Ethics in Research What is meant by ethics

Ethics in Research

What is meant by ethics? n Ethics is the science of criteria, norms and values for human action and conduct. It is engaged in reflection and analysis of morals concerning whether an act is good or bad and how it influences our basic quest for meaning, our search for humanity and our attempt to create a humane society. Its intention is to safeguard human dignity and to promote justice, equality, truth and trust. In a nutshell, ethics is critical reflection on morality.

Medical ethics n It can be described as the reflection on moral actions within the framework of health care. Its objective is to promote health, to care, to heal, to alleviate pain and to prevent suffering.

What is meant by research ethics? n Ethics for health research is the enterprise that determines norms and values to guide the systematic reflection and scientific evaluation or assessment of clinical knowledge and any form of experimentation or survey, with the prime objective of promoting health care. Its sole intent is to benefit patients, to alleviate pain and to prevent suffering

Tuskegee syphilis experiment n Also known as the Tuskegee syphilis study or Public Health Service syphilis study was an infamous clinical study conducted between 1932 and 1972 in Tuskegee, Alabama by the U. S. Public Health Service to study the natural progression of untreated syphilis in poor, rural black men who thought they were receiving free health care from the U. S. government.

Basic assumption and point of view The basic ethical assumption in health research is the autonomy of the individual within the broader context of human relations. The social and cultural environment should be taken into consideration in all circumstances. People should be treated as human beings in the context of their social, political, economic and religious environments.

v Assessment of both patients and healthy volunteers in research programmes should be made within the context of the family and cultural system. Research programmes should treat people as part of a community while simultaneously respecting their individual autonomy.

Basic ethics codes of behaviour n The following should apply to any research programme: 1. The participant as a person Respect for the autonomy of the participant, whether patient or volunteer, demands that the participant must be treated as a unique human person within the context of his or her community system. Freedom of choice must be safeguarded.

2. Human rights Respect for the basic rights of the individual as a human being as well as the rights of groups and communities 3. The ethic of justice, fairness and objectivity Research should always respect the dignity of people involved and should never expose them to intentions and motives not directly attached to the research project, its methodology and objectives

4. Competence Researchers must be professionally and personally qualified. In all circumstances they must be accountable and act in a responsible manner. Professional standards should be upheld in accordance with academic training

5. Integrity should be promoted by being honest and fair. Researchers must be honest about their own limitations, competence, belief systems, values and needs.

6. Sensitivity in research implies balancing scientific interest (the research) with general values and norms affecting the human dignity of the people involved 7. Confidentiality must be respected under all circumstances. Documentation should be safeguarded and viewed as strictly private in terms of the limits set by the research project

8. 9. Demarcation of roles There should be mutual understanding of the roles and interests of investigators and participants in research Communication Clear and understandable verbal communication is required, with factual data. Emotional and cultural values should be considered

Possible dangers to be taken into consideration n The danger of objectification and fragmentation Special care must be taken not to treat a participant as a mere object. Research objectives are subordinate to the following principle: to treat human beings with respect.

n The danger of direct or indirect coercion Direct or indirect coercion of people in the name of research must be avoided under all circumstances. Coercion may include the exploitation of vulnerable people; taking undue advantage of a participant, volunteer or any other person; or the misuse of the authority and influence of the research

Basic Ethical Principles n Respect for Persons 1. 2. Individuals should be treated as autonomous agents Persons with diminished autonomy are entitled to protection n An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give weight to autonomous persons’ considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated. The procedural implementation for the principle of respect for persons is embodied in the process of informed consent.

Basic Ethical Principles n Beneficence Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by efforts to secure their well-being. Such treatment falls under the principle of beneficence. Two general rules have been formulated as complementary: 1. Do not harm 2. Maximize possible benefits and minimize possible harms By approving research proposals that incorporate these rules, IRB implement the principle of beneficence.

Basic Ethical Principles n Justice An Injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. The formal principle of justice requires that individuals who are equal in relevant respect be treated equally. The implementation of this principle of fairness requires reasonable efforts to exercise equity in the selection of research subjects and is the application of knowledge gained through their participation.

Informed Consent n Informed consent is founded on the legal and ethical principles of autonomy, the right to selfdetermination, and non-maleficence, or “do no harm. ” n It is the outcome of a process in which information is shared between the patient/subject and practitioner. The patient/subject is the ultimate decision-maker in accepting or rejecting proposed medical treatment or research.

Informed Consent n Informed consent is the exercise of making informed choices and giving permission for others to act on those choices. n Informed consent in medicine/research requires respect for the informed and voluntary treatment choices of the patient/subject with respect to medical treatment being offered.

Elements of Informed Consent For an individual to give informed consent to participate in research, five elements are required: 1. 2. 3. 4. 5. Disclosure of information by investigator Capacity to have a preference and make a decision Voluntariness to choose without undue coercion Comprehension of information and its consequences Permission by subject to accept or refuse participation

Disclosure of Information The standard for disclosure of information that researchers and health care providers should employ in communicating with patients/subjects requires that the information disclosed be consistent with what a “reasonable person” would want to know in a similar situation.

Capacity n Every adult is presumed to have the capacity to make health care decisions unless determined otherwise. n The capacity to make health care decisions is typically defined as “the ability to understand appreciate the nature and consequence of health care decisions, including the benefits and risks of and alternatives to any proposed health care, and to reach an informed decision. ”

Voluntariness n Informed consent requires that the patient’s/subject’s participation in the decisionmaking process and in the decision arrived at be voluntary. n Investigators, providers, families, and significant others must be careful to avoid undue coercion.

Factors Affecting the Informed Consent Process: Patients/Subjects n n n values and priorities religious beliefs personality and coping style gender, age, race culture education n desire for information and control roles of the spouse, parents, child, guardian degree of dependence upon and trust in the patient-professional relationship

Factors Affecting the Informed Consent Process: Health Care Providers/Investigators n n n n education experience values and priorities knowledge communication style gender, age, race culture religious beliefs

Elements of informed consent 1. a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

n n 2. a description of any reasonably foreseeable risks or discomforts to the subject; 3. a description of any benefits to the subject or to others which may reasonably be expected from the research;

n 4. a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; n 5. a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

n 6. for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; n 7. an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a researchrelated injury to the subject; and

n 8. a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

n When appropriate, one or more of the following elements of information shall also be provided to each subject: 1. a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;

2. anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent; 3. any additional costs to the subject that may result from participation in the research; 4. the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;

n 5. a statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and 6. the approximate number of subjects involved in the study

Ethical Dimensions n Respect for the dignity and freedom of the child (even where autonomy is limited) n Expression of the health interests, concerns, and needs of the child n Articulation of the autonomy of the child n The primacy of the child’s assent or consent n

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