Human Subjects Research in the News
How electronic health records can benefit clinical trials
A new study has indicated that the Secure Anonymized Information Linkage (SAIL) Databank can provide a simple, cost-effective way to follow-up after the completion of randomized controlled trials.
Are research and medicine catered to only a certain type of people?
Populations such as children, women, and minorities have been consistently excluded from research, often due to unconscious or implicit bias or difficulty in adjusting research design to be more inclusive.
FDA Drafts Guidance on Scientific and Ethical Considerations in Including Pregnant Women in Clinical Trials
The US Food and Drug Administration (FDA) on Friday published draft guidance calling for the “judicious inclusion of pregnant women in clinical trials,” with “careful attention to potential fetal risk.”
Failure to publish trial results exposes patients to risks without providing benefits
Although the publication of results of clinical trials carried out in the USA within 12 months of their completion has been mandatory since 2007, an astoundingly high number of Phase III radiotherapy trials did not do so, according to new research. An analysis of 802 trials with a primary completion date of before Jan. 1, 2013, showed that 655, or 81.7 percent, did not publish even a summary result.
A biohacker injected himself with a DIY herpes treatment in front of a live audience
When asked if there was an ethical commission, he said no.
Common Rule Revision Delayed
On January 4, 2018, HHS submitted a final rule titled Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects. This final rule, which would delay the implementation date of the revised Common Rule for an unspecified amount of time, is currently undergoing regulatory review by the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB). This final rule is separate from the Federal Policy for the Protection of Human Subjects: Proposed 1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year, which was submitted on October 7, 2017, and remains under review at OMB.
Faced with public pressure, research institutions step up reporting of clinical trial results
The reporting of clinical trial results to a public database — mandated by a 10-year-old federal law — has improved sharply in the last two years, with universities and other nonprofit research centers leading the way, according to a new STAT analysis of government data.
NIH adopts new rules on human research, worrying behavioral scientists
The Washington Post
Risk factors for heart disease linked to dementia
NIH Research Matters
Global health: Probiotic prevents infections in newborns