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  • Verbal Consent and Other Alternatives to Signed Consent Documents
    Examples of minimal risk studies that may be eligible for a waiver of documentation include, but are not limited to: Surveys (mailed, in person, or online), interviews (via telephone or in person), educational tests, focus groups, and ethnographic fieldwork
  • Obtaining and Documenting Informed Consent without Signatures . . .
    You may wish to replace signed consent with implied consent —that is, a prospective subject is informed about a study where participation consists only of filling out an anonymous questionnaire The person completes the questionnaire and, by doing so, agrees to participate in the research
  • Attachment A: Minimal Risk Informed Consent Models
    The model documents below were written to provide examples of informed consent forms that would be appropriate in the context of minimal risk research and reflect the goal of reducing the length and complexity of the consent forms used for non-exempt minimal risk research activities
  • Verbal consent in biomedical research: moving toward a future . . .
    Generally, REBs permit the use of verbal consent where they are satisfied that the research is of minimal risk to participants and it is impractical to carry out the research without verbal consent (Canadian Institutes of Health Research et al , 2022)
  • Verbal Consent (Waiver of Documentation) | CHOP Research . . .
    When the IRB grants a waiver of documentation of consent, the investigator needs to obtain the subject’s consent but not the subject’s signature to document it In this case, the investigator can document having obtained consent (e g on the verbal consent form or in the study chart)
  • Instructions for Unsigned (vs. Signed) Consent Forms
    If you wish to obtain verbal or online unsigned consent instead of signed (written documented) consent: a For Verbal Consent: -In the protocol, you must apply for waiver of signed consent Go to the Informed Consent section; under the Informed Consent tab, in the pop-up box for Consent Waiver Description, click on Consent Type field and
  • Regulatory Requirements for Informed Consent - Rethinking . . .
    Oral Consent Oral consent relies entirely on verbal communication between the researcher and the participant To use an oral consent process, the research must be minimal risk with adult subjects and no vulnerable populations, and the IRB would need to grant a waiver of documentation of consent, which it could do under 45 CFR 46 117(c)(2





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