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[Preprint]. 2023 Jun 14:2023.06.12.23291231.

doi: 10.1101/2023.06.12.23291231.

Structured Ethical Review for Wastewater-Based Testing

Devin A Bowes^{1

2}, Amanda Darling³, Erin M Driver¹, Devrim Kaya^{4

5}, Rasha Maal-Bared⁶, Lisa M Lee⁷, Kenneth Goodman⁸, Sangeet Adhikari¹, Srijan Aggarwal⁹, Aaron Bivins¹⁰, Zuzana Bohrerova¹¹, Alasdair Cohen^{3

12}, Claire Duvallet¹³, Rasha A Elnimeiry¹⁴, Justin M Hutchison¹⁵, Vikram Kapoor¹⁶, Ishi Keenum¹⁷, Fangqiong Ling¹⁸, Deborah Sills¹⁹, Ananda Tiwari^{20

21}, Peter Vikesland³, Ryan Ziels²², Cresten Mansfeldt^{23

24}

Affiliations

¹ Biodesign Center for Environmental Health Engineering, The Biodesign Institute, Arizona State University, 1001 S. McAllister Ave, Tempe, AZ, 85287.
² Center on Forced Displacement, Boston University, 111 Cummington Mall, Boston, MA, 02215.
³ Department of Civil and Environmental Engineering, Virginia Tech, 1145 Perry Street; 415 Durham Hall; Blacksburg, VA 24061.
⁴ School of Chemical, Biological, and Environmental Engineering, Oregon State University, 105 26th St, Corvallis, Oregon 97331.
⁵ School of Public Health, San Diego State University, San Diego and Imperial Valley, CA.
⁶ Quality Assurance and Environment, EPCOR Water Services Inc., EPCOR Tower, 2000-10423 101 Street NW, Edmonton, Alberta, CA.
⁷ Department of Population Health Sciences and Division of Scholarly Integrity and Research Compliance, Virginia Tech, 300 Turner St. NW, Suite 4120 (0497), Blacksburg, VA 24061.
⁸ Institute for Bioethics and Health Policy, Miller School of Medicine, University of Miami, Miami, Florida.
⁹ Department of Civil, Geological, and Environmental Engineering, University of Alaska Fairbanks, 1764 Tanana Loop, Fairbanks, AK 99775.
¹⁰ Department of Civil & Environmental Engineering, Louisiana State University, 3255 Patrick F. Taylor Hall, Baton Rouge, LA 70803.
¹¹ The Ohio State University, Department of Civil, Environmental and Geodetic Engineering, 2070 Neil Avenue, 470 Hitchcock Hall, Columbus, OH 43210.
¹² Department of Population Health Sciences, Virginia Tech, 205 Duck Pond Drive, Blacksburg, VA 24061.
¹³ Biobot Analytics, Inc., 501 Massachusetts Avenue; Cambridge, MA; 02139.
¹⁴ Public Health Outbreak Coordination, Informatics, Surveillance (PHOCIS) Office - Surveillance Section, Division of Disease Control and Health Statistics, Washington State Department of Health, 111 Israel Rd SE, Tumwater, WA 98501.
¹⁵ Department of Civil, Environmental, and Architectural Engineering, University of Kansas, 1530 W 15th St, Lawrence, KS 66045.
¹⁶ School of Civil & Environmental Engineering, and Construction Management, University of Texas at San Antonio, 1 UTSA Circle, San Antonio, TX 78249.
¹⁷ Complex Microbial Systems Group, National Institute of Standards and Technology, 100 Bureau Dr, Gaithersburg, MD 20899.
¹⁸ Department of Energy, Environmental and Chemical Engineering, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130.
¹⁹ Department of Civil and Environmental Engineering, Bucknell University, Lewisburg, PA, 17837.
²⁰ Department of Food Hygiene and Environmental Health, Faculty of Veterinary Medicine, University of Helsinki, Agnes Sjöberginkatu 2 P.O. Box 66 FI 00014 Helsinki, Finland.
²¹ Expert Microbiology Unit, Finnish Institute for Health and Welfare, Kuopio, Finland.
²² Department of Civil Engineering, the University of British Columbia, 6250 Applied Science Ln #2002, Vancouver, BC V6T 1Z4.
²³ Department of Civil, Environmental, and Architectural Engineering, University of Colorado Boulder, UCB 428, Boulder, CO 80309.
²⁴ Environmental Engineering Program, University of Colorado Boulder, UCB 607, Boulder, CO 80309.

PMID: 37398480
PMCID: PMC10312843
DOI: 10.1101/2023.06.12.23291231

Structured Ethical Review for Wastewater-Based Testing

Devin A Bowes et al. medRxiv. 2023.

[Preprint]. 2023 Jun 14:2023.06.12.23291231.

doi: 10.1101/2023.06.12.23291231.

