Subject advocacy and the clinical trials nurse

ADVOCACY, one of the core provisions of the Code of Ethics for Nurses, is a pivotal role that a nurse undertakes when caring for patients.¹ When advocating for patients, the nurse promotes patients' best interests and defends them against violations of their rights.^2,3 Nurses are ideally positioned to act as advocates due to their proximity to patients and their caring nature.³

This is particularly true for the clinical trials nurse (CTN). As a result of education and experience, the CTN understands the difference between clinical care and clinical research; balances the roles of patient advocate, subject advocate, and research advocate; and uses nursing standards and research guidelines to direct subject advocacy.

Because of the CTN's rapport and frequent interaction with research subjects, this professional is in the best position to advocate for them. This article focuses on the role of the CTN in subject advocacy and the ethical principles involved.

Basic elements

To ensure that their rights, safety, and well-being are preserved, people participating in clinical trials need advocates for both clinical care and clinical research. Clinical or standard care includes interventions intended to promote the best medical interests of a patient.⁴ In contrast, clinical research employs human subjects to investigate human biology, health, or illness.⁴

Ethical clinical research depends on the appropriate conduct of the clinical research team. The principal investigator (PI) is ultimately responsible for all study activities at the site. The PI may have an MD or PhD, or in the case of nursing research, a DNP, APRN, or MSN. The CTN, another integral member of the research team, coordinates the daily management of the clinical trial.⁵ The CTN may be an RN, have an advanced nursing degree, and/or be certified in the field of clinical trials research. The CTN's role may include recruiting and screening participants, obtaining informed consent, ensuring randomization, collecting and recording data, and following up with participants.⁶

Clinical care versus clinical research

To understand the challenges the CTN faces when advocating for research subjects, weigh the differences between the goals of clinical care and clinical research. When providing clinical care, clinicians carry out certain interventions or procedures because they're believed to be safe and effective.⁴ In the clinical care setting, healthcare providers rely on evidence-based practice to direct care.

In clinical research, activities are designed to answer a question and generate knowledge to provide evidence-based practice for the clinical care of patients or society in the future.⁴ Determining the safety or effectiveness of an intervention is the rationale for research.⁴ Most clinical research takes place in clinical trials, which are intended to test the safety and efficacy of interventions in humans.⁴

Nursing advocacies

To act as an advocate, the CTN must balance the various roles of clinical research. This includes advocating for the patient, the research subject, and the research.⁴ In accordance with the Code of Ethics for Nurses, the CTN acknowledges that the primary commitment is to the patient.^1,5

The CTN, who as a nurse is educated as a patient advocate, must take into account what's best for the patient when considering someone as a research subject.⁴ For instance, the CTN is considering recruiting an older woman who meets study criteria. The CTN knows that for this patient, traveling to follow-up visits in the winter could be difficult or dangerous.⁷ Acting as a patient advocate, the CTN would discuss these concerns with the PI and advise against recruiting this patient in order to keep her safe. Ultimately the decision is made by the PI. However, advocacy dictates always keeping the patient's best interests at the forefront.

As a subject advocate, the CTN helps ensure that subjects are recruited in a responsible manner and are well-informed about all aspects of the clinical trial and alternatives, and that subjects' rights and well-being are protected.⁴ The informed-consent process ensures subjects are well-informed about the clinical trial.

Consider this example. A patient who speaks and understands little English approaches the CTN about possibly enrolling in a clinical trial of an investigational treatment for advanced heart failure. The patient meets the eligibility criteria, and the CTN is considering recommending the patient for enrollment in the trial. The CTN arranges for a medical translator to be present during the informed-consent discussion. In this case, the CTN acts as an advocate for the subject by helping to ensure the subject understands the clinical trial and what researchers expect of the subject. By ensuring the subject receives and understands this information, the CTN helps the subject make a truly informed decision.⁴

The CTN is responsible for supporting the goals of research and maintaining the legitimacy and integrity of the research trial.⁴ The CTN must collect and record data, manage regulatory documents, report all adverse events, and make certain everyone adheres to the protocol. A critical role is ensuring subjects comply with the research protocol to minimize the number of deviations from the protocol and collect valid data.

For example, a patient who's participated in clinical trials in the past approaches the CTN about enrolling in a trial for a new drug for hypertension. The CTN knows that this patient hasn't adhered to research protocols in the past. As an advocate for the research, the CTN wouldn't enroll this patient in order to protect the validity of the research trial.

