Guidance & FAQs
Revised Human Subjects Regulations (Common Rule) Wednesday, June 20th 2018
The regulations that human subjects researchers must adhere to (referred to as the Common Rule Regulations) were established in 1991. In 2011, federal agencies began the long-awaited process to revise these regulations and, on January 18, 2017, the final revisions to the Common Rule (Final Rule) were posted in the federal register. The effective and implementation dates have recently changed. As posted in the federal register on June 18, 2018, the revised final Common Rule is both effective and to be implemented on January 21, 2019 with the option of implementing 3 burden-reducing provisions before January 21, 2019.
|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.
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.
|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.
If you will be conducting research abroad, please use this International Research Checklist
Check out these tip sheets if you are planning to conduct research online. SACHRP Internet Research
|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.
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|
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.