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consent_rules [2016/06/13 18:18]
consent_rules [2019/04/02 09:04] (current)
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 ##Consent ##Consent
-**1. RECOMMENDED CONTENTS OF CONSENT FORM-INFORMATION INCLUDED IN CONSENT FORM** +**1. //Consent//. The consent shall conform to the requirements of an informed consent which are competenceamount and accuracy ​of information, ​patient understanding ​and voluntariness. The following are the characteristics of a valid informed ​consent: \\ \\ 
-   * A separate, standard consent form for PHIE entitled "Consent ​for Participation to PHIE" shall be developed by health facilities. The consent ​form must be clear, simple, and have a local translation which the patient can understand. Within its contents there shall be an opt-out clausea list of information ​to be gathered for shared purposedate and time the consent ​was givencontact number of the patient or legal representative, and a provision stating that the patient'​s identity will be protectedUpon obtaining consentthe patient shall affix his/her printed name below the Patient ​Admission Form. If consent was denieda refusal form shall be provided.\\ +a.) //​Competence//​- Sound mindat least 18 years old, and not under the influence of drugs or liquor; \\ \\ 
-   * The consent form shall take into the decision ​of the deceased patient'​s family members regarding organ donation. \\+b.)//Amount and Accuracy of Information//​- Relevant factual data about a procedure and/or treatmentsits benefits, risks, and possible complications or outcomes;\\ \\ 
 +c.)//​Patient ​Understanding//​- Educationlanguage or dialect;​\\ ​\\ 
 +d.) //​Voluntariness//​- Make an autonomous ​decision ​without force or intimidation,​ and understands that he/she can withdraw consent anytime without consequence.\\ \\
-**2MANNER OF OBTAINING CONSENT**\\+**1.1. For Persons with Disabilities (PWDs).** Use of appropriate means of communication such as verbal or sign language.\\ ​\\
-  ​The consent procedure must adequately inform patients about the choices they have and the consequences ​of their choices, and the procedure must be conducted in a manner that ensures that consent is entirely voluntary.\\+**1.2. Persons to Obtain Consent.** Consent shall be obtained by a duly authorized staff who shall be responsible for the orientation ​of the patients regarding PHIE implementation and validation of patient information.\\ \\
-//aWho shall consent-who shall consent and exceptions-form of consent// +**1.3. Persons to Give Consent.*The following persons ​are authorized to give consent: ​\\ \\ 
-  ​For patients who are physically or mentally incapable of giving consent, the persons ​authorized to sign the consent ​in their behalf are: \\ +a.) Patient of legal age and of sound mind;\\  
-a. Immediate relatives within ​the 3rd degree of consanguinity based from hierarchy;​\\ +b.) Immediate relatives within 3rd degree of consanguinity based on hierarchy;\\ \\ 
-b. Cohabitant partner for a minimum of 1 year or identified guardian;;\\ +c.Cohabitant partner for a minimum of 1 year or identified guardian;​\\ 
-c. Social worker; \\ +d.Persons with special power of attorney\\ 
-d. Persons with special power of attorney.\\ +e.) For minor patients, the consent ​shall be given by either parents if legally married;​\\ 
-  ​* ​For minor patients.  Consent ​shall be given either ​by the parents ​(if legally married, either of the twoif child is less than 7 years old consent shall only be given by the mother and if the child is 8-21 years old anyone who has been legally declared as the legal guardian), descendant, ascendant, and/or guardian. The family'​s decision may also be obtained by the physician. ​\\ +f.) Social worker;\\ 
-  * For unconscious patientsThe attending physician may decide in behalf of the patient; if there are no relatives: \\ +g.Attending physician.\\ \\
-(aImmediate relatives within the 3rd degree of consanguinity,​ based from hierarchy;\\ +
-(bCohabitant partner for a minimum of 1 year or identified guardian;;​\\ +
-cSocial worker; ​\\ +
-d. Persons with special power of attorney.\\+
-  ​In emergency situations, the persons authorized to sign consent in their behalf are: \\ +**1.4When to get consent.** Upon order of discharge/ prior to discharge from the health facility.\\ \\
-(a) Immediate relatives within the 3rd degree of consanguinity,​ based from hierarchy;​\\ +
-(b) Cohabitant partner for a minimum of year or identified guardian;;​\\ +
-cSocial worker; \\ +
-dPersons with special power of attorney.\\ +
-However, the consent ​for sharing information in PHIE shall not be applicableObtaining such consent may be delayed until patient is already capable ​of consenting ​to participate.\\+
-//When will consent ​be obtained//+**1.5. The Consent Form.** The standard "​Consent for Participation to PHIE" shall be used by participating health care providers.\\ \\
