Institutional Review Board

General Information

The IRB was established by SAGU in accordance with Federal Regulations ( 45 CFR 46 ) to review research conducted with human subjects by faculty, staff, students, and external researchers. The IRB was established to ensure the safety, privacy, and well-being of all human subjects throughout the research process.

Institutional Review Board Statement of Purpose – Mission Statement

The purpose of SAGU’s Institutional Review Board (IRB) is to aid researchers academically and professionally by ensuring they conduct research on human subjects in accordance with Christian principles, federal regulations, and the best practices of the academic and scientific communities.

The IRB Review Process

What is involved in the IRB review process?

Through both initial and periodic reviews of ongoing research, the IRB assures the University that appropriate steps are being taken to protect the rights and welfare of humans participating as subjects in research. The IRB typically uses a group process in which its members review a completed application for IRB approval and its related materials (e.g., informed consent documents), then reach a decision about the ethical acceptability of the proposed (or ongoing) study.

Will my proposed study be considered research with human subjects?

What is “research” as defined by the IRB?

• “Research” refers to a systematic investigationdesigned to develop or contribute to generalizable knowledge, including research development, testing, and evaluation. (Taken from Office for Human Research Protections )

What are “human subjects” as defined by the IRB?

• “Human subjects” are living individuals about whom an investigator obtains (1) data through intervention or interaction with the individuals, or (2) identifiable private information (IPI). (If the researcher collects IPI, the identity of the subjects is or may readily be ascertained by the investigator or associated with the information.) (Taken from Office for Human Research Protections )

Seeking IRB Approval

What are the steps required to obtain IRB approval of my research protocol?

Four key steps are involved when seeking IRB approval:

1. In the case of student researchers, secure approval of your proposed study by your research committee. (The approved proposal is a required addendum to the IRB application.)
2. Download and complete the SAGU IRB Approval Application.
3. Submit the application for review after attaching all requested documents. These include:
   • the research proposal approved by your research committee.
   • the certificate of completion for the Protecting Human Research Participants course
   • the Informed Consent documents.
4. Await IRB approval before collecting data from human subjects, including pilot testing.

Note: The decision to approve the research protocol will be communicated in writing (via e-mail) by the IRB Chairperson.

What is the timeline for the review?

For simple and straightforward studies, the proposal is reviewed by a committee of two to three individuals from the IRB, who have two weeks to read through the documents and send their recommendations to the IRB chair. A study involving a high-risk, vulnerable population may require a review by the entire IRB board. In these cases, allow for 6 to 8 weeks for the board to meet, discuss the proposal, and make recommendations.

Once the IRB approves your research protocol, you are free to engage in research with human subjects, under the supervision of your research advisor or supervisor.

You must inform the relevant IRB Chair immediately of:

problems encountered in the data-collection phase of your study.

substantive changes made to the research methodology.

What do I do if the IRB does not approve my research protocol?

If your application for IRB approval is not approved, you will be informed in writing (via e-mail) of that decision. Student researchers will be informed through their sponsoring faculty supervisors. Faculty, staff, and outside researchers will be informed directly in writing (via e-mail).

The email will explain why that decision was reached and the steps you can take to refine the study’s design to obtain IRB approval.

Note: you may not proceed with data collection without IRB approval of your protocol.

Instructions to Student Researchers

Following approval of their proposals by their supervisors, student researchers must apply to the IRB for approval to conduct research with human subjects. The IRB application consists of a description of the proposed research (i.e., the research protocol) to ensure that the methods proposed conform to ethical guidelines for research with human subjects. Student researchers are responsible for initiating this review process.

All researchers intending to conduct research on human subjects must complete the online short course entitled “ Protecting Human Research Subjects ”, offered by PHRP Online Training. The registration fee is $39.99. Student researchers are strongly encouraged to complete this certification prior to developing their research proposals involving human subjects. A copy of the course completion certificate must be included with each research protocol application submitted to the IRB.

Frequently Asked Questions

Regarding Research Conducted by Faculty and Staff

If my research was approved by another IRB board at a different institution, do I still need approval from the IRB at SAGU?

The short answer is yes. Follow the steps listed below and refer back to the Section above on Seeking IRB Approval for additional information.

