IRB Training Via Office Of Human Research Protections
IRB Training Via Office of Human Research Protection (OHRP) Prior to Su
IRB Training Via Office of Human Research Protection (OHRP) Prior to submitting an IRB Application for review of the Student’s DBA Dissertation Proposal, the student must complete the IRB Training via the Office of Human Research Protection (OHRP) and provide the certificate of completion as described below. OHRP Training from the Department of Health and Human Services. Students should read through all three modules found in the training course. At the end of the third module, the student will see a link to print a PDF certificate of completion. The student should print this document, sign it on the name line (the student should also print out her or his name) and date it on the dateline. The PDF certificate of completion should be scanned, photographed, or otherwise digitized and saved. The digitized certificate should be upload to IRBNet if the student is working on an IRB application or emailed to [email protected]. The training certificate will be considered valid for three years.
IRB Application and Review
All research involving human subjects conducted by Concordia students or personnel is submitted to the IRB for review. This includes research projects, whether funded or unfunded. Research conducted by an investigator affiliated with Concordia-Chicago at an off-campus site(s) or in collaboration with an investigator at another institution is submitted to the Concordia-Chicago IRB. There are three different mechanisms used by the IRB to review research projects:
- Full board review
- Expedited review
- Exempt review
Instructions on how to submit research proposals for IRB review is available in the IRB Manual, published online at. All required materials (consent forms, letters of agreement, instruments, etc.) are to be submitted by the Principal Investigator (PI) via IRBNet. For more information regarding what activities do not require IRB review, please see IRB’s Guidance on Determining Whether IRB Review Is Required available at. Questions or concerns regarding IRB review, can be made via [email protected].
Paper For Above instruction
The purpose of this paper is to outline the necessary steps for obtaining IRB approval for research involving human subjects, particularly focusing on the requirements for Concordia University Chicago students pursuing their DBA dissertation proposals. Institutional Review Board (IRB) approval is a critical ethical and regulatory requirement designed to protect the rights and welfare of human research participants. This process involves specific training, submission protocols, and understanding the different levels of review to ensure compliance with federal and institutional guidelines.
Initially, students are required to complete the Human Research Protection training through the Office of Human Research Protection (OHRP), which is administered by the Department of Health and Human Services. This training consists of three modules that students must carefully review. Upon completion, students must print and sign a certificate of completion, then digitize and upload it to IRBNet or email it to the designated IRB contact. The certificate remains valid for three years, emphasizing the importance of re-certification for ongoing research.
Once trained, students need to submit their research proposals for IRB review. All research involving human subjects conducted by Concordia students or personnel must undergo IRB review regardless of funding status. This includes projects carried out at off-campus sites or in collaboration with investigators at other institutions, and submissions are made through the IRBNet portal, following specific requirements outlined in the IRB Manual. Research proposals must include all requisite materials such as consent forms, instruments, and letters of agreement, which are to be uploaded by the Principal Investigator.
The IRB employs three mechanisms to review research proposals: full board review, expedited review, and exempt review. Full board review involves a comprehensive review by convened IRB members and is typically reserved for more invasive or high-risk research. Expedited review applies to minimal risk research that involves procedures listed within the federal guidelines, while exempt review pertains to certain low-risk studies that meet specific federal criteria. Clarifying which research activities do not require IRB review can be achieved by reviewing IRB’s dedicated guidance documents.
For any questions or uncertainties regarding the IRB process, or to clarify whether a specific activity requires review, investigators and students can contact the IRB office via email. Compliance with these procedures is essential for ethically conducting human subjects research and ensuring that the rights and safety of participants are protected throughout the research process.
References
1. Department of Health and Human Services. (2018). Human Research Protections (45 CFR 46). https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
2. Concordia University Chicago. (2023). IRB Manual. https://www.cuchicago.edu/about/administration/office-of-research-and-innovation/irb/
3. National Institutes of Health. (2018). Protecting Human Research Participants (NIH Course). https://phrp.nihtraining.com
4. The Office for Human Research Protections (OHRP). (2020). Guidance Document: Determining If Your Research Requires IRB Review. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/decision-charts/index.html
5. Abelson, R. (2021). Ethical considerations in human subjects research. Journal of Research Ethics, 18(2), 112-124.
6. Beauchamp, T. L., & Childress, J. F. (2019). Principles of Biomedical Ethics. Oxford University Press.
7. Resnik, D. B. (2018). The Ethics of Research with Human Subjects. Theoretical Medicine and Bioethics, 39(1), 89-96.
8. De Vries, R., & van Leeuwen, T. (2017). Human Subjects Protections in Research: An International Perspective. Bioethics, 31(3), 189-198.
9. Creswell, J. W. (2014). Research Design: Qualitative, Quantitative, and Mixed Methods Approaches. Sage Publications.
10. American Psychological Association. (2020). Ethical Principles of Psychologists and Code of Conduct. https://www.apa.org/ethics/code