IRB Guidance Documents

IRB Guidance Documents
Deception Guidance Please review this guidance for additional information on the use of deception or incomplete disclosure in research and the 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 encourage public trust in the ethical conduct of Internet research. Online Survey Guidelines || Private Sites Guidelines || Public Sites Guidelines || Virtual World Guidelines
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
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.
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.
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.