TY - JOUR
T1 - The Ottawa Statement implementation guidance document for cluster randomized trials in the hemodialysis setting
AU - Goldstein, Cory E.
AU - Taljaard, Monica
AU - Nicholls, Stuart G.
AU - Beaucage, Mary
AU - Brehaut, Jamie
AU - Cook, Charles L.
AU - Cote, Brenden B.
AU - Craig, Jonathan C.
AU - Dixon, Stephanie N.
AU - Du Toit, Jessica
AU - Du Val, Catherine C.S.
AU - Garg, Amit X.
AU - Grimshaw, Jeremy M.
AU - Kalatharan, Shasikara
AU - Kim, Scott Y.H.
AU - Kinsella, Austin
AU - Luyckx, Valerie
AU - Weijer, Charles
PY - 2024/5
Y1 - 2024/5
N2 - Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.
AB - Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.
KW - cluster randomized trial
KW - ethics guidance implementation
KW - in-center maintenance hemodialysis
KW - informed consent
KW - patient and public involvement
KW - research ethics committee
UR - http://www.scopus.com/inward/record.url?scp=85189755717&partnerID=8YFLogxK
U2 - 10.1016/j.kint.2024.03.001
DO - 10.1016/j.kint.2024.03.001
M3 - Article
C2 - 38642985
AN - SCOPUS:85189755717
SN - 0085-2538
VL - 105
SP - 898
EP - 911
JO - Kidney International
JF - Kidney International
IS - 5
ER -
