What are the Major Changes to the IRB under the Final Common Rule?

1. What are the Major Changes to the IRB under the Final Common Rule? Prepared by Susan Brater, IRB Coordinator

2. Due to a delay at the federal level, the changes will not go into effect until January 21, 2019. First, when do the changes go into effect?

3. Studies approved prior to the implementation date will not be affected by the Final Common Rule changes. • They will continue to be governed by the pre-Final Common Rule regulations. What research studies are affected?

4. Some research that used to be considered “expedited” will now be considered “exempt” when the only risk is privacy or confidentiality and those risks are appropriately safeguarded. Some exempt research will require “limited review” by an IRB member and may take just as long in the review process as an expedited study. The exempt category has expanded.

5. The Office for Human Research Protections (OHRP) recognizes that privacy and confidentiality often are the main risk in minimal risk research. OHRP may soon release guidance for IRBs to use during the review of such research. It is possible that the Exempt category of review will be further expanded. Privacy and Confidentiality

6. The definition now includes: • “Information or biospecimens” obtained through intervention and interaction with individuals, or • “Identifiable private information or identifiable biospecimens.” The definition of Human Subjects has changed.

7. The following activities are deemed not to be research: • Certain journalistic, public health surveillance, and criminal justice or intelligence activities. The definition of Research has changed.

8. Information provided must facilitate a potential subject’s understanding of why one would participate in research. There are new Consent Templates to assist you in developing your consent forms. Consent forms must be clearer and more focused.

9. Previously, a study was required to remain active if the investigator was still analyzing identifiable data. Under the Final Rule, a study may be closed once all subject enrollment and data collection is complete. If the investigator only has to complete an analysis of data, whether identifiable or not, the study may be closed. Renewals and Closures

10. Complete the online Drupal application and click submit. All review and communication with the IRB occurs electronically. The method for submitting an application has not changed.

11. Applications are submitted via Drupal. The Coordinator reviews the applications to make sure the primary required elements are included. If there are omissions, the Coordinator contacts the researcher. The Coordinator either reviews the application or sends it to the IRB reviewer for review and approval. The review process has not changed.

12. Once approved, the Coordinator sends an approval letter to the researcher via email. The Coordinator tracks all contacts, requests,renewals, modifications, etc. The process for receiving approval has not changed.

13. If you have any questions, please contact the IRB at irb@humboldt.edu or 826-5165. Questions?