The Ultimate Guide to IRB SDSU: Navigating Human Subjects ResearchThe Ultimate Guide to IRB SDSU: Navigating Human Subjects Research at San Diego State Universityat San Diego State University

Introduction

Conducting research that involves human participants requires rigorous ethical oversight, and at San Diego State University, this responsibility falls under the purview of the Institutional Review Board, commonly known as the IRB SDSU. Whether you are a faculty member launching a groundbreaking study, a graduate student preparing a dissertation, or an undergraduate embarking on a research project, understanding the IRB process is essential to ensuring your work complies with federal regulations, state laws, and university policies. The SDSU IRB serves as the guardian of human subject welfare, reviewing research proposals to ensure that participants’ rights are protected and that the research is conducted ethically and responsibly. This comprehensive guide will walk you through everything you need to know about the IRB SDSU, from understanding review categories to submitting your protocol and navigating the reliance process for multi-site studies. With the right knowledge and preparation, you can navigate the IRB system efficiently and focus on what truly matters—advancing knowledge while safeguarding the individuals who make your research possible.

Understanding the SDSU Institutional Review Board

The Institutional Review Board at San Diego State University operates as a vital component of the university’s Human Research Protection Program (HRPP), which falls under the jurisdiction of Research Support Services. The HRPP is a comprehensive university-wide program committed to advancing research while ensuring the safe and ethical conduct of all SDSU faculty, staff, and students engaged in human subjects research . The IRB itself is a committee comprised of faculty members, a student representative, and a community member, ensuring diverse perspectives in the ethical review process. This committee meets monthly to review research proposals involving human subjects, evaluating whether the rights and welfare of participants are adequately protected and whether the proposed research aligns with federal regulations, applicable state laws, and local policies . The SDSU IRB holds registration number IRB #00000576 and operates under Federalwide Assurance FWA #00003782, designations that formalize its commitment to compliance with the U.S. Department of Health and Human Services regulations outlined in 45 CFR 46, commonly known as the Common Rule . These designations are critical because they establish SDSU’s eligibility to receive federal funding for research involving human subjects and demonstrate institutional accountability to federal oversight bodies.

Types of IRB Review at SDSU

Understanding which review category applies to your research is the first critical step in the IRB submission process. The SDSU IRB evaluates research protocols through three primary pathways, each with distinct requirements and timelines. The first category is Exempt Review, which applies to research that poses minimal risk to participants and falls into specific categories defined by federal regulations under 45 CFR 46.104. Despite the term “exempt,” these studies still require IRB determination and do not exempt researchers from the obligation to protect participant welfare; however, they do not require full committee review and typically have no submission deadlines, allowing for more flexible submission timelines throughout the academic year . The second category is Expedited Review, designed for research that involves no greater than minimal risk but does not qualify for exempt status. These proposals are reviewed by a small number of IRB reviewers within the HRPP office rather than the full convened committee. Expedited reviews are appropriate for studies that fit into one of nine specific categories outlined in federal regulations, including collection of blood samples by noninvasive means, prospective collection of biological specimens, and research involving voice, video, or digital recordings . The third category, Full Committee Review, is required for research that presents greater than minimal risk to participants or involves vulnerable populations. These proposals are reviewed at convened IRB meetings, which typically occur monthly except during July and December, and require submission by specific deadline dates to be placed on the meeting agenda . Importantly, researchers should note that the majority of proposals submitted to the SDSU IRB qualify for either exempt or expedited review, meaning most studies can proceed without the lengthier full committee process .

The IRB Submission Process Step by Step

Navigating the IRB submission process at SDSU requires careful preparation and attention to detail, but understanding the steps involved can significantly streamline your experience. The process begins with ensuring all study personnel have completed the Collaborative Institutional Training Initiative (CITI) Human Subjects Research training, which is a mandatory prerequisite for IRB approval. This web-based training system provides comprehensive education in human subjects protection, offering both biomedical and social-behavioral modules tailored to different research contexts . Investigators are required to renew their training every three years to maintain active status, and all study team members listed on an IRB protocol must have current certification before the IRB will approve a study . Once training is completed, researchers must develop their research plan, consent forms, and supporting documents such as recruitment flyers, emails, scripts, and questionnaires or surveys. The SDSU HRPP office provides consent and assent form templates to guide researchers through the documentation requirements . The actual submission occurs through iRIS, SDSU’s electronic submission platform, where researchers upload their complete protocol package. First-time users with an SDSU email address do not need to request a new account, as access is automatically granted through university credentials . After submission, the IRB analyst verifies CITI training for all personnel and begins the review process, which may result in the proposal being approved, returned for corrections, or requiring additional clarification . Most submissions will be returned for corrections at some point, and researchers should expect this as a normal part of the process, addressing the analyst’s stipulations promptly to move their proposal toward approval.

