Compliance In Focus

Coming from a background of working as a patient care nurse in the ICU, I would witness the consent process on a daily basis for biopsies, bronchoscopies, chest tubes, arterial lines, etc... These were non-research procedures; they were procedures to assist in the treatment of the critically ill. When I first started a career in research, I already knew that obtaining consent was more than a piece of paper and that it was a discussion and a process, but “a consent is a consent” for standard treatment in a hospital or for research, right? WRONG- I found out very quickly through IMARC’s training program that obtaining consent in research involves so many different specific elements, different from an informed consent for non-research procedures.

The terms Essential Documents, Investigator Binder or Study Binder are sometimes used interchangeably. For all clinical research trials involving human subjects, there must be a file maintained by the Sponsor and the Investigator containing all the necessary paper work to support the clinical trial and could be called any of the above-mentioned names. During an onsite review of study records by an IMARC monitor, essential documents are reviewed to ensure that they are present, accurate, complete and current by following the ALCOA checklist and as specified in the FDA regulation 21 CFR 812.140.

When the words “Clinical Research Trial” are heard, many questions may come to one’s mind. What is being tested?  What is involved? Where will it be taking place? Who came up with the trial? Who is paying for it? What doctors are participating? Many of these answers for an Investigational Device (IDE) clinical research trial can be found on ClinicalTrals.gov.

Coming from a background of working as a patient care nurse in the ICU, I would witness the consent process on a daily basis for biopsies, bronchoscopies, chest tubes, arterial lines, etc... These were non-research procedures; they were procedures to assist in the treatment of the critically ill. When I first started a career in research, I already knew that obtaining consent was more than a piece of paper and that it was a discussion and a process, but “a consent is a consent” for standard treatment in a hospital or for research, right? WRONG- I found out very quickly through IMARC’s training program that obtaining consent in research involves so many different specific elements, different from an informed consent for non-research procedures.

Since the suicide death of Dan Markingson in May of 2004, there has been a lot of debate as to whether or not the 26 year old psychiatric patient should have been approached to consent to participate in a clinical research trial for the comparison of three atypical antipsychotic drugs. Recently, there has been an article published in the Minnesota Daily about a petition signed by over 3,000 ethicists, researchers and scholars asking the University of Minnesota’s President to review the case to prevent future tragedies at the institution. Such a petition was created due to several errors in processes related to human subject protection.