If you are requesting a waiver or alteration of consent or waiver of documentation of consent, please attach the Waiver or Alteration of Informed Consent Request to your application to COUHES.
Waiver or Alteration of Informed Consent
COUHES may approve a consent procedure which does not include, or which alters, some or all of the required elements of informed consent, or waive the requirement to obtain informed consent provided COUHES finds that:
- The research involves no more than minimal risk to the subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research could not practicably be carried out without the waiver or alteration; and
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Note: If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.
Waiver of Documentation (signature) of Consent
COUHES may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds any of the following:
- That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
- That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
- If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
In cases in which the documentation requirement is waived, COUHES may require the investigator to provide subjects or legally authorized representative with a written statement regarding the research.