Several months ago, we wrote the above blog about consent by phone. Recently, I discovered the following guidance from a FAQ document:

In a perfect world, all the data needed to complete a clinical trial case report form would be found in the medical record. Unfortunately, we do not live in a perfect world!

The Department of Health and Human Services (HHS) is the United States government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves, according to the government website.

The informed consent process is arguably one of the most important parts of a clinical research study. From the Principles of ICH GCP: the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. Proper informed consent ensures that the patient is aware of the risks and requirements of being in a research study and has voluntarily agreed to participate in research.  The regulations, CFR part 50 also cover the importance, rules and process of informed consent.

Have you ever worked at a site where they follow a practice just because “that is how they have always done it?”  At IMARC, we like to apply the FAIR Shake™ to these scenarios. What is the FAIR Shake™?

Recently, my inbox has been inundated with training opportunities for Risk-Based Monitoring.  Since the FDA’s release of its latest guidance on monitoring in August 2011, the pharmaceutical and device industries have made this a hot topic of discussion.  It seems the term, Risk-Based Monitoring, in spite of the guidance, has become an obstacle.  What is Risk-Based Monitoring?  And what is causing the confusion?  Perhaps the clearest definition for Risk-Based Monitoring was given by a presenter at the Global ACRP Conference this year in Tampa.  She referred to it as “Intelligent Monitoring”.  That says it all, doesn’t it?  Visually, I see the AT&T Commercial (It’s Not Complicated “Infinity”) with all the kids sitting around a table discussing big numbers with a grown-up.  When a little girl responds “Infinity times infinity” the grown man responds by motioning that his head just burst.

According to the National Institute of Health (NIH), nearly 3,500 people participate in the Clinical Research Healthy Volunteer Program (CHVP). The program, started in 1954, provides an opportunity for healthy volunteers, locally, nationally, even internationally, to participate in medical research studies to provide researchers with important information for comparison with people who have specific illnesses.

We have had this discussion numerous times over the years.  Many believe that the informed consent form is documentation enough.  On the other hand, others would like to see all consent processes documented with a progress note, in addition to the consent document.

It just depends!

On a recent monitoring visit, the coordinator asked an IMARC monitor if the study sponsor could have their consent translated into Spanish. However, the site had one caveat – their IRB also required a “back translation” of the translated consent. Why would the IRB require this back translation?