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Genearl Policies Categories of Review IRB Application Procedures Continuing Review Informed Consent 4-H Institutional Review Board Forms/Additional Info
 
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Kinds of Research Requiring Review

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Training for Researchers

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

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General Guidelines for the Protection of Human Research Participants
 
What Are Researcher’s Responsibilities After Protocol Approval?
 

You are responsible for

    1. Familiarizing yourself with ethical guidelines and regulations regarding the protection of human participants from research risks;
    2. Conducting the research according to the approved protocol;
    3. Obtaining written informed consent using the approved consent form for each and every study participant if required by the IRB;
    4. Immediately reporting to the IRB and your immediate cognizant administrator (1) any unanticipated effects on participants which become apparent during the course of or as a result of experimentation and the actions taken as a result; (2) emergency protocol changes; (3) new information that may impact the risk/benefit ratio of a study; (4) irregularities in conducting the study; and (5) Data and Safety Monitoring Board reports as soon as they are available;
    5. Obtaining prior review from the IRB if you amend or alter the scope of the project or implement changes in the approved consent form;
    6. Maintaining documentation of consent forms and progress reports;
    7. Cooperating with the IRB in the continuing review of and final reporting on the project as required by Federal regulations and the IRB.
     

    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 ma terials, and in particular commends the design and content of the University of Maryland Baltimore Campus website.
     
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