Guideline:
Guideline on informed consent
Bibliographic Source(s)
- American Academy of Pediatric Dentistry (AAPD). Guideline on informed consent. Chicago (IL): American Academy of Pediatric Dentistry (AAPD); 2005. 2 p. [11 references]
Guideline Status
This is the current release of the guideline.
Guideline Category
Treatment
Intended Users
Dentists
Physicians
Guideline Objective(s)
To provide recommendations for obtaining informed consent from patients receiving oral health care
Target Population
Patient or in the case of a minor or incompetent adult the custodial parent or legal guardian who is providing informed consent for oral health care
Interventions and Practices Considered
Informed consent for oral health care procedures
Major Outcomes Considered
Adequate informed consent
Methods Used to Collect/Select Evidence
Searches of Electronic Databases
Description of Methods used to Collect/Select the Evidence
This guideline was developed through consultation with medical and legal experts and a review of literature including a MEDLINE search utilizing the terms "informed consent" "pediatric consent" and "consent".
Number of Source Documents
Not stated
Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus (Committee)
Rating Scheme for the Strength of the Evidence
Not applicable
Methods Used to Analyze the Evidence
Review
Description of the Methods Used to Analyze the Evidence
Not stated
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
The oral health policies and clinical guidelines of the American Academy of Pediatric Dentistry (AAPD) are developed under the direction of the Board of Trustees utilizing the resources and expertise of its membership operating through the Council on Clinical Affairs (CCA).
Proposals to develop or modify policies and guidelines may originate from 4 sources:
- The officers or trustees acting at any meeting of the Board of Trustees
- A council committee or task force in its report to the Board of Trustees
- Any member of the AAPD acting through the Reference Committee hearing of the General Assembly at the Annual Session
- Officers trustees council and committee chairs or other participants at the AAPD's Annual Strategic Planning Session
Regardless of the source proposals are considered carefully and those deemed sufficiently meritorious by a majority vote of the Board of Trustees are referred to the CCA for development or review/revision.
Once a charge (directive from the Board of Trustees) for development or review/revision of an oral health policy or clinical guideline is sent to the CCA it is assigned to 1 or more members of the CCA for completion. CCA members are instructed to follow the specified format for a policy or guideline. All oral health policies and clinical guidelines are based on 2 sources of evidence: (1) the scientific literature; and (2) experts in the field. Members may call upon any expert as a consultant to the council to provide expert opinion. The Council on Scientific Affairs provides input as to the scientific validity of a policy or guideline.
The CCA meets on an interim basis (midwinter) to discuss proposed oral health policies and clinical guidelines. Each new or reviewed/revised policy and guideline is reviewed discussed and confirmed by the entire council.
Rating Scheme for the Strength of the Recommendations
Not applicable
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
Peer Review
Description of Method of Guideline Validation
Once developed by the Council on Clinical Affairs (CCA) the proposed policy or guideline is submitted for the consideration of the Board of Trustees. While the board may request revision in which case it is returned to the council for modification once accepted by majority vote of the board it is referred for Reference Committee hearing at the upcoming Annual Session. At the Reference Committee hearing the membership may provide comment or suggestion for alteration of the document before presentation to the General Assembly. The final document then is presented for ratification by a majority vote of the membership present and voting at the General Assembly. If accepted by the General Assembly either as proposed or as amended by that body the document then becomes the official American Academy of Pediatric Dentistry (AAPD) oral health policy or clinical guideline for publication in the AAPD's Reference Manual and on the AAPD's Web site.
Major Recommendations
Informed consent is the process of providing the patient or in the case of a minor or incompetent adult the custodial parent or legal guardian with relevant information regarding diagnosis and treatment needs so that an educated decision regarding treatment can be made by the patient or custodial parent or legal guardian. Statutes and case law of individual states govern informed consent. Some states allow oral discussions which should be documented in the medical record while others may require written consent. Oral health practitioners should review applicable state laws to determine their level of compliance. Consent forms should be procedure specific utilize simple terms and avoid overly broad statements.
When a practitioner utilizes an "informed consent" form the following should be included:
- Name and date of birth of pediatric patient
- Name and relationship to the pediatric patient/legal basis on which the person is consenting on behalf of the patient
- Description of the procedure in simple terms
- Disclosure of known adverse risk(s) of the proposed treatment specific to that procedure
- Professionally-recognized or evidence-based alternative treatment(s) to recommended therapy and risk(s)
- Place for custodial parent or legal guardian to indicate that all questions have been asked and adequately answered
- Places for signatures of the custodial parent or legal guardian dentist and an office staff member as a witness
Clinical Algorithm(s)
None provided
Type of Evidence supporting the Recommendations
The type of evidence supporting the recommendations is not specifically stated for each recommendation. In general all oral health policies and clinical guidelines are based on 2 sources of evidence: (1) the scientific literature; and (2) experts in the field.
Potential Benefits
- The informed consent process allows the patient or the custodial parent or in the case of minors legal guardian to participate in and retain autonomy over the health care received.
- Informed consent also may decrease the practitioner's liability from claims associated with miscommunication.
Potential Harms
Not stated
Description of Implementation Strategy
An implementation strategy was not provided.
IOM Care Need
Staying Healthy
IOM Domain
Patient-centeredness
Bibliographic Source(s)
- American Academy of Pediatric Dentistry (AAPD). Guideline on informed consent. Chicago (IL): American Academy of Pediatric Dentistry (AAPD); 2005. 2 p. [11 references]
Adaptation
Not applicable: The guideline was not adapted from another source.
Source(s) of Funding
American Academy of Pediatric Dentistry
Guideline Committee
Council on Clinical Affairs
Composition of Group that Authored the Guideline
Not stated
Financial Disclosures/Conflicts of Interest
Council members are asked to identify potential conflicts of interest; none was disclosed.
Guideline Status
This is the current release of the guideline.
Guideline Availability
Electronic copies: Available from the American Academy of Pediatric Dentistry Web site.
Print copies: Available from the American Academy of Pediatric Dentistry 211 East Chicago Avenue Suite 1700 Chicago Illinois 60611
Availability of Companion Documents
The following is available:
- Overview. American Academy of Pediatric Dentistry 2007-08 definitions oral health policies and clinical guidelines. Available in Portable Document Format (PDF) from the American Academy of Pediatric Dentistry Web site.
Patient Resources
None available
NGC STATUS
This NGC summary was completed by ECRI Institute on August 7 2007. The information was verified by the guideline developer on August 23 2007.
COPYRIGHT STATEMENT
This summary is based on the original guideline which is subject to the guideline developer's copyright restrictions.
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