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As you begin making your summer plans, don't forget to renew your expedited and full board studies that will expire over summer. You can go ahead and submit for a renewal in Cayuse IRB. The system will email you if any revisions are needed and after your renewal has been approved. Another option is to change the default for studies expiring from 30 to 60 or even 90 days. Depending on the option you choose, Cayuse IRB will send you a reminder email to renew your study based on your default setting. Click on the down arrow next to "Studies Expiring in ## days" to pick your default setting.
Fall Research Studies
At the beginning of the fall semester, the IRB will receive a high volume of IRB submissions. If you would like the research process (recruitment and data collection) to begin with the fall semester, make sure to submit your studies early. If you have any questions on your IRB development or when to submit, contact the HRPP office.
The Cayuse IRB Review Process
Researchers can track the review process of their submissions by looking at the Dashboard at the top of the Submission Details screen.
The green check mark indicates the requirements are complete for that review stage. The highlighted gray section shows where the submission is in the review process.
Cayuse IRB Test Site Available for Practice/Familiarization
The Sandbox UAT provides users a chance to practice or familiarize themselves with Cayuse IRB using a test site. The site allows test studies to be created providing practice before submitting a study through Cayuse IRB. Studies created in the Sandbox UAT are never processed.
To access the practice site, click on "Sandbox UAT" above. Enter session23 (lower case) as the user name and ttuttu as the password.
Cayuse IRB help files and "How To" Power Point presentations are also available to help guide you through the submission process.
Cayuse IRB Training Tutorials and PowerPoints
- Cayuse IRB: Basics
- Cayuse IRB: Creating a New Submission
- Adding Co-Investigators to Legacy Studies
- Modifications to Legacy Studies
- Cayuse IRB Help Tutorials
Request Training for your Group
Colleges, departments and organizations may request a Cayuse IRB training session for faculty, staff, and/or students. Please contact the HRPP office to schedule training at 806-742-2064 or email us at HRPP@ttu.edu.
Tip of the Month
Modifying Your Approved Study
Researchers can make changes to an approved study in Cayuse IRB by submitting a modification. Here are the steps to follow to create a Modification:
- From the Dashboard, click on the Approved Studies box and locate the study.
- In the Study Details screen, click on New Submission and then Modification.
- In the Submission Details screen, click on Edit.
- Provide a summary of proposed changes or additions.
- Make the changes to the appropriate section(s) and field(s). For example: to increase a population number, open the Human Subjects section and make the change.
- Attach any revised documents that are relevant to the requested changes, such as: revised surveys, additional recruitment messages, explanations of a different subject population.
- Save the changes and complete the submission.
If a study is expiring and a modification is needed, researchers will be required to submit the renewal first in its original format with the updated expiration date on the consent form. Once the renewal is approved, the modification can be submitted.
What does it mean to be a Research Principal Investigator at Texas Tech University?
The Office of Human Research Protections (HHS/OHRP, 2016)) describes the role and
responsibilities of a research investigator in the following way:
"Investigators play a crucial role in protecting the rights and welfare of human subjects and are responsible for carrying out sound ethical research consistent with research plans approved by an IRB. Along with meeting the specific requirements of a particular research study, investigators are responsible for ongoing requirements in the conduct of approved research that include, in summary:
- obtaining and documenting informed consent of subjects or subjects' legally authorized representatives prior to the subjects' participation in the research, unless these requirements have been waived by the IRB (45 CFR 46.116; 45 CFR 46.117);
- obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document, except those necessary to eliminate apparent immediate hazards to subjects (45 CFR 46.103(b)(4)) ; and
- ensuring that progress reports and requests for continuing review and approval are
submitted to the IRB in accordance with the policies, procedures, and actions of the
IRB as referenced in the institution's OHRP-approved Federalwide assurance (45 CFR
46.103(b)(4), 45 CFR 46.109(e), 45 CFR 46.115(a)(1)) . In certain circumstances, investigators
also would be responsible for meeting the following additional regulatory requirements:
- providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others 45 CFR 46.103(b)(5);
- providing to the IRB prompt reports of serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB (45 CFR 46.103(b)(5)); and
- keeping certain records as required by the HHS regulations for at least three years after completion of the study."
TTU Policy 74.09 (5) outlines the criteria for those researchers who are eligible
to assume the responsibilities as a Principal Investigator (PI) over a research study.
The Principal Investigator must be:
• a full time faculty member; or
• a tenured faculty member; or
• a full time employee with a terminal degree in his/her discipline.
Human Research Protection Program
Administration Building, Room 357
Box 41075 | MS 1075
Lubbock, TX 79409-1075
(806) 742-2064 Office| (806) 742-3947 Fax
August IRB Meeting
Aug. 29, 2016 (Tentative) 3 p.m.
Full Board submissions due by Aug. 8
June HRPP/IRB Stats:
- 141 Reviews Assigned
- 34 Initial Submissions
- 102 Proposals Approved
Leaving for Summer Break?
From the Dashboard under 'Studies Expiring' Cayuse IRB users can set the view to see those studies due to expire anywhere from 30, 60 or 90 days out.