Welcome to ConsentTools, an online toolkit designed to help you learn about and implement evidence-informed practices for consent in clinical trials. In this toolkit, you will find information on why and how to:
- Implement plain language strategies when writing key information
- Enhance readability using formatting practices of key information
- Assess participant understanding and appreciation using the Revised UBACC assessment tool
- Incorporate a Legally Authorized Representative (LAR)
We also provide resources (linked throughout) that will help you implement these practices into your own consent processes.
Introduction: Why Would You Want to Optimize Your Consent Process?
Informed consent is a cornerstone of the ethical conduct of research, and the duty to obtain informed consent is part of every major code of research ethics.1 Informed consent includes objective elements, specified in Federal Regulations, regarding the kinds of information that must be shared with potential participants. Informed consent also includes subjective elements such as a potential participant’s ability to understand and appreciate consent information.2
Evidence indicates that research participants frequently do not understand the information contained in consent forms.3-5 In addition, healthcare providers often overestimate participant comprehension of consent information.6
The National Institutes of Health (NIH) have made improving informed consent a high priority and have spent more than $80 million dollars identifying effective consent practices.7 Recent revisions to the Federal Regulations for the Protections of Human Subjects (45CFR46), or Common Rule, provide increased opportunities for researchers to improve their consent processes.
In addition to meeting Federal Regulations, improving the consent process has several benefits, including:
- Enhancing respect for persons and the ethical protections of research participants by ensuring participants have the necessary information to make a decision about whether to take part in research8
- Increasing the efficiency of Institutional Review Board (IRB) review by reducing concerns about informed consent processes
- Reducing legal liability in some cases or improving recruitment in studies involving cognitively impaired individuals
Older Adults and Cognitive Impairments
The NIH recently issued a policy requiring the inclusion of older adults (age 65+) in clinical trials unless there is a scientific or ethical reason not to include them.10 This policy is meant to address the frequent exclusion of many older adults from clinical research. Older adults are at increased risk of developing cognitive impairments, and this is one reason they have historically been excluded from research. A cognitive impairment is defined as “when a person has trouble remembering, learning new things, concentrating, or making decisions that affect their everyday life.”11
Cognitive impairments are a distinguishing feature of age-related neurological diseases like Alzheimer’s disease and other dementias.12 However, other common diseases associated with aging, such as diabetes, diabetic pain, and heart disease are also associated with cognitive impairments.13,14 Therefore, it is important to remember that risk of cognitive impairments are not limited to particular groups of older adults – such as those with neurological or psychiatric conditions.
Consent processes need to accommodate older adults with, or who are at risk of developing, cognitive impairments rather than simply excluding them. Such participants require additional safeguards to ensure they can provide informed consent.15,16
Evidence-Informed Practices for Consent in Clinical Trials
Systematic reviews and expert consensus have identified multiple consent practices that researchers can use to enhance their informed consent processes.4,7,17 Importantly, these practices have been tested and demonstrated to be effective in randomized clinical trials with cognitively impaired populations. These evidence-informed practices include:
- Using plain language and formatting to optimize readability. Consent forms are frequently long and complex documents. Participants prefer and achieve higher levels of understanding with consent forms that use plain language and are formatted to maximize readability.4,18-20 Required key information sections must be “organized and presented in a way that facilitates comprehension.”21
- Assessing understanding and appreciation of consent information. Using a validated assessment tool helps researchers confirm that a participant has understood the consent information.22
- Involving Legally Authorized Representatives (LARs) when appropriate. When a research participant may lack the capacity to provide informed consent, the Federal Regulations permit the involvement of a Legally Authorized Representative (LAR) as an additional safeguard. Recent studies have found that most older adults support the idea of allowing an LAR to make decisions for them regarding research participation if they become unable to make decisions for themselves.23-25
These evidence-informed practices are not routinely followed in clinical trials. ConsentTools aims to raise awareness of these practices among clinical research coordinators. The remaining portions of this toolkit provide further details on these evidence-informed practices and provide resources to help you implement them into your own consent processes. We encourage you to click on the resources linked throughout to learn more. Resources can also be found in the right-hand menu.
Using Plain Language and Formatting to Optimize Readability
The Federal Regulations for the Protections of Human Subjects (45CFR46), or Common Rule, require that informed consent documents begin with:
“A concise and focused presentation of the key information that is most likely to assist a participant in understanding the reasons why they might or might not want to participate in research. This part of the information must be organized and presented in a way that facilitates comprehension.”21
This section will provide an overview of evidence-informed strategies that can improve understanding and readability of the required key information.
The Key Information Requirement
Consent forms are often overly long, complex, and contain technical jargon that makes them difficult to understand.3,4 The key information section is meant to provide the most important information that a reasonable person would require to make a decision about whether to participate in research. Key information should not include the “pages of tables” or “hundreds of risks” that are commonly included in consent forms.26, 27
Why Focus on Key Information?
Informed consent documents generally serve two purposes: provide information to participants about research and protect institutions and sponsors from liability.26 As a result, sponsors and IRBs may not permit changes to template consent forms that they provide. In contrast, the Federal Regulations require that key information is specifically designed to enhance understanding of the main reasons a person would or would not want to take part in research. The Federal regulations require that information be “organized and presented in a way that facilitates comprehension.” As a result, IRBs and Sponsors should provide more flexibility in making changes to key information documents that maximize comprehension.
