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Informed consent: Revisiting the issues
Informed consent is necessary for the ethical conduct of research with human subjects and is required prior to surgery and invasive healthcare procedures. Frequently, researchers and healthcare professionals believe they are obtaining an individual’s informed consent.
They have explained the protocol, offered to answer any questions, and given the document to the person to review and sign in his or her presence. However, the goal seems to be to get the person’s signature, be it the individual or a surrogate if the person is impaired or incapacitated. The emphasis is often more on the product rather than the actual process of informed consent. The act of obtaining informed consent is based on several guiding ethical precepts: self-determination, protection of human dignity, and respect for persons. Protecting human dignity requires that persons be treated with respect; study participants are not solely a means to some other end. Each person has the right and freedom to choose to participate without duress.1,2
Issues related to informed consent
Issues related to informed consent focus on capacity to decide, disclosure of information, assessment of understanding, and voluntariness.
Capacity to decide. Individuals must have the capacity to make the choice that they are being requested to make. Therefore, what choices people can make themselves can vary on the basis of the level of understanding that is required for that situation.3 From an informed consent perspective, the goal is to make certain that participant rights are protected. The study protocol must be explained in such a way that individuals know what will be happening and what they are expected to do. These explanations need to be presented using language that potential participants understand.
Disclosure of information. How much information needs to be disclosed about the study? What would a reasonable person want to know if he or she was being asked to participate in the study? Considering these questions can provide a useful starting point for disclosing information. The goal is to provide potential participants with sufficient information such as the nature of study, what is expected of them, what are the potential risks and/or harms, what are the benefits, the right to withdraw, who has access to information, and how information will be disseminated. An additional goal is to decrease anxiety that can occur if too much detailed information is provided.4 Having a conversation with the potential participant provides a forum where information can be shared by someone who has knowledge about the study and who can facilitate the asking of questions, as well as provides appropriate answers.5,6. This approach helps to engage the potential participant and demonstrates respect for the person.
Understanding. Assessing a person’s understanding is often assumed if the person nods his or her head during the explanation and when asked about any questions, says, “No.” However, this assumption and the potential participant’s response may be incorrect. The possibility also exists that the person does not know what questions to ask. When the potential participant does not have any questions, the researcher can exercise the option to ask questions that address the essential elements of the study.
Voluntariness. Researchers and potential participants need to understand that a voluntary decision-making process is essential when someone gives informed consent. Several considerations are important to ensure the voluntary nature of informed consent. Blind trust in the person who is conducting the study can impede voluntary decision making. For example, if the person’s healthcare professional is the principal investigator, the potential participant may consent because of the trust relationship that already exists.
Making a voluntary decision to participate requires that the person weighs the information that was presented, reviews the informed consent document, has the opportunity to ask questions, and considers personal values and preferences. The person should want to participate rather than feel compelled to participate.
Addressing the issues
How information is presented, who describes the study protocol, and what individuals understand influence their decision making about participating in a study. Several strategies are relevant to address these issues: developing quality informed consent documents, training the research staff, and regular monitoring of the consent process.
Developing quality informed consent documents. Although there are specific components that are required in the consent document, there is no standard research protocol; every study is unique. Therefore, the consent document needs to be designed specifically for the study and the population from which participants will be sampled. Researchers need to provide a description of the study in plain language that can be easily understood by the potential participants. Having the content of the consent document reviewed by an advisory committee of individuals similar to the people who will be recruited is essential.7
Training the research staff. Once the research staff is selected, the investigator needs to implement a carefully designed orientation program. The researcher cannot assume that staff members are knowledgeable about informed consent because of their past experience on other projects.
Training requires more than reviewing the recruitment and enrollment process with the staff. Role-play and simulation can be used to allow the staff to practice introducing the study and responding to questions of potential participants. As staff members work through scenarios, they can begin to identify “talking points” about the study and learn the importance of taking time, assessing participant understanding, and using nonbiased language.
Depending on the nature of the study or the individuals who are being recruited, the consent process may take longer or occur in several steps. Some people may request that the study be explained when a family member is present. Some are more comfortable with having a family member present before saying “yes.” Another possibility is that a brief telephone explanation about the study can be offered when a person responds to a letter of invitation or recruitment flyer, followed by mailing a copy of the consent document, and then having a face-to-face conversation about the protocol and getting consent.
Frequently, the approach that is used to assess understanding is to ask a person whether there are any questions; however, this means may be ineffective, as the person may not feel comfortable asking questions. Providing sample questions for staff to use that address the salient points within the protocol will help to assess that the person understands the study and his or her rights as a participant.
Regular monitoring of the consent process. Besides having quality documents and training the research staff, the investigator needs to put into place a monitoring system to ensure that the protocol for obtaining informed consent is being followed. The protocol needs to identify how the cases, as well as the review criteria, will be selected. Both the content and level of engagement need to be assessed. This ongoing monitoring requires that enrollment conversations be audio-recorded for quality assurance purposes. The audiotapes are then reviewed using the specific criteria to ascertain that the protocol for enrollment is being followed throughout the study and that there is no drift.
Informed consent is more than obtaining a person’s signature prior to study participation, surgery, or invasive clinical procedure. Although the signature is necessary, it is not sufficient. It is the actual process of informed consent that is critically important.
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Adapted from Informed Consent: Revisiting the Issues by Judith A. Erlen The article originally appeared in the July/August 2010 issue of Orthopaedic Nursing. © 2010 Lippincott Williams & Wilkins.