Patient's rights and gcp compliant informed consent #cph may 2012


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Patient's rights and gcp compliant informed consent #cph may 2012

  1. 1. GCP-COMPLIANT INFORMED CONSENT &OTHER PATIENT’S RIGHTS ATTY. ELIZABETH R. PULUMBARIT University of the Philippines Manila © February 2010; May 2011; May 2012
  2. 2. HOSPITAL’S RESPONSIBILITY H “ ospitals, having undertaken one of mankind’smost important and delicate endeavors, must assumethe grave responsibility of pursuing it with appropriatecare. The care and service dispensed through this hightrust, however technical, complex and esoteric itscharacter may be, must meet standards of responsibilitycommensurate with the undertaking to PRESERVE andPROTECT the HEALTH, and indeed, the very LIVES ofthose 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.
  3. 3. OUTLINE1. 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
  4. 4. The Lessons from the Past Year Milestone460 BC Oath of Hippocrates1930s Pre-Nuremberg Clinical Studies/ Experiments; Enactment of U.S. Food, Drugs and Cosmetics Act1946-1947 Nuremberg Doctors’ Trial, Nuremberg Code1948 Declaration of Geneva, Declaration of Human Rights1962 Thalidomide –related Birth Defects1964 WMA Declaration of Hilsinki1966 Ethics of Clinical Research by Henry Beecher
  5. 5. The Lessons from the Past (2) Year Milestone1974 National Research Act and the IRB System (USA)1979 Belmont Report1982 CIOMS International Ethical Guidelines for Biomedical Research involving Human Subjects1991 European Union-GCP1993 WHO-Guidelines for GCP for Trials on Pharmaceutical Products1996 ICH-GCP
  6. 6. 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
  7. 7. 1964 Declaration of Helsinki  Two (2) Key Points 1. 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.
  8. 8. Salient Ethical Principles ofthe 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
  9. 9. PRINCIPLES OF BELMONT REPORT (Robert Amdur, IRB Member Handbook, 2003)No. Principle Inputs IRB/ERB Outputs 1 RESPECT/ Treat individuals as Participants voluntarily autonomous agents consent to participate in AUTONOMY Protect vulnerable research individuals Informed consent Protection of privacy & confidentiality 2 BENEFICENCE Golden Rule Assessment of risks & Trade-offs between benefits individual and societal Minimized risks benefit Non-conflict of interest 3 JUSTICE Equal distribution of Protection of vulnerable risks and potential subjects benefits of research People who are likely to among those who may benefit from research benefit therefrom participation are not excluded
  10. 10. 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
  11. 11. 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
  12. 12. WHAT IS INFORMEDCONSENT? Signature on a form? Document/Contract? Process?
  13. 13. INFORMED CONSENT IS ADOCUMENT 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.
  14. 14. GCP Definition of INFORMEDCONSENT(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.”
  15. 15. 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.”
  16. 16. PNHRS’ National EthicalGuidelines for Health Research “informed consent (verbal, video, written)-the process of obtaining approval to participate inan investigative study or permission to a medicalintervention. Consent must be freely given inverbal, video or written form. An important part ofthe process is the adequacy, appropriateness andtimeliness of the information for decision making.”
  17. 17. 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
  18. 18. THE LAW The New Civil Code PD 603: The Child and Youth Welfare Act EO 209: The Family Code
  19. 19. PERSONS  Natural Persons (Art. 5, PD 603, Art. 41, NCC)  Juridical Persons (Art.44, 47)
  20. 20. NATURAL PERSONSArt. 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.”
  21. 21. 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.”
  22. 22. 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.”
  23. 23. RESTRICTIONS &LIMITATIONS ON CAPACITY TOACT (Art. 38-39, NCC) Minority  Imbecility Insanity  Penalty State of being deaf-  Family Relations mute  Citizenship Prodigality  Absence Civil Interdiction  Insolvency (Art. 34, RPC)  Trusteeship
  24. 24. 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.
