Compliance In Focus

In July, 2014, FDA released a new draft guidance to reflect current thinking on the informed consent process:  Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.

If you’re at all familiar with the scientific community then you’ll probably recognize the National Institutes of Health, also known as the NIH, as scientific research’s biggest advocate. Part of the U.S. Department of Health and Human Services (HHS), the NIH serves as our nation’s premiere medical research agency, granting greater than 80% of its budget to research and academic institutions through the distribution of almost 50,000 competitive grants. With such a generous hand for developing research, there is no question as to why so many academic and medical professionals both welcome the support and praise the involvement of the NIH in their research ventures.

I came across an 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.

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.

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.

It is a common question that follows an informed consent document revision- does the subject need to re-sign? The answer could be yes or no depending on the type of revision that was made to the document. 

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?

Informed consent checklists, just like the informed consent, are more than just a document, but rather can be a process. To begin, what is an informed consent checklist and how do you use one?

When a monitor has a tiny epiphany while working through a difficult compliance issue with a site, or an ‘Ah-ha!’ moment, we call that a ‘Regulation Revelation.’ After reviewing an informed consent that lacked the required statement regarding registration on clinicaltrials.gov (21 CFR 50.25(c)), I discussed it with the sponsor and had an ‘Ah-Ha!’ moment I’d love to share.

Informed consent is arguably the most important aspect of patient protection in clinical research. The informed consent process is intended to protect the rights and welfare of subjects by educating them about their potential participation in a clinical trial. Unfortunately, informed consent remains an issue today. In fact, the FDA has sent out many warning letters regarding informed consent over the last few years.

As we enter 2013, how often do you find yourself in a city different from your relatives? In an emergency, many hospitals have policies and procedures to obtain consent for treatment from your legally authorized representative by phone, email or fax.  When a research subject is unable to participate in the informed consent process, and their Legally Authorized Representative cannot physically sign for them, should this automatically exclude them from participating in clinical research? Can a discussion via video chat or phone, well documented, satisfy the requirements?

We call it providing a "Third Set of Eyes."  Interestingly enough, most IMARC monitors have a background in nursing, or as research coordinators. It may very well be that this experience has assisted us in monitoring to empathize with each subject. After all, so many years were spent one-on-one with patients; we see them as individuals- not just subject numbers.

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.