Do systematic reviews require IRB approval?
If you are on the medical campus please visit the BUMC IRB website. The purpose of this policy is to outline the definitions of ‘research’ and ‘human subjects’ and the CRCCharles River
Campus IRB procedure for determining when projects do and do not require IRB review and approval. Activities that meet the federal definition of ‘human subjects’ at 45 CFR 46.102(e) and ‘research’ at 45 CFR 46.102(l) require IRB review and approval. The Charles River Campus (CRC) IRB is responsible for determining whether activities and projects meet these definitions and when or whether IRB review and approval is required. An IRB Member who
is designated as an expedited reviewer by the IRB Chair may make these determinations. Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. To be considered a “systematic investigation,” the concept of a research study ordinarily:
To be considered “generalizable knowledge,” the activity ordinarily includes the following concepts:
The following activities are deemed NOT to be research:
Human Subject is defined as a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. To meet the definition of a ‘human subject’, the following must apply:
ProceduresTo receive an official determination of whether a project is Research Involving Human Subjects, Investigators should complete and submit the Research with Human Subjects Determination Form and submit it along with any supporting materials, such as a grant or contract supporting the research, data collection forms, and other materials (e.g. assessments, questionnaires, etc.) to be used in the project. Informal inquiries into whether IRB review and approval may be needed do not require submission of the Determination Form. Review Process
Author: Pamela Richmond Date: April 7, 2020 Approved: CRC IRB, Kathryn Mellouk, Institutional Official Back to Human SubjectsWhich type of review does not require IRB approval?Data sets. The IRB recognizes that the analysis of de-identified, publicly available data does not constitute human subjects research as defined in federal regulations, and that it does not require IRB review.
Do you need ethical approval for a systematic review?Systematic reviewers use publicly accessible documents as evidence and are seldom required to seek an institutional ethics approval before commencing a systematic review. Institutional Review Boards for ethical conduct of research do not typically include guidelines for systematic reviews.
What research requires IRB approval?FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR Part 56).
What research is exempt from IRB review?Human subjects research that is classified as “exempt” means that the research qualifies as no risk or minimal risk to subjects and is exempt from most of the requirements of the Federal Policy for the Protection of Human Subjects, but is still considered research requiring an IRB review for an exemption determination.
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