Types of Consent/Assent
Reference the list below when deciding what the most appropriate type(s) of consent process(es) for this project would be. In some cases it is appropriate to select more than one choice. (i.e., Parental/ Guardian Consent & Written Assent Form)
1. Written Informed Consent Document:
An Informed Consent document is most commonly used to fully inform subjects of the project. Please visit: Required Elements of Consent, for required elements of an informed consent document. Additionally, a written informed consent document should contain a signature line for the subject (and/ or legally authorized representative, witness) and for the researcher obtaining consent.
2. Waiver of Signed Documentation of Informed Consent:
In some instances, it may be appropriate to waive the requirement for the investigator to obtain a signed consent form for some or all subjects, if requirements outlined here are justifiably met: 45 CFR 46.117(c).
3. Waiver or Alteration of SOME Informed Consent Elements:
In some instances, it may be appropriate to waive (or alter) the process of SOME elements of Informed Consent, if requirements outlined here are justifiably met: 45 CFR 46.116(c) and (d). NOTE: Projects involving deception or incomplete disclosure often uses this type of consent due to the nature of the design i.e., omitting/ waiving or altering consent elements so subjects are not aware of the purpose or other project details)
4. Waiver of ALL Informed Consent Document Elements:
In some instances, it may be appropriate to waive (or alter) the process of ALL elements of Informed Consent, if requirements outlined here are justifiably met: 45 CFR 46.116(c) and (d). Most often, when all consent elements are waived, researchers will be required to orally disclose specific key elements to the subjects (e.g., participation is voluntary). Such a script should be submitted to the IRB for review.
5. Oral Informed Consent Script:
In cases where ALL elements of an Informed Consent Document are waived, an oral script may be used to informed subjects about key points related to the project (i.e., participation is voluntary). This process should only be proposed if all waiver requirements have been met in #4 (above) and justification has been provided to the IRB as to why this proposed process meets the waiver criteria.
6. Written Parental/ Guardian Consent Document (or Parental/ Guardian Permission):
When someone under the legal age to consent, which is often the age of majority (i.e., child), will be recruited for a project, most commonly consent is sought from the parent or guardian BEFORE child assent (if child assent is appropriate for the age group). Please visit: Required Elements of Parent/ Guardian Consent, for required elements of a parent/ guardian consent.
7. Waiver of Signed Documentation of Parental/ Guardian Consent (or Parental/ Guardian Permission):
In some instances, it may be appropriate to waive the requirement for the investigator to obtain a signed consent form for some or all parental/ guardian figures, if requirements outlined here are justifiably met: 45 CFR 46.117(c).
8. Waiver or Alteration of SOME Parental/ Guardian Consent Elements (or Parental/ Guardian Permission):
In some instances, it may be appropriate to waive (or alter) the process of some elements of parental/ guardian consent, if requirements outlined here are justifiably met: 45 CFR 46.116(c) and (d).
9. Waiver of ALL Parental/ Guardian Consent Document Elements(or Parental/ Guardian Permission):
In some instances, it may be appropriate to waive (or alter) the process of ALL elements of parental/ guardian consent, if requirements outlined here are justifiably met: 45 CFR 46.116(c) and (d). Most often, researchers will still be required to use an oral script with subjects to briefly inform them of key elements.
10. Oral Parental/ Guardian Consent Script:
In cases where ALL elements of a Parental/ Guardian Consent Document are waived, an oral script may be used to informed subjects about key points related to the project (i.e., what the project will entail for their child).
11. Written Assent Form:
A Written Assent Form is most commonly used to fully inform children of the project and is most often used for those of a higher maturity,age and psychological state (i.e. a 16 year old perhaps). Most often, a signature is still required in addition to the Required Elements of Consent. Consent elements should be written at a reading level appropriate to the subjects grade level. For more information, visit: Child Assent Guidance. Parental/ guardian consent should be obtained before assent.
12. Waiver of Assent:
In some instances, it may be appropriate to waive the use of an assent form, if requirements outlined here are justifiably met: 45 CFR 46.116(c) and (d). Most often, researchers will still be required to use an oral script with subjects to briefly inform them of key elements. Parental/ guardian consent should be obtained before assent.
13. Oral (verbal) Assent Form:
A Oral (verbal) Assent form is most commonly used to inform children of the project and is most often used for those of a lower maturity, age and psychological state (i.e., a 7 year old perhaps). A signature may be required in some circumstances, in addition to a witness. For more information, visit: Child Assent Guidance. Parental/ guardian consent should be obtained before assent.
14. Short Form:
A Short Form is most commonly used when a a majority of the target population would not be able to understand the written consent document (e.g., illiterate, do not speak/read/ write in English) and use of a written translated consent document is not reasonable for the target population. A short form generally contains all the required elements of consent and is used in conjunction with an oral presentation of the required consent elements. The short form and a written summary of what will be presented orally must be approved by the IRB and presented orally to the subject in front of a witness. Copies of both documents should be given to the subject. The short form should be signed by the subject and the witness and the summary should be signed by the witness and person obtaining consent (e.g., researcher). The witnesses signature confirms the adequacy of the consent process and to the participant's voluntary consent. Please visit: Informed Consent Short Form
15. Exempt Research Category (IRB Review is Required):
If the research falls within an exempt research category, 45 CFR 46.101(b), it may not require a consent form. However, in most cases the researchers should provide the subjects with elements of informed consent that will assist them in making a voluntary decisions about whether or not to participate in the research. The final determination of exemption is made by the reviewing body after a complete review of the research protocol, associated measures and addenda, the consent process and relevant forms, and after careful consideration of the risks, benefits, confidentiality, voluntariness, and other features of the research. If the researcher selects this as their consent process type, be sure to attach any document with elements of consent you intend to provide the subjects and provide a description of the process you intend to follow.
For more information about the informed consent process, please visit: Informed Consent Guidance.
For more information about the assent and parental consent (permission) process, please visit: Research with Children FAQ's
