The correct answer is: "Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk"
The OHRP defines an unticipated problem in the scenario of a research involving human participants. Defining the problem as unanticipated means that it was not foreseen at all when detailing the possible risks for the parcipants of the study on when those were asked to sign a consent form. It is also unanticipated in the sense that the problem which have aroused does not match in terms of likelihood with the characteristics of the specific individual suffering it.
Such term does not refer to some inconvenience with minimum consequences, but it suggest that the problem occurring affects the research subjects or others and places them at a greater risk of harm - physical, psychological, economic ,etc.- than was anticipated before the research.
OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and giving advice on ethical and regulatory issues in biomedical research and social behavior.
The Office for the Protection of Human Research (OHRP) was established in June 2000 to lead the efforts of the Department of Health and Human Services to protect human subjects in biomedical and behavioral research and to provide leadership to all federal agencies conducting or supporting human subject research under the Federal Policy for the Protection of Subjects Humans, also known as General Rules.
OHRP also supports the Secretary's Advisory Committee for the Protection of Human Research (SACHRP), which advises the Secretary of the HHS on issues relating to protecting human subjects in research. SACHRP replaces NHRPAC on January 3, 2003, with similar responsibilities. OHRP has oversight of more than 13,000 institutions in the United States and around the world conducting research on human subjects not excluded by HHS.
From the Office of the Director, OHRP provides training to institutions involved in international research, to help ensure that ethical protection is provided to those who participate in research outside the United States. This office also provides international quality assurance consultations.
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Details
Class: High School
Subject: Social Studies
Keywords: OHRP, research, protect
