Human Research Training Updates

Human Research Training Updates

a) CITI refresher course content is changing

Remember when you'd take a refresher course every three years on the same topics over and over again? Well, those days are over. Starting next week, when it's time to recertify your training, you will still do refreshers on a *few* topics, however you will now also choose three (3) elective modules (out of about 25 choices) on topics that interest you! "Consent and Subject Recruitment Challenges: Therapeutic Misconception", "Research with Critically Ill Subjects", "Illegal Activities or Undocumented Status in Human Research" to name just a few.

b) The Good Clinical Practice (GCP) course through CITI satisfies NIH's new (1/1/17) training requirement

The NIH policy (https://www.grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html) applies to all NIH-funded investigator and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials . NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of these interventions on health-related biomedical or behavioral outcomes [emphasis mine]. And don't forget the clinicaltrials.gov requirement for these studies as well (as reported in previous VPR Research News-see #4 below)

c) The CITI course for Clinical Research Coordinators (CRC) is now available

Those of you who are "on file" as Research Coordinators through the SOM's Office of Clinical Trials recently received a message from me regarding the appreciation and importance of training initiatives for this extremely critical group in our HRPP. To this end, the CRC course through CITI is available for you to casually peruse so that you can learn for the first time or review your knowledge about the responsibilities of your profession. It's casual now, but of course it is important enough to make it a mandatory part of your training portfolio, effective June 30, 2017.

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