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acrp DOH
declaration of Helsinki
| Question | Answer |
|---|---|
| The Declaration of Helsinki (DOH) was developed by the ______________ | World Medical Association |
| P2: Consistent with the mandate of the WMA, the Declaration is addressed primarily to __________. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles. | physicians |
| P3: The Declaration of Geneva of the WMA binds the physician with the words, “________________________________,” | “The health of my patient will be my first consideration,” |
| P4: It is the duty of the physician to promote and safeguard the ______________________________________, including those who are involved in medical research. | health, well-being and rights of patients |
| P5: Medical progress is based on _____________ that ultimately must include studies involving _________________. | research; human subjects |
| P6(1): The primary purpose of medical research involving human subjects is to understand the causes, development and effects of __________ and improve preventive, diagnostic and therapeutic ____________ (methods, procedures and treatments). | diseases; interventions |
| P6(2): Even the best proven interventions must be_________________ through research for their safety, effectiveness, efficiency, accessibility and quality. | evaluated continually |
| P7: Medical research is subject to ______________ that promote and ensure respect for all human subjects and protect their health and rights. | ethical standards |
| P8: While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the ______________ of individual research subjects. | rights and interests |
| P9: The responsibility for the protection of research subjects must always rest with the _______________________ and never with the ________________, even though they have given consent. | physician or other healthcare professionals; research subjects |
| P10: ... No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth _______________________. | in this Declaration |
| P11: Medical research should be conducted in a manner that minimizes possible harm to _______________. | the environment |
| P12: ... Medical research involving human subjects must be conducted only by individuals with the appropriate ________________ education, training and qualifications. | ethics and scientifc |
| P13: Groups that are _________________ in medical research should be provided appropriate access to participation in research. | underrepresented |
| P14: Physicians who combine __________________________ should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and [paragraph continues re: no adverse affects] | medical research and medical care |
| P15: Appropriate ____________________________ for subjects who are harmed as a result of participating in research must be ensured. | compensation and treatment |
| Paragraphs 1 and 2 of the DOH are under the heading ____________. Paragraphs 3-15 fall under _____________________. | Preamble ; General Principles |
| P16: In medical practice and in medical research, most interventions involve ___________. Medical research involving human subjects may only be conducted if the _________________________ outweighs the risks and burdens to the research subjects. | risks and burdens; importance of the objective |
| P17: Research involving human subjects must be preceded by careful assessment of ___ to the individuals and groups involved in the research in comparison with ______ to them and to other individuals or groups affected by the condition under investigation. | predictable risks and burdens; foreseeable benefits |
| P17(2): Measures to __________ the risks must be implemented. The risks must be continuously monitored, assessed and _____________ by the researcher. | minimize the risks; documented |
| P18: Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be ___________________. | satisfactorily managed |
| P18(2): When the risks are found to outweigh the potential benefits or when there is ____________, physicians must assess whether to continue, modify or immediately stop the study. | conclusive proof of definitive outcomes |
| Paragraphs 16-18 are fall under the heading ___________________. Paragraphs 19 and 20 fall under _____________________. | Risks, Burdens, and Benefits; Vulnerable Groups and Individuals |
| P19: Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive _______________. | specifically considered protection |
| P20: Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a _______________. | non-vulnerable group |
| P20(2): In addition, this group should stand to benefit from the _____________________ that result from the research. | knowledge, practices or interventions |
| P21: Research involving human subjects must conform to generally accepted _____, be based on a thorough knowledge of the _________, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. | scientific principles; scientific literature |
| P21(2): The welfare of __________ used for research must be respected. | animals |
| P22: The __________ of each research study involving human subjects must be clearly described and justified in a research protocol. | design and performance |
| P22(2): The protocol should contain a statement of the _______ involved and should indicate how the principles in this Declaration have been addressed. | ethical considerations |
| P22(3): The protocol should include information regarding _________________________ and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. | funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects |
| P22(4): In clinical trials, the protocol must also describe appropriate arrangements for ______________________. | post-trial provisions |
| P23: ... The research ethics committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be _______. ... | duly qualified |
