A5051459471- Ethics in Clinical Research
- Biomedical Ethics and Regulation
- Historical and Cultural Archaeology Studies
- Health Systems, Economic Evaluations, Quality of Life
- Archaeology and ancient environmental studies
- Archaeology and Natural History
- Ethics in medical practice
- HIV/AIDS Research and Interventions
- Mobile Learning in Education
- American Environmental and Regional History
- HIV, Drug Use, Sexual Risk
- Healthcare Policy and Management
- Medical Malpractice and Liability Issues
- Pharmaceutical industry and healthcare
- Opioid Use Disorder Treatment
- Health and Medical Research Impacts
- Primary Care and Health Outcomes
- Pharmaceutical Economics and Policy
- Archaeological Research and Protection
- Academic integrity and plagiarism
- Library Collection Development and Digital Resources
- Nursing Roles and Practices
- Latin American history and culture
- Academic Publishing and Open Access
- Asian American and Pacific Histories
Brigham and Women's Hospital
2016-2024
National Park Service
1984-2022
Yale University
1994-2021
DAISY Foundation
2016-2021
National Society of Genetic Counselors
2020
University of Waterloo
2020
University of Alberta
2012-2020
Respect
2020
Barrie Urology Group
2020
Jonathan A Law & Associates
2013-2020
The authors review the potential benefits and unintended consequences of broad sharing participant-level data from clinical trials. Several options for governance structures that could be implemented to provide expanded access trial are discussed.
ward.Instead of spending time and resources on complicated techniques to try deidentify anonymize complex patient data -and risk failing making populations or groups skeptical about the whole concept sharing -it may be better define a core set that can released (and freely accessed) from all trials allow more only through real inclusive collaborations, way successful related specific diseases already happens in global health today."It is not raw data, but questions, problems, code everybody...
Health care is transitioning from genetics to genomics, in which single-gene testing for diagnosis being replaced by multi-gene panels, genome-wide sequencing, and other multi-genic tests disease diagnosis, prediction, prognosis, treatment. This health transition spurring a new set of increased or novel liability risks providers test laboratories. article describes this both medical liability, addresses 11 areas potential risk, offering recommendations legal actors address manage those risks.
Economic partnerships between industry and academia accelerate medical innovation enhance patient access to advances, but such have sometimes eroded public trust in the research enterprise. There is particular risk for conflict of interest when economic extend beyond a university's corporate interests involve institutional decision makers. Institutions makers should fully disclose industry-related financial relationships. Without legitimate justification interests, individuals divest...
In the last decade, Canadian provincial and territorial health systems have taken diverse approaches to strengthening primary care delivery. Although US differ in significant ways, important commonalities include organization of delivery, core principles guiding reform, some degree provincial/state autonomy. This suggests that experiences, which employed a variety tools, strategies, policies, may be informative for efforts improve care.The range reform initiatives implemented across Canada...
The life expectancy of HIV-positive individuals receiving antiretroviral therapy (ART) is approaching that HIV-negative people. However, little known about how these populations compare in terms health-related quality (HRQoL). We aimed to HRQoL between and people Zambia South Africa.As part the HPTN 071 (PopART) study, data from adults aged 18-44 years were gathered Nov 28, 2013, March 31, 2015, large cross-sectional surveys random samples general population 21 communities Africa. collected...
Sharing of data for research beyond the EU must improve
To find research misconduct in that has been supported by federal funds, an institution must determine the was committed intentionally, knowingly, or recklessly. "Intentional" and "knowing" are straightforward standards. Yet "reckless" often mystifies institutions, which struggle to assess whether a respondent's conduct should be deemed "reckless," merely negligent. This difficulty is most pronounced when allegations lodged against author under whose supervision primary conducted—most often,...
The founders of PubPeer envisioned their website as an online form a "journal club" that would facilitate post-publication peer review. Recently, comments have led to significant number research misconduct proceedings - development could not been anticipated when the current federal regulations were developed two decades ago. Yet number, frequency, and velocity identifying data integrity concerns, institutional government practices treat all such potential allegations, overwhelmed...
Linguistic and cultural differences can impede comprehension among potential research participants during the informed consent process, but how researchers IRBs respond to these challenges in practice is unclear. We conducted in-depth interviews with 15 researchers, ethics committee (REC) chairs members from 8 different countries emerging economies, involved HIV-related sponsored by HIV Prevention Trials Network (HPTN), regarding ethical regulatory they face this regard. In interviews,...
Investigators and institutions have begun to prepare for new federal protections of study participants set take effect in 2018.
Healthcare organizations, nurses, patients, and their families benefit from the opportunity to say, "Thank you." The experience of being hospitalized can be devastating. Recognizing compassionate extraordinary nursing care in a meaningful way is powerful tool that supports healthy work environment, engages staff, impacts patient experience. DAISY Award™ legacy thanks exemplifies qualities "meaningful" recognition.
The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy trust in enterprise, regulators had initially proposed consent manner that would have rendered it exclusive approach to all biospecimens, regardless identifiability. Based on public comments from both researchers patients concerned this hinder important medical advances, however, decided largely...
In both academic literature and the media, financial conflicts of interest in human subjects research have come center-stage. The cover a recent edition Time magazine features subject cage with caption guinea pigs, signifying perhaps that are no more protected from abuses than laboratory animals. That issue highlights three well-publicized cases violations occurred at University Oklahoma, Pennsylvania, Johns Hopkins University. At St. John Medical Center Tulsa, study was co-sponsored by...
Investigations at an 18th century Jesuit mission near Nogales, Arizona were undertaken in 1964–65 and 1965–66 by the Archaeological Historical Society. Nine rooms living quarters fully or partially excavated as well some outlying structures. Material culture was sparse had evidently been intentionally stripped upon abandonment about 1773. Architectural remains not sufficiently diagnostic to determine functions for individual rooms. After abandonment, re-occupied local mining activities....
In July 1990, the federal Centers for Disease Control (CDC) reported first case of possible transmission Human Immunodeficiency Virus (HIV) to a patient from an HIV-infected health care worker. The may have occurred during invasive dental procedure performed on her by dentist who had AIDS, and in January 1991, CDC HIV procedures two other patients same dentist. Further, recent revelation that respected surgeon at major medical center many surgical while infected with created substantial...
A novel Protocol Ethics Tool Kit ('Ethics Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center Brigham and Women9s Hospital Harvard. The purpose is to facilitate effective recognition, consideration deliberation critical ethical issues in clinical trial protocols. may be used investigators sponsors develop dedicated Section within protocol improve consistency transparency between protocols research ethics committee reviews. It also streamline...
Abstract Objectives The National Cancer Institute (NCI) Clinical Trials Network performs phase II and III clinical trials, which increasingly rely on the submission of diagnostic formalin-fixed, paraffin-embedded tissue blocks for biomarker assessment. Simultaneously, advances in precision oncology require that centers maintain specimens ancillary, standard-of-care diagnostics. This has caused to become a limited resource advancing NCI trial enterprise practice modern molecular pathology....
THE DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) has proposed sweeping revisions to the federal regulations for protection of human research participants. The goal is “enhance while simultaneously eliminating unreasonable burdens.” Although admirable, some changes intended remove unnecessary regulatory burdens may allow serious risks (ie, probability harm significant, not merely possible or conceivable), particularly highly vulnerable participants participants’ ability give free and...