Scope

The Point Park University IRB will first determine if the proposal is an actual research study, and secondly, it will determine if such research involves human and non-human subjects. Approval by the IRB of a researcher's degree-granting institution shall not be a substitute for the need for approval by the Point Park University IRB. A proposal approved by another institution's IRB will not automatically be accepted or approved by the Point Park University IRB. Research is defined by the regulations as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" [Federal Policy § 46.102 (d)]. 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" [Federal Policy § 46.102 (f)]. (Section 102(f) goes on to define the meaning of such terms as "intervention" and "private information.")

Guidelines for the Initial IRB Research Review

Upon receipt of fully completed IRB proposals to conduct research, the chairperson of the IRB shall convene a meeting of the IRB Committee to review the proposal. Five of the eleven members of the IRB will constitute a quorum at meetings of the IRB to review research proposals. The IRB chairperson will receive proposals and convene the Committee within thirty (30) days. Roberts Rules of Order will provide the structure to the board meetings.

The IRB chairperson will identify one ad hoc member of the Committee with competencies in the areas of research contained in the proposal to fill the rotating position on the Committee. This ad hoc member may come from either within or outside of Point Park University.

A majority vote of those present at a duly convened meeting is required for an official decision of the IRB. The Committee may vote to either:

Approve as is the research proposal without any required modifications or changes to the proposal;
Approve with modifications specified by the A second meeting will be conducted by the IRB after the researcher has made the specified changes to the proposal;
Not approved. The research proposal is rejected as is for reasons that are indicated in the Committee's written

The Point Park University IRB will consider the following criteria in reviewing IRB applications:

Real and potential risks to the physical, emotional, and/or psychological safety of human and non-human subjects;
Respect for the personal dignity and autonomy of individuals, including special protection of those persons with diminished capacities;
Beneficence for human and non-human subjects which is achieved by maximizing the anticipated benefits and minimizing potential risks of harm;
Informed active consent from all human Consent forms that require potential human subjects to sign off if they do not wish to participate in a research study shall not constitute informed active consent;
Feedback on the findings and significance of the study to all research participants upon completion of the study. Such feedback may be provided in written form, through face-to-face feedback, or both;

In addition to submitting the Point Park University IRB Review Form, the researcher will also provide, where applicable, the following documentation to the IRB:

complete copies of all research instruments;
consent forms; grant applications;
recruitment brochures or announcements;
advertisements that are intended to be seen or heard by potential research participants;
scoring rubrics.

Required Signatures on the IRB Proposal

The signature of the faculty sponsor and the Department's IRB representative is required for all IRB proposals involving students who are conducting research involving human and non-human subjects at Point Park University. These signatures are required prior to review of such proposal by the IRB.

All faculty and staff members submitting proposals to the IRB who are conducting research involving human or non-human subjects as part of their doctoral degree requirements must obtain the signature of their dissertation chairperson. The dissertation committee chairperson's signature on the IRB proposal will be obtained before the proposal is submitted to the IRB.

All Point Park University students, faculty, and staff members who are conducting research involving human and non- human subjects as a part of their ongoing professional research endeavors, and such research is not being conducted as a component of their doctoral dissertation requirements, may submit research proposals directly to the IRB.

For staff members, the signatures of the individual overseeing the academic/administrative Department and the standing staff member of the IRB are required.

The primary investigator and the faculty advisor (Dissertation Chair) must attach a copy of the certificate received at the completion of the CITI Human Subjects training to the proposal. All students doing research with human subjects must complete this training.

Chairs of dissertation and thesis committee heads must attach their own certification of completion of the CITI training to the investigator’s proposal. These will be retained on file by the IRB Support Staff so that Chair copies are not required for future submissions.

Guidelines for the Continuing IRB Research Review

Research involving human and non-human subjects that spans more than one academic year shall be required to submit a continuation application to the Point Park University IRB. Such continuation applications are required for each academic year that a research program operates continuously;

The IRB chairperson may designate a primary IRB reviewer for all continuation applications. When used, the primary reviewer will conduct an in-depth analysis of the operations of the research program over the past year. The primary reviewer will play a lead role in reviewing the continuation application by the full IRB; Continuing research reviews will include:

a status update on the operation of the research proposal;
the number of human and non-human research participants to date;
a description of any modifications to the original proposal;
a summary of any problems encountered;
a summary of the number of research participants who discontinued their involvement or failed to participate to completion;
the projected completion date

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