To be an effective advocate, the CTN has to recognize the magnitude of each of these advocacies and balance them according to the situation.⁴

Nursing standards versus research guidelines

The nurse who works in research can rely on nursing standards and research guidelines to guide practice and deliver care ethically, including the American Nurses Association (ANA) Code of Ethics for Nurses and the ANA's Nursing: Scope and Standards of Practice.^1,8 The Code of Ethics is the nursing profession's nonnegotiable ethical standard.¹ Outlining every nurse's ethical obligations and duties, it articulates nursing's commitment to society.¹

Nursing: Scope and Standards of Practice discusses the duties that all nurses are expected to perform, regardless of their role, the patient population, or practice specialty.⁸ These standards may function as evidence of the standard of care; that is, by performing to these standards, the nurse is providing the standard of care.⁸

CTN must use the Code of Ethics as the foundation for advocacy.¹ It contains nine provisions: The first three describe the value and commitments of the nurse, the next three deal with the boundaries of duty and loyalty, and the last three discuss aspects of duties beyond individual patient encounters.¹ Provision 3 specifically applies to the CTN as an advocate: “the nurse promotes, advocates for and strives to protect the health, safety, and rights of the patient.”¹

Each person has the right to decide whether or not to participate in clinical research. The person must receive adequate information about the research and fully understand it to make an educated voluntary decision about participation.¹ The CTN can guarantee that the research subject has been provided with this information and understands it by asking the subject to repeat the explanation in his or her own words.⁹

Nursing:Scope and Standards of Practice is divided into two sections: Standards of Practice and Standards of Professional Performance.⁸ The six standards of practice are elements of the nursing process: assessment, diagnosis, outcomes identification, planning, implementation, and evaluation. Using the nursing process when caring for a research subject, the CTN

• assesses whether the subject is eligible for the research study.
• confirms that the subject's diagnosis qualifies the subject for the research.
• sets goals for the subject based on the research protocol.
• implements the plan and continuously monitors or evaluates the subject's progress in the research study.

The Standards of Professional Performance contain 10 standards for behavior of the nurse in the professional role. Standard 7, Ethics, specifically applies to the CTN as an advocate. The competencies for this standard include:

• using the Code of Ethics to guide practice¹
• delivering care that preserves the subject's autonomy, rights, values, and beliefs
• assisting the subject in self-determination and informed decision making
• taking appropriate action against unethical or inappropriate behavior that can jeopardize the best interests of the subject.⁸

To meet this standard of performance, the CTN must comply with the competencies. At each encounter, the CTN should question the subject to ensure that (1) informed consent has been received, (2) his or her participation is voluntary, and (3) the subject wants to continue in the study. By ensuring adherence with the protocol, the CTN can make sure the subject is protected from harm.¹⁰ If fraudulent research is suspected, the CTN is required to report this information to the FDA.

Setting high standards

According to Nursing: Scope and Standards of Practice, the nurse promotes healing and health.⁸ In clinical research, rather than promoting healing and health, the CTN promotes the testing of a drug, biologic, device, or product that may promote healing or health for future patients. Nursing: Scope and Standards of Practice also states that nursing interventions are intended to produce beneficial effects, contribute to quality outcomes, and, above all, do no harm.⁸ In clinical research, the CTN hopes the interventions being tested will produce the desired effects but can't be sure they will.⁴

Because no recognized standard of care existed in clinical research, an international standard for clinical research implementation was established: Good Clinical Practice (GCP).¹¹ GCP “is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.”¹² (For more information, see Exploring additional resources.) By following the nursing standards and research guidelines, the CTN can be sure to advocate for subjects and protect them from harm.

Challenging role

Advocacy is one of the most important duties of a nurse. The CTN must be able to balance the nursing advocacies for the patient, the subject, and the research. Further research is needed about the role of the CTN as a subject advocate.

Exploring additional resources

These documents provide guidelines and laws that govern the codes of research ethics and help guide the CTN in practice:

• The Belmont Report
• The Declaration of Helsinki
• 21 Code of Federal Regulations (CFR) and 45 CFR 46
• International Conference on the Harmonisation of Technical Requirements for Regulation of Pharmaceuticals for Human Use
• GCP.¹¹

For example, The Belmont Report focuses on the basic ethical principles that should underlie the conduct of research involving human subjects: respect for persons, beneficence, and justice.¹³ The CTN should rely on these basic ethical principles when recruiting subjects through the informed-consent process and by consistently assessing the risk/benefit ratio of each clinical research protocol.

For more information on GCP documents, please visit the following websites:

• FDA: http://www.fda.gov
• National Institutes of Health: http://www.nih.gov
• The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): http://www.ich.org.