| Abstract|| |
Dental professionals belong to a group of health-care providers that are governed by a uniform code of ethics. An important component of ethics is the informed consent, which corresponds to the basic principle of patient autonomy and respect. Informed consent signifies that every patient should provide autonomous, voluntary and informed consent for the treatment rendered to him/her. The process of informed consent is also helpful in improving the dentist-patient relationship thereby providing quality treatment. Informed consent in biomedical research is required to obtain the participants voluntary approval for being part of the study after understanding the various aspects of research and their role in it. This article outlines the various aspects of informed consent such as the types, the process of obtaining consent in clinical practice and biomedical research. Information regarding the regulations outlined by the governing bodies in India such as Dental Council of India, Indian Council of Medical Research and Indian penal code for informed consent is also provided in this article.
Keywords: Biomedical research, clinical dentistry, informed consent, medical ethics
|How to cite this article:|
Sridharan G. Informed consent in clinical dentistry and biomedical research. J Educ Ethics Dent 2012;2:65-8
| Introduction|| |
Dental practitioners are part of a profession which deals with human rights and situations requiring judgment based on ethical principles and thereby guided by a professional ethical code of conduct.  Current trends indicate that analysis of dentally related ethical problems and application of ethical theories to them is still a young field.  Medical ethics in general is described primarily as a field of applied ethics, the study of moral values and judgment as they apply to medicine. It is the application of general ethical theories, principles and rules to solve the problems of health-care delivery and research.  Dental ethics were formulated in line with medical ethics and are governed by a set of principles, which include autonomy, veracity, beneficence, non-maleficience and justice that dictate clinical dental practice. 
Autonomy is the right of patient to decide what should be done with one-self. Respect for patient autonomy is a major factor in doctor-patient relationship and forms the foundation for informed consent, protecting patient confidentiality and for upholding veracity. Informed consent is one of the central concepts of present day dental ethics. It is defined to encapsulate a dentist's moral duty to provide the sufficient information to a competent patient for making an informed and rationale choice, the information including the inherent risks and any alternatives of the proposed treatment.  The amount of information needed to be disclosed is based on the reasonable person standard, which indicates that the explanation given to a patient for the purpose of achieving an informed consent must meet the informational needs of the patient.  This is a marked deviation from the previously established professional community standard wherein information was divulged as per the professional's understanding. Consent in a clinical setting is considered as a specialized and formalized type of communication, which should be a continuous educational process rather than a single step process. 
Informed consent is considered equally important in biomedical research. It is a process in which a patient/participant consents to participate in a research project after being informed of its procedures, risks and benefits.  The process of informed consent in biomedical research 1 st began with the creation of Nuremberg code, which was initiated in 1947 during the trial of Nazi doctors accused of performing unethical and inhuman research on war prisoners. The basic principle of the code established the requirement of obtaining free and informed consent on the part of the research participants.  Subsequently, the Declaration of Helsinki  and the Belmont report  refined the rules and regulations concerning the informed process. An important principle of Belmont report advocates respect of persons, which demands that the subject enter into research voluntarily after obtaining adequate information.  In India, Indian Council of Medical Research (ICMR) brought out the policy statement on ethical considerations involved in research on human subjects in 1980 followed by subsequent revisions. The document provides detailed regulations to be followed in human research that includes informed consent. 
Keeping in view the significance of informed consent, this review discusses the various aspects of informed consent as applicable to clinical dentistry and biomedical research with special emphasis on regulations prevailing in India.
| Types of Informed Consent|| |
Informed consent broadly comprises of implied and expressed consent. Implied consent is assumed by the patient's attitude and applied mostly to non-invasive procedures such as consultation, examination and diagnosis.  Examples of implied consent include instances such as when the patient presents himself in the clinic or when the patient opens his mouth for examination wherein the patient based on their actions implies that he/she is willing to be examined. Expressed consent is a more formal type of consent, which could be either in oral or written form. Such type of consent may be required for invasive procedures.
| Waiver of Informed Consent|| |
Certain circumstances exist where informed consent may not be taken or cannot be taken. A patient at times may not wish to hear about the risks and may waive the right to be informed. The responsibility of deciding the treatment plan may be given to the dentist who may decide based on its best judgment. In such cases, a note should be made by the dentist regarding waiver of informed consent. Therapeutic privilege is a circumstance under which the dentist decides not to inform the patient if he/she considers that the harm would be serious by disclosure than non-disclosure. In such cases, the dentist shall discuss the procedure with patient's kin or guardian. Such a situation in dental practice is likely to occur in elective oral and maxillofacial surgeries where the associated risks would be high.  Another situation where informed consent cannot be procured will be in emergency situations when the patient is unable to provide consent. In such cases, the dentist could proceed with the treatment, but preferably obtain consent from a professional colleague.
