What is Informed Consent?  

Informed consent is an ongoing process in which researchers provide potential participants with all necessary information about a study and answer their questions, ensuring that individuals fully understand what participation involves before agreeing to participate. The informed consent process is an important component of performing research ethically with human subjects. The consent form documents that participants were given information about the study and that they provide their willing consent to participate.  

The University of Texas at Arlington requires informed consent for all studies that involve human subjects regardless of risk level or review category. Informed consent must be obtained from the subject or the subject's legally authorized representative prior to initiating any research activities, including screening and recruitment.  

The consent form documents that consent has taken place and that the participant has been provided with accurate and complete information about the study. The consent form must contain all the required components of informed consent as presented in 45 CFR 46.116. UTA has templates which contain all the required components of informed consent here.     

Can Informed Consent be Waived? 

In most cases, written or electronic informed consent must be sought from each subject before research procedures begin. However, in some circumstances, it may be appropriate for the IRB to approve research where investigators leave out or alter elements of informed consent if the research meets all the applicable regulations in 45 CFR 46.116(f).  

You may submit a waiver to alter elements of informed consent or waive documentation of informed consent (physical or electronic signature).  

To approve a waiver to alter elements of informed consent, the IRB must have sufficient justification for ALL of the following criteria per 45 CFR 46.116(f). 

• The research involves no more than minimal risk* to the subjects. 

• The research could not practicably be carried out without the requested waiver or alteration. 

• 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.                                                                                                                                                     
• The waiver or alteration will not adversely affect the rights and welfare of the subjects.                                                                                                    
• Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation. 

To waive documenting informed consent with a physical or electronic signature, the IRB must have sufficient justification for AT LEAST ONE of the following criteria per 45 CFR 46.117(c) 

• 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 (or legally authorized representative) will be given the option to take a copy of the consent form, and the subject’s wishes will govern. 

• 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 

• If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk* of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained. 

Passive Consent (Opt-Out Consent) 

Passive consent is a form of consent that occurs when a parent or guardian’s consent is assumed unless they communicate otherwise. This form of consent may be used in educational studies where it may not be feasible to conduct a study otherwise. Passive consent may be appropriate when the following conditions are met: 

• The research involves no more than minimal risk to the subjects; 

• The waiver or alteration will not adversely affect the rights and welfare of the subjects; 

• The research could not practicably be carried out without the waiver or alteration; 

• The research could not practicably be carried out without utilizing a passive consent process; 

• All children that are capable will provide assent;                                                                                                                                                                      
• Whenever appropriate, the subjects and parents will be provided with additional pertinent information after participation 

Please note that some school districts require active parental consent regardless of whether the IRB approves of permitting passive consent, so researchers should check with the school district to ensure they permit passive consent. The IRB will check that the school district allows passive consent during their review, and you may be asked to provide proof of ISD permission with your application.  

Investigators wanting to design a passive consent process should provide the following details in their electronic submission in Mentis and protocol application:  

• Justification for waiving active consent. If your study is federally funded, please include Form 3 with your application.  

• Explanation of the opt-out process, including at least two weeks for the parents/guardians to read the opt-out form and respond. 

• Opt-out form using UTA’s template or the school district template. 

• Proof that the school district permits passive consent. Proof may be in the form of a permission letter or communication from the school district. If the ISD requires an IRB approval letter prior to providing a permission letter, please let the IRB know so that this can be documented. 

• Document ISD’s policies/requirements for passive consent at the time of approval. The PI can insert this into the protocol application. The PI should have a conversation with a school admin or teacher who would be working directly with the project, so they know exactly what the school permits and can confirm that their process aligns with the ISD policies. 

Broad Consent 

Broad consent is a consent process for the storage, maintenance, and secondary use of identifiable private information or identifiable biospecimens for future unspecified research. UTA has a consent template for researchers who want to use broad consent, however given the complexities of implementing broad consent, please reach out to our office to discuss your research prior to submitting a protocol that involves broad consent.