Read by QxMD icon Read

Waiver informed consent

Charles S White, Ekta Dharaiya, Erin Campbell, Lilla Boroczky
Purpose To assess the likelihood of malignancy among a subset of nodules in the National Lung Screening Trial (NLST) by using a risk calculator based on nodule and patient characteristics. Materials and Methods All authors received approval for use of NLST data. An institutional review board exemption and a waiver for informed consent were granted to the author with an academic appointment. Nodule characteristics and patient attributes with regard to benign and malignant nodules in the NLST were applied to a nodule risk calculator from a group in Vancouver, Canada...
October 13, 2016: Radiology
Clara Park, Tatjana Gruber-Rouh, Doris Leithner, Amelie Zierden, Mortiz H Albrecht, Julian L Wichmann, Boris Bodelle, Mohamed Elsabaie, Jan-Erik Scholtz, Moritz Kaup, Thomas J Vogl, Martin Beeres
BACKGROUND: Evaluation of latest generation automated attenuation-based tube potential selection (ATPS) impact on image quality and radiation dose in contrast-enhanced chest-abdomen-pelvis computed tomography examinations for gynaecologic cancer staging. METHODS: This IRB approved single-centre, observer-blinded retrospective study with a waiver for informed consent included a total of 100 patients with contrast-enhanced chest-abdomen-pelvis CT for gynaecologic cancer staging...
October 10, 2016: Cancer Imaging: the Official Publication of the International Cancer Imaging Society
Jeong Hee Yoon, Jeong Min Lee, Eunju Kim, Tomoyuki Okuaki, Joon Koo Han
Purpose To determine whether B1 inhomogeneity-corrected volumetric T1 maps of gadoxetic acid-enhanced liver magnetic resonance (MR) imaging are able to demonstrate global liver function and functional heterogeneity in patients with cirrhosis and to investigate their relationship with the development of hepatic insufficiency and decompensation. Materials and Methods This institutional review board-approved retrospective study with waiver of informed consent included 234 consecutive patients who underwent gadoxetic acid-enhanced liver MR imaging, including B1 inhomogeneity-corrected volumetric T1 mapping...
October 3, 2016: Radiology
Amir H Davarpanah, Avinash Kambadakone, Nagaraj S Holalkere, Alexander R Guimaraes, Peter F Hahn, Susanna I Lee
PURPOSE: The purpose of the study was to assess the diagnostic performance of qualitative and quantitative diffusion-weighted imaging (DWI) in differentiating benign from malignant ovarian and uterine masses. MATERIALS AND METHODS: Institutional review board approval was obtained for this HIPAA-compliant retrospective study, with waiver of informed consent. DWI MRIs of 222 women acquired over 1.5 years were evaluated. Reference standard was pathology or follow-up imaging...
September 22, 2016: Abdominal Radiology
Honsoul Kim, Song-Ee Baek, Jieun Mo On, Yun Ho Roh, Narae Lee, Arthur Cho
PURPOSE: Imaging features of sinusoidal obstruction syndrome (SOS), an increasingly common drawback of chemotherapy, were evaluated via 18F-fluorodeoxyglucose (FDG) positron emission tomography computed tomography (PET/CT). EXPERIMENTAL DESIGN: This retrospective study was approved by our Institutional Review Board, with a waiver of informed consent. FDG PET/CT studies of 35 patients (male, 24; female, 11; median age, 53.2 years) obtained between January, 2005 and December, 2012 were analyzed before and after systemic chemotherapy...
September 1, 2016: Oncotarget
Andrew M McDonald, Thomas A Swain, David L Mayhew, Rex A Cardan, Christopher B Baker, David M Harris, Eddy S Yang, John B Fiveash
Purpose To determine if computed tomographic (CT) metrics of bone mineral density and muscle mass can improve the prediction of noncancer death in men with localized prostate cancer. Materials and Methods Institutional review board approval was obtained, with waiver of informed consent. All patients who underwent radiation therapy for localized prostate cancer between 2001 and 2012 with height, weight, and past medical history documented and who underwent CT that included the L4-5 vertebral interspace were included...
