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

Author:

Pechero GuillermoORCID,Pfaff BrandenORCID,Rao Mayank,Pogorzelski David,McKay Paula,Spicer Ella,Howe AndreaORCID,Demyanovich Haley K.,Sietsema Debra L.ORCID,McTague Michael F.ORCID,Ramsey LolitaORCID,Holden Martha,Rudnicki JoshuaORCID,Wells JeffORCID,Medeiros MichelleORCID,Slobogean Gerard P.ORCID,Sprague SheilaORCID,Slobogean Gerard P.,Sprague Sheila,Wells Jeffrey,Bhandari Mohit,O'Toole Robert V.,D'Alleyrand Jean-Claude,Eglseder Andrew,Johnson Aaron,Langhammer Christopher,Lebrun Christopher,Manson Theodore,Nascone Jason,Paryavi Ebrahim,Pensy Raymond,Pollak Andrew,Sciadini Marcus,Slobogean Gerard P.,Degani Yasmin,Demyanovich Haley K.,Howe Andrea,O'Hara Nathan N.,Joseph Katherine,Rudnicki Joshua,Camara Megan,Slobogean Gerard P.,Bhandari Mohit,Sprague Sheila,D'Alleyrand Jean-Claude,Harris Anthony D.,Mullins Daniel C.,Thabane Lehana,Wells Jeffrey,Wood Amber,Della Rocca Gregory J.,Harris Anthony D.,Hebden Joan,Jeray Kyle J.,Marchand Lucas,O'Hara Lyndsay M.,Zura Robert,Gardner Michael J.,Blasman Jenna,Davies Jonah,Liang Stephen,Taljaard Monica,Devereaux P.J.,Guyatt Gordon H.,Thabane Lehana,Heels-Ansdell Diane,Marvel Debra,Palmer Jana,Wells Jeffrey,Friedrich Jeff,Mullins Daniel C.,O'Hara Nathan N.,Grissom Ms Frances,Della Rocca Gregory J.,Gitajn I. Leah,Jeray Kyle J.,Morshed Saam,O'Toole Robert V.,Petrisor Bradley A.,Camara Megan,Mossuto Franca,Harris Anthony D.,Joshi Manjari G.,D'Alleyrand Jean-Claude,Fowler Justin,Rivera Jessica,Talbot Max,Sprague Sheila,Bhandari Mohit,Dodds Shannon,Garibaldi Alisha,Li Silvia,Nguyen Uyen,Pogorzelski David,Rojas Alejandra,Scott Taryn,Del Fabbro Gina,Szasz Olivia Paige,Heels-Ansdell Diane,McKay Paula,Slobogean Gerard P.,O'Hara Nathan N.,Howe Andrea,Rudnicki Joshua,Demyanovich Haley,Little Kelly,Mullins C. Daniel,Medeiros Michelle,Kettering Eric,Hale Diamond,Petrisor Brad A.,Johal Herman,Ristevski Bill,Williams Dale,Denkers Matthew,Rajaratnam Krishan,Al-Asiri Jamal,Leonard Jordan,Marcano-Fernández Francesc A.,Gallant Jodi,Persico Federico,Gjorgjievski Marko,George Annie,Natoli Roman M.,Gaski Greg E.,McKinley Todd O.,Virkus Walter W.,Sorkin Anthony T.,Szatkowski Jan P.,Baele Joseph R.,Mullis Brian H.,Hill Lauren C.,Hudgins Andrea,Osborn Patrick,Fowler Justin,Pierrie Sarah,Martinez Eric,Kimmel Joseph,Jeray Kyle J.,Adams John D.,Beckish Michael L.,Bray Christopher C.,Brown Timothy R.,Cross Andrew W.,Dew Timothy,Faucher Gregory K.,Gurich Richard W.,Lazarus David E.,Millon S. John,Palmer M. Jason,Porter Scott E.,Schaller Thomas M.,Sridhar Michael S.,Sanders John L.,Rudisill L. Edwin,Garitty Michael J.,Poole Andrew S.,Sims Michael L.,Walker Clark M.,Carlisle Robert M.,Hofer Erin Adams,Huggins Brandon S.,Hunter Michael D.,Marshall William A.,Ray Shea Bielby,Smith Cory D.,Altman Kyle M.,Bedard Julia C.,Loeffler Markus F.,Pichiotino Erin R.,Cole Austin A.,Maltz Ethan J.,Parker Wesley,Ramsey T. Bennett,Burnikel Alex,Colello Michael,Stewart Russell,Wise Jeremy,Moody M. Christian,Tanner Stephanie L.,Snider Rebecca G.,Townsend Christine E.,Pham Kayla H.,Martin Abigail,Robertson Emily,Morshed Saam,Miclau Theodore,Kandemir Utku,Marmor Meir,Matityahu Amir,McClellan R. Trigg,Meinberg Eric,Shearer David,Toogood Paul,Ding Anthony,Donohoe Erin,Murali Jothi,Belaye Tigist,Berhaneselase Eleni,Paul Alexandra,Garg Kartik,Gary Joshua L.,Warner Stephen J.,Munz John W.,Choo Andrew M.,Achor Timothy S.,“Chip” Routt Milton L.,Rao Mayank,Pechero Guillermo,Miller Adam,Hagen Jennifer E.,Patrick Matthew,Vlasak Richard,Krupko Thomas,Sadasivan Kalia,Koenig Chris,Bailey Daniel,Wentworth Daniel,Van Chi,Schwartz Justin,Dehghan Niloofar,Jones Clifford B.,Tracy Watson J.,McKee Michael,Karim Ammar,Talerico Michael,Sietsema Debra L.,Williams Alyse,Dykes Tayler,Obremskey