Common Rule and Other Important Changes

The Federal Policy for the Protection of Human Subjects (the Common Rule) has been revised in order to reduce the overall burden placed on investigators and IRBs while preserving the protection of human subjects. The following programmatic changes are designed to phase in these new rules.  

The Department of Justice, the Department of Defense, and the FDA are not adopting the revised rules at this time.

 

self-determination for exemption - effective immediately

The IRB is piloting an online exemption self-determination program. Please complete the self-determination form if your study involves the survey or educational testing (cognitive, diagnostic, aptitude, achievement) of adult participants.    

 

Changes TO Continuing Review and approval intervals for some Level II studies - EFFECTIVE IMMEDIATELY

Some new level II/expedited projects will be approved for a three year interval and will require a three year check-in that resembles the current annual review process. When applicable, consent forms will be stamped with three year approval dates. 

IMPORTANT! If you have an open level II/expedited project you must submit an annual review or closeout form as specified in your current approval letter so the IRB can determine if your study is eligible for transfer to a three year approval interval and provide you with an updated approval letter and, if applicable, and updated consent form date stamp. A new annual review form has been posted to the forms page. 

If you are in receipt of a grant or contract that requires annual review, you are required to obtain IRB approval at least annually. Additionally, any longitudinal study extending beyond three years and any NIH funded clinical trial will require annual review. There may be other circumstances that require annual review. For example, an adverse event or unanticipated result may demonstrate the need for additional IRB oversight or a funder may require annual review. 

All level III/full board studies will continue to require review at least annually. 

Exempt/level I projects do not require continuing review, but it is important to report any project changes and adverse or unanticipated events - this is not a change!

Any study for which intervention and/or interaction are complete and data has been de-identified should be closed using the closure form.

 

OTHER Important Changes - Effective Immediately

  • CITI updates - please visit our training page to learn more about the transfer to single sign on and course selection. 
  • Research personnel management for level I studies - personnel changes to level I studies, other than change in PI or external personnel, no longer need to be reported to the IRB. The PI continues to be responsible for personnel and ensuring that all personnel are properly trained. Appendix A1, available on our forms page, must be used to document all Co-Is and key personnel and must be stored in the study records. There are no changes being made to personnel management processes for level II/III studies. 
  • NIH single IRB policy became effective in January 2018. This policy applies to all non-exempt, multi-site studies funded by NIH. 
  • The IRB will no longer be required to conduct a grant congruency review.  
  • The definition of clinical trial has been expanded.

 

new and expanded categories of exempt research - IN EFFECT 

Watch our webinar recording

The revised Common Rule is is fully effective. Please review our levels of review guidance document for a summary of levels under the revised Common Rule. This includes three new categories, revisions to four of the existing categories, elimination of one category and another unchanged. This means that some research that would be currently reviewed as level II research, will now be reviewed as exempt. This includes research involving benign behavioral interventions (category 3), some deception Additionally, the applicability of subparts b, c, and d has been clarified.     

Only research determined to be minimal risk and falls within one of the categories of exemption can be reviewed as exempt - this is not a change. Minimal risk is defined as "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."

  • Benign behavioral intervention is defined as an intervention that is brief in duration, harmless, painless, not physically invasive, not likely to have a significant impact on the subjects, and the investigator has no reason to think the subjects will find the intervention offensive or embarrassing. This includes studies that require the performance of a cognitive or behavioral task and sensory, emotional, and social environmental manipulations. Please view OHRP recommendations for more information.    
  • Deception can be reviewed as exempt, but only if the subject is prospectively informed that they will be deceived.  
  • Subparts b, c, and d:
    b (pregnant women, neonates and human fetuses) Projects involving this population can be exempt under any category.
    c (prisoners) Research involving this population can only be exempt if the research is aimed at a broader population that only incidentally includes prisoners.
    d (children) The new rule does not permit the inclusion of children in category 3 research and limits the inclusion of children in category 2 research to observation of public behavior. Children may be recruited to participate in all other exempt research.