Informed Consent and Assent Process

Informed consent is defined as an ongoing process whereby a subject voluntarily agrees, based upon adequate knowledge and understanding of relevant information, to participate in research.  

It is important to remember that informed consent is a process, not just a form. The language must be understandable to the participant with sufficient time given to the potential subject to make an informed decision about whether to participate in the research.     

• The prospective subject or the legally authorized representative (LAR) are given sufficient opportunity to discuss and consider whether to participate;   

• The possibility of coercion or undue influence is minimized; and  

• No informed consent may include any exculpatory language through which the subject or the LAR is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence

We have three sets of templates that can all be found on our Research Resources page:  

• Biomedical Studies - Expedited/Full Board
  • Biomedical Written Consent – Biomedical
  • Parental/Guardian Written Consent – Biomedical
  • Written Child Assent
• Social/Behavioral/Educational Studies - Expedited/Full Board
  • Written Consent - Social/Behavioral/Educational
  • Parental/Guardian Written Consent – Social/Behavioral/Educational
  • Written Child Assent
• Exempt Studies
  • Adult Consent – Exempt Project
  • Child Assent – Exempt Project
  • Review our Exempt FAQs for additional information specific to obtaining informed consent for exempt research.  

These templates include the elements of consent required by federal regulations and accreditation standards. They also include additional MU HRPP/IRB required elements.  

• If your survey or interviews contain sensitive questions of a personal nature, disclose this and give an example(s) of the most sensitive question(s). Then include the steps you will take should a subject become uncomfortable while answering a question. Such as allowing subjects to skip questions, providing resources, referrals, etc.  
• When appropriate, subjects or their LAR must be informed about Missouri State Law mandated reporting requirements if the potential exists that reporting may occur in the context of the study. If the victim of abuse or neglect is a resident of another state or was injured as a result of an act which occurred in another state, the investigator must abide by the other state laws. Legal counsel may be consulted.  
  • Title IX 
  • Missouri Department of Social Services (i.e., child abuse) 
  • Missouri Department of Health and Senior Services (I.e., elderly abuse) 
• If you will audio or video record subjects, disclose this in the consent forms along with the steps you will take to protect the recorded data.  
• In order to minimize coercion and undue influence, do not say that your study is “approved by the IRB” on your consent/assent forms.  
• Make sure the number of subjects participating, the amount of time participation will take, and the amount of compensation that subjects will receive matches up exactly with what is stated in the application and protocol.  

Yes. The HIPAA Authorization language is included in our “Written Consent – Biomedical” template, located on our Researcher Resources page. If combined in the consent form, the IRB will approve the HIPAA Authorization. However, if it’s uploaded as a separate document, the IRB will only acknowledge the HIPAA Authorization. 

If subjects do not read or speak English, a consent form should be provided in their native language. English versions must be submitted to the IRB application for review. Once approved, translated consent materials must be submitted to the IRB via the Amendment (for Expedited and Full Board studies). In some cases, it may be appropriate to use a Short Form Consent for unexpected enrollment of non-English speaking subjects (see question below regarding types of consent).    

Exempt studies are not required to submit translated consent forms. They are submitted in English for IRB approval and then translated, using the approved language, by the investigator before use with subjects. See Informed Consent Requirements SOP.  

Under no circumstances should anyone who is not listed as key personnel on the IRB application and not current with IRB training requirements, obtain consent, interact, or intervene with, or access identifiable data of a potential study participant. Key personnel who will obtain consent must also be designated as “Authorized to Obtain Consent” on the application. 

 For some studies, the board may require consent only be obtained by certain individuals. In these studies, only they may have the consent role as authorized to obtain consent. Some of these studies may include treatment studies, greater than minimal risk studies, and studies involving research-only medical procedures. This requirement will be communicated as part of the review and approval process in ensuring the appropriate roles are being utilized. 

Studies Involving MU Health:

In certain studies, where research activities are occurring within MU Health, the IRB may follow MU Health clinical policy to determine which research personnel can be authorized to obtain consent, especially for studies where there is no standard of care consent and the research consent is the only consent.

MU Health policy entitled “Patient Rights & Responsibilities – Consent for Medical and Surgical Treatment” outlines their requirements for who is responsible for ensuring informed consent is properly obtained for medical and surgical treatment in the clinical setting. See our Informed Consent Requirements SOP under “Authorization to Obtain Consent” for an outline of MU Health policy.

Key personnel are defined as all persons obtaining:    

• Data about the subjects of the research through intervention or interaction with them; 
• Identifiable private information about the subjects of the research; or 
• The informed consent of human subjects for the research.   

All key personnel must be listed on the IRB application and have up-to-date IRB training. If restrictions are in place on who may be authorized to obtain consent, the study team must adhere to the requirements as future personnel changes are made.

*Exempt study consent questions and answers can be found in the Exempt FAQs.   

