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consent_rules [2016/06/13 21:43]
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 consenter understands the following prior to obtaining consent:\\ +
-(a) Purpose ​of the collection of data. \\ +
-(b) A separate consent form is obtained for treatment.\\ +
-(cIn so far as practicable,​ potential publication of personal information in public website or bulletin as compliance to existing laws\\ +
-(d) That the consenter can withdraw the consent anytime without consequence or disadvantage.\\ +
-//​Voluntariness//​- the consenter'​s right to make a decision freely without external pressure or coercion. The following are considered acts of coercion (but are not limited to) and invalidate consent:​\\ +
-(a) Bribery or corruption\\ +
-(b) Threat\\ +
-(c) Vexation/ aggravation\\ +
-(d) Wrongful persuasion/ fraud\\ +
-(e) Providing internal or external incentives provided to the patient which may affect his or her decision.  +
-//Consent or Decision//- the consenter'​s authorization for PHIE. \\+
-//​Acceptable forms of obtaining consent.// The following are considered valid format of consent: +----
-  * Written consent signed by the patient or guardian.  +
-  * A finger print/ 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.// 
-  * The informed consent shall remain valid unless a refusal form will be submitted by the patient or any authorized representative.\\ 
-//​Provisions on revoking or reinstating consent.// 
-  * Consenting patient may revoke the signed informed consent provided that there is a justifiable reason/​primary reason for revocation.\\ 
-  * 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:​\\