ETHICAL GUIDELINES IN THE CONDUCT OF HEALTH RESEARCH Michael Jhon M. Tamayao, M.Phil. SEMINAR WORKSHOP ON HEALTH RESEARCH Cagayan State University

Topic Outline I. INTRODUCTION II. THE ETHICAL GUIDELINES FOR HEALTH RESEARCH AS FORMULATED BY THE PHILIPPINE HEALTH RESEARCH ETHICS BOARD III. SUMMARY AND EVALUATION

Objectives At the end of this training-workshop, the participants must be able to: 1. Identify and understand the general ethical guidelines on Health Research as formulated by PNHRS in its 2006 publication of National Ethical guidelines for Health Research. 2. Synthesis & Evaluation of the Guidelines

INTRODUCTION The ethical man constructs the best path towards his end, which is Happiness. Health is a form of happiness. And health research is a means towards that happiness. Ethical Problem: WHAT IS THE BEST COURSE OF ACTION WHEN WE CONDUCT HEALTH RESEARCHES?

INTRODUCTION Most important issues: How to uphold the dignity and right of a human person as a research participant. How to foster good researches not just basing on technical standards but also on ethical norms.

INTRODUCTION major issues concerning the the proper administering of research are: 1. “informed consent” of the prospective subject, 2. Risks, benefits, and safety of the human participant, 3. community care, 4. Privacy and confidentiality of the participant's information, 5. Disclosure of research results, 6. standard of care for research subjects, 7. compensation for research subjects, 8. Special protection /consideration for some subject groups, 9. Absence of direct benefit of the human subject, 10. (the quality of research which includes) the role of the ethics review committee (ERC),

INTRODUCTION 11. the research protocol, 12. qualifications of investigators, 13. Protection of the environment and biosafety, 14. Welfare of animals

INTRODUCTION The ethical man constructs the best path towards his end, which is Happiness. Health is a form of happiness. And health research is a means towards that happiness. Ethical Problem: WHAT IS THE BEST COURSE OF ACTION WHEN WE CONDUCT HEALTH RESEARCHES?

I. Elements of Research Ethics 1. Informed consent “For all biomedical research involving humans, the investigator must obtain the voluntary informed consent of the prospective subject or, in the case of an individual who is incapable of giving informed consent, the permission of a legally authorized representative in accordance with applicable laws.” (16) A “waiver of informed consent” is deemed necessary for the approval of the research.

I. Elements of Research Ethics The investigator must provide the following informations to the potential participant: a. the invitation, the rationale of the study, and explicitation that the participation is voluntary. b. the participant's freedom of refusal and freedom of withdrawal at any phase of the research without penalty or loss of benefits to which he is entitled.

I. Elements of Research Ethics c. “purpose” and “procedures” of the research, and an explanation of how the research differs from routine medical care. d. explanation of the research design e. expected duration of the individual's participation f. foreseeable risks or discomforts to the individual associated with participation in the research (in both the control and experimental group)

I. Elements of Research Ethics g. Direct benefits to the subjects h. amount of money or kind of material goods involved if there are any i. the subjects right to access to data j. that after the completion of the study the subject will be informed of any findings related to his/her health status k. expected benefits of the research to the community or society at large, or contribution to scientific knowledge

I. Elements of Research Ethics l. whether, when, or how, any products or interventions proven by the research to be safe and effective will be available to the subjects after their participation in the research is completed m. Any current available alternative interventions or courses of treatment n. the provisions that will be made to ensure respect for the privacy of subjects and the confidentiality of records in which the subjects are identified

I. Elements of Research Ethics o. the limits, legal or other, to the investigator's ability to safeguard confidentiality, and the possible consequences of breaches of confidentiality; p. the sponsors of the research, the institutional affiliation to safeguard confidentiality, and the possible consequences of breaches of confidentiality q. the possible research uses, direct or secondary, of the subject's medical records

I. Elements of Research Ethics r. If the specimens collected will not be destroyed, where, how, and for how long they are going to be stored s. that the subjects have the right to decide about such future use, continued storage, or destruction of collected specimens t. whether commercial products may be developed from biological specimens, and whether the participant will receive monetary or other benefits from the development of such products

I. Elements of Research Ethics u. whether the investigator is serving only as an investigator or as both investigator and the subject's physician v. the extent of the investigator's responsibility to provide medical services to the participant w. that treatment will be provided free of charge for specified types of research-related injury or for complications associated with the research, the nature and duration of such care, the name of the organization or individual that will provide the treatment, and whether there is any uncertainty regarding funding of such treatment.