Informed consent need not always mean that the patient agrees to the treatment plan. A subset of informed consent known as informed refusal should be obtained when the patient does not wish to undergo treatment recommended by the dentist. 
Application of informed consent
As per Indian penal code (IPC) 87 and 88, persons above 18 years of age can give valid consent either implied or expressed, to suffer any bodily harm which may result from an act of good faith for the person's benefit and is not intended to cause death or grievous hurt.
Consent of children and insane persons
In case of children under 12 years of age and in persons of unsound mind, IPC 89 prescribes that consent should be obtained from the guardian or other person having lawful charge of that person for any act done in good faith for the person involved. Section 90 of IPC considers consent ineligible if it is given by a person under fear of injury or under a misconception of fact. This section also considers consent of an insane person (person of unsound mind or intoxication who is unable to understand the nature and consequence of that to which he gives consent) and children less than 12 years of age as ineligible consent. In regard to treatment, which are performed in the absence of consent, IPC 92 states that any act which may cause harm to a person, but done in good faith and for persons benefit can be done without consent, if the circumstances are such that it is impossible for that person to signify consent or if that person is incapable of giving consent and has no guardian or other person in lawful charge of him from whom consent can be obtained for the thing to be done with the benefit. 
Informed consent as applicable to dentistry
Dental council of India (DCI) guidelines require dentists to obtain informed consent of their patients or patient's representatives before performing high risk dental procedures, subjecting them to clinical trials and publishing such photographs or case reports by which their identity can be revealed. Consent of a nearest relative/guardian is required in case the patient is a minor or when patient is physically or mentally incompetent. The regulation also suggest that such informed consent shall be preferably written and taken after explaining the purpose, methodology, risks involved, alternative strategies and prognosis of the procedure. 
Informed consent for adolescents
Any type of consent obtained from children between 12 years and 18 years of age is also considered invalid. However, such persons can give consent for physical examination alone and for other procedures consent is required from a parent or guardian.
Process of informed consent
Informed consent is a continuous process, which includes educational materials, discussion, consent forms and documentation.  The process involves explaining the treatment options available, the risks and benefits associated with each of them in a manner understandable to a competent patient so as to aid in making an acceptable decision. No type of coercion or statements that guarantee a treatment outcome should be utilized, which may influence the patient's decision making ability. It is the dentist's responsibility to discuss the risks, benefits and alternatives. The consent consultation is a duty that cannot be delegated to others. The consent obtained in such a manner is invalid.
Problems that are generally associated with obtaining consent includes illnesses, poor education, language barriers, lack of formal training in ethics, communication skills and delegation of duty to others who may not be the actual treatment providers. 
The informed consent documents needs to be preserved for an appropriate time for medico-legal purposes. The time frame for preserving such records depends on the regulations prescribed by the governing authority. As per DCI regulations, dentists shall maintain patient records as well as a register of certificates, money receipts and official notifications issued by them for a period of at least 3 years. A sample copy of the informed consent document is available as an appendix in drafts ethics regulations 2003 for the benefit of practicing dentists. 
Consent in biomedical research
All modern codes of ethics concerning research with human subjects affirm the moral importance of the principle of informed consent. The concept of informed consent as the key principle in human research initiated since the happenings at Nazi camps where life-threatening experiments were conducted on war prisoners without obtaining their consent. This led to the formulation of the first international statement on ethics in human research named as Nuremberg code in 1947. The first principle of the code pertains to informed consent, which emphasizes on voluntary consent of the human subjects to be part of the research.  Later in order to adopt a uniformity to conduct research, the World Medical Association in 18 th General Assembly at Helsinki, Finland in June 1964 adopted the Declaration of Helsinki: Ethical principles of medical research involving human subjects for the understanding of the medical community regarding human experimentation.  The declaration was subsequently revised. Further Belmont report was tabled, which summarizes the basic ethical principles and guidelines, which include respect for persons, beneficence and justice. The principle of respect for persons is the most important principle with regard to consent process. This principle establishes that all human participants are to be treated as autonomous individuals capable of self-determination and they must give voluntary informed consent to be a part of the research process. 