September 5, 2016: Radiology
Shona Kalkman, Ghislaine J M W van Thiel, Diederick E Grobbee, Anna-Katharina Meinecke, Mira G P Zuidgeest, Johannes J M van Delden
BACKGROUND: We explored the views of key stakeholders to identify the ethical challenges of pragmatic trials investigating pharmaceutical drugs. A secondary aim was to capture stakeholders' attitudes towards the implementation of pragmatic trials in the drug development process. METHODS: We conducted semistructured, in-depth interviews among individuals from different key stakeholder groups (academia and independent research institutions, the pharmaceutical industry, regulators, Health Technology Assessment (HTA) agencies and patients' organizations) through telephone or face-to-face sessions...
2016: Trials
Hyungjin Kim, Chang Min Park, Sang Joon Park, Yong Sub Song, Jong Hyuk Lee, Eui Jin Hwang, Jin Mo Goo
OBJECTIVES: The aim of this study was to describe the temporal changes of various texture features extracted from pulmonary nodules on dynamic contrast-enhanced computed tomography (DCE-CT) and to compare the feature values among multiple scanning time points. We also aimed to analyze the variability of texture features across multiple scan delay times. MATERIALS AND METHODS: This retrospective study was approved by the institutional review board of Seoul National University Hospital with waiver of patients' informed consent...
September 2016: Investigative Radiology
Kate M Sahan, Keith M Channon, Robin P Choudhury, Rajesh K Kharbanda, Regent Lee, Mark Sheehan
Research in the emergency setting involving patients with acute clinical conditions is needed if there are to be advances in diagnosis and treatment. But research in these areas poses ethical and practical challenges. One of these is the general inability to obtain informed consent due to the patient's lack of mental capacity and insufficient time to contact legal representatives. Regulatory frameworks which allow this research to proceed with a consent 'waiver', provided patients lack mental capacity, miss important ethical subtleties...
April 2016: European Journal of Cardiovascular Medicine
Scott Y Kim
Fifty years after Beecher's landmark article, an old question is being debated anew: is it ethical to conduct clinical research without consent? This paper provides a systematic analysis of this question. First, it describes five clinical trials that have either been conducted (or proposed) without the subjects providing consent. Second, it reviews a number of conditions that are often provided to justify bypassing of consent and finds that only some of them qualify as necessary conditions for bypassing consent...
2016: Perspectives in Biology and Medicine
Jennifer G Jetton, Ronnie Guillet, David J Askenazi, Lynn Dill, Judd Jacobs, Alison L Kent, David T Selewski, Carolyn L Abitbol, Fredrick J Kaskel, Maroun J Mhanna, Namasivayam Ambalavanan, Jennifer R Charlton
INTRODUCTION: Acute kidney injury (AKI) affects ~30% of hospitalized neonates. Critical to advancing our understanding of neonatal AKI is collaborative research among neonatologists and nephrologists. The Neonatal Kidney Collaborative (NKC) is an international, multidisciplinary group dedicated to investigating neonatal AKI. The AWAKEN study (Assessment of Worldwide Acute Kidney injury Epidemiology in Neonates) was designed to describe the epidemiology of neonatal AKI, validate the definition of neonatal AKI, identify primary risk factors for neonatal AKI, and investigate the contribution of fluid management to AKI events and short-term outcomes...
2016: Frontiers in Pediatrics
Kathryn Macapagal, Ryan Coventry, Miriam R Arbeit, Celia B Fisher, Brian Mustanski
Sexual and gender minority (SGM) adolescents under age 18 are underrepresented in sexual health research. Exclusion of SGM minors from these studies has resulted in a lack of knowledge about the risks and benefits youth experience from sexual health research participation. Institutional Review Boards' (IRB) overprotective stances toward research risks and requirements for guardian consent for SGM research are significant barriers to participation, though few have investigated SGM youth's perspectives on these topics...
July 28, 2016: Archives of Sexual Behavior
Samantha P Zuckerman, Emily F Conant, Brad M Keller, Andrew D A Maidment, Bruno Barufaldi, Susan P Weinstein, Marie Synnestvedt, Elizabeth S McDonald
Purpose To evaluate the early implementation of synthesized two-dimensional (s2D) mammography in a population screened entirely with s2D and digital breast tomosynthesis (DBT) (referred to as s2D/DBT) and compare recall rates and cancer detection rates to historic outcomes of digital mammography combined with DBT (referred to as digital mammography/DBT) screening. Materials and Methods This was an institutional review board-approved and HIPAA-compliant retrospective interpretation of prospectively acquired data with waiver of informed consent...
