Changes in IRB Regulations – Effective January 21, 2019

Published 1/17/19

The Office for Human Research Subject Protection (OHRP) have issued new federal regulations (known as the Final Rule) effective January 21, 2019. Below are highlights of changes that will impact UMaine researchers:

Changes to Informed Consent Regulations:

• Long informed consent documents for projects that are federally funded must begin with a concise and focused presentation of the key information that helps prospective participants understand why they might or might not want to participate in the research. This requirement is not applicable to consent documents that are relatively short.

Changes to Continuing Review Regulations:

• As part of the new regulations, annual continuing reviews are eliminated for all new expedited studies approved on or after January 21, 2019, unless the IRB determines that a continuing review should be required for a specific study.
• Full board studies will still need annual continuing review approval.

New exempt category – benign behavioral interventions

• The new regulations include changes to the exempt categories. In most cases, they have been expanded to include research that previously could not be exempt. The most notable change for researchers is that “benign behavioral interventions” will now be considered exempt.
• The former exempt category 3 was eliminated and replaced with a category granting exemption to studies involving only “benign behavioral interventions” with adult subjects. The data must be anonymous or non-sensitive, or have sufficient protections in place to ensure data security.
• Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection.
• Benign behavioral interventions are defined as: “brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.”

Examples that would fit under Category 3:

1. having subjects play an online game
2. having subjects solve puzzles under various noise conditions
3. playing economic games

• If a study involves deception, it can be exempt under category 3 if the participants are told during the recruitment/consent process that there is an element of deception in the study, and they agree to participate knowing this.