Reform of Clinical Research Regulations, Finally.

n engl j med 373;24 nejm.org december 10, 2015 2296 Another set of proposed changes aims to match the level of oversight to the level of risk the research poses to participants, by defining categories of research that are excluded from the Common Rule or are exempt from one or more of its requirements (e.g., IRB review). The excluded categories are activities that are deemed not to meet the rule’s definition of research (such as public health surveillance and some quality-assurance activities), to be very low-risk social science research (such as surveys, focus groups, and interviews), or to be subject to other rules with appropriate requirements (such as research involving medical records and Medicare claims data that is subject to the privacy rule of the Health Insurance Portability and Accountability Act). Determinations of whether specific research proposals are exempt from the rule can be made with a Web-based decision tool. For example, one category of research that will be exempt from nearly all requirements includes certain types of studies involving standard educational practices, public program evaluations, or benign interventions (such as interactions that are temporary and painless with no lasting negative effects). Another category includes certain uses of sensitive information from which individuals are identifiable, if proper privacy and security safeguards are in place. Establishment of biospecimen and data repositories will be exempted from full IRB review if initial broad consent has been obtained, safeguards are in place, and to ensure that both these requirements are met, a limited IRB review is conducted. Secondary research using these repositories will be required only to have safeguards in place, and no IRB review will be necessary. These long-overdue reforms will bring the Common Rule into the 21st century. They should help the scientific community take a giant leap forward in showing respect for research participants, without whom the biomedical research enterprise would cease to exist. Just as the Lacks family’s experience helped clarify how research needed to change, the perspectives of researchers, the public, and patients should be heard as these reforms are finalized. The NIH urges all stakeholders to closely review the proposed changes and participate in the comment process by the deadline of December 7, 2015. Editor’s note: HHS has extended the comment period by 30 days, to January 6, 2016.