-Consent for the PHIE shall be obtained upon admission but if the patient ​does not give consent upon admission ​or is in an emergency case, efforts should be made to obtain consent upon discharge. To avoid missing consent, a system may be developed to indicate completion of consent taking. Viable occasions to obtain consent: admissionadmitting orderdischarge.\\ +**1.6. Valid formats of consent.** The consent can either ​be in written and/or electronic form that is signed by the patient, guardian, ​or legal representative. Once the consenting patient ​is incapable ​to imprint his signature, a finger printthumb markelectronic signaturebiometrics may be considered but must be witnessed by person of legal age. \\ \\
-* //Case Exemptions.//​\\ +
-For national security purposethe following situations do not need consent for information to be processed in the PHIE:\\ +
-a. Emerging diseases identified in R.A. 3573.\\ +
-b. Public health emergency and international concerns.\\+
-//Who will obtain consent// +**1.7. Revocation and Reinstating Consent.** When an unconscious patient becomes able (becomes conscious and is of legal age)he/she may revoke ​the consent ​previously given by their authorized representative.\\ \\
-  ​A designated staffnot necessarily a doctor, shall obtain ​the consent ​for PHIE. \\+
-**VALIDITY OF CONSENT**\\ +**1.8. Exemptions for Consent** For national security purpose, the following situations do not need consent for information to be processed in the PHIE provided that these are not in conflict with other existing laws\\ \\ 
-For consent to be considered validit must contain all of these 5 elements: //​Disclosure//​- the consenter has the information ​needed ​to make an autonomous decision, //Capacity or Competence//​- ​the consenter'​s ability to understand the information to make judgments about the potential consequences of his or her decision;  +a.Republic Act 3573: Law of Reporting Communicable Diseases;\\  
-If a person cannot do one or more of the following conditions, the person is considered incapable of giving consent: \\ +b.Administrative Order No2008-0009: Adopting ​the Revised List of Notifiable Diseases, Syndromes, Health-Related Events ​and Conditions; \\ 
-(a) Understand the information given to them+c.) Public health emergency and international concerns.\\ \\ \\
-(b) Recall the information long enough; +
-(c) Communicate their decision through verbal or sign language; +
-(d) Is under the influence of drug or alcohol.\\ +
-//​Understanding or Comprehension//​- the consenter'​s comprehension ​of the information provided, Health ​care providers shall ensure that the consentee +
-//​Voluntariness//​the consenter'​s right to make a decision freely without external pressure or coercion, ​and //Consent or Decision//- the consenter'​s authorization for PHIE. \\+
-//​Acceptable forms of obtaining consent.//​ +----
-  * A thumb mark may be considered once the consenting patient is incapable to imprint his signature but must be witnessed by a person of legal age.\\+
-//​Provisions on duration of validity.// 
-  * Health care providers shall comply with the medical records requirements electronically. OPD: 5 years, In-patient:​10-15 years, Medico-legal cases: lifetime.\\ 
-//​Provisions on revoking or reinstating consent.// 
-  * A valid court order shall prevail over written consent.\\ 
-  * For unconscious and minor patients, when the patient becomes able (becomes conscious and is of legal age), he/she may revoke the consent previously give by their authorized representative.\\ 
-  * DOH shall enforce an information drive regarding the PHIE consent in public and private facilities as well as other health centers. \\ 
-  * The social worker will prepare a clinical case study on the physically or mentally incapable patient who cannot give consent in time of health need.\\ 
-  * Triage personnel must be oriented regarding PHIE and consent form for data collection.\\ 
-  * Religious and cultural beliefs shall be included in the patient'​s basic information to avoid complications in the management and treatment of patient.\\ 
-  * In order to reduce errors, please provide a standard case definition for the following: \\ 
-a. OPD\\ 
-b. Emergency\\ 
-c. In-patient\\ 
-d. Referred patient for laboratory and radiology procedures and other services\\ 
-  * Outpatient- a patient who receives healthcare services without being admitted for inpatient medical care or healthcare services and does not occupy a bed for any length of time; or a patient who consults and receives healthcare services in the healthcare facility without being admitted.\\ 
-  * Emergency- unforeseen combination of circumstances which calls for immediate life-preserving or quality-of-life preserving actions (to preserve sight in one or both eyes, hearing in one or both ears, extremities at or above the ankle or wrist). \\ 
-  * Inpatient- a patient admitted in the hospital receiving healthcare services and who is provided room, board and continuous nursing services in a unit area of the healthcare facility.\\ 
 References:​\\ References:​\\