Guidance & FAQs

IRB Guidance Documents
Collaborating with Researchers outside of CSU When a CSU human subjects research project will involve one or more institutions or individuals/businesses not associated with CSU, the regulations provide for a few mechanisms to facilitate that collaboration.
Consent Waiver Checklist Consent requirements for non-exempt, human subjects research are defined by the HHS regulations in the Revised Common Rule and include detail on the content and method of documentation. There are a few options when crafting your consent process that will fulfill both the consent and documentation requirements. This checklist will walk you through the options.
Compensating Participants If you will be providing your participants compensation or incentives, please review these guidance tips. IRB oversight of research compensation is to ensure that compensation paid to research subjects is fair and does not create undue pressure (coercion) for the volunteers to participate.
Deception Guidance Please review this guidance for additional information on the use of deception or incomplete disclosure in research and requirements to meet in such research practices.
Research that involves Deception There may be an occasion when, to answer a research question, a researcher may need to use an element of deception. By default, the IRB will review all protocols that involve an element of deception at a fully convened IRB meeting. Also note that Federal regulations prohibit the use of deceptive techniques that place participants at greater than minimal risk.
International Research If you will be conducting research abroad, please use this International Research Checklist
Internet Research Check out these tip sheets if you are planning to conduct research online. SACHRP Internet Research “Investigators and IRBs should remember that the Belmont Report’s fundamental principles of respect for persons, beneficence, and justice are as applicable to Internet research as they are to any other form of human subjects research. Regardless of how the regulations may be interpreted in individual studies, adherence to these fundamental principles is important to encouraging public trust in the ethical conduct of Internet research.”Online Survey GuidelinesPrivate Sites GuidelinesPublic Sites GuidelinesVirtual World Guidelines
Letters of Cooperation When sites are included in the study that are assisting in the research (e.g., providing mailing lists/names & addresses/handing out recruitment flyers to selected clients), documentation that this location understands the project and agrees to assist the Investigator must be received from each site.
Native American Research If you are planning to conduct research with a Native American Population, please plan to submit your protocol to the CSU IRB well in advance of when you wish to begin recruitment. Keep in mind that your protocol may need to be reviewed by both the CSU IRB and the Tribal IRB. Human Research Participant Protection
Research in the Public Schools School districts vary in their process to review research conducted in their schools and with their students. Contact the school well in advance to see what their process and timeline is to review proposed research and what type of research is allowed.
Student Researcher Getting ready to conduct a research project for your Master’s thesis or doctoral dissertation? Have you been assigned to do research for a class and would like the option to publish the results for research purposes later? Is your project “research” with “human subjects”? If so, review this tip sheet to know your responsibilities as a student researcher.
Who Can Be PI? Conducting research with humans is a privilege and carries with it ethical and legal responsibilities. The Principal Investigator (PI) is the individual responsible for writing an accurate proposal to utilize human subjects, and for designing practices and implementing the approved use(s) of those subjects. This tip sheet will help you establishing the personnel for your research.
Will your work include human specimens? Check out this quick guide to get started with obtaining the required regulatory approvals
IND Decision Tree IND Decision Tree Flow Chart If you are an investigator using a drug in research, you or the manufacturer of the drug may require an IND. This tool is based on FDA’s 21 CFR 312 requirements for an IND submission. For further inquiry, please contact the IRB Office.
Research Credit & Extra-Credit Policy Planning to offer research credit or extra-credit as part of your IRB protocol? Please refer to the IRB’s Policy on Research credits or offering extra-credit for projects that are subject to IRB review and approval.
Templates Consent, assent, and recruitment templates, along with tips and checklists to assist you in protocol creation.
Clinical Trials Instructions is a database of privately and publicly funded clinical studies conducted around the world. A clinical study involves research using human volunteers that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. includes both interventional and observational studies..
IRB COVID Vaccination Status or Negative Test Guidance If you plan to request COVID vaccination status or COVID test results as an inclusion criterion or to comply with a facility requirement, please review this guide on how the IRB will approach these requests.
Qualitative Data Repository QDR is an NSF-funded repository dedicated to curating, publishing, and preserving data generated through qualitative and multi-method research in the social sciences. Check out their website for an overview of qualitative data sharing as well as guidance on informed consent for data sharing.