Nuremberg Code 1. The voluntary consent of the human subject is absolutely essential. ….the person involved should have legal capacity to give consent; …be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.
Nuremberg Code …before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature duration purpose of the experiment the method and means by which it is to be conducted all inconveniences and hazards reasonably to be expected the effects upon his health or person which may possibly come from his participation in the experiment.
Nuremberg Code The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
Declaration of Helsinki 24. In medical research involving competent human subjects, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, any other relevant aspects of the study.
Declaration of Helsinki After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.
Declaration of Helsinki 26. When seeking informed consent … if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent should be sought by an appropriately qualified individual who is completely independent of this relationship.
Declaration of Helsinki 27. For a potential research subject who is incompetent, the physician must seek informed consent from the legally authorized representative. These individuals must not be included in a research study that no likelihood of benefit for them unless it is intended to promote the health of the population represented by the potential subject, the research cannot instead be performed with competent persons, the research entails only minimal risk and minimal burden.
Declaration of Helsinki 28. When a potential research subject who is deemed incompetent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorized representative. The potential subject’s dissent should be respected.
Declaration of Helsinki 29. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research population. In such circumstances the physician should seek informed consent from the legally authorized representative.
Declaration of Helsinki If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol the study has been approved by a research ethics committee. Consent to remain in the research should be obtained as soon as possible from the subject or a legally authorized representative.
Declaration of Helsinki 33. At the conclusion of the study, patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it, For example, access to interventions identified as beneficial in the study or to other appropriate care or benefits.
The Belmont Report Respect for Persont subjects enter into the research voluntarily and with adequate information 2 requirements : to acknowledge autonomy to protect those with diminished autonomy 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, circumstances that severely restrict liberty
Respect for person 3 elements of the consent process 1.Information 2.Comprehensive 3.Voluntariness The Belmont Report
Information the research procedure their purposes risks and anticipated benefits alternative procedures (where therapy is involved) a statement offering the subject the opportunity to ask questions to withdraw at any time from the research Additional items how subjects are selected the person responsible for the research, etc.
Incomplete disclosure 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 3. there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them information about risks should never be withheld for the purpose of eliciting the cooperation of subjects truthful answers should always be given to direct questions about the research
Comprehensive necessary to adapt the presentation of the information to the subject's capacities (intelligence, rationality, maturity and language) when the risks are serious, it may be suitable to give some oral or written tests of comprehension seeking the permission of other parties (most likely to understand the incompetent subject's situation and to act in that person's best interest) in order to protect the subjects from harm should be given an opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research
Voluntariness free of coercion and undue influence Coercion - an overt threat of harm intentionally presented by one person to another in order to obtain compliance Undue influence - an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance, manipulating a person's choice through the controlling influence of a close relative and threatening to withdraw health services