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consent_rules [2016/06/28 21:32] jillian_nadette_de_leon |
consent_rules [2016/07/27 11:35] 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. 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 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.) //Competence//- Sound mind, at 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//- Education, language or dialect;\\ | ||
| + | d.) //Voluntariness//- Make an autonomous decision without force or intimidation, and understands that he/she can withdraw consent anytime without consequence.\\ | ||
| - | **2. Obtaining 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. \\ | + | |
| - | *//Validity of Consent// Consent shall be given voluntarily and will be considered valid if the patient is able to: \\ | + | **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.\\ |
| - | 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.\\ | + | |
| - | *//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.\\ | ||
| - | * //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 discharge/ prior to discharge from the health facility.\\ |
| - | * For patients who are unconscious, are physically or mentally incapable of giving consent, the following persons are authorized to give consent on their behalf: \\ | + | **1.5. The 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 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.\\ | + | **1.6. 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. \\ |
| - | * //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 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.\\ | + | **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.\\ | ||
| - | **4. OTHER PROVISIONS, CAPACITY BUILDING, INFORMATION DISSEMINATION, OTHERS...** | ||
| - | * 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:\\ | ||