Informed Consent

Informed Consent Process

The informed consent process is a phrase that is used to describe the discussion used to inform the participant about the research study.  Any process is a series of actions rather than a one-time occurrence.  Therefore, an informed consent process needs to allow for the following actions to occur:

1. All elements of the informed consent form are discussed with the participant  through one or multiple conversations
2. The participant is given adequate time to consider their decision
3. The participant is able to have all their questions answered to their satisfaction

At the end of the discussion(s), it is suggested to test the participant’s comprehension of the research study.  A comprehension assessment can be done using the Teach-Back Method. Information regarding the Teach-Back Method can be found on the Agency for Healthcare Research and Quality’s website.

For clinical research, the occurrence of the informed consent process, along with the participant’s comprehension, should be documented in the participant’s chart. It is important to document all steps of the process. Documentation can occur in progress notes, telephone logs, a standardized consent process form, etc.

An example of a standardized consent process form can be found here.

An example of documentation of the Teach-Back Method can be found here.

 

Informed Consent Form

The informed consent form, often abbreviated as ICF, is the physical document explaining the research study.  The ICF is the form that the participant signs to indicate their agreement to participate. Federal regulations, University of South Alabama policy, and Good Clinical Practice require the ICF to contain specific elements and be written in a specific manner.  The requirements of the ICF is discussed in the next section.

The specific requirements of the informed consent form can be confusing and lengthy.  While most requirements are needed in all studies, there are some requirements that are only needed when particular circumstances occur as part of the research study.

Please review the below sections carefully.  You can reach out to the Office of Research Compliance for any questions.  The contact information for this department can be found here.

 

Federal Regulations Requirements

Federal regulations (45 CFR 46.116) provide the framework for the type of information that must be included in the informed consent document.  Several elements are mandated by the regulations to be present in the informed consent document.

A checklist of the federally required elements can be found here.  This document also has tips on how to write some of these elements into the ICF.

 

University of South Alabama Requirements

The University of South Alabama mandates specific language to be used under certain circumstances.  Such circumstances include, but are not limited to, the use of biological materials, the use of Protected Health Information, research related injury, and a participant’s Bill of Rights.

Reference the Consent Templates and Resources section on this page for further guidance on mandated USA Local Context Language.

 

Good Clinical Practice Requirements

Good Clinical Practice (GCP) is a set of international standards created to ensure ethical and high-quality research data. GCP standards are applied to all aspects of human subject research. The elements of GCP that apply to an informed consent are listed below.

1.  Readability- the ICF should be written in plain language at a 6th to 8th grade reading level. This can be achieved by:

• Tailoring the document to the subject’s population
• Avoid technical jargon or overly complex terms
• Use straightforward language that is understandable

A toolkit is available here to offer guidance on how to write an effectively readable informed consent form.

2.  Writing tips

• Use the second (you) or third person (he/she) to present the study details.
• Include a statement of agreement at the conclusion of the informed consent document. Avoid using “You understand…” statements.
• Use wide margins (i.e. 1” margins) and bullet points when possible.

The Institutional Review Board (IRB) may approve a waiver to obtain consent or a waiver that alters the required elements of an ICF.  Below list criteria for a waiver of consent:

All four of these requirements must be met

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 subject
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

The form used to request a waiver of consent can be found on irbnet.org under forms and templates.

The Institutional Review Board (IRB) may approve a waiver to obtaining a signed informed consent form.  Below list criteria for a waiver of documentation of consent:

All two of these requirements must be met

1. That 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.
2. That 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.

Even though a signature maybe be waived, the act of obtaining consent may not be. If this occurs, then an Information Sheet can be used. An Information Sheet contains the information required in a consent form. However, the participant’s signature is not required. The informed consent process must still occur (unless waived by the IRB). This method is commonly used in exempt studies.

An example of an Information Sheet can be found here.

The form used to request a waiver of consent can be found on irbnet.org forms and templates.

The Medical Research Subject's Bill of Rights is a separate handout that is given to a potential clinical trials research participant prior to the informed consent process. It is only required for clinical trials. Participants are not required to sign this form.

In addition to providing the Bill of Rights handout, the following language must be inserted into the consent form above the participant signature line:

"You acknowledge receiving and reading the Medical Research Subject's Bill of Rights."

Medical Research Subject's Bill of Rights Handout

The Genetic Information Nondiscrimination Act of 2008 (GINA) is a federal law that prohibits discrimination in health coverage and employment based on genetic information. This law prevents health insurers and employers from requiring or discriminating based on genetic information. 

If your study will involve genetic testing, the GINA information sheet must be provided to study participants during the consent process.
Additionally, the below language must be included on the consent form.

