Cargando…

The impact of central IRB's on informed consent readability and trial adherence in SPRINT

BACKGROUND: Federal agencies have encouraged the use of central institutional review boards (CIRBs) for multi-site clinical trials. There is limited evidence supporting the use of CIRBs. Our aim is to evaluate how SPRINT sites regulated by CIRBs performed regarding informed consent readability and p...

Descripción completa

Detalles Bibliográficos
Autores principales:	Tamariz, Leonardo, Gajardo, Mitscher, Still, Carolyn H., Gren, Lisa H., Clark, Elizabeth, Walsh, Sandy, Whittle, Jeff, Nord, John, Ramsey, Thomas, Contreras, Gabriel
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Elsevier 2019
Materias:	Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6627564/ https://www.ncbi.nlm.nih.gov/pubmed/31338481 http://dx.doi.org/10.1016/j.conctc.2019.100407

Ejemplares similares

2030: “Understandable to the subject”: Plain language IRB informed consents
por: Moore, Tina, et al.
Publicado: (2018)

How local IRBs view central IRBs in the US
por: Klitzman, Robert
Publicado: (2011)

Readability of consent forms in veterinary clinical research
por: Sobolewski, Josey, et al.
Publicado: (2019)

4186 Single IRB and the CTSI: Liaison Model for the IRB Reliance Process
por: Caldwell, Christine Sego, et al.
Publicado: (2020)

Readability and Comprehensibility of Informed Consent Forms for Clinical Trials
por: Pandiya, Anvita
Publicado: (2010)

The Readability of Information and Consent Forms in Clinical Research in France
por: Ménoni, Véronique, et al.
Publicado: (2010)

Readability of patient information and consent documents in rheumatological studies
por: Hamnes, Bente, et al.
Publicado: (2016)

Dairis Rihards Irbe
por: Irbe, Dairis Rihards
Publicado: (2023)

The informed consent form navigator: a tool for producing readable and compliant consent documents
por: Bona, Jonathan P., et al.
Publicado: (2022)

The SMART IRB platform: A national resource for IRB review for multisite studies
por: Cobb, Nichelle, et al.
Publicado: (2019)

Performance of IRBs in China: a survey on IRB employees and researchers’ experiences and perceptions
por: Liu, Xing, et al.
Publicado: (2022)

Improving readability of informed consents for research at an academic medical institution
por: Hadden, Kristie B., et al.
Publicado: (2018)

Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia
por: Vučemilo, Luka, et al.
Publicado: (2015)

Readability of informed consent forms for whole-exome and whole-genome sequencing
por: Niemiec, Emilia, et al.
Publicado: (2017)

The IRB Reliance Exchange (IREx): A national web-based platform for operationalizing single IRB review
por: Serdoz, Emily Sheffer, et al.
Publicado: (2022)

Principal Investigator Views of the IRB System
por: Whitney, Simon N., et al.
Publicado: (2008)

The IRB structure and medical research reform
por: Babyar, Julie
Publicado: (2018)

Assessment of Length and Readability of Informed Consent Documents for COVID-19 Vaccine Trials
por: Emanuel, Ezekiel J., et al.
Publicado: (2021)

Is Medication Adherence Predictive of Cardiovascular Outcomes and Blood Pressure Control? The Systolic Blood Pressure Intervention Trial (SPRINT)
por: Glasser, Stephen P, et al.
Publicado: (2021)

The Ethics Police?: IRBs' Views Concerning Their Power
por: Klitzman, Robert
Publicado: (2011)

GCP compliance and readability of informed consent forms from an emerging hub for clinical trials
por: Nair, Satish Chandrasekhar, et al.
Publicado: (2015)

Readability of informed consent forms in clinical trials conducted in a skin research center
por: Samadi, Aniseh, et al.
Publicado: (2016)

Use of SmartIRB Does Not Reduce IRB Review Time in a Non-federally Funded, Multi-Site Malnutrition Study
por: Lamers-Johnson, Erin, et al.
Publicado: (2022)

IRB practices and policies regarding the secondary research use of biospecimens
por: Goldenberg, Aaron J, et al.
Publicado: (2015)

Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China
por: Wen, Gaiyan, et al.
Publicado: (2016)

Institutional improvements in readability of written informed consent forms sustained post-revised Common Rule
por: Caballero, Alison, et al.
Publicado: (2021)

Determination of the Readability Level of Consent Forms Used in the Gynecology and Obstetrics Clinic at Suleyman Demirel University
por: Dağdelen, Cem, et al.
Publicado: (2023)

Journalists, district attorneys and researchers: why IRBs should get in the middle
por: Chodos, Anna H, et al.
Publicado: (2015)

IRB Process Improvements: A Machine Learning Analysis
por: Shoenbill, Kimberly, et al.
Publicado: (2017)

Applying a Digital Health Checklist and Readability Tools to Improve Informed Consent for Digital Health Research
por: Nebeker, Camille, et al.
Publicado: (2021)

Readability of information on colonoscopy preparation on the internet
por: MacLean, Sarah A., et al.
Publicado: (2018)

Institutional review board (IRB) and ethical issues in clinical research
por: Kim, Won Oak
Publicado: (2012)

From anonymity to “open doors”: IRB responses to tensions with researchers
por: Klitzman, Robert
Publicado: (2012)

Using Central IRBs for Multicenter Clinical Trials in the United States
por: Flynn, Kathryn E., et al.
Publicado: (2013)

Clinical Ethics Committees in Africa: lost in the shadow of RECs/IRBs?
por: Moodley, Keymanthri, et al.
Publicado: (2020)

The Association between the Montreal Cognitive Assessment and Functional Activity Questionnaire in the Systolic Blood Pressure Intervention Trial (SPRINT)
por: Still, Carolyn H, et al.
Publicado: (2018)

Conducting Science in Disasters: Recommendations from the NIEHS Working Group for Special IRB Considerations in the Review of Disaster Related Research
por: Packenham, Joan P., et al.
Publicado: (2017)

Research Ethics Boards: No Data on Quality of For-Profit or Non-Profit IRBs
por: Shamoo, Adil E, et al.
Publicado: (2006)

IRB perspectives on obligations to disclose genetic incidental findings to research participants
por: Gliwa, Catherine, et al.
Publicado: (2015)

Big Data, Biomedical Research, and Ethics Review: New Challenges for IRBs
por: Ferretti, Agata, et al.
Publicado: (2020)

Cannot write session to /tmp/vufind_sessions/sess_o3ot2bvd68vqdm6300nr81h39m