Upcoming Changes to Human Research Subjects Protections (effective 1/21/2019)

Changes to the federal human subjects protections regulations are due to take effect on January 21, 2019.  All studies (regardless of funded status or funding source) approved by the UNH Institutional Review Board (IRB) before this date will be grandfathered under the existing regulations.

The effect of changes in the regulations for new studies (regardless of funded status or funding source) approved by the IRB after January 21, 2019 is anticipated to be minor, and includes:

  1. New and revised Exempt review categories (see this chart for a comparison with the current categories).
  2. No annual continuing review requirement for studies approved at the Expedited review level except for certain studies (for example, those that involve children, physiological interventions, or novel methodologies).
  3. Required use of the UNH IRB’s informed consent document/letter template language.
  4. Closure of IRB approval for studies once data collection is complete and in data analysis, even if data are identifiable.

Note: In order to effectively manage IRB operations to accommodate this transition, the UNH IRB will process applications submitted on or after December 20, 2018 but will not grant approval until on or after January 22, 2019.

The change in regulations on January 21, 2019 and the grandfathering of studies approved by the IRB before this date means that researchers may experience different requirements for similar existing and new studies.  To help identify the regulatory schema under which a study was approved by the IRB, the IRB will start numbering studies approved under the forthcoming regulations at 8000.

The Department of Justice (DOJ) has not codified the new regulations, and thus any studies funded by DOJ and approved by the UNH IRB after January 21, 2019 will be reviewed under the pre-January 21, 2019 regulations.  Such studies will be identified with a “J” at the end of the number (for example, 8046J).

The IRB will add FAQs to the existing list as they are developed.  The IRB will also post revised documentation on its website, once finalized.

For more information, please contact Melissa McGee (603) 862-2005 or Julie Simpson (603) 862-2003 in Research Integrity Services.

View Human Subjects Knowledge Base

The Knowledge Base contains forms, instruction and training material, policies, guidance, tools, and other resources to support your research efforts by topic area.


CONTACT INFORMATION

Melissa McGee, Compliance Officer
Research Integrity Services
Service Building, Room 106B
51 College Road
Durham, NH 03824
Phone: (603) 862-2005
Email: melissa.mcgee@unh.edu

Julie Simpson, Director,
Research Integrity Services
Service Building Room 107
51 College Road
Durham, NH 03824
Phone: (603) 862-2003
Email: julie.simpson@unh.edu