7MÊÓƵ

Students: If your Cayuse account says it is disabled, you must contact your faculty advisor. Students cannot request their own access to Cayuse.

Faculty/Staff: All requests for Cayuse access must come from a faculty or staff member and be sent from a 7MÊÓƵ email address.

The following information must be sent to rspa@lamar.edu

•  Name
• LEA Email Address
• Department
• Department P O Box
• Contact Phone Number

All investigators, co-investigators, and key personnel must complete human subjects training prior to submitting an IRB. 7MÊÓƵ uses CITI (Collaborative Institutional Training Initiative) for Basic Human Subjects Research (BHSR) training. Registration for courses is available through CITI

Electronic surveys used in conjunction with an IRB must use a secure survey platform. It is suggested electronic surveys at 7MÊÓƵ use Qualtrics.

Qualtrics is a survey platform managed by Lamar University Enterprise Services. For questions or issues with Qualtrics contact the Lamar IT Service Desk at servicedesk@lamar.edu or 409-880-2222

Any human subjects research conducted by 7MÊÓƵ (LU) faculty, staff, or students must be reviewed and approved by the LU Institutional Review Board (IRB) before the research begins. For full details view the Research Requiring IRB Review webpage.

Exempt Review - Research is no more than minimal risk to human subjects as determined by regulatory guidelines. May be granted by the IRB upon review of the application.

Expedited Review - Research only involves no more than a minimal risk to human subjects, including blood sampling in minimal amounts, review of records collected for non-research purposes, and survey research.

Full Board Review - Research involving greater than minimal risk, including studies with vulnerable populations or sensitive questions, as well as studies with the possibility of physical risk.

Various factors influence the length of time necessary to approve an IRB, including the quality of the application, current volume of applications submitted and under review, and the type of review. The approval process also depends on the type of IRB review submitted. Exempt and Expedited submissions are approved fairly quick but Full Board submissions take longer.

• Human Subjects training is not current
• Plan for protecting privacy of participants and maintaining confidentiality of their data is inadequate
• Consent documents lack required elements
• Missing or incomplete responses on IRB submission
• Information on submission or consent form is inconsistent
• Insufficient detail in description of procedures
• Misunderstanding of eligibility for exempt review

A third-party collector is an independent person who has no authority over students and assist with recruitment, consent, and data collection when needed to ensure students do not feel pressured to participate. If the third-party is only responsible for temporarily holding consent, they are not considered part of the project team.

To ensure IRB submissions are not delayed for approval, researchers are encouraged to review the IRB Submission Checklist to make certain all steps have been completed.

The s (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).

, the Code of Federal Regulations, provides guidance on the requirements for the protection of human research subjects.

OHRP provides a to aid those who need to decide if an activity is research involving human subjects that must be reviewed by an institutional review board (IRB).

The 7MÊÓƵ Policies and Procedures on the Use of Human Subjects in Research provides guidance on the protection of the rights, welfare, and wellbeing of human subjects in research.

A consent form is a written document that explains the research study to potential participants. The Informed Consent Template is a guide to assist researchers that all aspects of consent are properly conveyed to the study participants.

Approval by an off-site agency is required prior to a member of the 7MÊÓƵ research community conducting research at their site. The Off-Site Approval Template is a guide to assist researchers that all aspects of the approval letter are addressed.

If there are questions whether your project is human subject research, complete the Determination of Human Subjects Research form and email the completed copy to rspa@lamar.edu. The ORSPA will review the form and contact you upon the decision.