Waiver of Documentation

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National Jewish Health will comply with federal regulations and guidelines when requesting and granting a waiver of documentation of informed consent.

PROCEDURES:

1. IRB may waive requirement to obtain a signed informed consent for some or all of subjects if:
   Both requirements must be met.
   1. The only record linking the subject and the research would be the consent document and the principle risk would be harm resulting from breach of confidentiality and
   2. the research presents no more than minimal risk and involves no procedures for which written consent is normally required [21 CFR 56.109 (C)].
2. In cases where documentation is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research
3. If an investigator wishes to obtain a waiver of the requirement to obtain a signed informed consent document, s(he) must submit a request in writing to the IRB. That request must include justification as to why the request meets the federal guidelines stated above.