Institutional Review Board
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The IRB review process takes time and research protocols are reviewed on a first-come, first-serve basis. The IRB's ability to conduct a timely review of your research is very dependent on the quality and clarity of your submission. Please plan accordingly and develop a clear and detailed research plan.
The Principal Investigator and members of the research team are required to complete the CITI Program training. See the CITI Training page for more information.
If the CITI training requirement is not complete for all research personnel involved with human subjects in your study, your application is deemed incomplete and cannot be processed for IRB review.
This includes any researcher who:
• obtains information about living individuals by intervening or interacting with them for research purposes;
• obtains identifiable private information about living individuals for research purposes;
• obtains the voluntary informed consent of individuals to be subjects in research; and/or
• is studying, interpreting, or analyzing identifiable private information or data for research purposes.
To submit materials for IRB review, the Principal Investigator must register with IRBNet, the online document management system used by the HSPP to receive and process IRB submissions and reviews. At MSU Denver, the Principal Investigator must be a member of the faculty or staff. Students may not register with IRBNet and any account created by a student will be deleted.
Detailed instructions on how to use IRBNet for project submissions is available on the IRBNet Training webpage.
Once you register with IRBNet, you can access the library for submission materials, including application forms and templates. These materials are also available on the Researcher Materials webpage. For any new project, the best place to start is the HRP-103: Investigator Manual. This manual will guide you on the requirements for submissions. For a new project, your submission packet is comprised of the HRP-211 FORM: Initial Review , your research protocol, and all relevant and requested supplements (informed consent forms, study instruments, recruitment materials, grant information, etc.).
Will you be conducting research at a school, public or private agency, or collaborating with an organization?
A letter of cooperation, authorization, or support to conduct research may be required. In many cases, the IRB needs documentation that the researchers have permission to conduct the study in a specific setting. These documents can sometimes take time to get, so plan ahead. Some organizations or institutions may also require their own ethics or IRB review process in addition to MSU Denver's IRB review and approval. Multiple review processes can occur concurrently in many cases.
Are you proposing to recruit students from MSU Denver classrooms or student organizations?
Classes or student groups that are targeted for recruitment must be directly relevant to the proposed research and not simply a matter of convenience for the investigators. In some studies, the IRB may request documentation of permission from the course instructor or faculty or staff advisor that he/she is aware of the study and what is being asked of the students. As there are specific considerations of potential coercion or undue influence with recruiting students into a study, researchers are advised to clearly outline the measures they are taking to minimize this risk in their submission materials.
Use of Listservs
The Institutional Review Board (IRB) is seeing an increase in the request to use specific listservs for recruitment of participants into a research study. The IRB is trained and responsible for assessing the risk to human subjects of all research proposals including research design, recruitment and consent processes, data management and confidentiality according to the three principles contained in the Belmont Report and the Code of Federal Regulations (45 CFR 46). https://www.hhs.gov/ohrp/. Upon review and approval of a research proposal that intends to use any internal or external listservs for recruitment, the IRB requests that the Principal Investigator (PI) obtains permission from the owner of the listerv, to encourage responsible use. This step ensures that the IRB carries out its charge and responsibilities to protect human subjects, and also decreases administrative burden on offices who are not trained in assessing the risk to human subjects of research per federal regulations. PIs will be instructed that it is their responsibility to request permission to use a listserv prior to recruitment. The decision to approve this request is up to the individual unit, office, department, etc. that controls the listserv. Approval to use a listserv to distribute recruitment information does not change the PIs responsibility to the protection of the rights and welfare of subjects in human research, including obtaining informed consent of individual subjects.
Many researcher questions will be answered in the Investigator Manual, by completing the required CITI training, and by reviewing the information on the IRBNet Training webpage. If you are unsure what information to include in your protocol, how to create a good consent form for your study, or need guidance on the submission process, please ask. The HSPP staff welcomes your questions and can provide assistance before and throughout the IRB review process!
Researchers (faculty, staff, and students) can make an appointment with HSPP staff to consult on their IRB application prior to submission or during the IRB review process. Please email the HSPP with questions or for a consultation (firstname.lastname@example.org). This is a great opportunity to learn about the requirements for IRB approval and will make subsequent applications to the IRB easier.
All requests for IRB review should be submitted through IRBNet.
Submissions will NOT be accepted through the HSPP email or any other method other than via IRBNet.
Submission materials should be complete and documents should be clearly titled. Instructions for submitting materials for IRB review can be found in the Investigator Manual and on the IRBNet Training page.
A note on HSPP application forms that require a "signature": There is no requirement to provide a hand-signed, scanned copy on any IRB submission materials. Your 'electronic' signature (typed name) is sufficient for all application materials in the submission process.