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Frequently Asked Questions
2. Before starting a project at GU, all proposed research using human subjects, human data or human anatomical substances must be evaluated and approved by the Institutional Review Board (IRB). In addition, some classifications of ongoing research are reviewed at least annually or when certain changes are made to the research's scope or activities. The University requires that all research be conducted within the highest possible legal requirements, federal policies and ethical principles.
3. Legal requirements to protect human participants apply to a much broader range of research than you may realize. Often, additional ethical standards are applied in many disciplines.
4. Faculty, staff, or students conducting human research, or involved as key personnel in a research or training project, may complete an online educational tutorial and certification. This tutorial is accessed through the Collaborative Institutional Training Initiative (CITI Program) at https://www.citiprogram.org/, or the National Institutes of Health, Office of Human Subjects Research website: http://ohsr.od.nih.gov/
GU's Institutional Review Board evaluates both (a) initial research protocols, and (b) ongoing research projects that use human subjects, human data or human anatomical substances.
Every protocol is assessed for the necessary triad of qualities: Regulatory Compliance, Ethics and Scientific Integrity Quality and Validity.
The standard includes the legal requirements and the ethical guidelines that exist for each discipline. For example, research using humans often involves:
2. Evaluation and Approval of all research protocols for initial (new) research.
3. Classification of all research protocol categories.
Yes, both you and your collaborators must have your respective institutions approval and ongoing approval. However, you do NOT need ongoing (Continuing Review) if:
(a) the initial IRB review classifies your research proposal as Exempt (free) from continuing reviews each year, and
(b) no changes are made to ongoing research that alters the Exempt classification.
(Federal) Office for Human Research Protections (OHRP) http://www.hhs.gov/ohrp/NHGRI Ethical and Social Issues Program http://www.nhgri.nih.gov/ELSI/
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