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Institutional Research Board

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IV:  Review Procedures

All research involving human subjects that is conducted by any employee or agent of Viterbo University (VU), or otherwise conducted at or sponsored by VU, irrespective of the risks, scope, funding, or location of the research, must comply with federal and campus policies for the protection of human subjects (see Part I: Research Subject to IRB Review).

A. Review of Human Subjects Research

Prior to any involvement of human subjects, all human subjects research must be reviewed and approved or determined to be exempt.

Researchers who believe their research qualifies for an exemption at 45 CFR 46.101(b) should submit an Application for Exemption using IRB Web Application Form. The designated IRB member will make a determination that the research is exempt and will communicate this in writing to the researcher. If the research is not exempt the researcher will be asked to submit an IRB application for expedited or full review.

For all non-exempt human subjects research, review must occur and approval must be granted by a VU IRB review, prior to any involvement of human subjects in the research. For all projects, an IRB application or an exemption request form, with relevant attachments, must be submitted to the IRB Web application form. The IRB asks for information about the investigator(s), the nature of the research, the funding source, targeted subject groups, how subjects will be recruited, how informed consent will be obtained, how confidentiality will be protected, and the risks and benefits of the proposed research. More information about these topics is provided in this handbook. In completing their application, investigators should avoid the use of acronyms, abbreviations, and jargon that might not be familiar to reviewers.

Upon completion of the review, a letter will be sent to the responsible principal investigator (RPI) authorizing initiation of the project or containing stipulations that must be met before approval is granted. The involvement of human subjects may begin only after stipulations have been satisfactorily addressed and formal, written approval is given.

Continuation Reviews

The VU IRB committee conducts continuing reviews of nonexempt research at intervals appropriate to the degree of risk, but at least once per year.

B. Exempt Research

All human subjects research at VU, whether exempt or not, must be conducted in accordance with VU policies, the VU Federalwide Assurance, federal guidelines, and the ethical principles set forth in the Belmont Report. Unless it will involve prisoners as subjects or certain activities involving children, research may be exempt from the review of a convened IRB if the only involvement of human subjects will be in one or more of the six categories described in this section. The determination of exemption may not be made by the investigator. All human subjects research must be submitted for approval on the Web-based application form. The researcher may request exemption from review, expedited review, or full IRB review. No involvement of human subjects may take place prior to formal, written determination from the appropriate body.

If a project meets any of the following six exemption categories it may be approved under an exemption. This determination shall be made by the designated IRB Office person(s) (or by the IRB committee) after a complete review of the research protocol, associated measures and addenda, and the proposed consent process and relevant forms. Research involving more than minimal risk is not exempt. The following exemption categories are from Title 45, Part 46 of the Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46 ).

  1. Title 45 Code of Federal Regulations §46.101(b)(1) exempts research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
    1. research on regular and special education instructional strategies, or
    2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  1. Title 45 Code of Federal Regulations §46.101(b)(2) exempts research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior can be exempt, unless
    1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
    2. any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

NOTE: Exemption 2 does not apply to the following types of research involving children: surveys, interviews, and observations of public behavior when the investigator is a participant in the activities being observed.

  1. Title 45 Code of Federal Regulations §46.101(b)(3) exempts research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if
    1. human subjects are elected or appointed public officials or candidates for public office; or
    2. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

  1. Title 45 Code of Federal Regulations §46.101(b)(4) exempts research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. NOTE: In order to be eligible for exemption 4, all of the materials have to exist at the time the research is proposed and must have been collected for purposes other than the proposed research.
  1. Title 45 Code of Federal Regulations §46.101(b)(5) exempts research and demonstration projects that are conducted by or subject to the approval of department or agency heads, and that are designed to study, evaluate, or otherwise examine
    1. public benefit or service programs;
    2. procedures for obtaining benefits or services under those programs;
    3. possible changes in or alternatives to those programs or procedures; or
    4. possible changes in methods or levels of payment for benefits or services under those programs.
  1. Title 45 Code of Federal Regulations §46.101(b)(6) exempts taste and food quality evaluation and consumer acceptance studies,
    1. if wholesome foods without additives are consumed; or
    2. if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the US Department of Agriculture.

C. Grant Submissions that Involve Human Subjects

Most funding agencies require certification of IRB review and approval prior to making the award or allowing expenditure of funds. Requirements for the timing of IRB approval vary across agencies. When submitting the IRB application form, it is the responsibility of the responsible principal investigator (RPI) to provide the IRB with the address to which certification of approval should be sent and with adequate time to meet agency deadlines.

Training Grants

When training grants are submitted and some projects are expected to involve human subjects, the training grant will be reviewed administratively by the IRB and a certification of IRB review and approval will be sent to the funding agency. The grant's principal investigator is responsible for ensuring that all projects supported by the training grant are submitted for IRB review prior to initiation. The annual continuing review of the training grant requires submission of a list of projects that involve human subjects and documentation that they have been approved by the IRB.

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