Navigating IRB Reliance for Multi-Site Studies

For researchers engaged in collaborative or multi-site studies, understanding the IRB review-reliance process is essential to avoid delays and ensure compliance. IRB review reliance is an arrangement where one Institutional Review Board reviews a research study for multiple institutions or sites, eliminating the need for each participating institution to conduct its own separate review . The reviewing IRB handles the ethical review and oversight for all sites involved, while relying institutions cede their review authority to the designated reviewing IRB. At SDSU, reliance agreements are documented using the SMART IRB platform or the Letter of Acknowledgment (LOA), a formal document that institutionalizes the review-reliance arrangement . It is critical to note that SDSU only enters into review-reliance agreements for non-exempt human subjects research, meaning studies that require expedited or full committee review. If the IRB determines that a study meets exempt criteria, no reliance agreement is needed . For students in the Joint Doctoral Program (JDP) with UC San Diego, the process is particularly important. The reviewing IRB is determined by the primary institutional affiliation of the faculty mentor responsible for oversight of the proposed research, and the review-reliance arrangement is formalized through the SMART LOA submitted with the IRB package . Students should be aware that under the UC San Diego system, students are no longer permitted to serve as Principal Investigators; however, they may submit the IRB application on behalf of the PI, who must be a UCSD employee . Failure to follow the proper reliance procedures can result in significant delays to IRB approval, so coordination with collaborating institutions from the earliest stages of project planning is strongly encouraged.

Recent Updates and Policy Developments

The SDSU IRB continually evolves to address emerging research challenges and regulatory requirements, making it essential for researchers to stay informed about recent policy developments. One of the most significant recent updates is the January 2026 guidance document on the Use of Artificial Intelligence (AI) in Human Subjects Research, which outlines important requirements for researchers who incorporate AI tools at any stage of study design, data analysis, or document preparation . This guidance addresses critical areas including data privacy and security, algorithmic bias, and informed consent. Researchers are now required to specify the purpose of AI use, detail the specific tools and platforms employed (using SDSU-licensed versions of tools like ChatGPT, CoPilot, or Gemini), describe steps taken to minimize algorithmic bias, and explain how human oversight will be incorporated. These requirements must be addressed in the IRB application through an updated iRIS system that now captures the scope and nature of AI and machine learning use in research . Additionally, the April 2025 Recruitment Material Policy provides clear guidance on the required content, presentation standards, and review procedures for recruitment advertisements such as flyers, social media posts, and other public communications . The policy aims to ensure that recruitment materials accurately and ethically inform prospective research participants while aligning with the approved research protocol. Another important update concerns the injury paragraph in informed consent forms. According to SDSU IRB guidelines, this paragraph is required only for studies deemed greater than minimal risk, as well as specific categories under exempt and expedited reviews, clarifying when researchers must inform participants about what happens in the unlikely event of injury during the study . These updates reflect the IRB’s commitment to maintaining robust protections while adapting to evolving research methodologies.

Training and Educational Resources

The SDSU HRPP office places significant emphasis on education and training, recognizing that well-informed researchers are better equipped to conduct ethical research. Beyond the required CITI training, the HRPP staff are available to meet with investigators one-on-one or speak to groups and classes regarding human subjects research, providing personalized guidance tailored to specific research contexts . For community health workers and promotoras engaged in human subjects research, the SDSU IRB accepts existing training programs such as BRIC, though these do not replace the CITI training requirement for SDSU faculty, staff, and students, who must still complete the CITI modules to comply with institutional and regulatory requirements . The HRPP maintains a comprehensive guidance page on its website, providing access to consent templates, policy documents, and step-by-step instructions for IRB submission . Researchers are also encouraged to familiarize themselves with the SDSU IRB Standards and Practices document, which details the policies and procedures based on regulations governing human subject research . This resource serves as a reference for IRB members, analysts, faculty, students, and others associated with the HRPP program. The HRPP office also offers in-person or virtual visits to classes, labs, and student organizations to educate researchers about various topics in compliance, including how to use human participants in research, determining appropriate review levels, and submitting applications through iRIS .