Authors

Affiliations

¹ Biodesign Center for Environmental Health Engineering, The Biodesign Institute, Arizona State University, 1001 S. McAllister Ave, Tempe, AZ, 85287.
² Center on Forced Displacement, Boston University, 111 Cummington Mall, Boston, MA, 02215.
³ Department of Civil and Environmental Engineering, Virginia Tech, 1145 Perry Street; 415 Durham Hall; Blacksburg, VA 24061.
⁴ School of Chemical, Biological, and Environmental Engineering, Oregon State University, 105 26th St, Corvallis, Oregon 97331.
⁵ School of Public Health, San Diego State University, San Diego and Imperial Valley, CA.
⁶ Quality Assurance and Environment, EPCOR Water Services Inc., EPCOR Tower, 2000-10423 101 Street NW, Edmonton, Alberta, CA.
⁷ Department of Population Health Sciences and Division of Scholarly Integrity and Research Compliance, Virginia Tech, 300 Turner St. NW, Suite 4120 (0497), Blacksburg, VA 24061.
⁸ Institute for Bioethics and Health Policy, Miller School of Medicine, University of Miami, Miami, Florida.
⁹ Department of Civil, Geological, and Environmental Engineering, University of Alaska Fairbanks, 1764 Tanana Loop, Fairbanks, AK 99775.
¹⁰ Department of Civil & Environmental Engineering, Louisiana State University, 3255 Patrick F. Taylor Hall, Baton Rouge, LA 70803.
¹¹ The Ohio State University, Department of Civil, Environmental and Geodetic Engineering, 2070 Neil Avenue, 470 Hitchcock Hall, Columbus, OH 43210.
¹² Department of Population Health Sciences, Virginia Tech, 205 Duck Pond Drive, Blacksburg, VA 24061.
¹³ Biobot Analytics, Inc., 501 Massachusetts Avenue; Cambridge, MA; 02139.
¹⁴ Public Health Outbreak Coordination, Informatics, Surveillance (PHOCIS) Office - Surveillance Section, Division of Disease Control and Health Statistics, Washington State Department of Health, 111 Israel Rd SE, Tumwater, WA 98501.
¹⁵ Department of Civil, Environmental, and Architectural Engineering, University of Kansas, 1530 W 15th St, Lawrence, KS 66045.
¹⁶ School of Civil & Environmental Engineering, and Construction Management, University of Texas at San Antonio, 1 UTSA Circle, San Antonio, TX 78249.
¹⁷ Complex Microbial Systems Group, National Institute of Standards and Technology, 100 Bureau Dr, Gaithersburg, MD 20899.
¹⁸ Department of Energy, Environmental and Chemical Engineering, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130.
¹⁹ Department of Civil and Environmental Engineering, Bucknell University, Lewisburg, PA, 17837.
²⁰ Department of Food Hygiene and Environmental Health, Faculty of Veterinary Medicine, University of Helsinki, Agnes Sjöberginkatu 2 P.O. Box 66 FI 00014 Helsinki, Finland.
²¹ Expert Microbiology Unit, Finnish Institute for Health and Welfare, Kuopio, Finland.
²² Department of Civil Engineering, the University of British Columbia, 6250 Applied Science Ln #2002, Vancouver, BC V6T 1Z4.
²³ Department of Civil, Environmental, and Architectural Engineering, University of Colorado Boulder, UCB 428, Boulder, CO 80309.
²⁴ Environmental Engineering Program, University of Colorado Boulder, UCB 607, Boulder, CO 80309.

PMID: 37398480
PMCID: PMC10312843
DOI: 10.1101/2023.06.12.23291231

Update in

Structured Ethical Review for Wastewater-Based Testing in Support of Public Health.
Bowes DA, Darling A, Driver EM, Kaya D, Maal-Bared R, Lee LM, Goodman K, Adhikari S, Aggarwal S, Bivins A, Bohrerova Z, Cohen A, Duvallet C, Elnimeiry RA, Hutchison JM, Kapoor V, Keenum I, Ling F, Sills D, Tiwari A, Vikesland P, Ziels R, Mansfeldt C. Bowes DA, et al. Environ Sci Technol. 2023 Sep 5;57(35):12969-12980. doi: 10.1021/acs.est.3c04529. Epub 2023 Aug 23. Environ Sci Technol. 2023. PMID: 37611169 Free PMC article.

Abstract

Wastewater-based testing (WBT) for SARS-CoV-2 has rapidly expanded over the past three years due to its ability to provide a comprehensive measurement of disease prevalence independent of clinical testing. The development and simultaneous application of the field blurred the boundary between measuring biomarkers for research activities and for pursuit of public health goals, both areas with well-established ethical frameworks. Currently, WBT practitioners do not employ a standardized ethical review process (or associated data management safeguards), introducing the potential for adverse outcomes for WBT professionals and community members. To address this deficiency, an interdisciplinary group developed a framework for a structured ethical review of WBT. The workshop employed a consensus approach to create this framework as a set of 11-questions derived from primarily public health guidance because of the common exemption of wastewater samples to human subject research considerations. This study retrospectively applied the set of questions to peer- reviewed published reports on SARS-CoV-2 monitoring campaigns covering the emergent phase of the pandemic from March 2020 to February 2022 (n=53). Overall, 43% of the responses to the questions were unable to be assessed because of lack of reported information. It is therefore hypothesized that a systematic framework would at a minimum improve the communication of key ethical considerations for the application of WBT. Consistent application of a standardized ethical review will also assist in developing an engaged practice of critically applying and updating approaches and techniques to reflect the concerns held by both those practicing and being monitored by WBT supported campaigns.

Synopsis: Development of a structured ethical review facilitates retrospective analysis of published studies and drafted scenarios in the context of wastewater-based testing.

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Figures

**Figure 1.**
The distribution of assigned flags (“minimal review required”, “review suggested”, “review strongly suggested”, “not available in the main text”, “not applicable”) for the top 11 categories in the structured ethical review, represented as a fraction percent of all publications analyzed (n=53) with multiple reviewers providing reports for select individual studies, resulting in more reviews than studies (n=79) ^,–,–. In total, 56 publications were represented by these studies, with 3 having two publications describing the same monitoring campaign and were considered in concert. The categories are sorted by ascending proportion of “minimal review required”.

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References

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This is a preprint.

Structured Ethical Review for Wastewater-Based Testing

Affiliations

Structured Ethical Review for Wastewater-Based Testing

Authors

Affiliations

Update in

Abstract

Figures

References

Publication types

Grants and funding

LinkOut - more resources

Full Text Sources

Miscellaneous