The Role of Ethics from a Clinical Research Associate’s Perspective: Patient-Centered Research

A contract research organization (CRO) functions as the intermediary between a biopharma company sponsoring clinical trials and the research sites where trials are conducted. An important element of value the CRO brings to the table is its study monitor team made up of clinical research associates (CRAs) delegated to perform a wide variety of tasks from the inception of a trial until the end, and mandated with the goal to reduce costs and ensure trials are completed on schedule.

The role of the clinical research associate (CRA) requires that many competing priorities are top-of-mind for the duration of a trial; there are stringent timelines to meet, study amendments that are always coming through the pipeline, and site needs that vary from one hospital to the next. With all of these moving parts, skillfully juggling these competing priorities is the cornerstone of success. Above all, however, the one thing that must remain in the foreground for every skilled and effective CRA is the quality of care study participants receive.

The most successful CRO team keeps all parties happy; assuring the Sponsor meets all set timelines requires skill, finesse and organization to effectively collaborate and not overburden study sites, all the while ensuring that study participants receive ethical treatment.

So, how does a skilled and effective clinical research associate balance all of these factors while maintaining an ethical mindset and keeping the patient in mind?

For starters, all study members at all levels from the Sponsor to the CRO to the Site are familiar with, and have trained on, the ICH-GCP, the gold standard for clinical trials involving human research.

Furthermore, under the responsibility and guidance of the clinical research associate (CRA) study team members present participants with informed consent forms to ensure they are clearly aware of the risks, benefits, privacy specifics, and details of the trial in which they’re about to participate. Once this step is completed the skilled and effective CRA reviews the participant’s signed informed consent form for accuracy along with the Site’s consenting procedures to confirm that the participant is indeed aware of their legal and ethical rights.

Study participant privacy is another very important facet for concern. Even though privacy laws are in place at the national level, privacy standards can differ from one study Site to the next. For instance, some personal health information (PHI) that is approved by the research ethics board (REB) to be used in a trial at one Site (e.g. initials, month and year of birth, etc.), could constitute a privacy incident at another.

Therefore, to mitigate the occurrence of a privacy breach the skilled and effective clinical research associate (CRA) is familiar with each of the different REB processes involved in the study they are monitoring and is thereby able to anticipate a privacy incident before it occurs. Also, of extreme importance in protecting privacy is the deidentification of study documents as they will be retained for 25 years as per the Health Canada: Part C, Division 5 Guidance Document; this is mentioned in the informed consent form for the participant.

What are the two key questions to constantly address?

During the life of a trial, there are going to be unforeseen challenges. As the key player on Site for a CRO the skilled and effective clinical research associate (CRA) is constantly seeking out ways to address the following two constant and critical questions:

• What can be done to minimize the risks and discomfort that a participant may experience during this trial?
• How can we best ensure trial participants are being treated ethically?

What does communication have to do with it?

What it boils down to is communication, communication, communication! Conducted in an effective and timely manner, most importantly between-site visit communication is key. As the CRA is on-site once every few weeks, it’s fundamental to engender trust and open communication with the study team so that the CRA is updated whenever study-related events occur at the site level, whether that be a patient experiencing a serious adverse event or a study physician leaving the Site.

The skilled and effective clinical research associate (CRA) is committed to establishing and maintaining a positive relationship with Sites. In so doing they’re considered a valued member of the study team and are made aware of ongoing study activities occurring at the site level. If a Site is happy with their CRA, not only will they pay closer attention to the trial, they will work harder to meet deadlines set by the Sponsor. Likewise, the CRA is trusted to responsibly communicate new study information to the Site, and, can be counted on to support the study team in adhering to timely submission of study documents to the REB.

There are many parties involved in clinical trials and a lot of moving parts when it comes to ensuring that trial participant safety is not jeopardized over the course of a study. In the end, all of us are working toward the same goal and it’s important that study members at all levels have a symbiotic relationship built on trust and mutual respect.

Contributed by: Aaron Zambrana, Clinical Research Associate