Abstract
The treatment therapies and technologies currently emerging from the rapidly evolving health care industry must undergo full examination in a clinical setting if they are to be marketed to the public. All elements of clinical studies involving human subjects must undergo thorough IRB review before study activities can commence. Regulations regarding IRB oversight apply to all clinical studies—including retrospective examinations of private medical data and identifiable biological samples. It is not uncommon for researchers to be unsure whether, or on what level, IRB review and oversight are required for a particular project. Yet, if human subjects or their private medical data are utilized in a study, peer-reviewed journals will require relevant IRB approval information be provided as a requirement for publication. This article examines IRB processes and review types, offers insight into the IRB decision-making process, and emphasizes the importance of engaging an IRB consultant early in the clinical study design process.
Highlights
From Phase I through post-market analysis, clinical investigations are continually developed and implemented to test a product or intervention’s safety and effectiveness
The assessment of interventions related to human subjects typically begins by performing preclinical animal tests to determine how the drug and/or intervention works and if it will be safe enough to be tested in humans
Clinical research regulation changes: Research in which the subjects may be placed at risk and are identifiable could qualify for an exemption determination, thereby expanding the exempt category
Summary
From Phase I through post-market analysis, clinical investigations are continually developed and implemented to test a product or intervention’s safety and effectiveness. When implementing an investigational protocol, a clinical study’s principal investigator (PI) is responsible for following and complying with all applicable federal regulations regarding human subject research [1] These responsibilities include obtaining initial and continuing IRB review and approval of the proposed research study. An IRB may not review projects retrospectively This includes proposed research involving previously collected human fluid and tissue samples and existing data, as well as advertising and recruitment procedures. Clinical Investigation: "Involves use of a test article (i.e., drug, device, food substance or biologic), one or more human subjects, meets requirements for prior submission to FDA, or results are intended to be part of an application for research or marketing permit.".
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