1. Download and complete the SAGU IRB Approval Application.
2. Submit the application for review after attaching all requested documents. These include:
   • the research proposal approved by the IRB of the institution sponsoring your research.
   • the certificate of completion for the Protecting Human Research Participants course
   • the Informed Consent documents.
3. Await IRB approval before collecting data from human subjects, including pilot testing.

Regarding Research Conducted by Individuals from Outside the University

As you might imagine, we receive numerous requests throughout the school year to use our students as subjects for important research such as yours. Given our small student body, we are only able to accommodate a few such requests from outside our university.

To assist us with the approval process, there are several steps you will need to go through. First, you must solicit a faculty, staff member, or administrator from SAGU to sponsor your research on campus. That person assumes responsibility for walking your research through the remaining steps needed to approve your project. Second, follow the steps outlined in the section above, Seeking IRB Approval. Once you’ve filled out the appropriate documents, your sponsor must review your research proposal before presenting it to the Chair of the IRB, who then requests permission from the Vice-President of Academic Affairs for you to collect data from our students. Once approval is obtained from the administration, our IRB must approve your proposal, even if you received approval from your IRB. Once our IRB approves your study, you may collect data from our students, faculty, and/or staff.

About the IRB

What is an IRB?

“A specifically constituted review body established or designated by an entity to protect the rights and welfare of human subjects recruited to participate in biomedical, behavioral or social science research.” (Mayo Clinic: http://www.mayo.edu/research/institutional-review-board/definition-terms )

“An IRB is an appropriately constituted group that has been formally designated to review and monitor research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in proteccting the rights and welfare of human research subjects…The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.”
(FDA: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm )

As indicated in the quotations above, an Institutional Review Board protects the rights and welfare of human research subjects. It does this by:

• Reviewing the research proposals of faculty and student researchers (and other researchers seeking approval to conduct research at the university);
• Monitoring the ongoing research efforts by all researchers who receive initial approval to conduct research with human subjects.
• Promoting in various contexts the practice of ethical research.

Why did SAGU establish an IRB?

The IRB at SAGU was established to ensure and promote the best research practice with human subjects as a category V university offering advanced degrees requiring research. A primary advantage of establishing the IRB was the facilitation of grant writing for doctoral research in the fields of mental health and education, and for federally funded or approved research projects.

What is the role of IRB members?

Federal regulations require that each IRB Committee be comprised of at least five members who vary in gender, educational backgrounds, and professional expertise such that they are able to provide a complete and thorough review of research activities commonly conducted by the Institution.

Each IRB committee includes at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in non-scientific areas. Further, each IRB committee includes at least one member who is not otherwise affiliated with the University.

The IRB members at SAGU fall into three distinct categories: a leadership team comprised of the Chair, Chair-Elect, and Past Chair, the University-affiliated members, and the non-affiliated members.

If my research committee approves my proposal, why is IRB approval needed?

Your research committee evaluates your research proposal with a focus on the study’s research design, principally focusing on its relevance to the body of knowledge and its credibility as judged by empirical literature. Your committee members will require you to address research ethics in your research proposal; , typically, However, they do not have advanced training in understanding and applying federally mandated research requirements and guidelines.

What is the relationship between my supervisor/advisor and the IRB?

Your supervisor or advisor is approved by the university as either a faculty member, research supervisor, or research sponsor. All but two members of the IRB are colleagues at the University.

Should your supervisor/advisor/sponsor also be a member of the IRB, that person will recuse himself or herself from the IRB’s deliberations.

Additional FAQs (PDF)

IRB Committee

Contact Person:
Terance Espinoza, Ph.D.
IRB Chair
[email protected]

Committee Members:

• Shelly Zaldivar, Ph.D. – Chair Elect
• John Savell, Ph.D. – Past Chair
• Bruce Rosdahl, Ph.D. – Dean of the Harrison Graduate School
• Shelly McMullen, Ph.D. – Director of Institutional Research
• Sherry Jones, Ed.D. – Administrative Dean – SAGU AIC
• Tony Gryskiswicz, Ph.D. – Professor
• Marcus Alexander, PhD (community representative)
• Elizabeth Ortiz, PhD (community representative)