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The CME objectives for IRB Advisor are to help physicians be able to:
• establish clinical trial programs using accepted ethical principles for human subject protection;
• understand the regulatory qualifications regarding human subject research;
• comply with the necessary educational requirements regarding informed consent and human subject research;
• apply the necessary safeguards for patient recruitment, follow-up, and reporting of findings for human subject research;
• have an understanding of the potential for conflict of financial interests involving human subject research;
• understand reporting adverse events during research.
5. The Office of Human Research Protections investigators concluded a total of how many findings against the research program at Johns Hopkins University’s medical institutions:
D. more than 100
6. According to Robert M. Nelson, MD, PhD, associate professor of anesthesia and pediatrics at The Children’s Hospital of Philadelphia, which of the following lessons can IRBs take from the Office of Human Research Protections report on research at Johns Hopkins?
A. Conduct independent reviews
B. Review the use of off-label drugs
C. Review informed consent documents
D. All of the above
7. According to Christopher P. Steidle, MD, a researcher for AmericasDoctor and medical director of Northeast Indiana Research, the best method to ease fears for potential patient volunteers in medical research is through:
A. thorough screening processes
B. weekly communication
D. all of the above
8. One of the main findings of a recent Government Accounting Office report on women and clinical trials found:
A. both government regulatory agencies and medical research programs adequately recruit and monitor women’s differences in medications and no changes were recommended.
B. the U.S. Food and Drug Administration doesn’t adequately oversee the testing through outcomes data related to the differences in sex.
C. more women need to be recruited by research investigators into clinical trials so that government agencies can adequately monitor differences.
D. the Office of Human Research Protections needs to develop an educational awareness program for research investigators on the necessity of more women in clinical trial research.