GCP-COMPLIANTINFORMED CONSENT &

OTHER PATIENT’S RIGHTS

ATTY. ELIZABETH R. PULUMBARITUniversity of the Philippines Manila

© February 2010; May 2011; May 2012

HOSPITAL’S RESPONSIBILITY

“Hospitals, having undertaken one of mankind’s most important and delicate endeavors, must assume the grave responsibility of pursuing it with appropriate care. The care and service dispensed through this high trust, however technical, complex and esoteric its character may be, must meet standards of responsibility commensurate with the undertaking to PRESERVE and PROTECT the HEALTH, and indeed, the very LIVES of those placed in the hospital’s keeping.”

-Professional Services, Inc. v. Agana ( G.R. No. 126297, Jan. 31, 2007), citing Beeck v. Tucson General Hospital, 500 P. 2d 1153 which cited Darling vs. Charleston Community Memorial Hospital, 33 Ill. 2d 326.

OUTLINE 1. Lessons from the Past? Rationale?2. Is informed consent

A signature on a form? A contract? A process?

3. Ethical requirements?4. Legal Basics of Consent?5. Persons and their Legally Effective

Representatives?6. Other Patient’s Rights

Quality Care Management Privacy and Confidentiality No Deposit No Detention Senior Citizen’s Rights

The Lessons from the Past

Year Milestone

460 BC Oath of Hippocrates

1930s Pre-Nuremberg Clinical Studies/ Experiments;Enactment of U.S. Food, Drugs and Cosmetics Act

1946-1947 Nuremberg Doctors’ Trial, Nuremberg Code

1948 Declaration of Geneva, Declaration of Human Rights

1962 Thalidomide –related Birth Defects

1964 WMA Declaration of Hilsinki

1966 Ethics of Clinical Research by Henry Beecher

The Lessons from the Past (2)

Year Milestone

1974 National Research Act and the IRB System (USA)

1979 Belmont Report

1982 CIOMS International Ethical Guidelines for Biomedical Research involving Human Subjects

1991 European Union-GCP

1993 WHO-Guidelines for GCP for Trials on Pharmaceutical Products

1996 ICH-GCP

1964 Declaration of Helsinki

Adopted by WMA Last amended in 2008 Recognition that medical progress is based on

research, including experimentation involving human subjects

Statement of 25 Ethical Principles to provide guidance to physicians and participants in medical research involving human subjects, including identifiable human material and data

1964 Declaration of Helsinki

Two (2) Key Points1. Interests of the human subject should always be given a higher priority than those of society.

2. Every subject in clinical research should get the best known medical treatment.

Salient Ethical Principles of the Declaration of Helsinki Conformity to scientific principles Design of and implementation of clinical research

according to Protocol Requirement for independent review committees (IRC) Supervision and conduct of clinical trials by suitably

qualified persons Assessment and balancing of possible benefits against

risks to subjects Confidentiality and respect for privacy of human

subjects Minimal physical and mental impact on the human

subjects Informed consent

PRINCIPLES OF BELMONT REPORT(Robert Amdur, IRB Member Handbook, 2003)

No. Principle Inputs IRB/ERB Outputs

1 RESPECT/AUTONOMY

Treat individuals as autonomous agentsProtect vulnerable individuals

Participants voluntarily consent to participate in researchInformed consentProtection of privacy & confidentiality

2 BENEFICENCE Golden RuleTrade-offs between individual and societal benefit

Assessment of risks & benefits Minimized risksNon-conflict of interest

3 JUSTICE Equal distribution of risks and potential benefits of research among those who may benefit therefrom

Protection of vulnerable subjectsPeople who are likely to benefit from research participation are not excluded

Key Principles of the CIOMS – International Ethical Guidelines Ethical justification and scientific validity of research Ethical Review Informed Consent Vulnerable Population/ Groups/ Persons (children,

women, disabled/challenged, prisoners, military/police) Choice of control (comparator/ placebo trials) Confidentiality Compensation for injury Obligations of sponsor to provide health care services

INFORMED CONSENT:FROM PAST TO PRESENT

Born out of the lessons from the past: Protection of the rights, safety, and well-being of

human subjects of clinical trials. Cornerstone of clinical trials/ researches involving

human subjects International ethical and legal principles System of checks and balances

WHAT IS INFORMED CONSENT?

