TY - JOUR
T1 - A risk assessment tool for resumption of research activities during the COVID-19 pandemic for field trials in low resource settings
AU - HAPIN investigators
AU - Simkovich, Suzanne M.
AU - Thompson, Lisa M.
AU - Clark, Maggie L.
AU - Balakrishnan, Kalpana
AU - Bussalleu, Alejandra
AU - Checkley, William
AU - Clasen, Thomas
AU - Davila-Roman, Victor G.
AU - Diaz-Artiga, Anaite
AU - Dusabimana, Ephrem
AU - Fuentes, Lisa de las
AU - Harvey, Steven
AU - Kirby, Miles A.
AU - Lovvorn, Amy
AU - McCollum, Eric D.
AU - Mollinedo, Erick E.
AU - Peel, Jennifer L.
AU - Quinn, Ashlinn
AU - Rosa, Ghislaine
AU - Underhill, Lindsay J.
AU - Williams, Kendra N.
AU - Young, Bonnie N.
AU - Rosenthal, Joshua
AU - Aravindalochanan, Vigneswari
AU - Barr, Dana Boyd
AU - Burrowes, Vanessa
AU - Campbell, Devan
AU - Campbell, Julia Mc Peek
AU - Canuz, Eduardo
AU - Castañaza, Adly
AU - Chang, Howard
AU - Chen, Yunyun
AU - Chiang, Marilú
AU - Craik, Rachel
AU - Crocker, Mary
AU - Dávila-Román, Victor
AU - De Léon, Oscar
AU - Diaz-Artiga, Anaité
AU - Elon, Lisa
AU - Espinoza, Juan Gabriel
AU - Fuentes, Irma Sayury Pineda
AU - Garg, Sarada
AU - Goodman, Dina
AU - Gupton, Savannah
AU - Hardison, Meghan
AU - Hartinger, Stella
AU - Harvey, Steven A.
AU - Hengstermann, Mayari
AU - Herrera, Phabiola
AU - Moulton, Lawrence
N1 - Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - 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. The trial is registered with clinicaltrials.gov NCT02944682 on October 26. 2016.
AB - 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. The trial is registered with clinicaltrials.gov NCT02944682 on October 26. 2016.
KW - Biosafety
KW - COVID-19
KW - Research
KW - Risk assessment
KW - SARS-CoV-2
UR - http://www.scopus.com/inward/record.url?scp=85104346553&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85104346553&partnerID=8YFLogxK
U2 - 10.1186/s12874-021-01232-x
DO - 10.1186/s12874-021-01232-x
M3 - Article
C2 - 33845785
AN - SCOPUS:85104346553
SN - 1471-2288
VL - 21
JO - BMC medical research methodology
JF - BMC medical research methodology
IS - 1
M1 - 68
ER -