I. Elements of Research Ethics x. In what way, and by what organization the subject or subject's family or dependents will be compensated for disability or death resulting from such injury y. that an ethics review committee has approved or cleared the research protocol

I. Elements of Research Ethics 3. After ensuring that the subject has understood the information, the physician should then obtain the subject's freely given informed consent, preferably in writing. If the consent cannot be obtained in writing, the non-written consent must be properly documented and witnessed. 4. Caution must be exercised in obtaining informed consent for a research project if the subject is in a dependent relationship with the investigator (e.g., as a patient) to ensure that the consent is not given under duress.

I. Elements of Research Ethics 5. The participation of children in research requires extra protection 6. In obtaining informed consent, sponsors and investigators have a duty to: a. avoid deception, undue influence, or intimidation b. seek consent only after ascertaining that the prospective subject has adequate understanding of the relevant facts and the consequences of participation c. as a general rule, obtain from each prospective subject a signed form as evidence of informed consent d. renew the informed consent of each subject if there are any significant changes in the conditions or procedures of the research, e. renew the informed consent of each subject in long- term studies at pre-determined intervals even if there are no changes in the design or objectives of the research.

I. Elements of Research Ethics d. renew the informed consent of each subject if there are any significant changes in the conditions or procedures of the research, e. renew the informed consent of each subject in long- term studies at pre-determined intervals even if there are no changes in the design or objectives of the research. Risks, Benefits, and Safety 7. Health research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the research result

I. Elements of Research Ethics 8. Every health research project involving human subjects should be preceded by a careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others [Principle 16-Declaration of Helsinki, 2004] (apply the principle of double negation) 9. Every precaution should be taken to minimize the negative impact of the study on the subject's physical and mental integrity [Principle 16-Declaration of Helsinki, 2004] 10. There must be an assurance of a reasonable availability of a research product within the local market.

I. Elements of Research Ethics Community Care The conclusion or termination of the research activity should preclude the possiblity of administering extended community care. Privacy and Confidentiality Every precaution should be taken to respect the privacy of the participant and the confidentiality of the participant's information.

I. Elements of Research Ethics Disclosure of research results Disclosure of research results to subjects should occur only when all the following apply: a. the findings are scientifically valid and confirmed b. the findings have significant implications for the subject's health concerns c. the course of action to improve these concerns is readily available when research results are disclosed to its subjects

I. Elements of Research Ethics Standard of care Special consideration is given to economically and medically disadvantaged research subjects 15. The benefits, risks, burdens, and effectiveness of the new method should be tested against those of the best current methods. Compensation for research subjects compensation must be given to subjects for their lost; the compensation should not be too large

I. Elements of Research Ethics Subject groups that require special consideration special considerations for vulnerable groups, children, individuals incapable of giving informed consent, and pregnant women. - Research cannot be carried out equally well to other more common subject groups. - The main purpose of the research is to obtain knowledge relevant to the health needs of the special groups. -For children and individuals incapable of giving informed consent, permission of parents or legally authorized representatives is needed.

I. Elements of Research Ethics -A discussion of the risks & benefits involved -Competent advice and assistance are also given Absence of Direct Benefit – 23. If the risks from research do not have the prospect of direct benefit, then the risks should be no greater than the risks attached to routine medical or psychological examination of such persons.

II. Ensuring Quality Research Role of Ethical Review Committee It reviews the scientific merit and ethical acceptability of health researches. -It conducts stringent reviews -Ensures that the proposed researches are responsive to the health needs of the country. -It issues ethical clearance -it reviews amendments in the protocol of researches

II. Ensuring Quality Research Research Protocol- 25 – 29 - Researchers must follow a code of conduct that adequately addresses the four ethical principles: respect for persons, beneficence, non-maleficence, and justice. -It should be sufficiently detailed to serve as documentation of the study. Qualifications of investigators -Investigators should be scientifically qualified.

II. Ensuring Quality Research Protection of the environment and biosafety caution shall be exercised to avoid harm or damage to the environment -caution to the use of biological and hazardous materials Welfare of animals Investigators shall abide by RA No – Animal Welfare Act.

SUMMARY major issues concerning the the proper administering of research are: 1. “informed consent” of the prospective subject, 2. Risks, benefits, and safety of the human participant, 3. community care, 4. Privacy and confidentiality of the participant's information, 5. Disclosure of research results, 6. standard of care for research subjects, 7. compensation for research subjects, 8. Special protection /consideration for some subject groups, 9. Absence of direct benefit of the human subject, 10. (the quality of research which includes) the role of the ethics review committee (ERC),

SUMMARY 11. the research protocol, 12. qualifications of investigators, 13. Protection of the environment and biosafety, 14. Welfare of animals

“every person should be treated as an end in himself and never as a means to the advantage of anyone else.” -Immanuel Kant Consent + proper information

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