Conclusion

Navigating the IRB SDSU process is an essential responsibility for any researcher conducting human subjects research at San Diego State University, but with proper preparation and understanding, it need not be an intimidating experience. The institutional framework established through the Human Research Protection Program reflects SDSU’s deep commitment to protecting the rights and welfare of research participants while advancing scientific knowledge. By understanding the three primary review categories—exempt, expedited, and full committee review—researchers can appropriately classify their studies and plan their submission timelines accordingly. The submission process itself, while requiring careful attention to detail, follows a clear pathway from CITI training through iRIS submission to final approval, with the IRB staff available to provide guidance at every stage. For researchers engaged in collaborative or multi-site studies, the review-reliance process ensures efficient oversight without compromising ethical standards, particularly through the SMART IRB platform and the Joint Doctoral Program agreements with UC San Diego. The recent policy updates, particularly concerning artificial intelligence use in research and recruitment materials, demonstrate the IRB’s responsiveness to evolving research methodologies and emerging ethical considerations. Ultimately, the IRB review process serves not as an obstacle to research but as a vital safeguard that upholds the integrity of the scientific enterprise and the dignity of the individuals who participate in research. Researchers who approach the IRB process with thorough preparation, attention to regulatory requirements, and a genuine commitment to ethical conduct will find their proposals move through the system efficiently, allowing them to focus on their contributions to knowledge and human welfare.

Frequently Asked Questions (FAQ)

Q1: What is the SDSU IRB and what does it do?

The SDSU Institutional Review Board (IRB) is a committee comprised of faculty members, a student representative, and a community member that reviews research proposals involving human subjects . Its primary purpose is to protect the rights and welfare of research participants by ensuring that proposed research meets federal regulations, conforms to applicable state laws, and adheres to local university policies . The IRB operates as part of the Human Research Protection Program (HRPP) under Research Support Services at San Diego State University.

Q2: What are the different types of IRB review at SDSU?

The SDSU IRB conducts three types of review: Exempt Review, Expedited Review, and Full Committee Review . Exempt Review applies to minimal risk research that falls into specific federal categories, Expedited Review is for studies that involve no greater than minimal risk and fit into designated categories, and Full Committee Review is required for research involving greater than minimal risk or vulnerable populations that requires review by the full convened IRB committee .

Q3: How do I submit my research protocol to the SDSU IRB?

Researchers submit their protocols through iRIS, SDSU’s electronic submission platform . Before submitting, all study personnel must complete the required CITI Human Subjects Research training . The submission package should include the research plan, consent forms, recruitment materials, and supporting documents. First-time users with SDSU email addresses automatically have access to iRIS .

Q4: What is IRB review-reliance and when is it needed?

IRB review-reliance is an arrangement where one IRB reviews a research study for multiple institutions, eliminating the need for each site to conduct its own review . SDSU only enters into reliance agreements for non-exempt human subjects research (studies requiring expedited or full committee review). The arrangement is formalized through the SMART IRB platform or a Letter of Acknowledgment (LOA) .

Q5: Do I need IRB review for research that is not human subjects research?

No. Research that does not meet the federal definition of human subjects research does not require IRB review. Human subjects research is defined as research involving living individuals about whom investigators obtain information or biospecimens through intervention or interaction, or obtain, use, study, analyze, or generate identifiable private information or identifiable biospecimens . However, researchers uncertain about their project’s status should contact the IRB office for guidance.

Q6: What is the deadline for IRB submission?

There are no submission deadlines for studies qualifying for Exempt or Expedited review, as the IRB reviews these submissions on an ongoing basis throughout the academic year . However, studies requiring Full Committee Review must be submitted by specific deadlines to be placed on the monthly IRB meeting agenda. The IRB does not meet in July or December .

Q7: How do I get help with my IRB submission?

The SDSU HRPP staff are available to meet with investigators one-on-one or speak to groups regarding human subjects research. Researchers can contact the HRPP staff via email at irb@sdsu.edu . The HRPP website also provides extensive guidance documents, consent templates, and policy information . Additionally, the office can arrange in-person or virtual visits to classes, labs, or student organizations to provide education on IRB compliance .

Q8: What training is required before submitting an IRB protocol?

All personnel listed on an IRB protocol application must complete the Collaborative Institutional Training Initiative (CITI) Human Subjects Research training before the IRB will approve a study . Investigators must renew their training every three years . The CITI modules offer both biomedical and social-behavioral tracks tailored to different research methodologies .