  25. 25. 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
  26. 26. VICES OF CONSENT Mistake Violence Intimidation Undue Influence Fraud
  27. 27. CAVEAT and BEWARELack of informed consent is MEDICAL MALPRACTICETherefore, subject to liabilities:  Administrative  Civil  Criminal
  28. 28. SOURCES OF PATIENT’SRIGHTS 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
  29. 29. SOURCES OF PATIENT’SRIGHTS (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)
  30. 30. 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)
  31. 31. 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
  32. 32. STANDARDS FOR PATIENT’SRIGHTS 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)
  33. 33. PATIENT CARE STANDARDS  Access  Entry  Assessment  Care Planning  Implementation of Care  Evaluation  Discharge
  34. 34. NO DEPOSIT OR ADVANCEPAYMENT LAW (BP Blg. 702, as amended by RA No.8344)COVERAGEProprietor, president, director, manager or any otherofficer, medical practitioner, and/or employee of a hospitalor medical clinicEmergency or serious cases: presence of immediatedanger and where delay or inattention may cause loss oflife or permanent disability of patient
  35. 35. NO DEPOSIT OR ADVANCEPAYMENT LAW (2)PROHIBITIONRequest, solicit, demand or accept any deposit or anyform of advance payment as a prerequisite for confinementor medical treatment of patient, orRefuse to administer medical treatment and support asdictated by good practice of medicine to prevent death orpermanent disability
  36. 36. NO DEPOSIT OR ADVANCEPAYMENT LAW (3)EXCEPTION TO PROHIBITIONTransfer of Patient to another hospital under the followingconditions:inadequacy of medical capabilities of the hospital/ medicalclinicPatient or next of kin consents to the transferReceiving hospital / clinic agrees to the transfer
  37. 37. NO DEPOSIT OR ADVANCEPAYMENT LAW (4)EXCEPTION TO THE EXCEPTIONPatient is unconscious or unaccompanied and thus,cannot give consentTransfer is done only after administration of necessaryemergency treatment and support to stabilize patientTransfer is less risky than patient’s continued confinementReceiving hospital/ clinic shall not refuse to receive patientor demand deposit or advance payment
  38. 38. NO DEPOSIT OR ADVANCEPAYMENT LAW (5)PENALTIES Hospital official, medicalpractitioner or employee: 6 mos.1 day- 2 yrs 4 mos. P20K - P100KDirector or officer if policy existson deposit or advance payment 4 to 6 yrs. P100K - P500K
  39. 39. NO DETENTION LAW(RA No. 9439; DOH Admin. Order No. 2008-0001) COVERAGE All 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, defined A single occupancy room or a ward type room divided by either a permanent or semi-permanent partition (except curtains); with 4 patients per room
  40. 40. NO DETENTION LAW (2)SCOPE AND EXTENT OF COVERAGE2.Partiallyor fully recovered patients who wish to leave thehospital/ clinic but are incapable to pay their hospital bills ormedical expenses3.Surviving relatives of deceased patient who wish therelease of the cadaver but are incapable to pay thehospital bills or medical expenses of said deceasedpatients
  41. 41. NO DETENTION LAW (3)PROHIBITED/ ILLEGAL ACTDetention of a patient, i.e., an act of restraining a person, fornon-payment of hospital bills or medical expenses, in part orin full, despite execution of the following documents bypatient/ surviving heirs:Promissory Note (PN)Mortgage or JSS of co-maker as security for PNIn the case of deceased patient whose benefits shall bedrawn from SSS, GSIS, Philhealth, and private insurancecompanies, execution of Deed of Assignment of proceedsthereof up to the extent of unpaid obligation
  42. 42. NO DETENTION LAW (4)Collateral DetentionRefusal to issue medical certificate and other pertinentdocuments for patient’s releaseRefusal to issue death certificate of deceased patient andother documents for internment purposes only
  43. 43. NO DETENTION LAW (5)Penalties Imprisonment of 1 mo. to 6 mos. Fine of P20K to P50K
  44. 44. 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
  45. 45. 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 - Thesenior citizens shall be entitled to the grantof twenty percent (20%) discount and to anexemption from the value-added tax (VAT),IF APPLICABLE, on the sale of the goodsand services covered by Section 1 to 6 ofthis Article, from all establishments for theexclusive use and enjoyment or availmentof senior citizens.”
  46. 46. 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)
  47. 47. 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
  48. 48. 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.
  49. 49. 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.
  50. 50. 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.
  51. 51. 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.
  52. 52. 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
  53. 53. 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
  54. 54. SC CASES TO READ Lucas v. Tuano (GR No. 178763;  Reyes v. Sisters of Mercy April 21, 2009) Hospital ( GR No. 130547; Lasam v. Ramolete (GR No. October 3, 2000) 159132; Dec. 18, 2008)  Ramos v. CA (GR No. Flores v. Pineda (GR No. 124354; Dec. 29, 1999; April 158996; Nov. 14, 2008) 11, 2002) Cantre v. Go (GR No. 160889;  Cruz v. CA (GR No. 122445; April 27, 2007) Nov. 18, 1997) Professional Services, Inc. v.  Batiquin v. CA (GR No. Agana (GR No. 126297, January 118231; July 5, 1996) 31, 2007; February 11, 2008;  Manila Doctors Hospital v. So February 2, 2010) Un Chua (GR No. 150355; Nogales v. Capitol Medical July 31, 2006) Center (GR No. 142625; Dec.  Ty v. People (GR No. 149275; 19, 2006) Sept. 24, 2004)
  55. 55. hank You. Thank You ATTY. ELIZABETH R. PULUMBARIT University Legal Counsel and Head, Intellectual Property Office University of the Philippines Manila Email:;