Home / Help for Researchers and Study Personnel / Waiver of the Requirement to Obtain Written Documentation of the Consent Process (Option #1)

Waiver of the Requirement to Obtain Written Documentation of the Consent Process (Option #1)

Robert Hood

04/25/2008 04:37 pm

Help for Researchers: Waiver of the Requirement to Obtain Written Documentation of the Consent Process (Option #1)

  What researchers need to explain What the IRB needs to determine
General Considerations
  • The application and protocol should detail plans to collect individually-identifiable information. Explain why the identities of individuals would not be readily ascertainable. Document that the only record linking the participant and the research is the consent document.
  • The application and protocol should explain why a breach of confidentiality might cause harm (for example, due to stigma and risks to insurability or employability)
  • The application and protocol should detail plans for asking participants whether they want documentation linking them to research, and their plans for insuring that participants make an informed decision (for example the researcher could submit a script or outline of information to be presented)
  • The researcher should document that this research is not FDA-regulated
  • Include a script for the consent discussion that includes all required disclosures
  • The only record linking the participant and the research is the consent document
  • The principal risk is potential harm resulting from a breach of confidentiality.
  • Each participant will be asked whether he or she wants documentation linking the participant with the research, and the participant's wishes will govern
  • The research is not FDA-regulated.
  • The investigator has provided a script of the consent discussion that meets the requirements for the consent process and includes all required and appropriate additional elements of consent disclosure.
  • The IRB has considered whether the investigator is to provide written information to the participant that includes all required and appropriate additional elements of the consent disclosure.
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