EDITORIAL  |   January 2020
Innovation in Clinical Research Regulation
Author Notes
  • From the Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina.
  • This editorial accompanies the articles on pp. 44 and 82.
    This editorial accompanies the articles on pp. 44 and 82.×
  • Accepted for publication September 9, 2019.
    Accepted for publication September 9, 2019.×
  • Address correspondence to Dr. Kharasch: evan.kharasch@duke.edu
Article Information
Editorial / Ethics / Medicolegal Issues / Quality Improvement
EDITORIAL   |   January 2020
Innovation in Clinical Research Regulation
Anesthesiology 1 2020, Vol.132, 1-4. doi:https://doi.org/10.1097/ALN.0000000000003026
Anesthesiology 1 2020, Vol.132, 1-4. doi:https://doi.org/10.1097/ALN.0000000000003026
Innovation in research encompasses new questions, drugs, devices, and protocols, but also new research methods and regulations. Whereas innovative new results receive most of the investigator and public attention, innovation in research regulation is critical to enabling and facilitating research conduct, and to reducing research cost, increasing efficiency, and ensuring the rights and protections of those patients and volunteers on which research depends, and for whose eventual benefit research is conducted.
This issue of Anesthesiology contains two articles that illustrate innovative and flexible approaches in research regulation.1,2  One article is an Original Investigation which reports a clinical study of two methods for assessment of patient frailty and their performance in predicting hospitalization and serious complications after surgery.1  The study was performed using a waiver of written informed consent of the research subjects, which was done with the approval of the hospital’s institutional review board. Investigators provided each patient, ahead of surgery, a patient information sheet with details of the study. Verbal consent for inclusion in the study was obtained by the anesthesia provider during the preoperative visit, and patients were given the opportunity to opt out if they desired to do so. A more traditional and expansive written informed consent document, signed by both patient and investigator, was not required. The second article is a Special Article that addresses the alteration or waiver of consent for minimal risk comparative effectiveness trials.2  It presents perspectives and approaches in three different countries. These two articles illustrate innovative and flexible approaches to clinical research and the consent and protections of human research participants.