Waivers - Informed Consent & HIPAA
Informed Consent The IRB may approve an informed consent process that waives the requirement to obtain informed consent, alters some or all of the elements of informed consent, or waives the requirement to document informed consent (i.e., to obtain a signature).
The IRB may approve an informed consent process that: To waive informed consent, the IRB must determine that: The most important discussion should target why it is not practicable (not possible) to conduct the research without the waiver. The justification must provide a reasonable rationale for why the research would not be possible without the waiver. Studies that are entirely retrospective (use existing data, specimens and medical records that are available as of the date of IRB submission) represent a large percentage of the studies submitted to the IRB. These studies generally request and obtain a waiver of consent. However, if there are additional prospective components to the research, e.g. some subjects will be telephoned and asked to complete a questionnaire, it then becomes entirely practicable to obtain consent for the entire study, not just the questionnaire portion. If the data will be collected prospectively (after the date of IRB approval), a thorough justification is needed since it would be (or would have been) practicable to obtain consent. Waiving Parental Permission for Children The IRB may approve a waiver of parental permission only for research involving retrospective or prospective record review studies when the regulatory requirements are met. Waiver of Consent Process for Emergency Research This waiver is for IRB approved research that is done in emergency situations when there is no time to obtain informed consent. [CHECKLIST: Waiver of Consent for Emergency Research (HRP-419)] Things to Consider
The IRB may approve an informed consent process that: Alteration of the Requirements for Informed Consent When the IRB approves a waiver of one or more of the elements of consent (this is called alteration), the information provided to the subject does not have to include information related to the waived element during the consent discussion or in the written consent document. This is often found in studies involving Deception or Incomplete Disclosure. To alter informed consent elements, the IRB must determine that:
A waiver of documentation of informed consent (waiver of the requirement for a signature on a consent form) can be obtained under certain circumstances by the Investigator: The investigator must obtain consent following the same requirements as written consent, but the subject does not sign a consent form. It may still be appropriate to document that the consent process took place.
HIPAA
A waiver of authorization may be granted in situations where an individual’s authorization to access their PHI will not be obtained. In this case, the IRB can waive authorization for an entire conduct of the study . The most frequent situation where the IRB approves a full waiver of HIPAA is when the research also qualifies for a waiver of the requirements for consent for studies such as retrospective chart reviews. The waiver may only be approved by the IRB when specific regulatory requirements are met. The IRB will also expect the PI to provide an attestation in the protocol that:
A waiver of authorization for recruitment may be granted to review information in the medical record, record the minimum necessary information needed to contact a potential subject and to make that contact. The IRB will also expect the PI to provide an attestation in the protocol that:
It is vital to scientifically justify in the research protocol why research could NOT practicably be conducted without access to and use of the protected health information. Practicable means possible; it does not mean convenient. For example, if a subject is available to provide then it is usually practicable to obtain their authorization.
The most frequent alteration is for verbal HIPAA Authorization when the IRB has also waived the requirement for written consent. Demonstrating that the "research could not practicably be conducted without the waiver or alteration" is the main obstacle to approving an alteration. If the subject is physically present, it is usually practicable to obtain written HIPAA Authorization.