Research Ethics

• Science is commonly thought of as amoral; from a scientific point of view, facts discovered through science are neither moral nor immoral they just happen to exist.
• Science per se does not include values.
• The well-being of the individual research participant is no less important than the search for knowledge. Research that is harmful to participants is undesirable even though it may increase wisdom.
• A researcher is legally responsible for what to research participants. He or she is liable for any harm to subjects, even if it occurs unintentionally.
• The Philippine Health Research Ethics Board (PHREB) is the national policymaking body on health research ethics, was created under DOST Special Order No. 091, which is mandated to ensure that all phases of health research shall adhere to the universal ethical principles that value the protection and promotion of the dignity of health research participants.
• In 1932, the Public Health Service, working with the Tuskegee Institute, began a study to record the natural history of syphilis in hopes of justifying treatment programs for blacks. It was called the “Tuskegee Study of Untreated Syphilis in the Negro Male.”
• In the Tuskegee Experiment, there was no evidence that researchers had informed them of the study or its real purpose. The men had been misled and had not been given all the facts required to provide informed consent.
• On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
• One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.
• Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings.
• Practice refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals.
• Research designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships).
• Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.
• When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is "experimental," in the sense of new, untested or different, does not automatically place it in the category of research.
• Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy.
• The general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.
• Basic Ethical Principles refers to those general judgments that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions.
• The three basic ethical principles laid down by the Belmont Report are beneficence, respect for persons, and justice.
• Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.
• The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.
• Autonomy is defined as having the freedom to act independently self-governing, independent, free, self-determining
• An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation.
• The capacity for self-determination matures during an individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or circumstances that severely restrict liberty. True
• Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated.
• Respecting persons, in most hard cases, is often a matter of balancing competing claims urged by the principle of respect itself.
• Beneficence is when persons are treated ethically not only by respecting their decisions and protecting them from harm but also by making efforts to secure their well-being.
• Primum non nocere means First do no harm
• Two general rules have been formulated as complementary expressions of beneficent actions in this sense:
• One should not injure one person regardless of the benefits that might come to others. However, even avoiding harm requires learning what is harmful
• The obligations of beneficence affect both individual investigators and society at large, because they extend both to particular research projects and to the entire enterprise of research.
• In the case of scientific research in general, members of the larger society are obliged to recognize the longer term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures.
• Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved."
• Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are (1) to each person an equal share (2) to each person according to individual need (3) to each person according to individual effort (4) to each person according to societal contribution, and (5) to each person according to merit
• Informed Consent means that the subject agrees to participate after having been fully informed about the nature of the study.
• The purpose of informed consent is to give subjects enough information about the experiment so that they can make an informed decision about whether or not they want to participate.
• A special problem of consent arises where informing subjects of some pertinent aspect of the research is likely to impair the validity of the research.
• In all cases of research involving incomplete disclosure, such research is justified only if it is clear that (1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them.
• Incomplete disclosure applies when information about the real purpose or nature of the research is withheld from participants.
• Deception in the context of human research refers to providing false information to prospective participants.
• Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the research.