July 28, 2016: Radiology
Wendy Hansen, Mariam Moshiri, Angelisa Paladin, Ramit Lamba, Douglas S Katz, Puneet Bhargava
The purpose of our study was to determine the current practice patterns of U.S. radiologists in imaging pregnant or potentially pregnant patients with acute abdominal and pelvic conditions. After obtaining an Institutional Review Board waiver, all members of the Association of University Radiologists, the Association of Program Directors in Radiology, and the Society of Radiologists in Ultrasound were invited via e-mail to take a 23-question online survey on radiology practices and clinical scenarios about acute abdominal and pelvic imaging of pregnant patients...
June 22, 2016: Current Problems in Diagnostic Radiology
Rebecca Smith-Bindman, Yifei Wang, Thomas R Yellen-Nelson, Michelle Moghadassi, Nicole Wilson, Robert Gould, Anthony Seibert, John M Boone, Mayil Krishnam, Ramit Lamba, David J Hall, Diana L Miglioretti
Purpose To determine patient, vendor, and institutional factors that influence computed tomography (CT) radiation dose. Materials and Methods The relevant institutional review boards approved this HIPAA-compliant study, with waiver of informed consent. Volume CT dose index (CTDIvol) and effective dose in 274 124 head, chest, and abdominal CT examinations performed in adult patients at 12 facilities in 2013 were collected prospectively. Patient, vendor, and institutional characteristics that could be used to predict (a) median dose by using linear regression after log transformation of doses and (b) high-dose examinations (top 25% of dose within anatomic strata) by using modified Poisson regression were assessed...
July 20, 2016: Radiology
Jenny A Mountain, Anett Nyaradi, Wendy H Oddy, Rebecca A Glauert, Nick H de Klerk, Leon M Straker, Fiona J Stanley
The Western Australian Data Linkage System is one of a few comprehensive, population-based data linkage systems worldwide, creating links between information from different sources relating to the same individual, family, place or event, while maintaining privacy. The Raine Study is an established cohort study with more than 2000 currently active participants. Individual consent was obtained from participants for information in publicly held databases to be linked to their study data. A waiver of consent was granted where it was impracticable to obtain consent...
2016: Public Health Research & Practice
Angela E Li, Darryl B Sneag, Harry G Greditzer, Christine C Johnson, Theodore T Miller, Hollis G Potter
Purpose To determine the diagnostic accuracy of magnetic resonance (MR) imaging for differentiating synovial patterns in patients with total knee arthroplasty (TKA), whether diagnostic accuracy differs in index versus revision TKA, and interobserver and intraobserver reliability for assessment of synovial patterns at MR imaging. Materials and Methods This retrospective cross-sectional study included 108 consecutive patients with TKAs who underwent MR imaging within 1 year prior to revision surgery from 2012 to 2014...
May 27, 2016: Radiology
Jon B Cole, Jeffrey D Ho, Michelle H Biros
Cole JB , Ho JD , Biros MH . Randomizing patients without consent: waiver vs exception from informed consent. Prehosp Disaster Med. 2016;31(4):457-458.
August 2016: Prehospital and Disaster Medicine
Henry Y Chou, Scott D Steenburg, Jeffrey W Dunkle, Sean D Gussick, Matthew J Petersen, Marc D Kohli, Changyu Shen, Hongbo Lin
This study aims to determine whether a modified four-view hand and wrist study performs comparably to the traditional seven views in the evaluation of acute hand and wrist fractures. This retrospective study was approved by the institutional review board with waiver of informed consent. Two hundred forty patients (50 % male; ages 18-92 years) with unilateral three-view hand (posteroanterior, oblique, and lateral) and four-view wrist (posteroanterior, oblique, lateral, and ulnar deviation) radiographs obtained concurrently following trauma were included in this study...
August 2016: Emergency Radiology
S Xu, R Gong
AIM: To investigate whether clivus height (CH; the distance of the basion above Chamberlain's line) could be used to diagnose basilar invagination (BI) at computed tomography (CT). MATERIALS AND METHODS: This retrospective study received institutional review board approval, and was performed from 1 January 2013, to 1 July 2015 with a waiver of informed consent. CH was measured on mid-sagittal reconstructed CT images from 65 BI patients and 85 control subjects to compare the two groups by using the independent-samples t-test...
November 2016: Clinical Radiology
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"