Universidad Peruana Cayetano Heredia

A risk assessment tool for resumption of research activities during the COVID-19 pandemic for field trials in low resource settings

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dc.contributor.author Simkovich, S.M.
dc.contributor.author Thompson, L.M.
dc.contributor.author Clark, M.L.
dc.contributor.author Balakrishnan, K.
dc.contributor.author Bussalleu Cavero, Alejandra Estefania
dc.contributor.author Checkley, W.
dc.contributor.author Clasen, T.
dc.contributor.author Davila-Roman, V.G.
dc.contributor.author Diaz-Artiga, A.
dc.contributor.author Dusabimana, E.
dc.contributor.author Fuentes, L.L.
dc.contributor.author Harvey, S.
dc.contributor.author Kirby, M.A.
dc.contributor.author Lovvorn, A.
dc.contributor.author McCollum, E.D.
dc.contributor.author Mollinedo, E.E.
dc.contributor.author Peel, J.L.
dc.contributor.author Quinn, A.
dc.contributor.author Rosa, G.
dc.contributor.author Underhill, L.J.
dc.contributor.author Williams, K.N.
dc.contributor.author Young, B.N.
dc.contributor.author Rosenthal, J.
dc.contributor.author HAPIN Investigators
dc.date.accessioned 2021-05-18T21:44:14Z
dc.date.available 2021-05-18T21:44:14Z
dc.date.issued 2021
dc.identifier.uri https://hdl.handle.net/20.500.12866/9349
dc.description.abstract RATIONALE: The spread of severe acute respiratory syndrome coronavirus-2 has suspended many non-COVID-19 related research activities. Where restarting research activities is permitted, investigators need to evaluate the risks and benefits of resuming data collection and adapt procedures to minimize risk. OBJECTIVES: In the context of the multicountry Household Air Pollution Intervention (HAPIN) trial conducted in rural, low-resource settings, we developed a framework to assess the risk of each trial activity and to guide protective measures. Our goal is to maximize the integrity of reseach aims while minimizing infection risk based on the latest scientific understanding of the virus. METHODS: We drew on a combination of expert consultations, risk assessment frameworks, institutional guidance and literature to develop our framework. We then systematically graded clinical, behavioral, laboratory and field environmental health research activities in four countries for both adult and child subjects using this framework. National and local government recommendations provided the minimum safety guidelines for our work. RESULTS: Our framework assesses risk based on staff proximity to the participant, exposure time between staff and participants, and potential viral aerosolization while performing the activity. For each activity, one of four risk levels, from minimal to unacceptable, is assigned and guidance on protective measures is provided. Those activities that can potentially aerosolize the virus are deemed the highest risk. CONCLUSIONS: By applying a systematic, procedure-specific approach to risk assessment for each trial activity, we were able to protect our participants and research team and to uphold our ability to deliver on the research commitments we have made to our staff, participants, local communities, and funders. This framework can be tailored to other research studies conducted in similar settings during the current pandemic, as well as potential future outbreaks with similar transmission dynamics en_US
dc.language.iso eng
dc.publisher BioMed Central
dc.relation.ispartofseries BMC Medical Research Methodology
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject COVID-19 en_US
dc.subject SARS-CoV-2 en_US
dc.subject Research en_US
dc.subject Biosafety en_US
dc.subject Risk assessment en_US
dc.title A risk assessment tool for resumption of research activities during the COVID-19 pandemic for field trials in low resource settings en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1186/s12874-021-01232-x
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.03.09
dc.relation.issn 1471-2288


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