Research Ethics

Why is ethics needed in healthcare?

• most reserach in healthcare involves HUMAN SUBJECTS

What are the rights of human subjects?

• Right to Self-Determination (Autonomy)

• Right to Privacy and Dignity

• Right to Anonymity and and Confidentiality

• Right to Fair Treatment

• Right to Protection from Discomfort and Harm

• right of prospective participant to dceide voluntarily, freely, and without coercion to participate or not

• participant must be fully informed about the study before he consents to participate and before signing the consent form

Right to Self-Determination (Autonomy)

Whart should be communicated to each participant?

• By deciding to participate in a research, one opens himself up and subjects his personal life to intrusion from researchers

• Every subject has the right to expect that researchers shall ensure that the provided information and his identity will be kept in highest level of confidentiality

Right to privacy and Dignity

• is the guarantee that the subject's identity cannot be linked (even by the researcher) with his individual responses

Anonymity

• ensures that the identity of the research subject will not be linked with the informaton he provides and will not be publicly divulged

Confidentiality

Before, during, and after participation, subject has the right to fair and equitable treatment which includes courtesy and tact, respect for sociocultural diversity, honoring researcher-subject agreements

Right to Fair Treatment

• Risk could be physicial (physical injury, fatigue, bodily harm) or non-physical (psychological, social, economic, or legal harm)

• Subject's right to protection from undue discomfort and harm makes it mandatory for researchers to strive to minimize all types of discomfort and harm

Right to Protection from Discomfort and Harm

Ethical Principles in Research

• Autonomy

• Beneficence

• Nonmaleficence

• Justice

• self-determination that fosters subject's independence and self-regulation

• before participation, he/she shall fully informed and consent shall be given voluntarly

Autonomy

From the principle of autonomy, the rules of informed consent are derived, which contain the basic elements of:

• disclosure

• understanding

• voluntariness

• competence

• permission-granting

• involves positive action towards preventing, or removing evil, or harm, and doing or promoting good

Beneficence

Multiple dimensions of beneficence:

• Freedom from harm

• Freedom from exploitation

• Benefits from research

• Risk-Benefit ratio

• requires that the researcher does not cause direct harm nor inflict unnecessary pain/injury to the subjects of the study, although unanticipated harm may occur during its course

Nonmaleficence

_ may take the form of physical injury, incapacitation, mentak and psychological streaa amd anxiety, social disbility, and spiritual distress

Harm

• To be just is to be fair. Justice is fairness.

• Includes the subject's right to fair treatment and his right to privacy; non-discriminatory selection of research subjects and fair and equitable sharing of benefits and risks

Justice

• - (age, compromised position, sociocultural deprivation) shall be treated with fairness, respect, courtesy

Vulnerable groups

Elements of Research Ethics

• Social Value

• Informed Consent

• Vulnerability of Research Participants

• Risks, Benefits, and Safety

• Privacy and Confidentiality of Information

• Justice

• Transparency

• refers to the relevance of the study to an existing social or health problem where results are expected to bring about a better understanding of related issues, or contribute to the promotion of well-being of individuals , their families, and communities

Social value

A decision of a competent potential participant to be involved in research after receiving and understanding relevant information, without having been subjected to coercion, undue influence, or inducement

Informed consent

• Vulnerable participants refer to those who are relatively or absolutely incapable of deciding for themselves whether or not to participate

Vulnerability of Research Participants

• All research involving human participants shall be preceded by a careful assessment of predictable risks, burdens, and forseeable benefits to the research participants or to others

Risk, Benefits, and Safety

• participant’s right to privacy must be respected

• unless required by law, confidentiality of information shall at all times be observed

• records that link individuals to specific information shall not be released

• requirement shall be included in the informed consent

Privacy and Confidentiality of Information

• there should be fair selection in the choice of population, sampling, and assignments

• there shall be provision of appropriate care to research participants regardless of economic status, gender, race, or creed

• compensation for harms brought by participation in research

• shall be reimbursed for lost earnings when taking part in study

• have access to benefits related to participation in the stud

Justice

Transparency

• Disclosure of research results to research participants shall occur only when all the following apply:

• findings are scientifically valid and confirmed

• findings have significant implications for the participant's well-being

• the course of action to ameliorate these concerns is readily available when research results are disclosed to its participants

Research problem is ethical if _

rights of participants are respected