Joining the military in America is, by some, considered the most patriotic duty one can fulfill; a noble and brave decision made by young men and women to protect and fight for our country.

Often, when one thinks of the team that actually brings a new medical device or drug to market, the first people that come to mind are those at the sponsor company and the investigators at the individual sites – the leaders of the study.  What may be less known, though, is that often the study hinges on the shoulders of the Clinical Research Coordinator (CRC).  Briefly, CRCs are responsible for the accurate maintenance of the records for the trial, as well as many parts of the trial that otherwise may be overlooked.  Some of the major responsibilities of the CRC are:

I came across this article describing the benefits to having a shortened informed consent form.  As a monitor who has had experience with reviewing informed consents, as well as a former research coordinator who has obtained consent from study participants, I have mixed feelings on the topic.

Poor literacy and health literacy levels are barriers to proper health care across all clinical areas. This includes the informed consent process within clinical research, which is intended to protect the rights and welfare of subjects by educating them about their potential participation in a clinical trial.

Informed consent must be obtained from research subjects prior to having any study-related testing or procedures completed for clinical trials.  For the requirements of informed consent, we refer to the Code of Federal Regulations (CFR), Title 21, Part 50: Protection of Human Subjects.   21 CFR 50.20 states, “The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.”  And 21 CFR 50.25 describes elements which have to be included in the Informed Consent.   But what does this mean exactly?

It’s official! According to the new guidance released on the FDA’s website all applicable clinical trials initiated on or after March 7, 2012, informed consent documents must be in compliance with the new requirement in 21 CFR § 50.25(c) and include this specific statement that refers to the trial’s description on http://www.clinicaltrials.gov:

I recently came across this article describing the benefits to having a shortened informed consent form. As a monitor who has had experience with reviewing informed consents, as well as a former research coordinator who has obtained consent from study participants, I have mixed feelings on the topic.