Cargando…

Systems approach to assessing and improving local human research Institutional Review Board performance

OBJECTIVE: To quantifying the interdependency within the regulatory environment governing human subject research, including Institutional Review Boards (IRBs), federally mandated Medicare coverage analysis and contract negotiations. METHODS: Over 8000 IRB, coverage analysis and contract applications...

Descripción completa

Detalles Bibliográficos
Autores principales:	Fontanesi, John, Magit, Anthony, Ford, Jennifer J., Nguyen, Han, Firestein, Gary S.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Cambridge University Press 2018
Materias:	Translational Research, Design and Analysis
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6799096/ https://www.ncbi.nlm.nih.gov/pubmed/31660223 http://dx.doi.org/10.1017/cts.2018.24

Ejemplares similares

A multisite study of performance drivers among institutional review boards
por: Caligiuri, Michael, et al.
Publicado: (2017)

Opportunities for life course research through the integration of data across Clinical and Translational Research Institutes
por: Hanson, Heidi A., et al.
Publicado: (2018)

Effect of a Clinical and Translational Science Award institute on grant funding in a major research university
por: Kabo, Felichism W., et al.
Publicado: (2017)

Delivery of the research participant perception survey through the patient portal
por: Kelly-Pumarol, Issis J., et al.
Publicado: (2018)

The innovation scorecard for continuous improvement applied to translational science
por: Kotarba, Joseph A., et al.
Publicado: (2017)

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

Patient-Centered Network of Learning Health Systems: Developing a resource for clinical translational research
por: Finney Rutten, L. J., et al.
Publicado: (2017)

Effectiveness and cost of recruiting healthy volunteers for clinical research studies using an electronic patient portal: A randomized study
por: Samuels, Mary H., et al.
Publicado: (2018)

The integration of emerging omics approaches to advance precision medicine: How can regulatory science help?
por: Adamo, Joan E., et al.
Publicado: (2018)

Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products
por: Adamo, Joan E., et al.
Publicado: (2018)

Rapid clinical diagnostic variant investigation of genomic patient sequencing data with iobio web tools
por: Ward, Alistair, et al.
Publicado: (2018)

Maintenance efficacy designs in psychiatry: Randomized discontinuation trials – enriched but not better
por: Ghaemi, S. N., et al.
Publicado: (2017)

Toward a science of translational science
por: Smith, Caleb, et al.
Publicado: (2017)

Realizing the full potential of precision health: The need to include patient-reported health behavior, mental health, social determinants, and patient preferences data
por: Glasgow, Russell E., et al.
Publicado: (2018)

Uncertainty quantification in breast cancer risk prediction models using self-reported family health history
por: Pflieger, Lance T., et al.
Publicado: (2017)

Informed consent for next-generation nucleotide sequencing studies: Aiding communication between participants and investigators
por: Kost, Rhonda G., et al.
Publicado: (2017)

Integration of patient and clinician narratives into systematic reviews: An applied proof of concept
por: Christensen, Vivian, et al.
Publicado: (2021)

Do Bayesian adaptive trials offer advantages for comparative effectiveness research? Protocol for the RE-ADAPT study
por: Connor, Jason T, et al.
Publicado: (2013)

Design of the HPTN 065 (TLC-Plus) study: A study to evaluate the feasibility of an enhanced test, link-to-care, plus treat approach for HIV prevention in the United States
por: Gamble, Theresa, et al.
Publicado: (2017)

The optimal design of stepped wedge trials with equal allocation to sequences and a comparison to other trial designs
por: Thompson, Jennifer A, et al.
Publicado: (2017)

Experiences of running a stratified medicine adaptive platform trial: Challenges and lessons learned from 10 years of the FOCUS4 trial in metastatic colorectal cancer
por: Brown, Louise C, et al.
Publicado: (2022)

Designing a childhood obesity preventive intervention using the multiphase optimization strategy: The Healthy Bodies Project
por: Francis, Lori A, et al.
Publicado: (2023)

Rationale and design of the Medical Research Council's Precision Medicine with Zibotentan in Microvascular Angina (PRIZE) trial
por: Morrow, Andrew J, et al.
Publicado: (2020)

Redesigning a large school-based clinical trial in response to changes in community practice
por: Gerald, Lynn B, et al.
Publicado: (2011)

Randomized trials of alcohol-use interventions with college students and their parents: lessons from the Transitions Project
por: Fernandez, AC, et al.
Publicado: (2011)

Evaluating the safety of a rotavirus vaccine: the REST of the story
por: Heyse, Joseph F, et al.
Publicado: (2008)

Overcoming challenges in designing and implementing a phase II randomized controlled trial using a presurgical model to test a dietary intervention in prostate cancer
por: Demark-Wahnefried, Wendy, et al.
Publicado: (2008)

Rationale, challenges, and participants in a Phase II trial of a botanical product for chronic hepatitis C
por: Reddy, K Rajender, et al.
Publicado: (2012)

A point-of-care clinical trial comparing insulin administered using a sliding scale versus a weight-based regimen
por: Fiore, Louis D, et al.
Publicado: (2011)

The development and description of the comparison group in the Look AHEAD trial
Publicado: (2011)

Statistical aspects of the TNK-S2B trial of tenecteplase versus alteplase in acute ischemic stroke: an efficient, dose-adaptive, seamless phase II/III design
por: Levin, Bruce, et al.
Publicado: (2011)

Design and analysis considerations in the Ebola_Tx trial evaluating convalescent plasma in the treatment of Ebola virus disease in Guinea during the 2014–2015 outbreak
por: Edwards, Tansy, et al.
Publicado: (2016)

Data on the Amphidinium carterae Dn241EHU isolation and morphological and molecular characterization
por: Seoane, S., et al.
Publicado: (2018)

Chromatin structure profile data from DNS-seq: Differential nuclease sensitivity mapping of four reference tissues of B73 maize (Zea mays L)
por: Turpin, Zachary M., et al.
Publicado: (2018)

Data based investigation of the energy metering type, billing and usage of sampled residents of Ota Community in Nigeria
por: Adekitan, Aderibigbe Israel, et al.
Publicado: (2018)

Extensional rheological data from ex-situ measurements for predicting porous media behaviour of the viscoelastic EOR polymers
por: Azad, M.S., et al.
Publicado: (2018)

Technical data of a grid-connected photovoltaic/wind hybrid system with and without storage battery for residential buildings located in a warm area
por: Baglivo, Cristina, et al.
Publicado: (2018)

Dataset for the estimation of costs for direct contact condenser
por: Liu, Dunyu, et al.
Publicado: (2018)

Data on safe hydrogen production from the solar photovoltaic solar panel through alkaline electrolyser under Algerian climate
por: Menad, Chawki Ameur, et al.
Publicado: (2018)

Data on combination of parabolic solar system with CH(4) cycle and power tower solar system with Cu–Cl cycle for hydrogen production in the city of Ghardaia (Algeria)
por: menad, Chawki Ameur, et al.
Publicado: (2018)

Cannot write session to /tmp/vufind_sessions/sess_d1kojdol4g5pm9qckih154fcb6