Understanding the Clinical Trial Enrollment Process

Part One: Informed Consent and Screening

Whether a person has been newly diagnosis with HIV and referred to an ACTG Network site, is living with HIV and has relocated for school/work or elects to change doctors, there are a variety of reasons why someone might want to learn more about the clinical trials we conduct. This initial contact is often the beginning of a long- term relationship between a study participant and a researcher like Cheryl Keenan, RN, Research Nurse, at our Brigham and Women’s Hospital Clinical Research Site in Boston, MA.  Cheryl notes that the process of educating potential study participants about our trials begins during informed consent, but it also continues for the duration of someone’s participation in current and future trials. 

Informed consent must be given freely, without coercion, and must be based on a clear understanding of what study participation involves. This discussion begins well in advance of the start of any study-related procedures and allows potential study participants time to reflect on the possible benefits, risks and discomforts of participation in a clinical trial.  Not only does this interaction provide potential study participants with information about how clinical trials are conducted, it also serves as a way to begin to establish rapport and trust.

“Informed consent is a vital part of the research process, and as such entails more than simply obtaining a signature on a form,” said Cheryl. “Researchers must fully educate potential study participants to ensure they can reach a truly informed decision about whether or not to participate in a trial.”

When meeting with a potential study participant to review and discuss details of a specific trial, researchers use an institutionally approved document as a guide.  This allows them to go over all of the required elements of informed consent, for example, the purpose of the research, the procedures to be followed, the risks and discomforts along with potential benefits associated with participation, and alternative procedures or treatments. In addition, the required length of the trial and number of clinic visits is discussed as well remuneration. Potential study participants are then given a copy of the informed consent document so they have the opportunity to carefully read and discuss the research with their family, friends and/or physician and to develop any questions. Once they have fully read the informed consent document and all of their questions have been answered, if they decide to agree to be a study participant in a trial, they sign and date the informed consent document. After informed consent is given, the screening process begins.

The screening process is not just lab work; rather it is a chance for researchers to gather a better sense of whether an individual will be able to commit to the requirements and is a good fit for a study. Cheryl notes that effectively screening potential study participants is a careful and thoughtful process that can have significant implications with regard to successful enrollment and retention. The screening process involves more than just discussing pill counts and the importance of treatment adherence, researchers are trying to determine if an individual will stay in contact with them, provide timely responses to requests and commit to regular clinic visits.  If all the lab results fit within inclusion criteria for a study and both parties agree it is a good fit, it is then that the study participant will actually be enrolled in the trial.  At this stage, solid rapport and trust has been established and typically is the beginning of a long-term relationship between a researcher and study participant.

“I try to build the best relationship possible with all the study participants I work with because I know they rely on me to not only serve as a resource, but also to be their confidant and cheerleader,” said Cheryl.  “I make sure that every study participant has my full contact information and knows that I am available 24/7 to support them and answer any and all questions they may have. Whether it is about how to connect with a social worker or support group or how to deal with the stress of managing a chronic disease like HIV, I want our study participants to know that I am there for them.”

Cheryl has developed numerous special relationships with the study participants she interacts with over the course of trials.  In some cities with a large college or university presence, younger study participants sometimes view her as a mother figure. For individuals who have been living with HIV for many years and decide to participate in clinical trials, many find it comforting to know that Cheryl is always advocating for their best interests.

The importance of the informed consent and screening process should never be taken lightly.  Not only do we have to ensure beneficence (benefiting others) and non-maleficance (ensuring no harm) to all of our study participants, we must always remember that without them, there would be no ACTG Network.