title: Quality issues in clinical research and the implications on health policy (QICRHP).
abstract: Scientific (research) misconduct relating to fraudulent behaviors, plagiarism, and violations in research protocol is extant in the literature. These behaviors result in inadvertent infringement on subjects' rights, safety, and confidentiality, and can negatively impact the implementation of health policies. Funding agencies, legislators, regulators, clinicians, and scientists continue to subject researchers' work to scrutiny and in-depth analyses to evaluate its quality because of increased reports of scientific misconduct. Therefore, clinical researchers are motivated to restore and maintain credibility throughout clinical trials to regain public trust because of adverse publicity. Quality in clinical research addresses the study's integrity and merit, which has important practice and policy implications. Study integrity and merit encompass both the scientific and ethical components of clinical research studies. Researchers suggest using structured evaluation processes, educating, and mentoring aspiring scientists on scientific integrity to prevent scientific misconduct. In addressing these issues, this article explicates and provides a synthesized critique of quality issues in clinical research, analyzes its implications on health policy and clinical practice, and proposes a systematic framework to evaluate clinical research studies.
authors.affiliation: Baltimore City Community College, Baltimore, MD 21215, USA. vnjie@bccc.state.md.us
authors.forename: V P
authors.initials: VP
authors.lastname: Njie
authors.forename: A C
authors.initials: AC
authors.lastname: Thomas
mesh_terms: D015400:Clinical Nursing Research / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards*; D006291:Health Policy; D006801:Humans; D011785:Quality Assurance, Health Care / Q000379:methods; D015871:Scientific Misconduct; D014481:United States