| P23 (2): The researcher must provide monitoring information to the committee, especially information about __________. ... | any serious adverse events; |
| P23(3): After the end of the study, the researchers must submit a final report to the committee containing a summary of the ______________. | study’s findings and conclusions |
| P24: Every precaution must be taken to protect the privacy of research subjects and the confidentiality of _______________. | their personal information |
| Paragraphs 21 and 22 fall under the heading _____________. Paragraph 23 falls under _____________. Paragraph 24 falls under ______________. | Scientific Requirements and Research Protocols (21 and 22); Research Ethics Committees (23); Privacy and Confidential (24) |
| P25: Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. ... no individual capable of giving informed consent may be enrolled in a research study unless ___________. | he or she freely agrees |
| P26: ... Special attention should be given to the specific information needs of individual potential subjects as well as to the _______________. | methods used to deliver the information |
| P26(2): ... If the consent cannot be expressed in writing, the non-written consent must be _______________. | formally documented and witnessed |
| P26(3): All medical research subjects should be given the option of being informed about _______________________________. | the general outcome and results of the study |
| P27: When seeking informed consent the physician must be particularly cautious if the potential subject is in a ________ with the physician or may consent under duress. In such situations the informed consent must be sought by ____________. | dependent relationship; an appropriately qualified individual who is completely independent of this relationship |
| P28: For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the ___________________. | legally authorised representative |
| P28(2): [Those incapable of giving informed consent] must not be included in a research study that has no likelihood of benefit for them unless _________ (3 things) | (1) it is intended to promote the health of the group represented by the subject, (2) the research cannot instead be performed with persons capable of providing informed consent, and (3) and the research entails only minimal risk and minimal burden. |
| P29: When a potential research subject who is deemed incapable of giving informed consent 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 authorised representative |
| P30: Research involving subjects who are physically or mentally incapable of giving consent may be done only if the physical or mental condition that prevents giving informed consent is a ____________ of the research group. | necessary characteristic |
| P30(2): If no LAR is available and the research cannot be delayed, the study may proceed without consent provided that the reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in ____ | the research protocol; |
| P30(3): [If the study proceeds without consent] Consent to remain in the research must be obtained as soon as possible from ___________. | the subject or a legally authorised representative (LAR) |
| P31: The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never adversely affect ______. | the patient-physician relationship. |
| P32: There may be exceptional situations where consent would be impossible or impracticable to obtain for [human material/ data/biobank] research. In such situations the research may be done only after _____________. | consideration and approval of a research ethics committee. |
| Paragraphs 25-32 fall under the heading _____________. | Informed Consent |
| 33: The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances: __________ (3 things) | (1) no proven intervention exists, (2) compelling scientific methodological reasons compel the use of a less effective intervention, placebo, or no intervention, (3) recipients of alternate intervention not subject to additional risks or serious harm |
| Paragraph 33 falls under the heading _________. | Use of Placebo |
| P34: In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need _____________________. | an intervention identified as beneficial in the trial |
| Paragraph 34 falls under the heading __________. | Post-Trial Provisions |
| P35: Every research study involving human subjects must be registered in a __________ before recruitment of the first subject. | publicly accessible database |
| P36: Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the ______________ of the results of research. | publication and dissemination |
| P36(2): Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the ____________________ of their reports. All parties should adhere to accepted guidelines for ethical reporting. | completeness and accuracy |
| P36(3): Negative and inconclusive as well as positive results must be ____________________. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. | published or otherwise made publicly available |
| Paragraph 35-36 fall under the heading __________. | Research Registration and Publication and Dissemination of Results |
| P37: Where proven interventions do not exist or other interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or LAR, may use an unproven intervention if it offers ____________ . (3 things) | (1) hope of saving life, (2) re-establishing health or (3) alleviating suffering |
| 37(2): Unproven interventions as described above should subsequently be made the object of research designed to evaluate its ________. In all cases, new information must be recorded and, where appropriate, made publicly available. | safety and efficacy |
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