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Research Guidelines

Human Subjects Review


DATE OF LAST REVIEW:

September 2009



PURPOSE

Specify steps necessary for processing proposals for the use of human subjects.



REVIEW

This OP will be reviewed by May 1 of each year by the COHS Research Committee with recommendations for revision presented to the Dean of the COHS.



POLICY

All COHS researchers planning to use human subjects in their research must follow the instructions described in TTU OP 74.09. The Assistant Dean for Research (ADR) is authorized to review, approve, and sign all COHS human subjects proposals prior to their submission to the Office of Research Services (ORS). Institutional Review Board (IRB) approval for human subjects is required for all such research whether it be funded, unfunded, or associated with a class project.



PROCEDURE

  1. A researcher who will be including human subjects in their research will complete the appropriate cover sheet and appropriate forms (found at the ORS website, then linking to Human Subjects, then TTU Human Subjects Forms). After completion, the IRB packet should be submitted to the Assistant Dean for Research (ADR) for review. The ADR will notify the PI of any changes if necessary. After the researcher has completed the necessary changes, the ADR will sign the proposal on behalf of the COHS and return the materials to the PI. The PI will then forward the materials to the IRB Coordinator, ORS, MS 1035.
  2. The IRB Coordinator will forward the proposal to a member of the TTU Committee for the Protection of Human Subjects. If the research involves minors or other special populations, at least two committee members will review the proposal. At the discretion of the reviewers, proposals may be referred to the entire Committee for the Protection of Human Subjects.
  3. Data collection may not begin until the proposal has been approved by the committee, and has been properly filed with the IRB Coordinator. The researcher will be informed in writing by the IRB Coordinator of this approval.
  4. If faculty members or staff members are unfamiliar with the IRB process, the ADR can assist by making arrangements for a personal consultation or identifying a speaker to make class presentations about the current regulations governing the use of human subjects.


FORMS USED

TTU OP 74.09

IRB forms available in PDF format on the ORS website and then linking to Human Subjects, and then TTU Human Subjects Forms.

Cover Sheet for Human Subjects Proposal

Claim for Exemption

Expedited Review Form

Information also is available at the same site about the proposal format and written consent forms.


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