Is My Project Research?
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. Learn more about the regulations.
Did you know that even if you consider your project research, it may not be considered “research” according to the code of federal regulations that CSU’s IRB adheres to? So – what is the definition of Research, and if your project isn’t considered “research,” what next?
A systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
What is Generalizable Knowledge?
Knowledge where the intended use of the research findings can be applied to populations or situations beyond the studied population. Do you plan to submit the findings from your research project to journals for publication? Will you be presenting your findings at professional meetings? If so, this is considered contributing to generalizable knowledge, and thus your project would need to be reviewed by the IRB.
Examples of Projects That Are Considered Research
- Asking a group of participants questions that would reveal their opinions and beliefs associated with a topic, and then submitting this data to a journal for publication.
- Project conducted to complete the requirements for a dissertation or thesis. The student’s first publication will be the finished dissertation or thesis placed in the CSU library. The results may be submitted to journals for publication and/or presented at professional meetings.
Examples of Projects That Are Not Considered Research §46.102
- Scholarly & journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the specific individuals about whom the information is collected;
- Public health surveillance activities, including the collection & testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority;
- Collection & analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes;
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
If your project is not considered Research, you do not need to submit any paperwork to the IRB.If you are not certain if your project qualifies as research or not, please complete the “Does My Project Require IRB Review” form and submit it to RICRO for review.