Do you do research with human subjects?

Under the NIH's new definition of "clinical trial", your study might become one, soon.

Due to upcoming policy changes in the definition which broaden the requirements that qualify a study as a clinical trial, you may have to start checking "yes" to clinical trial on the Notice of Intent to Submit form and registering your studies on ClinicalTrials.gov, when you did not have to do so previously.

The NIH has created a helpful page at https://grants.nih.gov/policy/clinical-trials.htm that provides more information about the changes in policy, and the four questions which, if you answer "yes" to all, will define your human-subject study as a clinical trial.

Office for Human Research Protections to hold community forum

The OHRP is teaming up with Hackensack University Medical Center on April 4-5, 2017 for a conference and community forum on "Big Data, Small Data and the Implications for Human Subject Research". The conference will be held at the Hilton Meadowlands in East Rutherford, NJ. A summary of the event:

Human research increasingly relies on the collection and analysis of data. Big Data uses large data sets that may be analyzed computationally to reveal patterns, trends, and associations. Personalized medicine seeks to identify treatment tailored to the individual patient based on their predicted response or risk of disease; medical decision making, interventions and/or treatment modalities are identified through analysis of data sets. Genomics research has relied on the sharing of genome data since its inception. In all these cases, there are legal, regulatory and ethical implications related to the use of data both alone and in combination with bio-specimens. This conference seeks to create a dialogue that addresses the interception of these implications.

More information about the conference, the hotel and registration links can be found here: http://www.cvent.com/d/yvql9b.