January 1, 2019
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Informed Consent Rule Changes Could Help IRBs, Expand Research
The FDA has issued a proposed rule that some say would provide research institutions with much-needed clarity on informed consent regulations and open the door to clinical breakthroughs.
HIV Cure Research Includes Tricky Ethical Challenges
Some geneticists compared the work by He Jiankui of the Southern University of Science and Technology in Shenzhen, China, to the pioneering in vitro fertilization efforts that resulted in the birth of Louise Brown in 1978. Many others criticized the scientist for the ethical issues his experiment raised.
HIV Research Poses Unique Ethical Issues
When IRBs review HIV studies, particularly those aimed at finding a cure to the disease, there are some tricky ethical challenges that might not be seen in other types of research.
Children’s Hospital Improves Assent-Consent With Animation Board Video
When a children’s hospital needed to approach research informed consent and pediatric assent with more creativity and flair, the research office asked children for input.
IRB Overhauls Its Minutes Template, Saving Time and Reducing Words
Before the revision, 23% of minutes were sent out within the same week as the IRB meeting. Now, 63% of minutes are sent out during the same week.
IRBs Can Learn to Deal With Medical Innovation Ambiguity
The lines between research and medical innovation can be blurry. When does a new surgical practice cross from case study to a study that must adhere to human research protection regulations?
OHRP Issues Guidance on Public Health Surveillance vs. Research
The Office for Human Research Protections recently published new draft guidance to clarify the difference between human research that might require IRB review and public health surveillance that is not defined as research.