This patient education program explains clinical trials and answers some frequently asked questions. This is a MedlinePlus Interactive Health Tutorial from the National Library of Medicine, designed and developed by the Patient Education Institute.
Background All clinical research benefits from transparency and validity. Transparency and validity of studies may increase by prospective registration of protocols and by publication of statistical analysis plans (SAPs) before data have been accessed to discern data-driven analyses from pre-planned analyses. Main message Like clinical trials, recommendations for SAPs for observational studies increase the transparency and validity of findings. We appraised the applicability of recently developed guidelines for the content of SAPs for clinical trials to SAPs for observational studies. Of the 32 items recommended for a SAP for a clinical trial, 30 items (94%) were identically applicable to a SAP for our observational study. Power estimations and adjustments for multiplicity are equally important in observational studies and clinical trials as both types of studies usually address multiple hypotheses. Only two clinical trial items (6%) regarding issues of randomisation and definition of adherence to the intervention did not seem applicable to observational studies. We suggest to include one new item specifically applicable to observational studies to be addressed in a SAP, describing how adjustment for possible confounders will be handled in the analyses. Conclusion With only few amendments, the guidelines for SAP of a clinical trial can be applied to a SAP for an observational study. We suggest SAPs should be equally required for observational studies and clinical trials to increase their transparency and validity.
By the end of this section, you will be able to:Discuss the guiding principles of ethical researchDiscuss how research involving human subjects is regulatedSummarize the processes of informed consent and debriefingExplain how research involving animal subjects is regulated
Psychology is designed to meet scope and sequence requirements for the single-semester introduction to psychology course. The book offers a comprehensive treatment of core concepts, grounded in both classic studies and current and emerging research. The text also includes coverage of the DSM-5 in examinations of psychological disorders. Psychology incorporates discussions that reflect the diversity within the discipline, as well as the diversity of cultures and communities across the globe.Senior Contributing AuthorsRose M. Spielman, Formerly of Quinnipiac UniversityContributing AuthorsKathryn Dumper, Bainbridge State CollegeWilliam Jenkins, Mercer UniversityArlene Lacombe, Saint Joseph's UniversityMarilyn Lovett, Livingstone CollegeMarion Perlmutter, University of Michigan
By the end of this section, you will be able to:Discuss how research involving human subjects is regulatedSummarize the processes of informed consent and debriefingExplain how research involving animal subjects is regulated
Student teams investigate the migration of small-particle plastic pollution by exposing invertebrates found in water samples from a local lake or river to fluorescent bead fragments in a controlled environment of their own designs. Students begin by reviewing the composition of food webs and considering the ethics of studies on live organisms. In their model microcosms, they set up a food web so as to trace the microbead migration from one invertebrate species to another. Students use blacklights and microscopes to observe and quantify their experimental results. They develop diagrams that explain their investigations—modeling the ecological impacts of microplastics.