There are risks of loss of privacy, getting insured, being employed, and stigmatization (treated badly due to your genetic testing results). There are some protections afforded by the Genetic Information Nondiscrimination Act (GINA). For a detailed listing of protections, please read the GINA information sheet that has been printed for you and that you have received with this consent. You can also find The Genetic Information Nondiscrimination Act at: http://www.genome.gov/Pages/PolicyEthics/GeneticDiscrimination/GINAInfoDoc.pdf

A child is considered to be a person under the age of 18 years old.  Special consideration is given to research involving children. One such consideration is obtaining the child’s assent to participate. Assent means the child’s affirmative agreement to participate in research. Mere failure to object should not be construed as assent.

 

Requirements for obtaining minor assent and parental permission

Minors are not able to consent to research activities for themselves.  Therefore, the parent/legal guardian must give permission to participate in research and the minor may give assent to participate.  A child may not take part in a study if they do not provide their assent.

Younger children have limited capacity to understand what participation in a research study means. Therefore, an assent is only required for children 7 to 18 years of age.  This age range is in line with the standard set forth by the American Academy of Pediatrics.

Federal regulations describe when one or both parents need to provide permission. The below table displays the requirements. 

When your study is...	Then this is required...
Minimal Risk	One parent/legal guardian may be sufficient
Greater than Minimal Risk, Direct Benefit to participant	One parent/legal guardian may be sufficient but the IRB must determine whether one or two is required
Greater than Minimal Risk, No Direct Benefit to participate, but likely to yield generalizable knowledge about the participant's condition	Both parents/legal guardians, unless one parent is deceased, unknown, incompetent, not reasonably available, or does not have legal responsibility for the custody of the child
Greater than Minimal Risk, No Direct Benefit to participant, but results may alleviate serious problems of children's health or welfare	Both parents/legal guardians, unless one parent is deceased, unknown, incompetent, not reasonably available, or does not have legal responsibility for the custody of the child

 

Additional requirements regarding children in research can be found here.  

Participants who have limited or no English proficiency may be enrolled in your research provided that you have the resources to communicate effectively during the recruitment process, while obtaining consent, and for the duration of the study. The short form consent is typically used when an unexpected potential participant does not speak English and there is not enough time to translate the English version of the approved consent document into a language the potential participant understands.

A short form consent document attests that the elements of informed consent, as required by DHHS and the FDA, have been presented orally to either the participant or the participant’s legally authorized representative.  A short form consent may be used as described in IRB SOP 702: Consent Documentation. The Office of Research Compliance will utilize the resources provided by WCG. WCG has Short Form Consent Templates available in English and other languages. If the language you need is not available on the WCG’s website, you must have the English short form translated into the appropriate language prior to submitting your request to the IRB.

The short form process may be used twice for a particular language in a study. After the second use of the short form consent process, the informed consent document must be translated into that particular language as it can be anticipated you will encounter additional potential participants that understand that language.

Short forms in various languages can be found at https://www.wcgirb.com/how-to-submit/resources/ 

Requirements For Use

The investigator must provide the following to the IRB:

• A written summary of what is to be said to the participant or the participant’s legally authorized representative. The summary must include all of the required and appropriate elements outlined in federal regulations. Generally, the English version of the IRB-approved informed consent document is used. 
• The short form document that will be signed by the potential participant.
• Confirmation that:
  
  • The oral presentation will be conducted in a language understandable to the participant.
  • There will be a witness to the oral presentation (this cannot be the same person who is obtaining consent).  The witness should be fluent in both English and the language of the participant. When the person obtaining consent is assisted by a translator, the translator may serve as the witness.
  • The short form will be signed by the participant and the witness.
  • The written summary will be signed by the witness and the person actually obtaining consent.
  • A copy of the oral summary and the short form will be given to the participant.

SOP 701: Informed Consent
SOP 702: Consent Documentation
SOP 705: Translation Interpretation

All research is being affected by the COVID-19 pandemic. Challenges such as self-isolation, restrictions at the site, travel constraints, disruption in the supply of the investigational product, etc. can lead to difficulties in providing a sufficient informed consent process.

The Food and Drug Administration (FDA) has issued guidance on how to consent subjects during major disruptions due to disasters and public health emergencies, such as the COVID-19 pandemic: Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters Due to Disasters and Public Health Emergencies

The guidance can be overwhelming and is not concentrated on consenting. We have created a flowchart to assist you in deciding the appropriate method of consenting.

Flowchart for Consenting During COVID-19

Templates

1. Biomedical Research Consent Template
2. Social, Behavioral, and Education Research (SBER) Consent Template
3. Assent Template
4. Information Sheet Template

 

Resources

1. Consent Process Documentation Form
2. Informed Consent Form Element Checklist
3. USA Local Context Language
4. Readability Toolkit
5. Participant Comprehension Assessment