The primary purpose of a Certificate of Confidentiality is to:
Prevent subjects from knowing the purpose of a study. Allow law enforcement to investigate abuse cases. Protect researchers from disclosing
Read moreIRB Law Questions with Certification
If disclosure of a subject’s involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful:
Have the subject sign the consent form under an assumed name. Obtain a Certificate of Confidentiality. Code the subjects’ responses.
Read moreAn investigator wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:
Experience emotional or psychological distress. Lose their legal status. Lose their employment. Feel that their privacy has been invaded. CLICK
Read moreWhich of the following statements about the relationship between an institution and the institution’s IRB(s) is correct?
Institutional priorities take precedence over all IRB determinations. Department chairs can overturn an IRB disapproval. Officials of the institution may
Read moreContinuing review of an approved and ongoing protocol
Is limited to review of unanticipated problems. Must be conducted by a convened IRB. Is not required unless additional risks
Read moreAccording to federal regulations, the expedited review process may be used when the study procedures pose
A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting. More than minimal risk,
Read moreIn addition to pregnant women, fetuses, and neonates, another subpart of the DHHS regulations provides additional protections for which of the following vulnerable populations?
College students. Adults with decisional impairments. The elderly Prisoners. CLICK HERE TO DOWNLOAD FULL EXAM ANSWERS SHEET (PDF FORMAT) To
Read moreAccording to the federal regulations, research is eligible for exemption, if
All the subjects are adults and the risk is minimal. The investigator is experienced in the field of inquiry. The
Read moreAccording to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or:
Identifiable public information. De-identified private information. Identifiable private information. Observations of public behavior. CLICK HERE TO DOWNLOAD FULL EXAM ANSWERS
Read moreAccording to the federal regulations, which of the following studies meets the definition of research with human subjects?
A feasibility study for implementing a year-round school program, focusing on economic issues such a facilities utilization and transportation costs.
Read more