I have worked in the field of clinical research for the past 10 years as a regulatory documents specialist. It is my job to review documents to make sure they follow requirements and regulations of the Food and Drug Administration and European Medicines Agency. Much of what is required by the FDA and EMA is based upon Good Clinical Practices, which are in turn based upon ethical codes established to protect the rights and welfare of research subjects. The first such code was created as a reaction to the atrocities, labeled “medical research,” that took place during the Holocaust. That precedent-establishing document is called The Nuremberg Code. It was written as a result of the trials focused on prosecuting war criminals, including doctors involved in the human experiments in concentration camps.
On behalf of our clients, the Clinical Development team at United BioSource Corp., an Express Scripts Company, supports programs that embrace paramount ethical and scientific obligations for the protection of study patients and for the integrity and reliability of data. There is no one at UBC who does not enthusiastically agree with and act in accordance with these obligations.
Verifying Qualifications of Investigators
Ensuring that only qualified medical personnel conduct studies protects the patients and data. In my role, I verify the qualifications of principal investigators and study staff. The quantity and quality of relevant education, responsibility during study conduct, research experience and licensing level must be explicitly listed, and required site personnel documents must be supplied.
I am always on the look-out for inconsistencies or things that simply don’t make sense, which are indications of possible irregularities and may require further investigation. For example, the investigator’s CV may not list the research site as a place of current affiliation, the license may have lapsed or is from a state different from the site’s state, errors on documents are obscured with white-out or multiple cross-through lines, or signatures of the same person appear radically different from one document to the next.
Ensuring Patients’ Informed Consent
I ensure that all informed consent forms (ICFs) fulfill their intended function by fully –and in plain language – explaining the procedures, risks, alternative treatments available, and time commitment required from the study. ICFs must also explain completely the rights of subjects in a clinical study to:
- Be fully informed before consenting,
- Withdraw consent at any time without penalty,
- Be compensated for injury related to study participation, and
- Release or restrict to whom their protected health information can be given.
The rigorous set of checks and balances is needed to ensure patient protection as well as to reduce the chance of fraud and misconduct within clinical studies.
Preventing Fraud and Misconduct
Some obvious cases of fraud and misconduct occur because an investigator is looking for monetary gain or prestige. Yet more commonly, misconduct occurs when investigators and their staff become sloppy with data collection or when investigators use poor judgment by not following the patient inclusion criteria.
Our teams at UBC consider it our responsibility and privilege to uphold the codes of Good Clinical Practices for the protection of patients and the integrity of clinical research.
Standing Up for Human Rights
The Auschwitz camp was the primary location of the medical experiments, as directed by Josef Mengele, nicknamed the Angel of Death. My dad narrowly passed through many “selections” for death and medical experimentation, but luck seemed to always be with him. As the war was coming to its end in the winter of 1945, the Allied forces were sweeping across Germany. In an attempt to cover up for some of what they had done, the Nazis emptied out many of the camps by making the survivors go on "Death Marches" to other locations. My father was forced to endure this last torture, to trudge through cold and snow, with little food and minimal clothing. His group, which began with nearly 1000 prisoners, ended at the Dachau camp with a couple hundred. Although he was a mere 90 pounds when Dachau was liberated by the Americans, he maintained his strong will to survive and became physically well again.
The pain that comes with knowing what all Holocaust victims endured is profound, but so is the pride I feel for my father's courage and determination. Every day, with every document I review, for every informed consent form I edit, I am standing up for human rights, and there is nothing more fulfilling than that.
Today marks the 70th anniversary of the end of World War II in Europe. Just a few months before this day in 1945, Allied troops liberated Auschwitz-Birkenau, the largest Nazi death camp, where my father was imprisoned for nearly three years. For me, today is a day to honor him and all victims of the Holocaust. It’s also a day to reflect on how my work carries on his legacy.
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