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Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance.

Publication ,  Journal Article
Corneli, A; Dombeck, CB; McKenna, K; Calvert, SB
Published in: Ethics Hum Res
May 2021

The revised Common Rule requires using a single institutional review board (sIRB) for U.S.-based, multisite, nonexempt, federally conducted or supported research with human participants. The 21st Century Cures Act directs the Department of Health and Human Services (HHS) to harmonize differences between HHS and the U.S. Food and Drug Administration (FDA) regulations governing research with humans. Anticipating that the FDA may update its 2006 centralized IRB guidance, we conducted interviews with 34 stakeholders engaged in FDA-regulated clinical research to identify benefits and challenges of using sIRBs and to gather recommendations for revising the FDA's guidance. The main benefits were consistency and standardization, speed and efficiency, and streamlining and simplification. The main challenges were uncertainty at local institutions, including addressing local context; decreased timeliness of the research review process; variable processes; and insufficient communication. Several recommendations for FDA guidance focused on the local context and communication plans. Findings suggest that the sIRB review process may be gaining efficiency although challenges remain.

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Published In

Ethics Hum Res

DOI

EISSN

2578-2363

Publication Date

May 2021

Volume

43

Issue

3

Start / End Page

26 / 36

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Uncertainty
  • Reference Standards
  • Humans
  • Ethics Committees, Research
  • Communication
 

Citation

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Corneli, A., Dombeck, C. B., McKenna, K., & Calvert, S. B. (2021). Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance. Ethics Hum Res, 43(3), 26–36. https://doi.org/10.1002/eahr.500092
Corneli, Amy, Carrie B. Dombeck, Kevin McKenna, and Sara B. Calvert. “Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance.Ethics Hum Res 43, no. 3 (May 2021): 26–36. https://doi.org/10.1002/eahr.500092.
Corneli A, Dombeck CB, McKenna K, Calvert SB. Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance. Ethics Hum Res. 2021 May;43(3):26–36.
Corneli, Amy, et al. “Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance.Ethics Hum Res, vol. 43, no. 3, May 2021, pp. 26–36. Pubmed, doi:10.1002/eahr.500092.
Corneli A, Dombeck CB, McKenna K, Calvert SB. Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance. Ethics Hum Res. 2021 May;43(3):26–36.

Published In

Ethics Hum Res

DOI

EISSN

2578-2363

Publication Date

May 2021

Volume

43

Issue

3

Start / End Page

26 / 36

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Uncertainty
  • Reference Standards
  • Humans
  • Ethics Committees, Research
  • Communication