undertake research on human subjects, which research is believed to fall under the provisions for general exemption from prior review specified above, shall:

  1. Provide to every research student a written protocol establishing parameters for the research that will ensure that the research shall be and remain within the provisions for exemption
  2. Provide a copy of this protocol to the IRB before the research begins

See section 5 below for the procedure for exempt projects.

A faculty member making such a research assignment assumes full responsibility for ensuring that all research carried out by a student meets the parameters described in the protocol submitted to the IRB, and that any research outside the scope of that protocol is submitted for separate review by the IRB.


5. How is a research proposal submitted?


Non-Exempt Research

An investigator who plans research which falls within the scope of section 2 above shall make application to the IRB, through the Presidents Office, for approval of the research before beginning the actual research work. The IRB may not approve such research begun without its approval.

An application template, with instructions included, should be downloaded, filled in, and submitted (see application for specific instructions).

.pdf application  /     .doc application

 

Exempt Research

For a research project which is exempt according to the rules set forth in section 3 above, although no prior approval is needed in order to begin research, a registration of the project with the IRB is required. This can be done via an online form (linked below). In addition to the form submission, a copy of the protocol detailing the controlling parameters of the research (see section 4) should be submitted to the IRB.

Form for Registration of Exempt Research


 
6. What is the process of approval by the IRB?
 

The Chairman of the IRB shall provide a copy of the application to every member of the IRB. The members shall consider the application and meet to vote on the application. The IRB may approve the application, disapprove the application, or require modification of the research proposal.

The IRB must vote on the application and notify the applicant of the vote within thirty days of receiving the application, except, however, the IRB may extend its consideration for an additional thirty days if the complex or unusual nature of the proposed research requires more extended consideration or assistance from one or more outside experts. Any further extension may be appealed by the applicant to the President of the University, who must act within ten days either to approve or disapprove such further extension, which must be to a date certain.


 
7. What if an application is not approved?

Should an application be disapproved, the reasons therefore must be given in writing to the applicant. If the IRB requires modification of the research proposal, the required modification(s) must be specifically enumerated and the grounds for each modification must be stated.


8. What happens after approval?
 

Every investigator who has secured from the IRB prior approval of a research project shall annually report to the IRB on the progress of the investigation, specifically discussing the operation of the safeguards for the rights and welfare of the human subjects involved in the research, with special mention of any complaints or problems that have arisen in that regard.

The IRB shall have authority to oversee any research for which it has granted prior approval, and shall have power to require special reports of the investigators, and to stop the research work if it finds compelling evidence of damage to the rights or welfare of human subjects of the research, or failure to implement fully the safeguards of rights and welfare stated in the application for approval, even if there is no evidence of specific instances of damage or abuse. Researchers are required to notify immediately the IRB of any situation where there is an injury, harm, or complaint of a participant.


Appendix 1: What if it isn't clear that a research project is exempt from approval?
 

A faculty member who is not certain that a particular research project, of his own or of one or more of his students, is exempt from prior review under the provisions for general exemption in section 3 above shall make an application for prior approval as specified in section 5 and request an advisory opinion as to whether the research is exempt. Such an application may be eligible for expedited review by the Chairman of the IRB or by a single voting member of the IRB designated for such purpose by the IRB.

If the faculty member requests such expedited review, an opinion shall be rendered not later than the end of the second business day following the calendar day on which the request is made. Should the IRB or its designee issue an opinion that a particular research project is exempt from prior approval, that opinion may be relied upon, but only by that faculty member and only for the particular research project specified by the applicant in the application.


Appendix 2: Special Procedures in Respect of Research Falling under Federal Regulations
 

Research conducted or supported by a federal department or agency (45CFR46 101), or which a federal department or agency has specific responsibility for regulating as a research activity (45CFR46 102 (e)), shall be governed by the applicable regulations adopted by the U.S. Department of Health and Human Services and codified in Title 45, Subtitle A, Part 46 of the Code of Federal Regulations as revised. If, as, when, and where the provisions of these policies are deemed not to meet the minimum requirements of the federal regulations, such additional policies and procedures as are needed to conform to the minimum requirements of the regulations shall be formulated and proposed by the IRB for consideration and adoption in the usual channels as elsewhere specified in the policies and procedures of the University of Dallas.


Appendix 3: The Institutional Review Board
 

The Institutional Review Board is established to assist researchers in the protection of the rights and welfare of human subjects involved in research. It is responsible for prior approval of research involving human subjects that is conducted, sponsored, or funded by the University of Dallas or its faculty, in those instances in which prior approval is required by the provisions stated here. Prior approval by the IRB may be countermanded by the President of the University, but its disapproval is not subject to review. For the University of Dallas, the IRB is the Institutional Review Board required by the applicable regulations of the U.S. Department of Health and Human Services in respect of research involving human subjects that is

  1. Conducted or supported by a federal department or agency (45CFR46 101), or:
  2. which a federal department or agency has specific responsibility for regulating as a research activity (45CFR46 102 (e)).

The IRB functions as a Board of Inquiry into allegations that a researcher has not adhered to the policies and procedures set forth herein for research involving human subjects. In such instances, its findings and recommendations are made to the Dean of the faculty of which the chief investigator is a member, and to the President of the University.

Membership

General Procedures


 

 

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