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TheDeclarationofHelsinki(2013,Article17)declaresthat,"All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable ___________ to them and to other individuals or groups affected by the condition under investigation".

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TheDeclarationofHelsinki(2013,Article31)declaresthat,"Thephysicianmustfullyinformthepatientwhichaspectsoftheircarearerelatedtotheresearch.Therefusalofapatienttoparticipateinastudyorthepatient'sdecisiontowithdrawfromthestudymustneveradverselyaffectthe________________________".

TheDeclarationofHelsinki(2013,Article32)declaresthat,"For medical research using identifiable human material or data, such as research on material or data contained in ____________ or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations the research may be done only after consideration and approval of a research ethics committee".

TheDeclarationofHelsinki(2013,Article36)declaresthat,"Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and ___________________ must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication".

The United States Department of Health and Human Services (HHS) defines a human research subject as a living individual about whom a research investigator (whether a professional or a student) obtains data through 1) intervention or interaction with the individual, or 2) identifiable _______________________ (32 C.F.R. 219.102(f)).