Waiver of Documentation of Consent
In certain cases, the IRB may waive the requirement that an investigator obtain a participant’s signature as part of the consent process. This waiver is called a waiver of documentation of consent.
For research that is not FDA-regulated, there are three circumstances when the requirement for a signature [documentation] may be waived:
- When the only record linking the participant and the research is the consent document and the principal risk is loss of confidentiality.
- In this scenario, each participant must be asked whether he/she would like to sign a consent document. If the participant declines to sign, but voices consent verbally, he/she can still be in the study.
- When the research involves no more than minimal risk and involves no procedures for which written consent is normally required outside of the research context.
- When the research involves no more than minimal risk and the participants or representatives are members of a distinct cultural group or community in which signing forms is not the norm. In this case there must be an appropriate alternative mechanism for documenting that informed consent was obtained.
For research that is FDA-regulated, a waiver of documentation of consent may be granted only:
- When the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context.
Examples of studies that may be eligible for requesting a waiver of documentation of consent include:
- A minimal risk study involving phone interviews or data collection via a web-based portal.
- A study that seeks to collect information about a sensitive topic such as illicit drug use or immigration status where having participant name linked to participation in the study might pose a risk.
- A minimal risk study that involves focus groups in a community where the cultural norm is that individuals affirm agreement via handshake. Requesting a signature is seen as a symbol of distrust and would deter participation in the research.
When requesting a waiver of documentation of consent, study teams must consider which of the above options may apply to the study and describe the process for obtaining consent without a signature in Section 16 of the eIRB application.
Please note: Even when waiving the documentation requirement, all other required consent elements must still be addressed. In many cases, it is still appropriate to provide the participant with written information about the study. In all cases, the IRB requires a document that will be used for consent purposes. This could be in the form of short text, a cover letter, or a script [e.g. when consent will be presented orally].
The following guidance should be used when drafting the written or oral presentation of study information in studies where a waiver of documentation of consent is being requested.
The revised federal rule governing human subjects research (the “Common Rule”) includes the new element of “key information,” which must be presented at the beginning of the consent document.
The Common Rule defines key information as a concise and focused presentation that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. Please see link here for more guidance on key information.
Required Elements of Informed Consent
It is important to include the required elements of informed consent in the consent process.
Use the checklist HERE to make sure the basic required consent elements are included in your written or oral presentation of study information.
Additional Elements of Informed Consent
Based upon the type of research and what regulations the research is subject to, there may be additional elements of informed consent that are required.
The checklist HERE outlines additional elements of informed consent that you may wish to include in your written or oral presentation of study information:
If you are collecting protected health information (or “PHI”) for research purposes, the written presentation of study information [e.g. a script to be presented orally or text to that will appear on a web-based platform] must include required HIPAA authorization language in addition to the required and optional consent elements noted above.
<<Include this sentence if you have not previously stated this>>
We will collect information about you in this study.
<<Always include the following sentence>>
People at Johns Hopkins who are involved in the study or who need to make sure the study is being done correctly will see the information.
<<Include one of the following two paragraphs depending on whether this is a single-center, multi-center or sponsored study>>
<<For single-center non-sponsored studies>>
People at Johns Hopkins may need to send your information to people outside of Johns Hopkins (for example, government groups like the Food and Drug Administration) who need to make sure the study is being done correctly.
<<For multi-center or sponsored studies>>
People at Johns Hopkins may need to send your information to people outside of Johns Hopkins (for example, government groups like the Food and Drug Administration) who are involved in the study or who need to make sure it is being done correctly. If the study has a sponsor, people at Johns Hopkins will send your information to that sponsor.
<<For HIPAA language, the following paragraphs are always included>>
These people will use your information for the purpose of the study.
We will continue to collect information about you until the end of the study unless you tell us that you have changed your mind. If you change your mind and do not want your information to be used for the study, you must contact the Principal Investigator by using the contact information provided in this document. Your cancellation will not affect information already collected in the study, or information that has already been shared with others before you cancelled your authorization.
We try to make sure that everyone who needs to see your information uses it only for the study and keeps it confidential - but, we cannot guarantee this.
Other factors to consider when drafting your consent text
- Participants should be presented with information that a reasonable person would want to have in order to make an informed decision.
- Be sure to inform participants if your study involves the possible disclosure of confidential information (e.g. reportable diseases, disclosure of abuse, or self-harm).
- Use simple words and short sentences and language appropriate for your study population.
- If your study is a clinical trial that will be registered in clinicaltrials.gov, include the following information: “A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”