Biomedical research in India
Research in India is governed by set principles formulated and released by ICMR. The ICMR published the "policy statement on ethical considerations involved in research on human subjects" in February 1980 for the benefit of those involved in clinical research in India. This was revised in the year 2000 as "Ethical guidelines for biomedical research on human subjects." The latest edition of ethical guidelines was released in the year 2006 titled "Ethical guidelines for biomedical research on human participants." The committee laid down 12 principles under statement on general principles, which are common to all areas of biomedical research.  Among the statement of general principles, the 2 nd principle is the principle of voluntariness, informed consent and community agreement whereby research participants are fully apprised of research and participation is completely voluntary. The principles of informed consent and voluntariness are cardinal principles to be observed throughout the research and experiments including its aftermath and applied use, so that research participants are continually kept informed of any and all developments. 
Process of informed consent in biomedical research
Informed consent in biomedical research is a process that begins with the recruitment and screening of a subject and continues throughout the subjects' involvement in the research. The process involves providing scientific information about the study to the subjects in a way understandable to them, answering questions to better ensure subjects understand the research and their role in it; giving subjects adequate time to consider their decisions and obtain voluntary agreement of the subjects to take part in the study.
Consent process can be analyzed as containing four elements, which include information, understanding, voluntariness and decision making capacity.  An important aspect of the consent process involves providing all information that is relevant to a decision concerning participation in a manner that promotes their understanding of the subject. The decision made by the participant should be completely voluntarily without any coercion or other influences. In addition to having adequate information, understanding and freedom from controlling influences; informed consent requires that potential subjects have the capacity to make a decision about participation. They must have the ability to determine whether participation or non-participation is consistent with their authentic preferences, goals and values. 
Informed consent regulation for biomedical research in India
The DCI in its regulation mentions that ethical guidelines prescribed by ICMR must be stringently followed in research involving human subjects.  As per ICMR regulations, for all biomedical research involving human subjects, the investigator must obtain the informed consent of the prospective participant or in the case of an individual, who is not capable of giving informed consent, obtain the consent of the legal guardian. In cases of research involving children, a parent or legal guardian of the child should give proxy consent. In these cases, the assent of the child should be obtained to the extent of the child's capabilities such as in the case of mature minors from the age of 7-18 years of age. 
Contents of patient information sheet
The information that must be provided to the subjects are broadly divided into two categories; basic elements to be provided to the subjects and additional elements, which are to be included if appropriated. Basic elements generally includes the purpose of research, the title of the project, the foreseeable risks and possible benefits to the participant and the general public, the duration of participation, any alternatives to participation, statement regarding voluntariness of participation, steps taken to ensure confidentiality of the data and the contact details of the principal investigator. Additional elements may be needed depending on the project and subject population, which may include payments made to participants, risks to vulnerable subjects, circumstances for the investigator withdrawing the subject from the project, statement regarding how new information will be communicated and any other information required by Institutional Review Boards. A consent obtained at the beginning is not final and fresh or re-consent should be obtained in conditions, which necessitates deviation of protocol, when long-term follow-up or study extension is planned later, when there is change in treatment modality and procedures and before publication if there is a possibility of disclosure of identity through data presentation or photograph. 
Circumstances may exist that require a waiver of consent when it is justified that the research involves not more than minimal risk or when the participant and research do not come in contact or in emergency situations when the patients is unable to give consent.
Documentation of informed consent
Documentation of informed consent can be performed in two ways: Subject or subjects' legal representative signs a form containing all required elements of consent and consent is done orally and documented by an impartial witness. Documentation of consent can be waived in conditions when there is a risk associated with breach of confidentiality and when participation presents minimal risk of harm to the subject and if the research involves no procedures requiring consent outside the context of participant in a research study.
To summarize, this article provides an overview of the various types of informed consent, the need for informed consent in routine dental practice as well as biomedical research and the informed consent process. The guidelines prescribed by DCI for practicing dentists, the ICMR guidelines for biomedical researchers and the IPC regulations regarding informed consent have been outlined for the benefit of clinicians and researchers.
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Department of Oral Pathology and Microbiology, YMT Dental College and Hospital, Institutional Area, Sector-4, Kharghar, Navi Mumbai, Maharashtra
Source of Support: None, Conflict of Interest: None