Researchers must report potential unanticipated problems that involve risks to others directly to the: HIPAA Compliance Officer Institutional Risk Manager American Psychological Association Institutional Review Board (IRB)

All serious adverse events (SAEs) must be reported to the research site's Institutional Review Board (IRB).A. TRUEB. FALSE

Risk of harm in social and behavioral sciences generally fall in three categories, which are: Invasion of privacy, adverse reaction to study drug, and discrimination Breach of confidentiality, loss of autonomy, and study procedures Study procedures, breach of confidentiality, and loss of employment Invasion of privacy, breach of confidentiality, and study procedures

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Is limited to review of unanticipated problems. Is not required unless additional risks have been identified. Must occur within 12 months of the approval date. Must be conducted by a convened IRB.

You work for a biomedical organization using the three-challenge approach to risk communication. You are attempting to communicate the risks to your organization resulting from complications associated with patient age and health status. The risk analysis includes actuarial reports and medical assessments of existing patients. The audience includes the general public as potential recipients of your products.Based on the three-challenge approach it is important to communicate the technical data in a variety of different ways because:Group of answer choicesThe process challenge suggests that the audience needs to trust the transparency and completeness of informationThe communication challenge suggests that the risk manager needs to be an excellent communicator.The knowledge challenge suggests that technical information should be easily understood.The process challenge suggests that the audience needs to feel involved in the risk analysis process

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Is not required unless additional risks have been identified. Is limited to review of unanticipated problems. Must be conducted by a convened IRB. Must occur within 12 months of the approval date.