University of Maryland

IRB Consent Forms and Consent Waiver

Informed Consent Process

The informed consent process begins with the presentation of the study to the participant and continues until the participant’s study participation is completed. Obtaining the signature of the participant on an informed consent document is only one part of the process.

The informed consent process emphasizes that the participant is competent to understand the purpose and requirement of the research, is volunteering to participate in the research study, and has the ability to withdraw from the study at any time without any adverse effect. The process starts with the exchange of information, usually in an interview setting. The setting and the tone of the interview must be non‐coercive. A thorough explanation of the study along with all risks, benefits, and alternatives to participation is essential. The individual must be given an opportunity to ask questions and have those questions satisfactorily answered. The participant must be fully informed in order for consent to be truly voluntary. The informed consent document and other materials are used as a guide to this interview which is documented by the signing of the informed consent document along with a note in the research record.

The information that is given to the participant or the representative should be in language understandable to the participant or the representative.

The IRB has the authority to observe or appoint a designee to observe the informed consent process and conduct of the IRB-approved research process.


IRB Consent Forms

A consent form is used to provide information to prospective subjects to enable persons to voluntarily decide whether or not to participate as research subjects. A consent form usually contains the basic elements of informed consent as identified in and required by the Federal regulations for the protection of human subjects (45 CFR 46).

Consent Form Completion Instructions (PDF)

Consent Form Template (PDF)

Assent Form – 13 to 17 years old (PDF)

Assent Form – 12 years old and under (PDF)


CONSENT WAIVER CRITERIA

To request a waiver or alteration of the required elements of informed consent, address the following criteria in Section 7 of Initial Application Part 2:

(1) The research involves no more than minimal risk to the subjects.

(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects.

(3) The research could not practicably be carried out without the waiver or alteration.

(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Scenario: If a PI plans on getting oral or online consent that doesn’t require obtaining a signed consent form, they will be required to request a Consent Waiver.


Waiver of Written Informed Consent

The IRB may waive the requirement for the investigator to obtain a signed consent for some or all participants [45 CFR 46.117(c)] if it finds that:

  • The only record linking the participant to the research would be the consent document, and the principal risk to the participant is the potential harm resulting from a breach of confidentiality. In that event, each participant should be asked if he/she wishes to have documentation linking the participant with the research. The participant’s wishes will govern.
  • The research presents no more than a minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context (e.g., drawing a blood sample, or asking shoppers in a mall about the ambient lighting or temperature). In cases where the requirement of documentation is waived, the IRB may require that the Investigator provide the participant with a written statement regarding the research.
  • The Investigator may request the IRB’s ruling on waived consent at the time the project is submitted.

 

Waiver of the Requirement to Obtain Prospective Informed Consent from Participants

Federal regulations allow the IRB the ability to grant a waiver from the requirement to obtain any consent from research participants in non‐emergency research.

If an Investigator believes neither written nor oral consent can be obtained from any participants without jeopardizing the conduct of the project, arguments to support this position should be articulated in the application.