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Via media: Role and responsibilities of the independent safety officer

  • M. E. B. Holbein (a1), Barbara N. Hammack (a2), Ann J. Melvin (a3) and Tamsin A. Knox (a4)

Abstract

Every research study that includes volunteer participants requires safety assurances in proportion to the risks of the study. Investigator-initiated clinical research can present unique regulatory challenges particularly for studies with a risk profile that warrants more oversight than minimal risk but less than for large, commercial, or high-risk research. The use of an independent safety officer (ISO) offers a middle way of right-sizing oversight to match the risk. ISOs are clinicians or researchers with relevant expertise who are independent of the investigator and the research study. Their relationship to the study is defined by a formal charter which is aligned with the protocol and Data and Safety Monitoring Plan to address the oversight process, responsibilities of the ISO, and clearly describe the variables to be monitored. The ISO responsibilities include reviewing safety data, adverse events, recruitment, demographics, study progress, data quality, protocol changes, and any new scientific information that pertains to the trial. Finally, the ISO reports in their review on any significant findings may propose modifications to the study or a need to stop the trial.

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Copyright

This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.

Corresponding author

Address for correspondence: Tamsin A. Knox, MD, MPH, Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Avenue, Boston, MA 02111, USA, 617-636-3558. Email: Tamsin.Knox@tufts.edu

References

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1. Federal Policy for the Protection of Human Subjects. Title 45, Part 46. Final rule. Federal Register. 2017; 82(12): 71497274.
2. Food and Drug Administration. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1). Guidance for Industry, 2018.
3. Ellenberg, SS, Fleming, TR, DeMets, DL. Data Monitoring in Committees in Clinical Trials: A Practical Perspective. Chichester, England: John Wiley & Sons, 2002.
4. National Institute of Mental Health. NIMH guidance on risk-based monitoring [Internet]. 2018. Retrieved from https://www.nimh.nih.gov/funding/clinical-research/nimh-guidance-on-risk-based-monitoring.shtml. Accessed March 15, 2018.
5. Holbein, MEB, et al. CTSA Collaborative DSMB Workgroup. DSMB Training Manual. Medford, MA, USA: Tufts Digital Library, 2018. Retrieved from https://www.tuftsctsi.org/research-services/regulatory/data-and-safety-monitoring-board-training-manual-for-investigator-initiated-studies/. Accessed March 15, 2019.
6. National Institute of Neurological Disorders and Stroke. NINDS guidelines for monitoring in clinical trials [Internet]. 2018. Retrieved from https://www.ninds.nih.gov/Funding/Apply-Funding/Application-Support-Library/NINDS-Guidelines-Data-and-Safety-Monitoring. Accessed February 22, 2019.
7. National Institute of Mental Health. Policy governing independent safety monitors and independent data and safety monitoring boards. 2015. Retrieved from https://www.nimh.nih.gov/funding/clinical-research/policy-governing-independent-safety-monitors-and-independent-data-and-safety-monitoring-boards.shtml. Accessed March 14, 2019.
8. Chimonas, S, et al. Managing conflicts of interest in clinical care: a national survey of policies at U.S. medical schools. Academic Medicine: Journal of the Association of American Medical Colleges 2011; 86(3): 293299.
9. Investigational New Drug Application. IND Safety Reporting. CFR 312.32(a). 2018.

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