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consent_rules [2016/06/28 22:28] jillian_nadette_de_leon |
consent_rules [2016/07/01 19:38] jillian_nadette_de_leon |
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| - | **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 competence, amount and accuracy of information, patient understanding and voluntariness.\\ |
| - | *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 clause, a list of information to be gathered for shared purpose, date and time the consent was given, contact number of the patient or legal representative, and provisions stating that the patient's identity and health information will be protected. If consent will be denied, a refusal form shall be provided.\\ | + | a.) //Voluntariness//- Make an autonomous decision without force or intimidation, and understands that he/she can withdraw consent anytime without consequence;\\ |
| + | b.) //Competence//- Sound mind, at least 18 years old, and not under the influence of drugs or liquor;\\ | ||
| + | c.) //Amount and Accuracy of Information//- Relevant factual data about a procedure and/or treatments, its benefits, risks, and possible complications or outcomes;\\ | ||
| + | d.) //Patient Understanding//- Education, language or dialect;\\ | ||
| + | e.) //For Persons with Disabilities (PWDs).// Use of appropriate means of communication such as verbal or sign language.\\ | ||
| - | **2. Obtaining Consent**\\ | + | **1.2. Persons to Obtain Consent.** Consent shall be obtained by the Privacy Officer (or a duly authorized representative) who shall be responsible for the orientation of the patients regarding PHIE implementation and validation of patient information.\\ |
| - | * 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.\\ | + | **1.3. Persons to Give Consent.** The following persons are authorized to give consent: \\ |
| + | a.) Patient of legal age and of sound mind;\\ | ||
| + | b.) Immediate relatives within 3rd degree of consanguinity based on hierarchy;\\ | ||
| + | c.) Cohabitant partner for a minimum of 1 year or identified guardian;\\ | ||
| + | d.) Persons with special power of attorney; \\ | ||
| + | e.) For minor patients, the consent shall be given by either parents if legally married;\\ | ||
| + | f.) Social worker;\\ | ||
| + | g.) Attending physician.\\ | ||
| - | *//Validity of Consent// Consent shall be given voluntarily and will be considered valid if the patient is able to: \\ | + | **1.4. When to get consent.** Upon order of discharge/ prior to discharge from the health facility.\\ |
| - | a.) Make an autonomous decision;\\ | + | |
| - | b.) Understand the information given;\\ | + | |
| - | c.) Recall the information long enough;\\ | + | |
| - | d.) Communicate their decision through verbal or sign language;\\ | + | |
| - | e.) Is not under the influence of drug or alcohol; | + | |
| - | f.) Understands that he or she can withdraw consent anytime without consequence or advantage.\\ | + | |
| - | * //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.\\ | + | **1.5. The Consent Form.** The standard "Consent for Participation to PHIE" shall be used by participating health care providers.\\ |
| - | *//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: \\ | + | **1.6. 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 print, thumb mark, electronic signature, biometrics may be considered but must be witnessed by a person of legal age. \\ |
| - | a.) Immediate relatives within the 3rd degree of consanguinity based from hierarchy;\\ | + | |
| - | b.) Cohabitant partner for a minimum of 1 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 old, consent shall only be given by the mother and if the child is 8-21 years old, anyone who has been declared as the legal guardian), descendant, ascendant, and/or guardian.\\ | + | **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.\\ |
| - | * //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.\\ | + | **1.8. 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;\\ | |
| - | * //Revocation and reinstating consent.// The consenting patient may revoke the signed consent provided that there is a justifiable reason or primary reason for revocation. For 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 representative. A valid court order shall prevail over written consent.\\ | + | 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 Act No. 3573; | + | |
| - | b.) Public health emergency and international consents. | + | |