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consent_rules [2016/06/28 22:23]
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 participating health care providers. 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 provisions stating that the patient'​s identity ​and health information will be protectedIf consent will be denieda refusal form shall be provided.\\+a.) //​Competence//​- Sound mindat least 18 years old, and not under the influence of drugs or liquor; \\ \\ 
 +b.)//​Amount ​and Accuracy of Information//​- Relevant factual data about a procedure and/or treatments, its 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.\\ \\
-**2Obtaining Consent**\\ +**1.1. For Persons with Disabilities (PWDs).** Use of appropriate means of communication such as verbal or sign language.\\ \\
-  * Prior to obtaining consent, specific information with regard to the purpose, processes and procedures involved upon admission in the PHIE must be adequately explained and they shall be clearly informed ​of their choices and its benefits and consequences. \\+
-*//Persons to obtain consent// ​Consent shall be obtained by an authorized staff of the health facility upon patient ​admission/ upon visit to the health facility. If the patient does not give consent upon admission/​upon visit in the health facility, or is in an emergency case, health care providers shall make necessary effort to obtain consent prior to discharge. To avoid missing consent, a system shall be developed to indicate completion of obtaining consent.\\+**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.\\ \\
-  ​*//Validity of Consent// Consent shall be given voluntarily and will be considered valid if the patient is able to: \\ +**1.3. Persons to Give Consent.** The following persons are authorized ​to give consent\\ \\ 
-a.) Make an autonomous decision;\\ +a.) Patient of legal age and of sound mind;\\  
-b.) Understand the information given;\\ +b.) Immediate relatives within 3rd degree of consanguinity based on hierarchy;\\ \\ 
-c.) Recall the information long enough;\\ +c.) Cohabitant partner for a minimum of 1 year or identified guardian;\\ 
-d.) Communicate their decision through verbal or sign language;\\ +d.) Persons with special power of attorney; \\ 
-e.) Is not under the influence of drug or alcohol+e.) For minor patients, ​the consent shall be given by either parents if legally married;\\ 
-f.) Understands that he or she can withdraw consent anytime without consequence or advantage.\\+f.) Social worker;\\ 
 +g.) Attending physician.\\ ​\\
-  ​//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 print, thumb mark, electronic signature, biometrics may be considered but must be witnessed by a person of legal age.\\+**1.4. When to get consent.** Upon order of dischargeprior to discharge from the health facility.\\ \\
-  ​*//​Authorized persons to sign in behalf of the patients.// For patients who are unconscious,​ are physically or mentally incapable of giving consent, the following persons are authorized to give consent in their behalf: \\ +**1.5The Consent Form.** The standard "​Consent ​for Participation to PHIE" ​shall be used by participating health care providers.\\ \\
-a.) Immediate relatives within the 3rd degree of consanguinity based from hierarchy;​\\ +
-b.) Cohabitant partner for a minimum of year or identified guardian;​\\ +
-c.) Social worker;\\ +
-d.) Persons with special power of attorney.\\ +
-However, the consent ​for sharing information in PHIE shall not be applicable. Obtaining such consent may be delayed until patient is already capable of consenting to participate.\\+
-  ​For minor patients, the consent ​shall be given by either parents (if legally married, either of the two; if child is less than 7 years oldconsent shall only be given by the mother and if the child is 8-21 years oldanyone who has been declared as the legal guardian)descendantascendantand/or guardian.\\+**1.6. Valid formats of consent.** The consent can either ​be in written and/or electronic form that is signed ​by the patientguardian, or legal representative. Once the consenting patient ​is incapable to imprint his signaturea finger printthumb markelectronic signaturebiometrics may be considered but must be witnessed by a person of legal age\\ \\
-  ​//​Duration ​of validity of consent//The signed ​consent ​shall remain valid unless a refusal form will be submitted ​by the patient or by the authorized representative.\\+**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.\\ \\
-  ​//​Revocation and reinstating consent//​The consenting patient may revoke ​the signed ​consent provided that there is justifiable reason or primary reason for revocationFor unconscious and minor patient, when the patient becomes able (becomes conscious and is of legal age), he/she may revoke ​the consent previously given by their authorized representativeA valid court order shall prevail over written 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: \\ \\ 
 +a.) Republic Act 3573: Law of Reporting Communicable Diseases;\\  
 +b.Administrative Order No. 2008-0009: Adopting ​the Revised List of Notifiable Diseases, Syndromes, Health-Related Events and Conditions; \\ 
 +c.) Public health emergency and international concerns.\\ \\ \\
-**3. Exemptions for Consent.** For national security purpose, the 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 consents.+