William T.,Jahangir Amir Alex,Sethi Manish,Boyce Robert,Stinner Daniel J.,Mitchell Phillip,Trochez Karen,Rodriguez Andres,Gajari Vamshi,Rodriguez Elsa,Pritchett Charles,Boulton Christina,Lowe Jason,Wild Jason,Ruth John T.,Taylor Michel,Seach Andrea,Saeed Sabina,Culbert Hunter,Cruz Alejandro,Knapp Thomas,Hurkett Colin,Lowney Maya,Prayson Michael,Venkatarayappa Indresh,Horne Brandon,Jerele Jennifer,Clark Linda,Marcano-Fernández Francesc,Jornet-Gibert Montsant,Martínez-Carreres Laia,Martí-Garín David,Serrano-Sanz Jorge,Sánchez-Fernández Joel,Sanz-Molero Matsuyama,Carballo Alejandro,Pelfort Xavier,Acerboni-Flores Francesc,Alavedra-Massana Anna,Anglada-Torres Neus,Berenguer Alexandre,Cámara-Cabrera Jaume,Caparros-García Ariadna,Fillat-Gomà Ferran,Fuentes-López Ruben,Garcia-Rodriguez Ramona,Gimeno-Calavia Nuria,Graells-Alonso Guillem,Martínez-Álvarez Marta,Martínez-Grau Patricia,Pellejero-García Raúl,Ràfols-Perramon Ona,Peñalver Juan Manuel,Domènech Mònica Salomó,Soler-Cano Albert,Velasco-Barrera Aldo,Yela-Verdú Christian,Bueno-Ruiz Mercedes,Sánchez-Palomino Estrella,Guerra-Farfan Ernesto,Tomas-Hernandez Jordi,Teixidor-Serra Jordi,Molero-Garcia Vicente,Selga-Marsa Jordi,Porcel-Vasquez Juan Antonio,Andres-Peiro Jose Vicente,Minguell-Monyart Joan,Garcia-Sanchez Yaiza,Nuñez-Camarena Jorge,Tauste-Rubio Eladia,Gonzalez-Amigo Marta,Romeo Nicholas M.,Vallier Heather A.,Breslin Mary A.,Fraifogl Joanne,Wilson Eleanor S.,Wadenpfuhl Leanne K.,Halliday Paul G.,Viskontas Darius G.,Apostle Kelly L.,Boyer Dory S.,Moola Farhad O.,Perey Bertrand H.,Stone Trevor B.,Lemke H. Michael,Zomar Mauri,Spicer Ella,Fan Chen “Brenda”,Payne Kyrsten,Phelps Kevin,Bosse Michael,Karunakar Madhav,Kempton Laurence,Sims Stephen,Hsu Joseph,Seymour Rachel,Churchill Christine,Bartel Claire,Mayberry Robert Miles,Brownrigg Maggie,Girardi Cara,Mayfield Ada,Hymes Robert A.,Schwartzbach Cary C.,Schulman Jeff E.,Malekzadeh A. Stephen,Holzman Michael A.,Ramsey Lolita,Ahn James S.,Panjshiri Farhanaz,Das Sharmistha,English Antoinisha D.,Haaser Sharon M.,Cuff Jaslynn A.N.,Pilson Holly,Carroll Eben A.,Halvorson Jason J.,Babcock Sharon,Goodman J. Brett,Holden Martha B.,Bullard Debra,Williams Wendy,Higgins Thomas F.,Haller Justin M.,Rothberg David L.,Marchand Lucas S.,Neese Ashley,Russell Mark,Olsen Zachary M.,Gitajn I. Leah,Coe Marcus,Dwyer Kevin,Mullin Devin S.,Reilly Clifford A.,DePalo Peter,Hall Amy E.,Heng Marilyn,Harris Mitchel B.,Smith R. Malcolm,Lhowe David W.,Esposito John G.,Bansal Mira,Bergin Patrick F.,Russell George V.,Graves Matthew L.,Morellato John,Champion Heather K.,Johnson Leslie N.,McGee Sheketha L.,Bhanat Eldrin L.,Mehta Samir,Donegan Derek,Ahn Jaimo,Horan Annamarie,Dooley Mary,Kuczinski Ashley,Iwu Ashley,Potter David,VanDemark Robert,Pfaff Branden,Hollinsworth Troy,Weaver Michael J.,von Keudell Arvind G.,McTague Michael F.,Allen Elizabeth M.,Jaeblon Todd,Beer Robert,Demyanovich Haley K.,Gage Mark J.,Reilly Rachel M.,Sparrow Cindy

Publisher

Elsevier BV

Subject

Pharmacology,General Medicine

Reference18 articles.

1. International Ethical Guidelines for Health-related Research Involving Humans. Geneva: Council for International Organizations of Medical Sciences (CIOMS); Fourth Edition. https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf. Published 2016. Accessed May 27, 2020.

2. Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial;Milstone;Lancet,2013

3. Helping adolescents to better support their peers with a mental health problem: a cluster-randomised crossover trial of teen Mental Health First Aid;Hart;Aust. N. Z. J. Psychiatr.,2018

4. FLUID trial: a protocol for a hospital-wide open-label cluster crossover pragmatic comparative effectiveness randomised pilot trial;McIntyre;BMJ Open,2018

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