Potential participants, or the parents of children who are potential participants, are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the process (signing of the consent form) has been waived by the IRB.
Situations when it is used
This process is often used in minimal risk research involving the administration of online or mailed surveys, telephone interviews, or when anonymous sensitive information is collected and there is a desire to not have written documentation that links the participant to the research study.
Conditions for approval
The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all participants if either of the conditions below are true:
The research is not FDA regulated. The FDA has not adopted this category so it cannot be used if the research is subject to the FDA regulations 21 CFR 50. The written script of the information to be provided orally and all written information to be provided include all required and appropriate elements of consent disclosure in the WORKSHEET: Criteria for Approval (HRP-314). The only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether or not he or she wants documentation linking him or her to the research. The participant's wishes will govern.
- The written script of the information to be provided orally (if consent is obtained in person) and all written information to be provided or electronically displayed include all required and appropriate elements of consent disclosure in the WORKSHEET: Criteria for Approval (HRP-314). The research presents no more than minimal risk of harm to participants (i.e., the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests) and involves no procedures for which written consent is normally required outside of the research context. The research does not involve newborn dried blood spots.
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide participants with a written statement regarding the research.
If you plan to use or share protected health information (PHI) when conducting your research, you must conduct your study in accordance with the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA).
This means that when applying for a waiver of documentation of consent, you will also have to request a waiver or alteration of HIPAA Authorization. The IRB can grant the waiver of alteration if it determines the following criteria are met:
- Use or disclosure involves no more than minimal risk to the privacy of individuals because of the presence of at least the following elements:
- An adequate plan to protect health information identifiers from improper use or disclosure,
- An adequate plan to destroy identifiers at the earliest opportunity absent a health or research justification or legal requirement to retain them, and
- Adequate written assurances that the PHI will not be used or disclosed to a third party except as required by law, for authorized oversight of the research study, or for other research uses and disclosures permitted by the Privacy Rule;
- Research could not practicably be conducted without the waiver or alteration; and
- Research could not practicably be conducted without access to and use of PHI.