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Non-Exempt Studies: Informed Consent Templates

Expedited and Full Board Studies

Expedited studies are research projects that meet one of the categories under and involve minimal risk.

Full board studies are those the IRB determines does not fall under exempt or expedited categories and need to be reviewed at a convened meeting of the IRB in which a quorum of members are present. Often, these studies involve more than minimal risk, but this is not always true. 

Required Elements of an Informed Consent

Non-exempt studies must follow the HHS regulations  and  unless a waiver/alteration has been noted and strongly justified within the protocol application.

The application and consent must reflect the VA State Law and W&M Data Storage Guidance of maintaining study documentation for 5 years following study completion. Signed consent forms need to be maintained for a minimum of 5 years after the last action with the data. 

Key elements:

1. Disclosing to potential research subjects information needed to make an informed decision;
2. Facilitating the understanding of what has been disclosed;
3. Promoting the voluntariness of the decision about whether or not to participate in the research;
4. Document using a written document that provides key information regarding the research, i.e. ICF
5. The ICF should be updated when necessary (e.g. new risks, potential benefits, etc.)
6. Collection of identifiable information (e.g. audio/video recordings, PHI, etc.) should be made clear to the participant. If it is optional, the participant should be made aware that they can opt out of the collection of such information.
7. If using a wearable device or other technology to collected, please make sure to follow the guidance outlined in "Management and Retention of Data" informational page. 
   

Signatures on Informed Consent Forms 

Non-exempt studies requires the collection of signatures unless a Waiver of Documentation has been submitted with the protocol. This can be done signed in-person (i.e. wet signature) or signed via Qualtrics or DocuSign if administering the consent using an electronic platform. 

If the consent process takes place remotely and is not personally witnessed by study personnel, it may be required to have a method to ensure that the person electronically signing the informed consent is the subject who will be participating in the research or the subject’s legally authorized representative (LAR) (see ). FDA-regulated clinical studies must comply with .  

Informed Consent Form Templates

Click on each header below to view templates that can be used.

Note: The linked "templates" provide a skeleton of what should be included in your consent forms. Please adjust as you see fit.

Types of consent

Adult Informed Consent Generally required for research with human participants Document is signed by participant and/or LAR and researcher/personnel administering the consent. If any collection of identifiable information is optional (i.e. audio recordings), provide a separate section in the form that allows the participant to agree or not agree to the collection of this information. Can be obtained electronically via Qualtrics or DocuSign. Collection of electronic consent must be stated clearly in your protocol submission. Anonymity for the participants cannot be guaranteed if you are collecting a signature from a consent!

Implied Consent (no signature required) Eexpedited or a full board studies require a waiver of documentation of informed consent, and the study must meet the requirements stipulated by the Common in most Internet-based research. (Note: Adult survey research commonly falls into Exempt, and you may use the Exempt templates instead.) Only for use with participants 18 years or older. A question verifying age must be included before the participant begins with the study. Online surveys and consents must be administered through an approved W&M platform (such as Qualtrics).  Participants are still given all the information that would've been presented in a "signed consent"

Consent of Minors and Parents/Guardian Permission If either the child or parent/guardian says "no" at any point to participating, then the minor cannot participate. Both parties must consent/respond in the affirmative in order for the minor to participate.  Child Assent: a minor's affirmative agreement to participate in a study Assent is required for children between the ages of 7-17.  Signatures are not required for young children; however, the protocol submission should clearly document how consent will be obtained and how proof of consent will be recorded if no signatures are collected. Participants younger than 5 do not need to have a formal document given their limited reading and writing abilities. The researcher should instead have an age-appropriate conversation with the child to inform them of their rights (e.g. "we will stop if you say no.") Use of visual aids is encouraged when assenting young children.  Child Assent forms should be written to match the reading and comprehension level of your participant population. If there is a possibility that the minor will "age out" during the study, the minor (now adult) must be reconsented using the "Adult Informed Consent" If there will be both minors and adults as participants, a form for minor assent and adult consent must be developed and attached with the protocol.  Parental/Guardian Permission:  "Permission" from a parent/guardian or legally authorized representative (LAR) for the minor to participate.  Parent/guardian permission should be obtained for all studies involving minors.  The parent/guardian should sign the permission form before the minor assents. If the parent/guardian will also be a participant, the parent/guardian permission form can be combined with the "Adult consent" template to address both of their roles. There should be two signature lines at the end of the document: one to address minor permission and one to address the parent's/guardian's consent to participate.

Oral/Verbal Consent If you think this option is appropriate for your participants, please include this as part of the study plan in the protocol when describing your consent procedures and include the rationale for use of an oral/verbal consent method. The study must be eligible for a "waiver of documentation of informed consent." This should also be requested within the IRB protocol application. The script to be used must be attached within the IRB SPARCS protocol  It is recommended to also include an information sheet about the study using the "" to support the oral/verbal consent process The process should meticulously documented including who was present and date/time the consent was collected

Waiver or Alteration of Informed Consent

Per HHS regulations , the investigator must obtain informed consent from the participant or their legally-authorized representative (LAR). Unless the researcher applies for a waiver or alteration of consent (see ).

In order for a waiver or alteration to be granted, the IRB must find that all of the following criteria are met:

1. The research involves no more than minimal risk to the subjects;
2. The research could not practicably be carried out without the requested waiver or alteration;
3. 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;
4. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
5. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

Non-exempt research involving must meet the requirements for "alteration of consent" and must be requested within the SPARCS IRB protocol application. 

Waiver of Documentation of Consent

Non-exempt research that is not collecting signatures from participants must apply for a waiver of documentation of consent. 

The study team must provide a subject with the required consent information, but the study team is not required to obtain the subject’s signature on the informed consent document.

A waiver of documentation is permissible when:

• The signature on the informed consent document would be the only record linking the subject to the research and the principal risk of harm to the subject would be a breach of confidentiality.  For example, for research on sensitive topics, such as domestic violence or illegal activities;
• The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.  For example, minimal risk research that involves surveys/interviews conducted via telephone or online.
• Where the participants are members of a cultural group in which signing forms is not a normal/acceptable practice.
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Even though signatures are not required when a waiver of documentation has been obtained, Internet-based surveys or studies are required to include statements indicating what action "implies" consent (e.g. "check I agree to continue to the study," "if you consent, click next to begin the study")