Signature on a form?

Document/Contract?

Process?

INFORMED CONSENT IS A DOCUMENT AND A PROCESS DOCUMENT: A summary of the clinical trial (purpose,

treatment procedures and schedule, potential risks and benefits, alternatives to participation) and an explanation of the rights of a trial subject/ participant

PROCESS: A continuing discussion and interactive exchange of information and communications between the trial subject/ participant and the investigator so that the former can make educated decisions to continue or otherwise withdraw from clinical trial.

GCP Definition of INFORMED CONSENT(GCP 1.28)

“A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant in subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.”

FDA (USA) Definition (21 CFR 50.20)

“Except as provided in B50.23, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s rights, or releases or appears to release the investigator, the sponsor, the institution, or it agents from liability for negligence.”

PNHRS’ National Ethical Guidelines for Health Research

“informed consent (verbal, video, written)- the process of obtaining approval to participate in an investigative study or permission to a medical intervention. Consent must be freely given in verbal, video or written form. An important part of the process is the adequacy, appropriateness and timeliness of the information for decision making.”

PERSONS AND THEIR LEGALLY-EFFECTIVE REPRESENTATIVES

The Law Natural Persons Juridical Capacity and Capacity to Act Restrictions and Limitations on Capacity

to Act Legal Incapacity Vices of Consent

THE LAW

The New Civil Code PD 603: The Child and

Youth Welfare Act EO 209: The Family

Code

PERSONS

Natural Persons (Art. 5, PD 603, Art. 41, NCC)

Juridical Persons (Art.44, 47)

NATURAL PERSONS

Art. 5, PD No. 603

“The civil personality of the child shall commence from the time of his conception, for all purposes favorable to him, subject to the requirements of Article 41 of the New Civil Code.”

NATURAL PERSONS (Art. 41, NCC)

“For civil purposes, the fetus is considered born if it is alive at the time it is completely delivered from the mother’s womb. However, if the fetus had an intra-uterine life of less than 7 months, it is not deemed born if it dies within 24 hours after its complete delivery from the maternal womb.”

JURIDICAL CAPACITY andLEGAL CAPACITY TO ACTArticle 37, NCC

“Juridical capacity, which is the fitness to be the subject of legal relations, is inherent in every natural person and is lost only through death. Capacity to act, which is the power to do acts with legal effect, is acquired and may be lost.”

RESTRICTIONS & LIMITATIONS ON CAPACITY TO ACT (Art. 38-39, NCC)

Minority Insanity State of being

deaf-mute Prodigality Civil Interdiction (Art. 34, RPC)

Imbecility Penalty Family Relations Citizenship Absence Insolvency Trusteeship

SUBSTITUTE PARENTAL AUTHORITY

(Family Code) Court-appointed

guardian Surviving Grandparent Oldest brother or sister,

over 21 y.o. Child’s actual custodian,

over 21 y.o.

AUTHORITY OVER PERSON OF MINOR

(Philippine National Ethical Guidelines for Health Research 2006)

Parents Surviving Parents Grandparents Surviving Grandparents Oldest sibling over 21 y.o. Actual Custodian

VICES OF CONSENT

Mistake Violence Intimidation Undue Influence Fraud

CAVEAT and BEWARE

Lack of informed consent is

MEDICAL MALPRACTICE

Therefore, subject to liabilities: Administrative Civil Criminal

SOURCES OF PATIENT’S RIGHTS The Bill of Rights under the Philippine

Constitution Hippocratic Oath Code of Medical Ethics of the Board of Medicine Code of Ethics of the Medical Profession

SOURCES OF PATIENT’S RIGHTS (2) Benchbook on Performance Improvement of

Health Services (Philhealth, 2004) Batas Pambansa Blg. 702, as amended by RA

No. 8344 (No Deposit Law) RA No. 9439 (Non-Detention Law) RA No. 9257, as amended by RA No. 9994

