Differences
This shows you the differences between two versions of the page.
| Both sides previous revision Previous revision Next revision | Previous revision Next revision Both sides next revision | ||
|
consent_rules [2016/06/23 10:24] jillian_nadette_de_leon |
consent_rules [2016/07/19 13:37] jillian_nadette_de_leon |
||
|---|---|---|---|
| Line 1: | Line 1: | ||
| ##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 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 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 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 a provision stating that the patient's identity will be protected. Upon obtaining consent, the patient shall affix his/her printed name below the Patient Admission Form. If consent was 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;\\ |
| - | * The consent form shall take into the decision of the deceased patient's family members regarding organ donation. \\ | + | 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. MANNER 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.\\ |
| - | * 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.\\ | + | **1.3. 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.\\ | ||
| - | //a. Who shall consent-who shall consent and exceptions-form of consent// | + | **1.4. When to get consent.** Upon order of discharge/ prior to discharge from the health facility.\\ |
| - | * For patients who are physically or mentally incapable of giving consent, the persons authorized to sign the consent in their behalf are: \\ | + | |
| - | 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.\\ | + | |
| - | * For minor patients. Consent shall be given either by the 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 legally declared as the legal guardian), descendant, ascendant, and/or guardian. The family's decision may also be obtained by the physician. \\ | + | |
| - | * For unconscious patients. The attending physician may decide in behalf of the patient; if there are no relatives: \\ | + | |
| - | 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.\\ | + | |
| - | * In emergency situations, the persons authorized to sign consent in their behalf are: \\ | + | **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.\\ | + | |
| - | //When will consent be obtained// | + | **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. \\ |
| - | * 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: admission, admitting order, discharge.\\ | + | **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.\\ |
| - | * //Case Exemptions.//\\ | + | |
| - | 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 concerns.\\ | + | |
| - | //Who will obtain 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 designated staff, not necessarily a doctor, shall obtain the consent for PHIE. \\ | + | 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.\\ | ||
| - | **VALIDITY OF CONSENT**\\ | ||
| - | For consent to be considered valid, it 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; | ||
| - | If a person cannot do one or more of the following conditions, the person is considered incapable of giving consent: \\ | ||
| - | (a) Understand the information given to them; | ||
| - | (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, Primary 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.\\ | ||
| - | (c) In 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 and electronic consent signed by the patient or guardian. | ||
| - | * A finger print, thumb mark, biometrics, or electronic signature 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.\\ | ||
| - | |||
| - | **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:\\ | ||