This course was published in the November 2010 issue and expires November 2013. The authors have no commercial conflicts of interest to disclose. This 2 credit hour self-study activity is electronically mediated.
After reading this course, the participant should be able to:
- Define informed consent.
- Discuss the average level of literacy among Americans.
- List the key elements of an effective informed consent form.
- Explain the importance of obtaining informed consent.
Informed consent is the foundation of a binding legal agreement between a patient and a provider. It is a legal term that implies an individual has received appropriate information and has given his or her permission for a recommended treatment. Consent requirements vary from state to state but, in general, a patient must be presented with certain facts in an understandable language that a “reasonable person” would need in order to make a decision regarding treatment. Informed consent is a two-way process of communication that continues throughout an agreed-upon treatment. Obtaining a signature on a consent form does not complete the consent process. Patients should feel free to ask questions throughout the treatment and receive new information if it becomes available.
RESPONSIBILITY OF DENTAL HYGIENISTS
Responsible partnerships in health care require that patients have the basic right to understand, question, and accept or reject the proposed treatment. The informed consent process should be a meaningful exchange of information that will help guide individuals in their health care decision making. The purpose of obtaining informed consent is to verify that individuals fully understand the proposed treatment, risks and benefits, options, costs, and that they freely agree to the treatment.
According to the American Dental Hygienists’ Association (ADHA) Code of Ethics, patients “have the right to informed consent prior to treatment…”1 Therefore, it is the dental hygienist’s obligation to “provide clients with the information necessary to make informed decisions about their oral health…” and elicit participation in making treatment decisions.1 The emergence of the Advanced Dental Hygiene Practitioner and self-regulation has widened the scope of dental hygiene care. As the profession of dental hygiene expands its diagnostic, preventive, therapeutic, and restorative services, the need for obtaining informed consent expands as well.
Carlson et al state that the core value of every dental hygienist is to provide people with all treatment possibilities and to “guide them in autonomous decision making” toward oral and overall health decisions.2 Nonetheless, the authors caution that some dental hygienists may experience ethical dilemmas when faced with conflicting obligations, such as providing risks, benefits, and alternative treatments. For example, in the case of a patient faced with removing a tooth or receiving an implant and restorative treatment, the dental hygienist must make evidence-based decisions according to the patient’s needs, wants, and values as well as consider the dentist’s recommendations.
Orr and Curtis looked at obtaining written, informed consent for the administration of local anesthetic agents.3 The authors suggest that the process of obtaining informed consent is secured more often by dental specialists, such as oral surgeons, than by general practitioners. The authors propose that not only should all dentists secure consent for dental treatment but they should also obtain written informed consent before administering local anesthetic agents. Currently, 44 states allow the administration of local anesthetic agents by dental hygienists, thus practitioners in these states should obtain informed consent prior to administering local anesthesia as part of standard practice.
Table 1 provides a list of the specific requirements necessary to ensure informed consent is obtained.4 Individuals must also meet certain requirements in order to legally give informed consent (see Table 2). In the case of minors or incompetent adults, parents, legal guardians, or certain health care decision makers may sign.
CONSENT FORM LITERACY
Many informed consent documents are poorly written and not easily understood. In 2003, millions of Americans were surveyed in the National Assessment of Adult Literacy (NAAL), which categorized literacy performance into four levels: below basic, basic, intermediate, and proficient.5 Results determined that 30 million Americans (14%) had below basic literacy levels, 29% had basic, and 44% had intermediate skills.5
Most research conducted about adult literacy is not specific to health-related information. However, the NAAL survey collected data about adults’ ability to read and comprehend everyday health-related information.6 The survey revealed that 14% of adults had below basic health literacy, 22% were at the basic level, and 53% had intermediate skills.6 In order for an informed consent decision to be legally made, the document(s) must be understandable. In other words, the form is readable when the document contains words and phrases that are easily comprehended, absorbed, and retained. The Food and Drug Administration (FDA), the Code of Federal Regulations, 7,8 and private and academic institutional review boards provide guidance to researchers for complying with informed consent regulations. In contrast, many dental offices develop their own policies and procedures for gaining informed consent without the benefit of clear guidelines. Professional and ethical standards, lack of procedural understanding, uncertain legal requirements, and a diverse patient population are all factors that complicate the consent process. Yet, attempting to simply fulfill various consent responsibilities without fully understanding the legal and ethical obligations can lead to serious misconduct.
