Changes to IRB Human Subjects Protections are on the Horizon

The human subjects protections landscape will be changing somewhat in the near future, although not drastically, due to new legislation and a long-awaited revision of the Common Rule.

On December 13, 2016, the 21st Century Cures Act became law; specifically, this legislation contains provisions affecting research involving human subjects as follows:

  • Strengthening protections of human subjects’ information considered identifiable and sensitive;
  • Promoting access, sharing, and using of health data for research;
  • Harmonizing regulations between the FDA and the Common Rule;
  • Introducing waivers or alterations of informed consent for some clinical research overseen by the FDA;
  • Facilitating single IRB review for investigational device studies; and,
  • Increasing the representation of women and minorities in clinical research.

On January 18, 2017, the US Department of Health & Human Services (DHHS) published in the Federal Register changes to the federal human subjects protections regulations (45 CFR 46), known as the Common Rule; 15 federal agencies in addition to DHHS operate under these regulations. According to the DHHS press release, the new Common Rule includes the following changes:

  • “The requirement for consent forms to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
  • Requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies.
  • For studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement.
  • The establishment of new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants protected under the HIPAA rules.
  • Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
  • Requirement that consent forms for certain federally funded clinical trials be posted on a public website.”

The deadline for compliance with most of the new provisions of the new Common Rule is January 19, 2018. View the HHS final rule.

Over the next year, the Augustana IRB will work towards compliance with the revised regulations and the new law. The IRB will communicate with the AU community as it progresses in its work, and as the federal government issues guidance.

For more information on the Augustana Institutional Review Board or institutional requirements regarding research involving human subjects, please contact the IRB at irb@augie.edu.