An Obligation to Advise and Explain

Before they are permitted to enter a clinical trial, patients must first sign an informed consent form. The clinical trials nurse or nurse coordinator is usually responsible for this process. At Duke University Medical Center, patients are referred for a clinical trial after speaking with their oncologist or the principal investigator of the study. All of our oncologists can refer patients for studies but the principal investigator is responsible for ensuring informed consent is obtained prior to entering a trial. The principal investigator can delegate this process to the clinical trials nurse, who should be qualified, knowledgeable, and comfortable enough to answer prospective patients’ questions about the trial.

Obtaining informed consent is an ongoing process that is designed to provide comprehensive information to patients and give them time and support to decide whether they want to participate. Our nurses send copies of the informed consent prior to the patient arriving for their consult, giving them ample time to review the form and write down their questions.

The informed consent form itself is a document that provides a summary of the trial, outlining the trial’s purpose, discussing risks and benefits, listing a schedule of key events, and reviewing alternatives to participation. When obtaining informed consent, the nurse should be able to provide explanations without bias or coercion that will help patients decide whether participating in the trial is right for them. The patient should then be continually updated with any new information that may affect their participation.

The setting for obtaining informed consent is also an important consideration. The form should be explained in an unhurried, private atmosphere. It is also often helpful for patients to have a friend or family member present, because sometimes patients can be overwhelmed and only remember some of the conversation. At our hospital, the nurse reviews the consent form word-for-word, going over each section to make sure patients understand the information and have time to ask questions. Patients should be asked to explain in their own words what their understanding of the trial is, what they will be required to do during the trial, and what risks and benefits are involved. Patients must initial each page of the consent form and sign the last page. A copy of the signed consent should then be given to the patient.

According to the Code of Federal Regulations 50.25, an informed consent should include these elements:

1) A statement about the purpose of the study, the duration of the study, and procedures to be followed.

2) A description of any foreseeable risks involved in the study. This should include information based on previous research done with the drug.

3) A description of any benefits that the patient could receive from the drug under study.

4) An explanation of other alternative procedures that might be of advantage to the patient.

5) A statement regarding confidentiality of records and who can view records while the patient is in the study.

6) A statement that explains any compensation or medical treatments that are available if a patient is injured as a result of participation in the study.

7) An explanation of whom to contact regarding questions about rights as a research subject. Duke University Medical Center’s consent forms include the phone number of our Institutional Review Board office.

8) A statement that participation is voluntary and patients may withdraw from the study at any time.

Informed consent is an ongoing, interactive process that should allow the patient the opportunity to ask questions and raise concerns as needed. Oncology nurses are key players in this important part of the clinical trial process. They must not only be thoroughly knowledgeable about the trial itself but must also completely understand the informed consent process and patients’ rights. It is also critical that oncology nurses be able to explain the details of the trial in such a way that the patient fully comprehends the risks and benefits. During the study, oncology nurses are responsible for informing patients of any new findings or changes to the study protocol.

Roxanne Williams-Truax, RN, BSN, OCN, is a research nurse clinician with the Duke Clinical Cancer Trials Services at Duke University Medical Center.