CONSENT FORM DEVELOPMENT
Many informed consent documents are lengthy, filled with confusing language, and difficult to comprehend. Hence, people do not read them thoroughly and then lack the necessary information to make an informed decision. Developing suitable informed consent documents requires special attention to construction. Literacy levels and language barriers are important determinants of comprehension, yet countless documents are written without these factors in mind.9 When developing consent documents, the reading level of the proposed audience needs to be considered. Approximately 50% of the American population reads at the eighth grade level, thus, documents, such as informed consent, Health Insurance Portability and Accountability Act (HIPAA) authorizations, and treatment plan options, should be written at this level.5
Other elements contribute to document readability including subject matter, word choice, vocabulary, sentence complexity, and form layout. Often terms such as “administer,” hemorrhage,” “detrimental,” and “jeopardize” are unfamiliar and confusing to the general public. It is better to use common, lay terminology rather than professional terms or technical jargon to maximize reader comprehension. For instance, selecting the word “given” for “administer” or “loss of blood” for “hemorrhage” will increase readability. Replacing difficult words such as HIPAA may not always be feasible, but adding verbal clarification to technical terms will make documents easier to understand.
A translator may help facilitate the conversation with patients who are non-English speakers but the informed consent document should be in a language understood by the authorized representative. The legality of informed consent may be compromised if the agreement is made solely through the assistance of an interpreter/oral translation. If a person does not clearly understand the information presented by the health care provider, then the individual’s consent will not truly be informed and may not be legally binding.
People who speak and understand English but cannot read and write can consent by “making their mark” on the consent document when consistent with applicable state law. Legal consent of a competent person who has sufficient knowledge and can understand and comprehend spoken English but is physically unable to talk or write should be verified by a third party witness. In instances of non-English speaking individuals and people who cannot read or write, documentation on the consent form is essential and should include the person’s mark, in addition to the witness’ printed name, signature, and date.
In many instances, the person who conducts the consent interview is not the same as a witness. A witness is typically a third person who should be present whenever the patient in question is unable to read the document because he or she is illiterate, blind, or has extremely poor eyesight. The witness simply implies that “I saw this happen” whereas, the person who conducts the informed consent discussion is saying, “I had a discussion with the person. I think he/she understood enough to be able to give meaningful consent.”
CONSENT FORM DESIGN
Designing clear, concise, legally-binding forms can be challenging, but there are many design templates available to assist in form development. Serving as a reference to practitioners, the “Informed Consent Treatment Report” developed in 1984 by Murrell and Sheppard combines a guide for creating an informed consent and treatment plan document.10 Asking questions that will result in the use of negative words such as “not” should be avoided. For example, “My health has not given me trouble in the past 6 months.” Typically, open- ended questions provide more useful, subjective information. For instance, “Tell me about your heart disease” provides more valuable information than “Do you have heart disease?” which only requires a yes or no response.
Word processing software may include tools to help authors analyze and improve the readability of documents. For example, the Microsoft Word Toolbar includes a little-known feature called “Readability Statistics” located on the spelling and grammar tab. This feature aids in determining the readability of a document according to the Flesch Reading Ease Readability Formulas.11 These readability scores provide an idea of the readability of the document along with some general guidelines to help develop an understandable document. Once employed, the program will highlight possible problems in the document, such as excessive passive sentences and grade level. The Flesch Reading Ease Formula suggests that a score between 60 and 70 is easily read by eighth- and ninth-graders. A score of 90 to 100 is very easy to read, whereas a score of 30 and below is difficult and confusing.
Dental hygienists are legally responsible for the services they provide. As such, understanding the role and responsibilities of informed consent are essential. The informed consent process is less than perfect, yet attention to proper document development and procedural steps will help ensure the legality of the consent. Because of the ominous prospect of litigation, consent documents have become lengthier and include more legal terminology and defensive language. Although consent may be obtained verbally or in writing, verbal consent must be properly documented in the patient record. For example, writing “Mrs. Smith gave her oral consent for local anesthetic and periodontal debridement on the lower right quadrant” in the patient’s record provides documentation. Patients should also initial or sign the chart entry.
There are several legal requirements for a valid informed consent process. The individual must have the capacity or the ability to understand a document that has provided full disclosure and is not written using technical jargon. The consenting individual must be authorized to make a decision. Failure to adhere to these guidelines can result in serious legal consequences. Technical battery claims occasionally occur when treatment is provided without consent. However, most legal cases are based on negligence and focus on whether the patient was provided with sufficient information to make an informed decision. In dentistry and dental hygiene, neglecting to obtain informed consent prior to treatment is synonymous with malpractice.
