Waiver of Documentation of Consent
December 2014 Issue
By John F. Ennever, MD, PhD, CIP, Director, BUMC IRB
Waiver of Documentation of Consent
The IRB world is full of confusing terms made worse by the fact that very different things have names that sound very similar (e.g., exempt and expedited). This article will discuss, “waiver of documentation of consent.” (This is a very different subject from “waiver of consent,” which will be the subject of a future CR TIMES article.)
The Belmont Report (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html), which is the ethical foundation for human subjects research in the US, considers informed consent to be a process which is divided into three components: Information, Comprehension and Voluntariness. The IRB-approved consent form is meant to be the core of the information that is to be presented to the subject. The Belmont Report expands on the responsibility of the investigator when presenting information to subjects:
“The manner and context in which information is conveyed is as important as the information itself. For example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice. Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the subject's capacities.”
Some potential subjects may comprehend a study when they are instructed to read an IRB-approved form and ask questions, but this is not the process envisioned by the Belmont Report.
Many researchers think they have obtained informed consent when the subject signs and dates the form that has been approved by the IRB. The fact that a subject has signed the consent document is really no more proof that they have made an informed decision to participate in your study, than your clicking a box indicating you accept the terms and conditions for use of a website as proof that you have read and understand what the website will do with your data (think Facebook).
Investigators are responsible for the subject’s understanding of the study. Informed consent is a two-way discussion. The Belmont Report states: “While there is always an obligation to ascertain that the information about risk to subjects is complete and adequately comprehended, when the risks are more serious, that obligation increases. On occasion, it may be suitable to give some oral or written tests of comprehension.”
Nowhere in the Belmont Report is there a mention of the subject signing a form. The requirement for a signature does appear in the Federal regulations. For research governed by FDA regulations (i.e., a study involving a drug or device or biological, whether experimental or approved), the signature and date on the consent form are required. While neither OHRP nor FDA requires it, most consent forms (and our standard template) include a signature line for the person conducting the consent discussion. This signature is meant to attest that the subject has been sufficiently informed about the study; that the subject appears to understand what participation involves; and is providing an “informed consent” to participate. This signature may actually be more meaningful as a documentation of the consent process than the signature of the subject.
For research NOT governed by the FDA, we apply the OHRP regulations (45 CFR 46). These regulations require documentation of consent (a signature); however, if the research is no more than minimal risk, then there is a pretty low bar for waiving this requirement. Specifically, no written documentation of consent is required under OHRP when the research meets one of two conditions:
The first is when 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.
The second is when the only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern. This second part (letting the subject decide whether or not to sign the form) is logistically difficult, as it requires the presence of a signature line that may or may not be filled out. Thus, if you have a study where it makes sense to waive documentation as part of subject protections, then the waiver can be granted based upon the first condition as long as the overall study is minimal risk.
The majority of minimal risk research would fit into the first category and, therefore, be eligible for a waiver of documentation of consent. The IRB would approve a consent form that would have all of the required elements, but would not have a line at the end for the subject’s signature. The IRB normally requires that a copy of this form be given to the subject. For online studies, this can be accomplished by a statement such as “Please print or save a copy of this form for your records.”
The requirement for HIPAA authorization complicates this a bit. The HIPAA regulations do not have a similar provision for waiver of documentation of authorization for access to PHI. There are conditions where authorization may be waived (or altered), but in situations in which one has face-to-face interactions with subjects, it is difficult to meet one of the requirements for waiver of HIPAA authorization: “The research could not practicably be conducted without the waiver or alteration.”
Even with this limitation, a great deal of research done at BUMC is minimal risk and does not involve access to PHI. For these studies, a waiver of documentation of consent is often appropriate. If your study meets these criteria, then submit a consent form without a signature line, and indicate in the Consent section of INSPIR that you are requesting a waiver of documentation of consent.
In many ways, not requiring a signature should make the process of consent more robust, because it forces the person obtaining consent to play a more active role in the procedure. The study staff can no longer just hand a form to a subject and rely on a signature to presume comprehension, as a conversation is required. Recognizing this fact, some IRBs have begun to require investigators of minimal risk research to justify why they want to have a subject sign a consent form. Although we have not gone this far, it is certainly an idea worth exploring.
Consent is not a signature on a form – it is an interactive process between researchers and potential subjects.
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