(Expanded Senior Citizens Act)

PATIENT’S RIGHTS To choose physician To considerate and respectful

care To privacy and confidentiality To disclosure of information &

counseling To medical records & billing To self-determination To religious belief

(Code of Ethics)

PATIENT’S RIGHTS To leave and refuse

medical intervention To participate in or

refuse medical research To correspondence and

to receive visitors To express grievances &

resolve complaints To be informed of rights

and responsibilities as patient

STANDARDS FOR PATIENT’S RIGHTS Respect and support for patient’s rights and

responsibilities Patient’s pro-active involvement in health

care Confidentiality, privacy, security of

information and communication, including pastoral counseling

Feedback Staff Code of Ethics Resolution of Ethical Issues

(Benchbook)

PATIENT CARE STANDARDS

Access Entry Assessment Care Planning Implementation of Care Evaluation Discharge

NO DEPOSIT OR ADVANCE PAYMENT LAW (BP Blg. 702, as amended by RA

No.8344)

COVERAGEProprietor, president, director, manager or any other officer, medical practitioner, and/or employee of a hospital or medical clinicEmergency or serious cases: presence of immediate danger and where delay or inattention may cause loss of life or permanent disability of patient

NO DEPOSIT OR ADVANCE PAYMENT LAW (2)PROHIBITIONRequest, solicit, demand or accept any deposit or any form of advance payment as a prerequisite for confinement or medical treatment of patient, orRefuse to administer medical treatment and support as dictated by good practice of medicine to prevent death or permanent disability

NO DEPOSIT OR ADVANCE PAYMENT LAW (3)EXCEPTION TO PROHIBITIONTransfer of Patient to another hospital under the following conditions:inadequacy of medical capabilities of the hospital/ medical clinicPatient or next of kin consents to the transferReceiving hospital / clinic agrees to the transfer

NO DEPOSIT OR ADVANCE PAYMENT LAW (4)EXCEPTION TO THE EXCEPTIONPatient is unconscious or unaccompanied and thus, cannot give consentTransfer is done only after administration of necessary emergency treatment and support to stabilize patientTransfer is less risky than patient’s continued confinementReceiving hospital/ clinic shall not refuse to receive patient or demand deposit or advance payment

NO DEPOSIT OR ADVANCE PAYMENT LAW (5) PENALTIES Hospital official, medical practitioner or employee:

6 mos.1 day- 2 yrs 4 mos.

P20K - P100KDirector or officer if policy exists on deposit or advance payment

4 to 6 yrs.

P100K - P500K

NO DETENTION LAW (RA No. 9439; DOH Admin. Order No. 2008-0001)

COVERAGEAll patients who were admitted and availed of health care services in a government or private hospital/ clinic except those who stay in private rooms

PRIVATE ROOM, definedA single occupancy room or a ward type room divided by either a permanent or semi-permanent partition (except curtains); with 4 patients per room

NO DETENTION LAW (2)

SCOPE AND EXTENT OF COVERAGE1.Partially or fully recovered patients who wish to leave the hospital/ clinic but are incapable to pay their hospital bills or medical expenses

2.Surviving relatives of deceased patient who wish the release of the cadaver but are incapable to pay the hospital bills or medical expenses of said deceased patients

NO DETENTION LAW (3)

PROHIBITED/ ILLEGAL ACTDetention of a patient, i.e., an act of restraining a person, for non-payment of hospital bills or medical expenses, in part or in full, despite execution of the following documents by patient/ surviving heirs:Promissory Note (PN) Mortgage or JSS of co-maker as security for PNIn the case of deceased patient whose benefits shall be drawn from SSS, GSIS, Philhealth, and private insurance companies, execution of Deed of Assignment of proceeds thereof up to the extent of unpaid obligation

NO DETENTION LAW (4)

Collateral Detention

Refusal to issue medical certificate and other pertinent documents for patient’s releaseRefusal to issue death certificate of deceased patient and other documents for internment purposes only

NO DETENTION LAW (5)