Dental hygienists should secure consent for procedures such as administering local anesthetic agents, nitrous oxide-oxygen analgesia, periodontal debridement, radiographs, topical fluoride, intraoral and extraoral examinations, whitening, remineralization, and pit and fissure sealants. The more invasive the treatment, the greater the risk, consequently, the greater need for informed consent. Vaughn and Harvey discuss the concept of obtaining informed consent for protection against “tort battery.”12 Simply performing a head and neck examination without a full explanation of the process and without obtaining consent prior to performing the procedure could be misconstrued as battery.
Some dental practices prefer to have separate consent forms for specific procedures, such as endodontics, tooth removal, radiographs, restorative, or periodontal procedures, whereas others have one consent form with multiple procedures and service(s) listed as needed. Informed consent may be accomplished with a separate document or included in the treatment plan records. Still other clinical settings have moved to paperless records and offer informed consent with electronic signatures. Whatever informed consent form is chosen, it must be properly documented. At the end of the consent process, one copy of the document(s) should be provided to the patient and one copy should be retained in the patient’s record to help prevent future liability. Tables 3 and 4 provide the key aspects of developing an understandable informed consent document.
Occasionally people refuse treatment, usually due to finances, fear, or mistrust. If a patient refuses recommended treatment and/or declines to provide informed consent, he or she should be advised of possible consequences of no treatment and “informed refusal” should be documented in the patient’s record. The reasons for the decline should be noted in the individual’s own words, with the clinician’s name, the patient’s signature, and the date as part of the written documentation in the patient records. If a patient declines to provide consent for recommended treatment, such as radiographs or a referral to a specialist, the patient record should include written documentation that informed consent was sought and declined. Figure 1 provides an example of an informed refusal form. For example, “Discussed the purpose, treatment, benefits, risks, and costs of proposed treatment, as well as treatment options and risks associated with no treatment.”
Legal obligations vary from state to state, so dental professionals need to check their state regulations to ensure their policies and procedures meet the legal requirements. As a cautionary note, even if informed consent is obtained properly, dental professionals may still be subject to liability for malpractice if they fail to provide dental services according to the standard of care. In states where informed consent is not legally required for a particular procedure, it is still advisable to procure it. Questions about informed consent still remain: How much information is enough? Do we really expect patients to read and understand all of this material? The answer is yes. Informed consent is more than having an individual sign a piece of paper; it is a legal, professional, and ethical responsibility and should become an integral part of the dental hygiene process of care.
- ADHA Bylaws and Code of Ethics. Adopted June 22, 2009. Available at: www.adha.org/downloads/ADHA-Bylaws-Code-of-Ethics.pdf. Accessed October 21, 2010.
- Carlson C, Furnari W, Higbee LK, Lamb J. Core value: Individual autonomy and respect for human beings. Access. 2010;24(1):9-10.
- Orr DL, Curtis WJ. Obtaining informed consent for the administration of local anesthetic in dentistry. J Am Dent Assoc. 2005;136:1568-1571.
- Zarkowski P. Ethical and legal issues. In: Mosby’s Comprehensive Review of Dental Hygiene. 7th ed. St. Louis: Mosby Elsevier. In press.
- The National Assessment of Adult Literacy. Available at: http://nces.ed.gov/naal. Accessed October 21, 2010.
- The Health Literacy of American’s Adults: Results from the 2003 National Assessment of Adult Literacy (NAAL). Available at: http:// nces.ed.gov/ pubsearch/ pubsinfo.asp?pubid=2006483.Accessed October 21, 2010.
- FDA. A Guide to Informed Consent. Available at: www.fda.gov/ Regulatory Information/ Guidances/ucm126431.htm. Accessed October 21, 2010.
- US Department of Health and Human Services.Code of Federal Regulations, TITLE 45, Public Welfare, Department of Health and Human Services, Part 46, Protection of Human Subjects. Available at: www.hhs.gov/ ohrp/ humansubjects/guidance/45cfr46.htm. Accessed October 21, 2010.
- Kaestle CF, Damon-Moore H, Stedman LC, Tinsley K, Trollinger WV. Literacy in the United States Readers and Reading Since 1880. New Haven, Conn: Yale University Press; 1991:75-128.
- Murrell GA, Sheppard GA. The informed consent treatment report. J Prosth Dent. 1992: 68:970-973.
- The Flesch Reading Ease Readability Formula. Available at: www.readabilityformulas.com/flesch-reading-ease-readability-formula.php.Accessed October 21, 2010.
- Vaughn LD, Harvey L. Informed consent and the practice of dental hygiene. Access. 2008;22(11):10-15.
From Dimensions of Dental Hygiene. November 2010; 8(11): 60-63.