Research studies that qualify for one or more of the exempt categories defined by the federal regulations will be issued an exempt determination, rather than IRB approval. Exempt studies are exempt from the full criteria for approval defined in the federal regulations. However, exempt studies are not exempt from state laws, institutional policies, or the requirements for ethical research.
What does the term 'Exempt' actually mean in human subjects research?
If your project receives an exempt determination, this means that the HRPP determined that your study qualifies for exemption under 45 CFR 46, the federal regulations that govern human subjects research. Exempt studies must be no greater than minimal risk and all activities must fit into one or more exempt categories.
Who does an exempt determination cover?
In most cases, an exempt determination will cover OSU research personnel and external collaborators whose institutions do not have an IRB. Those without an IRB will also need to submit a signed Individual Investigator Agreement (IIA) to allow the OSU exemption to cover their work. External collaborators whose institutions have an IRB must contact their own IRB or HRPP for obtaining appropriate guidance
What are the training requirements for exempt studies?
All study personnel engaging in human subjects research activities are required to complete the Human Subjects Protection course (either Group 1 or Group 2) in CITI.
How long are exempt determinations valid?
The exempt determination is active for five years. If the study activities are completed prior to five years, then the study should be closed in Cayuse.
What are the informed consent requirements for exempt research?
Since there is no requirement for exempt studies to comply with the full set of consent elements required for IRB approval under federal regulations, researchers are free to use an appropriate consent process, as long as it is consistent with Belmont Report.
We have provided a template researchers may use for developing consent forms for exempt projects. You may also refer to our guidance on consent but note this guidance was created for non-exempt research, and not all of it will apply to your exempt study.
The HRPP does not review consent forms when making exempt determinations, however you may be asked to describe some consent procedures within the Cayuse HE application as part of the review process.
What if I need to make changes to my exempt study?
Only certain types of changes to exempt studies require modifications. These are outlined in our guidance When to Submit Project Revisions. If a modification is required, you will need to wait until the HRPP issues a new determination prior to implementing the changes. Modifications could impact the level of review, in which case you may be asked to complete the full IRB application.
Do I need to submit a modification in Cayuse to add or remove personnel on my exempt study?
Any OSU personnel can be added without modifying the study in Cayuse HE as long as they complete the Human Subjects Protection course (either Group 1 or Group 2) in CITI prior to engaging in any research activities. The PI is responsible for ensuring study personnel complete CITI training. If you are adding personnel from outside of OSU please contact the HRPP for guidance.
What are the mandatory reporting obligations for exempt studies?
When conducting any study, even if exempt, researchers should be aware of two sets of reporting requirements:
- All OSU employees are considered Mandatory Reporters of child abuse and neglect, and are required to report any time they have reasonable cause to believe that a person with whom they’ve come in contact abused a child or suffered child abuse in the past, regardless of how much time has passed since the abuse.
- Most Oregon State University employees are also considered "responsible employees" and are obligated to report incidents of sexual misconduct or discrimination to the Office of Equal Opportunity and Access (“EOA”) when they become aware of or have reason to believe that a violation occurred.
What other approvals or permissions do I need?
If your study has been issued an exempt determination you may still need to seek additional approval or permission from other OSU and non-OSU authorities, including but not limited to the following. For example:
Letters of Support
The PI is responsible for acquiring letters of support from external sites of recruitment or research before the project activities begin. These do not need to be submitted to the HRPP unless requested. The PI is responsible for ensuring any terms and conditions described in these letters are met.
Tribal Permission
The PI is responsible for acquiring permission from the appropriate authorities to conduct research with Tribal populations. Tribal authorities may require that information regarding data ownership before and after the research be described in the consent form. The PI is responsible for ensuring that all terms and conditions from Tribal authorities are met.
Family Educational Rights and Privacy Act (FERPA)
If this project involves OSU educational records, the PI is responsible for contacting the Office of the Registrar to fulfill any additional requirements related to FERPA.
Conflict of Interest (COI)
If any study team member has a COI, they must file a disclosure with the COI Administrator. If a conflict management plan requires that participants are informed of the conflict, the PI is responsible for ensuring that such information is included in the consent form as applicable.
General Data Protection Regulation (GDPR)
Contact the OSU Data Protections Officer if you plan to collect data from research participants who reside or will be in EU or EEA countries at the time of data collection, as your data may be subject to the GDPR.
Data Security
If you indicated that your research data is level 2 data, and you will store study data in a cloud-based server not licensed by OSU, your data-security plan must be reviewed by the Information Security Office.