Penalties Imprisonment of 1 mo. to 6 mos. Fine of P20K to P50K

RISK MANAGEMENT GUIDELINES

1. Classify Patients based on paying capacity (DOH Adm. Order No. 51-A, s. of 2000 dated 12 Oct. 2001)

2. Assist patients in sourcing financial assistance

3. Credit policy, billing and collection procedures

4. Written policies and procedures for admission and discharge of patients

SENIOR CITIZENS LAW(RA No. 7432, as amended by RA No. 9257 and 9994, IRR)

THE PRIVILEGE

“Article 7. Twenty Percent (20%) Discount and VAT Exemption - The senior citizens shall be entitled to the grant of twenty percent (20%) discount and to an exemption from the value-added tax (VAT), IF APPLICABLE, on the sale of the goods and services covered by Section 1 to 6 of this Article, from all establishments for the exclusive use and enjoyment or availment of senior citizens.”

SENIOR CITIZENS LAW (2)

Medicine and Drug Purchases, including influenza/pneumococcal vaccines, vitamins and mineral supplements

Essential medical supplies, accessories and equipment (eyeglasses, hearing aids, dentures, walkers, prosthetics, etc.)

Medical and dental services in the private facilities (x-rays, CT scans, blood tests, other diagnostic tests)

SENIOR CITIZENS LAW (2) Professional fees of attending physician/s Professional fees of licensed health workers providing

home health care services Free medical and dental services in government facilities Free vaccination for indigent senior citizens Mandatory Philhealth coverage for indigent senior

citizens

SUMMATION

Informed consent is an international ethical and legal principle in the conduct of clinical trials involving human subjects and a cornerstone/ standard in quality health care management.

Informed consent is not a mere signature on a form or a document, it is an interactive and continuing process.

SUMMATION

The purpose of informed consent is to protect the human subject / patient by providing access to information that can help him in making an informed choice, and to similarly make him aware of his or her rights.

SUMMATION

Informed consent is voluntary, sans coercion and undue influence, and without any waiver of subject’s rights to full disclosure of information in a clear, understandable and non-technical language, and with opportunity to decide on whether to participate or not, continue or not, or otherwise terminate participation in clinical trial or medical treatment.

SUMMATION

Informed consent is given by the subject of clinical trial/ patient. In his incapacity to give consent and/or for non-therapeutic trials, his legally effective representative may give the consent.

Flawed and defective informed consent constitutes medical malpractice.

SUMMATION

Quality health care means improved patient’s outcomes by respecting his rights and resolving ethical issues that arise in the course of providing care.

Standards for Patient Rights include patient’s pro-active involvement in health care decisions from access to discharge; confidentiality, privacy, security, counseling, and communication; and feedback mechanisms

SUMMATION

There are laws granting other patient rights and privileges: no deposit/ advance payment; no detention for non-payment of hospital bills; law of the elderly on discounts and VAT and E-VAT exemptions

SC CASES TO READ Lucas v. Tuano (GR No. 178763;

April 21, 2009) Lasam v. Ramolete (GR No.

159132; Dec. 18, 2008) Flores v. Pineda (GR No.

158996; Nov. 14, 2008) Cantre v. Go (GR No. 160889;

April 27, 2007) Professional Services, Inc. v.

Agana (GR No. 126297, January 31, 2007; February 11, 2008; February 2, 2010)

Nogales v. Capitol Medical Center (GR No. 142625; Dec. 19, 2006)

Reyes v. Sisters of Mercy Hospital ( GR No. 130547; October 3, 2000)

Ramos v. CA (GR No. 124354; Dec. 29, 1999; April 11, 2002)

Cruz v. CA (GR No. 122445; Nov. 18, 1997)

Batiquin v. CA (GR No. 118231; July 5, 1996)

Manila Doctors Hospital v. So Un Chua (GR No. 150355; July 31, 2006)

Ty v. People (GR No. 149275; Sept. 24, 2004)

Thank You.Thank You.ATTY. ELIZABETH R. PULUMBARITUniversity Legal Counsel andHead, Intellectual Property OfficeUniversity of the Philippines ManilaEmail: erpulumbarit@mail.upm.edu.ph; pulumbaritlaw@gmail.com