title: Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review.
abstract: Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants-yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28%) had no identifiable data collected from any research participants. Overall, only three trials (9%) indicated that a waiver of consent had been granted by a research ethics committee. When considering the combined requirement of research ethics review and informed consent (or a waiver), only one in three studies were compliant. Conclusion The ethical conduct and reporting of key ethical protections in stepped wedge trials, namely, research ethics review and informed consent, are inadequate. We recommend that stepped wedge trials be classified as research and reviewed and approved by a research ethics committee. We also recommend that researchers appropriately identify research participants (which may include health professionals), seek informed consent or appeal to an ethics committee for a waiver of consent, and include explicit details of research ethics approval and informed consent in the trial report.
authors.affiliation: 1 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.|2 School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, ON, Canada.
authors.forename: Monica
authors.initials: M
authors.lastname: Taljaard
authors.affiliation: 3 Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Karla
authors.initials: K
authors.lastname: Hemming
authors.affiliation: 4 Department of Epidemiology, Biostatistics and Occupational Health, Faculty of Medicine, McGill University, Montreal, QC, Canada.
authors.forename: Lena
authors.initials: L
authors.lastname: Shah
authors.affiliation: 5 INSERM Unit U1246, SPHERE and Université de Tours, Université de Nantes, Tours, France.|6 INSERM CIC 1415, CHRU de Tours, Tours, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Giraudeau
authors.affiliation: 1 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.|7 Department of Medicine, University of Ottawa, Ottawa, ON, Canada.|8 Center for Practice-Changing Research, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
authors.forename: Jeremy M
authors.initials: JM
authors.lastname: Grimshaw
authors.affiliation: 9 Rotman Institute of Philosophy, Western University, London, ON, Canada.|10 Department of Medicine, Western University, London, ON, Canada.|11 Department of Epidemiology and Biostatistics, Western University, London, ON, Canada.
authors.forename: Charles
authors.initials: C
authors.lastname: Weijer
mesh_terms: D003625:Data Collection / Q000592:standards*; D028744:Ethics Committees, Research / Q000706:statistics & numerical data*; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D012107:Research Design; D012108:Research Personnel / Q000592:standards*
keywords: Research ethics; cluster randomized trial; informed consent; research participant; stepped wedge; waiver of consent