Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

PREP-IT Investigators; Steering Committee; Adjudication Committee; Data and Safety Monitoring Committee; Research Methodology Core; Patient Centred Outcomes Core; Orthopaedic Surgery Core; Operating Room Core; Infectious Disease Core; Military Core; PREP-IT Clinical Sites; Aqueous-PREP and PREPARE; Aqueous-PREP; PREPARE

doi:10.1016/j.conctc.2021.100787

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

PREP-IT Investigators, Steering Committee, Adjudication Committee, Data and Safety Monitoring Committee, Research Methodology Core, Patient Centred Outcomes Core, Orthopaedic Surgery Core, Operating Room Core, Infectious Disease Core, Military Core, PREP-IT Clinical Sites, Aqueous-PREP and PREPARE, Aqueous-PREP, PREPARE

Orthopaedic and Plastic Surgery

Research output: Contribution to journal › Article › peer-review

Original language	English
Article number	100787
Journal	Contemporary Clinical Trials Communications
Volume	22
DOIs	https://doi.org/10.1016/j.conctc.2021.100787
State	Published - Jun 2021

ASJC Scopus Subject Areas

Pharmacology

Keywords

Cluster randomized crossover
Consent
Deferred consent
Patient advisors
Stakeholder engagement
Trial design

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10.1016/j.conctc.2021.100787

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PREP-IT Investigators, Steering Committee, Adjudication Committee, Data and Safety Monitoring Committee, Research Methodology Core, Patient Centred Outcomes Core, Orthopaedic Surgery Core, Operating Room Core, Infectious Disease Core, Military Core, PREP-IT Clinical Sites, Aqueous-PREP and PREPARE, Aqueous-PREP, & PREPARE (2021). Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials. Contemporary Clinical Trials Communications, 22, Article 100787. https://doi.org/10.1016/j.conctc.2021.100787

PREP-IT Investigators, Steering Committee, Adjudication Committee, Data and Safety Monitoring Committee, Research Methodology Core, Patient Centred Outcomes Core, Orthopaedic Surgery Core, Operating Room Core, Infectious Disease Core, Military Core, PREP-IT Clinical Sites, Aqueous-PREP and PREPARE, Aqueous-PREP & PREPARE 2021, 'Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials', Contemporary Clinical Trials Communications, vol. 22, 100787. https://doi.org/10.1016/j.conctc.2021.100787

PREP-IT Investigators, Steering Committee, Adjudication Committee, Data and Safety Monitoring Committee, Research Methodology Core, Patient Centred Outcomes Core et al. Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials. Contemporary Clinical Trials Communications. 2021 Jun;22:100787. doi: 10.1016/j.conctc.2021.100787

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title = "Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials",

keywords = "Cluster randomized crossover, Consent, Deferred consent, Patient advisors, Stakeholder engagement, Trial design",

author = "{PREP-IT Investigators} and {Steering Committee} and {Adjudication Committee} and {Data and Safety Monitoring Committee} and {Research Methodology Core} and {Patient Centred Outcomes Core} and {Orthopaedic Surgery Core} and {Operating Room Core} and {Infectious Disease Core} and {Military Core} and {PREP-IT Clinical Sites} and {Aqueous-PREP and PREPARE} and Aqueous-PREP and PREPARE and Guillermo Pechero and Branden Pfaff and Mayank Rao and David Pogorzelski and Paula McKay and Ella Spicer and Andrea Howe and Demyanovich, {Haley K.} and Sietsema, {Debra L.} and McTague, {Michael F.} and Lolita Ramsey and Martha Holden and Joshua Rudnicki and Jeff Wells and Michelle Medeiros and Slobogean, {Gerard P.} and Sheila Sprague and Jeffrey Wells and Mohit Bhandari and D'Alleyrand, {Jean Claude} and Harris, {Anthony D.} and Mullins, {Daniel C.} and Lehana Thabane and Amber Wood and {Della Rocca}, {Gregory J.} and Joan Hebden and Jeray, {Kyle J.} and Lucas Marchand and O'Hara, {Lyndsay M.} and Robert Zura and Gardner, {Michael J.} and Jenna Blasman and Jonah Davies and Stephen Liang and Monica Taljaard and Devereaux, {P. J.} and Guyatt, {Gordon H.} and Diane Heels-Ansdell and Debra Marvel and Jana Palmer and Jeff Friedrich and O'Hara, {Nathan N.} and Grissom, {Ms Frances} and Gitajn, {I. Leah} and Saam Morshed and O'Toole, {Robert V.} and Petrisor, {Bradley A.} and Michael Prayson and Brandon Horne and Jennifer Jerele",

note = "Publisher Copyright: {\textcopyright} 2021 The Authors",

year = "2021",

month = jun,

doi = "10.1016/j.conctc.2021.100787",

language = "English",

volume = "22",

journal = "Contemporary Clinical Trials Communications",

issn = "2451-8654",

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AU - Steering Committee

AU - Adjudication Committee

AU - Data and Safety Monitoring Committee

AU - Research Methodology Core

AU - Patient Centred Outcomes Core

AU - Orthopaedic Surgery Core

AU - Operating Room Core

AU - Infectious Disease Core

AU - Military Core

AU - PREP-IT Clinical Sites

AU - Aqueous-PREP and PREPARE

AU - Aqueous-PREP

AU - PREPARE

AU - Pechero, Guillermo

AU - Pfaff, Branden

AU - Rao, Mayank

AU - Pogorzelski, David

AU - McKay, Paula

AU - Spicer, Ella

AU - Howe, Andrea

AU - Demyanovich, Haley K.

AU - Sietsema, Debra L.

AU - McTague, Michael F.

AU - Ramsey, Lolita

AU - Holden, Martha

AU - Rudnicki, Joshua

AU - Wells, Jeff

AU - Medeiros, Michelle

AU - Slobogean, Gerard P.

AU - Sprague, Sheila

AU - Wells, Jeffrey

AU - Bhandari, Mohit

AU - D'Alleyrand, Jean Claude

AU - Harris, Anthony D.

AU - Mullins, Daniel C.

AU - Thabane, Lehana

AU - Wood, Amber

AU - Della Rocca, Gregory J.

AU - Hebden, Joan

AU - Jeray, Kyle J.

AU - Marchand, Lucas

AU - O'Hara, Lyndsay M.

AU - Zura, Robert

AU - Gardner, Michael J.

AU - Blasman, Jenna

AU - Davies, Jonah

AU - Liang, Stephen

AU - Taljaard, Monica

AU - Devereaux, P. J.

AU - Guyatt, Gordon H.

AU - Heels-Ansdell, Diane

AU - Marvel, Debra

AU - Palmer, Jana

AU - Friedrich, Jeff

AU - O'Hara, Nathan N.

AU - Grissom, Ms Frances

AU - Gitajn, I. Leah

AU - Morshed, Saam

AU - O'Toole, Robert V.

AU - Petrisor, Bradley A.

AU - Prayson, Michael

AU - Horne, Brandon

AU - Jerele, Jennifer

PY - 2021/6

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KW - Cluster randomized crossover

KW - Consent

KW - Deferred consent

KW - Patient advisors

KW - Stakeholder engagement

KW - Trial design

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VL - 22

JO - Contemporary Clinical Trials Communications

JF - Contemporary Clinical Trials Communications

M1 - 100787

ER -

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

ASJC Scopus Subject Areas

Keywords

Access to Document

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