Expedited/Full Board Studies:  

• Written Consent (or the Electronic Equivalent):  
  • Informed consent must be documented and signed by the subject or the subject’s LAR. This consent would include all basic elements of consent and any additional elements required by the study. The consent would include at minimum a signature line and date, and any other information necessary. 
  • A written copy shall be given to the person signing the form and sufficient time allowed to read or have the form read to them. It is recommended to be the signed copy but not required. 
  • Electronic platforms being utilized for obtaining an electronic signature must also ensure the ability of the PI to maintain the appropriate approved version of the IRB approved informed consent form is utilized at all times and documented in a manner that can be reviewed by an audit.
    • If electronic signatures are requested and the study is FDA regulated, the system to document electronic signature must comply with FDA regulations on electronic signature.  Be sure to check with the IRB and your IT department to make sure your process for obtaining electronic signatures is compliant, as policies are subject to change. 
• Waiver of Documentation of Consent (waiving the signature requirement):
  • Examples include a minimal risk study with a telephone or online survey/interview where no in-person interaction is taking place. It can also include greater than minimal risk studies where obtaining signatures is the main risk to the subject, so it should be waived to avoid harm to the subject. 
    • If the signature is waived, a written document containing all the elements of consent is still required to be provided to the subject.  
• Waiver of Consent: 
  • In certain circumstances, the IRB may waive the requirement to obtain informed consent.  This is common in minimal risk research when there is no planned interaction or intervention with subjects. Most studies involving secondary data only request a waiver of consent, and when applicable, a HIPAA waiver. See HIPAA FAQs for HIPAA guidance. At times, it may be appropriate for observation-only studies with no interaction. 
• Alteration of Consent:  
  • This is for when you would like to request an alteration of the written consent form/process. It would include waiving one or more required elements of consent.  
  • This commonly occurs in research involving deception (since doing so might affect the study results). Debriefing would be required (consent after participation) allowing the subject to withdraw from the study after disclosing the deception component. 
  • Justification must be provided to ensure that the research is no more than minimal risk to subjects and could not practicably be carried out without the alteration. 
• Short Form Consent:  
  • The short form method for obtaining informed consent should only be used for the occasional and unexpected enrollment of a non-English speaking subject in a study for which no consent form in the subject's language has been prepared.  
    • The request to use the short form consent process is typically made because time is of the essence. As such, the IRB prioritizes the review of these requests in order to avoid denying a patient an opportunity to participate in research.
  • An amendment is required to add the short form method before it is used.  The MU IRB has some already translated short form templates available to share with investigators upon request. If unavailable, the investigator will be required to create a translated short form. It is recommended to translate the entire consent form when able rather than using the short form. 
    • The short form process may be used a few times for a particular language in a study. After so many uses (determined by the IRB) of the short form consent process, the informed consent document will need to be translated into that particular language as it can be anticipated additional potential participants that understand that language will be encountered.
• Child Assent/Parent Consent:  
  • Child Assent: 
    • The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent considering age, maturity, and psychological state.  
    • A plan should be outlined to re-consent individuals who turn 18 while continuing to participate in research.  At that time, they must be afforded the opportunity to consider their continued participation and to provide or deny consent. 
    • State law will define the age of children and should be disclosed in the IRB application. 
  • Parent Consent:
    • Research involving children also requires the informed consent of one or both parents depending on the level of risk and whether there is a potential for direct benefit to the child.  
    • Minimal risk studies – one parent consent is allowed. 
    • Greater than minimal risk studies with a potential for direct benefit – one parent consent is allowed. 
    • Greater than minimal risk studies without the potential for direct benefit – two parent consent is required UNLESS one parent is deceased, unknown, incompetent, not readily available, or when only one parent has legal responsibility for the care and custody of the child. 
    • You can request a waiver of parental consent under certain circumstances, and the IRB will determine whether it is appropriate. 
    • Review the IRB approval letter to determine what is required for your study as determined by the board. 
    • Studies involving wards should follow the MU HRPP/IRB policy regarding their inclusion and who can consent on their behalf. See our Additional Protections for Vulnerable Populations, International and Non-English Speaking Participants SOP.    

See the Informed Consent Requirements SOP for more information on types of consent.  

• No; however, you need to consent if you are asking subjects to do something required by the protocol (i.e., fasting, withholding medications, alcohol, drugs, or exercise, etc.) prior to the first visit. 
• HIPAA regulations still apply to protected health information, and an authorization or waiver/alteration may still be required for these pre-consent activities.  

The IRB will determine re-consent is necessary when new information or findings may relate to the participants’ willingness to continue participation. This is usually discovered during an Amendment or Event submission. Re-consent requirements will be outlined in the IRB approval letter. Participants should be reconsented at their next scheduled visit or at another time specified by the IRB.  

An LAR is used when participants include adults who are unable to consent on their own behalf. State and local law must be followed when identifying the LAR. When consenting in the medical setting, the LAR should be documented in the medical record to help ensure the correct person is used.    

MO Rev Stat § 431.064 “Experimental treatment, tests, and drugs, consent to administer by third party--life-threatening emergencies, consent by whom” must be followed for studies conducted in Missouri.