Consent Process Checklist

Before any individual may be enrolled as a research participant, investigators must first obtain legally effective informed consent from the participant, or the participant’s legally authorized representative. This same requirement applies for children, although it is more commonly called “parental permission”. Whenever there are requirements for informed consent, the same would apply when seeking parental permission.

In the case of an adult with diminished decision-making capacity or non-autonomous child, permission of the parent or legally authorized representative is required. Any individual capable of some degree of understanding (generally, a child of seven or older, or an adult with diminished decision-making capacity) should participate in research only if they assent. Assent means a participant’s affirmative agreement to participate in research.

• 45 CFR 46.116(a)(1)

• 21 CFR 50.20

• Investigator Guidance Series: Parental Permission and Child Assent
• Investigator Guidance Series: Surrogate Consent by a Legally Authorized Representative
• Investigator Guidance Series: Research Involving Individuals with Decisional Impairment

Investigators should minimize the possibility of coercion or undue influence. Investigators should describe the consent process in the ERICA application, including a description of any measures taken to minimize the possibility of coercion or undue influence.

Investigators must provide the prospective research subject the opportunity to discuss and consider whether to participate. If the participant has questions about the study, the study team should ensure an appropriate individual is available to answer those questions. 

It is important the participants do not feel undue pressure to be in the study. Giving them enough time to think about their choice helps to reduce this pressure.  It is recognized that some studies have urgent timelines for enrolling in a study.  In these cases, the study team must consider additional ways to reduce the pressure. 

The inclusion of certain groups of participants who may be vulnerable to undue influence or coercion may require additional precautions. 

• 45 CFR 46.116(a)(2)

• 21 CFR 50.20

• Investigator Guidance Series: Children
• Investigator Guidance Series: Research Involving Individuals with Decisional Impairment
• Investigator Guidance Series: Research Involving Prisoners
• Investigator Guidance Series: Research Involving Wards of State

Information that is given to the subject should be in a language understandable to the subject. This means that you must give information in a language that the participant understands. Use the language (English, Spanish, Vietnamese, etc.) that the participant speaks, reads, and understands.

In addition, complex terms, technical or medical terminology should be avoided or explained in lay language.  Use terms that are appropriate for the participant's understanding. For the general population, this means simplifying scientific terms, using short sentences, etc.

• 45 CFR 46.116(a)(3)
• 21 CFR 50.20
  
  University of Utah Policy
• Investigator Guidance Series: Including Spanish-Speaking Individuals in Research

The investigator must provide information that is necessary to make an informed decision about whether to participate, and an opportunity to discuss that information. Although there are required elements of informed consent, it is important to remember that the investigator should provide the participant with information that a reasonable person would want to have in order to make an informed decision.

 For example, local and state health departments may require certain diseases to be reported in the interest of public health. If a reportable disease may be detected, diagnosed or treated during a research study, it would be reasonable to expect that participants should be informed details about the testing, reporting and the return of test results. Likewise, if a study has a Certificate of Confidentiality, or includes tissue banking or genetic testing, additional information should be provided to the participant.

 Additional information required by an ancillary committee of the Human Research Protection Program may also need to be included in the consent process, as necessary. For example, the Conflict of Interest committee may require disclosures to be added to the informed consent process. Likewise, the Radiological Drug Research Committee & Human Use Subcommittee (RDRC-HUS) may require that information be disclosed to participants.

• 45 CFR 46.116(a)(4)

Learn more about the concise summary here

Informed consent should begin with a concise and focused presentation of the key information that is most likely to facilitate understanding of the reasons why one may or may not want to participate in research. T University of Utah has consent process models that will assist investigators in ensuring this requirement is met.

How this requirement applies will depend on the nature of the specific research study and the information presented in the informed consent.

In general, the beginning of an informed consent would include a concise explanation of the following:

1. The fact that consent is being sought for research, and that participation is voluntary.
2. Purpose of the research, expected duration, and procedures.
3. Reasonably foreseeable risks.
4. Benefits that may be reasonably expected.
5. Appropriate alternative procedures or courses of treatment, if any.

For some studies, with limited risks or benefits, the entire informed consent may be relatively brief and will satisfy this requirement.

For some studies, with greater risks and more procedures, the key information to be presented in a concise and focused will differ greatly from those simple studies with limited risks. For example, a complicated clinical trial for cancer patients may have a consent document that is 20-25 pages. The concise summary would ideally be no more than a few pages. The most important foreseeable risks to participants could be summarized at the beginning of the informed consent, while the more comprehensive and detailed description of foreseeable risks would be presented later with the body of the informed consent.

The information included at the beginning need not be repeated later in the body of the consent. For example, if there is a statement about voluntary participation in the beginning of the consent as part of a concise summary, it would not need to be repeated later in the body of the document.

• 45 CFR 46.116(a)(5)(i)

Informed consent as a whole must present information in sufficient detail relating to the research. The information should be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective participant’s understanding of the reasons why one may or may not want to participate. This requirement is evaluated as a whole when reviewing the consent process.

• 45 CFR 46.116(a)(5)(ii)
• 21 CFR 50.20

Informed consent may not include exculpatory language. This means that the consent should not include language that waives or appears to waive any of the participant’s legal rights or releases the investigator, sponsor, or institution from liability for negligence.

• 45 CFR 46.116(a)(6)
• 21 CFR 50.20

As already mentioned in the introduction, there are required elements of informed consent. Most commonly, the required elements of informed consent are presented to the participant using a consent document and having a discussion. It is important to verify that the required elements of informed consent are included in the consent process, either by presenting the information orally or discussed and documented using a consent document.

Based upon the type of research conducted and what regulations the research is subject to, there may be additional elements of informed consent that are required.  Please see Consent Document Checklist page to review all the required elements of informed consent.

• 45 CFR 46.116(a)(6)
• 21 CFR 50.20