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CIP 1 Ethics Codes

QuestionAnswer
Belmont Report - Ethical Principles respect of persons, beneficence and justice.
Belmont Report - Justice Who receives the benefits of research and who bears its burdens/risks?
Belmont Report - Application of Princliple Justice Fair proceedures and outcomes in the selection of subjects of research.
Belmont Report - Application of Princliple Respect for Persons Informed consent of participants,
Belmont Report - Application of Princliple Benificence Assessment of risk/benefit and consideration of alternatives.
Nuerenberg Code - Injury, Disability and Death Avoid unnecessary suffering/injury. No experiment should be conducted, if injury/death is likely Prepare to protect subjects from remote possibilities of injury/death End study if continuation risks injury/death to subjects
Nuerenberg Code - Participant Rights during a study Human subjects should be at liberty to end participation during the course of the experiment,
Nuerenberg Code - Judging Necessity for Research Research should be for the good of society, unprocurable by other methods. Base study on animal studies & knowledge of the problem Risks should not exceed importance of results. Qualified persons must conduct the study
International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. Ethical and scientific quality standards for clinical trials that involve participation of human subjects to ensure that the RIGHTS, SAFETY and WELLBEING of the trial subjects are protected. Ensure the CREDIBILITY of clinical trial data.
Council for International Organizations of Medical Sciences International guidlines for informed consent, standards for external review, recruitment of participants, etc.
CIP Code of Ethics - Part I Professional conduct Inspire trust Give prime consideration to protection of subjects Apply the Belmont & other standards Adhere to laws & regulations; Respect the all people & be sensitive to cultura/indiv diff Disclose/avoid all conflicts of int
CIP Code of Ethics - Part II Avoid using proprietary knowledge for personal gain Protect confidential and private info Maintain the highest possible level of knowledge Facilitate & encourage open communication Protect the integrity and content of the CIP Exam
Nuerenberg Code Voluntary consent is absolutely essential. The person should have legal capacity for consent; should be able to make choices, w/o force, fraud, deceit, duress, or other coercion & have the knowledge and comprehension to enable an enlightened decision.
Which was first? Nuerenberg Code Declaration of Helsinki Nuerenberg Code - 1947 Declaration of Helsinki-1964 Amended: 1975, 1983, 1989, 1996, 2000, 2008
Who developed the Declaration of Helsinki The World Medical Association (WMA) NOT the WHO
Declaration of Helsinki is primarily addressed to which group? physicians
Declaration of Helsinki recognizes that Medical progress is based on research that will involve human subjects. Whose interests take precedence in this process? the well-being of the individual research subject must take precedence over all other interests.
Declaration of Helsinki - Review of research protocols The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins. The committee must be able to monitor ongoing studies.
Declaration of Helsinki - After subjects give consent - who is responsible for protecting them from harm? The responsibility must always rest with the physician or other health care professional and never the research subjects, even though they have given consent.
Declaration of Helsinki - Clinical Trials These must be registered in a publicly accessible database before recruitment of the first subject
Declaration of Helsinki - Consent for competent individuals Participation by competent individuals as subjects in medical research must be voluntary. It may be appropriate to consult family members/community leaders, no competent individual may be enrolled in a study unless he/she freely agrees
Declaration of Helsinki - Consent for "incompetent" individuals For a potential research subject who is incompetent, the physician must seek informed consent from the legally authorized representative.
Declaration of Helsinki - When can "incompetent" individuals be enrolled? The research will benefit the individual or the individual's population, it cannot be performed with competent persons, & the research entails only minimal risk & burden
Declaration of Helsinki - Asking "incompetent" individuals to particiapte Assent processes are discussed as are options for including individuals who are unconscious.
Declaration of Helsinki - Use of placebos in control groups New treatments should be compared to current treatments unless no proven treatment exists - or sound methodology requires use of placebo to determine efficacy or safety and this does not pose a serious risk to subjects
Declaration of Helsinki - Duty to subjects after the study They are entitled to be informed about the outcome of the study and to share any benefits that result from it,
CIP Code of Ethics - CIPs aspire to the highest possible standards of conduct in order to enhance the protection of persons who participate in research
Created by: OTTeacherLady
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