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Ethical Principles |
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Institutional Responsibilities |
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What is "Minimal Risk?" |
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Exemptions |
Kinds of Research Requiring Review
Categories of Review
III. Continuing Review
IV. Informed Consent
V. Required Education of Human Research Participants
VI. What Are Researcher's Responsibilities After Protocol Approval?
VII. Student Research
Institutional Review Board
Forms/Additional Info.
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General Guidelines for the Protection of Human Research Participants |
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| A. |
The IRB is required to perform continuing review or re-evaluations of all approved research studies. The purpose of the continuing review is to assure that initial judgments by the researcher and the IRB regarding research results, risk/benefits ratios, and procedures were correct and have not significantly changed. The IRB will inform the researcher of the date for the subsequent review at the time of approval of the initial review. In general, research studies that received approval based on full or expedited reviews will be re-evaluated no later than one (1) year from initiation of research activities. Research studies that initially received an exempt approval will be reviewed every three (3) years. Application involves submitting an electronic version and two signed copies of the Continuing Review Application for Research Involving Human Participants. |
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| B. |
The IRB has the authority to request more frequent continuing reviews or re-evaluation of research activities based on degree of risk or changes in the participant risk/benefit ratio. Examples of reasons for more frequent reviews may include the following: (1) issues of participant risks or harm, (2) participants’ complaints, (3) changes of the Primary Investigator(s), (4) notification of unforeseen problems or accidents, and (5) notification of significant changes in the informed consent process, research plans and procedures and data collection methods. This list of reasons is not to be considered exhaustive and the IRB will provide the researcher a statement of the reasons for more frequent reviews. |
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C. |
The researcher is obligated to keep the IRB informed of any unexpected finding involving risks to research participants and to report any occurrence of serious harm to research participants. |
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| D. |
The IRB has the authority to suspend or terminate approval or any research activity that is not being conducted in accordance with IRB requirements or that has been associated with unexpected serious harm to participants. Should the IRB decide to suspend or terminate its approval of a research project, the IRB will provide a statement of the reasons to the researcher and the Vice President for Academic Affairs (VPAA) through the Director of the Office of Sponsored Research and Programs (OSRP). |
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Prepared by the University of the District of Columbia Institutional Review Board (UDC IRB) with reference to the Institutional Review Board Guidebook (http://www.hhs.gov/ohrp/irb/irb_guidebook.htm). The UDC IRB acknowledges the assistance of the College of Charleston, which shared its web materials, on which UDC’s materials are based. The UDC IRB is also indebted to many other fine university web sites which it has visited in the course of preparing these materials, and in particular commends the design and content of the University of Maryland Baltimore Campus website. |
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