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The Complex Maze of the Informed Consent Process: Helping to Improve Comprehension in Clinical Trial Participants with Alzheimer’s Disease

Abstract

We intend for this article to provide a foundation toward the creation of a more patient-centric approach to the informed consent process. Our overall objectives are to promote ethical clinical research standards and procedures toward enhanced supportive systems for clinical trial participants. We provide a suggested format which multidisciplinary clinical trial researchers can adapt for their own clinical trial setting.

People who have been given the devastating diagnosis of Alzheimer’s disease live with the hope for a cure. There are thousands of individuals willing to try an innovative treatment in hopes of finding the secret to halting the disease progression. Many receive a physician’s recommendation to enroll in a clinical trial and others search www.clinicaltrials.gov to locate a hospital conducting a clinical trial. There are hundreds of clinical trials looking for study participants, and too-many-to-count potential participants who would be eager to join in the effort to find a cure or delay the onset of symptoms.

Over 5 million Americans are currently living with the diagnosis of Alzheimer’s disease. Worldwide, approximately 30 million people have been diagnosed with this condition and that number is projected to triple by 2050 [2]. There are a variety of ways to attempt to manage the disease process, but even with today’s modern miracles of medical interventions, the decline of Alzheimer’s disease is irreversible. Most people who are diagnosed with this progressive neurodegenerative disease do not notice the presence of symptoms when the disease is at the earliest stages [8]. Common disease-related changes include cognitive deterioration, memory loss, psychosocial incapacity, and decision-making difficulties [1]. Alzheimer’s disease is a leading cause of death in Americans 65 years of age or older [4]. Although many researchers are hard-at-work trying to find a cure, there is no cure for Alzheimer’s disease at this point in time [3]. This disease that affects the lives of so many people has no known effective affordable cure as of this date.

A physician or other researcher will go through a process of informed consent before a potential participant can sign-up for participation in a clinical trial [6]. A clinical trial is a closely controlled environment where an innovative new treatment, drug, or medical device is tested for effectiveness and safety [9]. The informed consent protocol can vary from requiring only a few minutes for a quick review of a couple of pages to hours of reading a detailed document of dozens of pages. The informed consent process includes, but is not limited to, a description of anticipated procedures with the probable risks, benefits, and financial costs. The participant will be told that there is a right to stop any procedure at any time during the trial period.

In all phases of clinical research (Phase 0–III), the informed consent process is important to protect the human participants from potential harm [6]. Moreover, this consent process is not merely a one-time signing of a document and it is not solely for researchers to obtain initial permission to conduct clinical research on human participants. This ever-changing process is ongoing throughout the clinical and regulatory phases with a primary aim to adequately inform the participants during the complete duration of the clinical trial [10]. This continuous informed consent process should emphasize and delineate all possible modifications to procedures and any change to risks and benefits. Any information that may help participants decide whether they should continue participation should be shared [3]. Furthermore, the informed consent process is an indication of respect for the individual participant and an acknowledgement of all participants’ right of autonomy, to either participate or to not participate in the clinical trial. Investigators are ultimately responsible for the conduct of all significant participants during the informed consent process, including the clinical investigators themselves.

The informed consent process is intended to protect participant rights and safety. The consent process for a study participant with Alzheimer’s disease or other cognitive limitation requires the engagement of an additional witness as an added level of protection for the study participant and the researcher. The investigator should attempt to maximize opportunity for clinical trial participants to not only learn about pertinent potential benefits and possible risks but to also comprehend the study goals. Accordingly, the informed consent process minimizes the scientific knowledge gap, aids in assessment, and promotes decision-making [7]. In this informed consent process, the participant is encouraged to adequately assess the risks of participation, such as the likely side effects and the time commitment, while the benefits of participation, such as the therapeutic value of feeling less anxious or improved concentration, can be more thoroughly discussed.

It is normal and usual for a potential participant to feel overwhelmed or confused when presented with the descriptions and amount of information shared as a part of the informed consent process prior to clinical trial participation. Potential participants may be overeager to quickly provide consent to join in the clinical trial due to the physical and emotional toll of Alzheimer’s disease and the lack of available treatment and cure options. Concerns may be generated from a fear of decreased ability to make correct decisions due to the progression of the disease. The symptoms associated with Alzheimer’s disease may negatively influence ability to comprehend and remember the information shared during the informed consent process. A better understanding of the informed consent process can help a potential clinical trial participant be better prepared to give permission for participation towards making a truly informed decision.

Our intent in designing this list of pointers and suggestions is to provide some guidance for the potential clinical trial participants as well as to assist the multidisciplinary clinical trial researchers mandated to obtain informed consent.

A GUIDE TO THE INFORMED CONSENT PROCESS FOR POTENTIAL CLINICAL TRIAL PARTICIPANTS

  • 1. Before the visit

    • a. Ask for a sample consent form and any other related documents before going to the office or clinical site.

    • b. Review the sample documents.

    • c. You are likely to meet many staff members when you visit our clinical trial investigation site. Our professional staff includes nurses, physicians, clinical research coordinators, insurance billing department analysts, and spiritual support leaders. While still at home, sit in a quiet spot and make a list of questions to ask members of our team. Question topics you might want to ask about include clinical therapeutic possibilities, medical implications, logistical procedures, financial policies, or spiritual issues.

    • d. Ask if a team member, such as a clinical nurse, physician, or other person very familiar with the clinical trial, can make time to be available to answer questions you would like answered before the scheduled visit.

    • e. Invite a trusted friend or family member to accompany you for support.

  • 2. During the visit

    • a. Bring a notepad and a pen to take notes. Take lots of notes!

    • b. Ask to slow down if the discussion becomes confusing or if you do not understand.

    • c. Ask questions for clarification and to eliminate doubts.

    • d. Use a highlighter to mark everything important on your notes.

    • e. List the next scheduled appointments including time and dates.

    • f. Note format for any follow-up recordkeeping and the frequency of the required documentation.

  • 3. Before you sign!

    • a. Ask for more time to think about it if you are not ready to give your consent. You do not have to sign on the dotted-line then and there! It is okay to take additional time for making your decision.

    • b. Carefully assess and weigh the risks (for example: the likely side effects) and benefits (for example: improved concentration) before deciding whether or not to enroll in the clinical trial.

    • c. Each participant has the right to end participation in a clinical trial. All trial participants have the right to withdraw informed consent at any time. There is no need to explain if you decide to end your participation.

The investigator is responsible for establishing an environment that will promote a patient-centric approach to the informed consent process. Providing a guide or a set of suggestions specifically directed toward a participant will promote a patient-centric approach to the informed consent process. In this setting, investigators are better able to align specific decisions with each participant’s wants, needs, and preferences. A patient-centric approach inherently increases participant ownership and autonomy. A higher level of trust-building between participant and investigator is built by providing this type of structured guidance to participants. Investigators must create a suitable practice with standard procedures to encourage the proper participant mindset for a true informed consent process.

CONFLICT OF INTEREST

The authors have no conflict of interest to report.

ACKNOWLEDGMENTS

We thank the following individual for their academic support and guidance in clinical research and the informed consent process: Samar Nasser, PhD, MS, MPH (The George Washington University) and Andrew H. Ko, MD (University of California, San Francisco). Additionally, we thank JAD Reports for providing the mentorship, guidance, and support for young investigators and authors.

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