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. HOSPITAL’S RESPONSIBILITY
H
“ ospitals, 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.

3. 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

4. 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

5. 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

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. 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. 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

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. 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. 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. WHAT IS INFORMED
CONSENT?
 Signature on a form?
 Document/Contract?
 Process?

13. 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.

14. 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.”

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. 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.”

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. THE LAW
 The New Civil Code
 PD 603: The Child and
Youth Welfare Act
 EO 209: The Family Code

19. PERSONS
 Natural Persons
(Art. 5, PD 603,
Art. 41, NCC)
 Juridical
Persons
(Art.44, 47)

20. 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.”

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. JURIDICAL CAPACITY and
LEGAL CAPACITY TO ACT
Article 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. RESTRICTIONS &
LIMITATIONS ON CAPACITY TO
ACT (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. 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. 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. VICES OF CONSENT
 Mistake
 Violence
 Intimidation
 Undue Influence
 Fraud

27. CAVEAT and BEWARE
Lack of informed consent is
MEDICAL MALPRACTICE
Therefore, subject to
liabilities:
 Administrative
 Civil
 Criminal

28. 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

29. 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)

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. 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. 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)

33. PATIENT CARE STANDARDS
 Access
 Entry
 Assessment
 Care Planning
 Implementation of Care
 Evaluation
 Discharge

34. NO DEPOSIT OR ADVANCE
PAYMENT LAW (BP Blg. 702, as amended by RA No.8344)
COVERAGE
Proprietor, president, director, manager or any other
officer, medical practitioner, and/or employee of a hospital
or medical clinic
Emergency or serious cases: presence of immediate
danger and where delay or inattention may cause loss of
life or permanent disability of patient

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

36. NO DEPOSIT OR ADVANCE
PAYMENT LAW (3)
EXCEPTION TO PROHIBITION
Transfer of Patient to another hospital under the following
conditions:
inadequacy of medical capabilities of the hospital/ medical
clinic
Patient or next of kin consents to the transfer
Receiving hospital / clinic agrees to the transfer

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

38. NO DEPOSIT OR ADVANCE
PAYMENT LAW (5)
PENALTIES
 Hospital official, medical
practitioner or employee:
6 mos.1 day- 2 yrs 4 mos.
P20K - P100K
Director or officer if policy exists
on deposit or advance payment
4 to 6 yrs.
P100K - P500K

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. NO DETENTION LAW (2)
SCOPE AND EXTENT OF COVERAGE
2.Partiallyor fully recovered patients who wish to leave the
hospital/ clinic but are incapable to pay their hospital bills or
medical expenses
3.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

41. NO DETENTION LAW (3)
PROHIBITED/ ILLEGAL ACT
Detention 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 PN
In 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

42. NO DETENTION LAW (4)
Collateral Detention
Refusal to issue medical certificate and other pertinent
documents for patient’s release
Refusal to issue death certificate of deceased patient and
other documents for internment purposes only

43. NO DETENTION LAW (5)
Penalties
 Imprisonment of 1 mo. to 6 mos.
 Fine of P20K to P50K

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. 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.”

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. 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. 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. 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. 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. 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. 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. 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. 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. hank You.
Thank You
ATTY. ELIZABETH R. PULUMBARIT
University Legal Counsel and
Head, Intellectual Property Office
University of the Philippines Manila
Email: erpulumbarit@mail.upm.edu.ph;
pulumbaritlaw@gmail.com