Use Plain Language When Writing
Plain language is writing in a way that is clear, concise, and simple.28 Nearly half of US adults have low literacy.29 However, studies have found that consent templates at major medical schools had an average reading level 2 to 4 grades higher than the general US population.3 Using plain language is an evidence-informed communication practice that promotes understanding of information.30
Text Box 1 summarizes guidance provided by the Federal Plain Language Guidelines.31
|Choose simple words
|• When writing key information, use simple words and phrases
• Define technical terms, and avoid using jargon or words that need defining
• Avoid using acronyms and abbreviations
• Replace difficult words with synonyms (Ex. replace “randomization” with “by chance,” replace “placebo” with “a pill with no medicine”)
|Keep sentences and paragraphs short
|• Reducing the number of words in a sentence enhances readability and understanding of the information
• Sentences should be less than 20 words
• Paragraphs should be short and contain a single idea
|Write in the active voice
|• The active voice more clearly conveys to participants what they will have to do as part of the study
• Using the active voice makes it clear who is supposed to do what (Ex. change “medication must be taken 3 times a day” to the more active “you must take medication 3 times a day”)
|• Less is more! Only provide the most pertinent information that the participant needs
• Include “you,” “we,” and other pronouns to keep the tone friendly and personal
• Use the same terms consistently. For example, if you use the word “research,” use this term consistently rather than switching between research, clinical trial, and project
Formatting Documents to Maximize Readability
The way a document is formatted has a major impact on how its content is understood by readers.17 Dense and cluttered text deters readers and can prevent comprehension of the material.
Consent forms often contain dense text, small font, and do not have headings to guide readers through the material. This leaves no way for readers to scan the information and quickly find what they are looking for. Documents with dense text contain very little white space. White space refers to areas of the document that do not contain text or graphics.
Formatting key information using evidence-informed practices can improve the reader’s understanding of the information.
Text Box 2 summarizes guidance on formatting to maximize readability provided by the Federal Plain Language Guidelines.31
|Increase white space
|• Use 1-inch margins throughout the document
|Use easy to read fonts
|• Use easy to read fonts
• Font should be 12pt or larger
|• Use bullets to break up dense paragraphs of text. This also increases white space
|• Use headings to make it easier to find information and guide the reader to relevant topics
• Set headings in bold
• Leave space before and after headings
• Headings should be 1 font size larger than body text
|• Tables can be used to highlight important information
• Tables and lists should be short and should not be used as an opportunity to cram in extra information
|• Visual aids are another way to convey information, but make sure they are clear and culturally appropriate
• When formatting your key information, use bold for emphasis. Avoid using all CAPITAL LETTERS, italics, or underlining
• Use ragged right margins
Formatting key information in the ways described may lead to a document that is longer than the original, but it will be easier to read and more easily understood. On the other hand, incorporating plain language may actually reduce the length, producing a document that is shorter and easier to read for participants.
Revisions to the Federal Regulations require that informed consent documents begin with a “concise and focused presentation” of the key information a participant requires prior to enrollment. Individuals frequently do not understand consent information, and the required key information is an opportunity to ameliorate consent comprehension. Evidence-informed strategies such as using plain language and formatting documents to maximize readability can improve participants’ ability to comprehend information.
- RESOURCES -
Take a moment now to review two resources that may assist you in implementing these practices. One is a downloadable document of key information samples with good readability and poor readability. Additionally, we provide sample IRB protocol language that can be used in your IRB application to justify the use of plain language and formatting, along with relevant references.
Assessing Understanding and Appreciation of Consent Information
A fundamental right of research participants is to make informed decisions that align with their personal preferences.1 However, research participants often fail to understand consent information due to a variety of factors. Using a validated instrument to assess participants’ understanding of consent information, in appropriate contexts, can help ensure participants are informed prior to deciding whether to participate in research. This section will provide an overview of:
- The benefits of assessing understanding and appreciation
- The Revised UBACC assessment tool
- What to do with assessment results
Understanding and Appreciation
In order to make informed decisions, participants must achieve both understanding and appreciation of consent information.2
- Understanding is the ability to comprehend the meaning of information.2
- Appreciation is the ability to recognize how facts are relevant to oneself.2 Appreciation also involves believing the information is true.
Why Do People Fail to Understand Consent Information?
People may fail to understand and appreciate consent information for a variety of reasons. For example, they may have a cognitive impairment caused by neurological, psychiatric, or other medical diagnoses.32 Data has also shown that people who are very young or very old often have difficulties understanding information.33 Understanding and appreciation may also be compromised if information is presented in an unclear manner, such as using language that is highly technical or legal.
Additional reasons that participants may not understand or appreciate consent information are:33,34
- Having limited English proficiency
- Perceiving the information as threatening
- Simply not believing the person providing information
- Feeling overwhelmed with information, such as a new diagnosis
An individual’s ability to understand information can change from one day to the next.
When Should I Assess Participants’ Understanding and Appreciation?
Researchers should assess participants’ understanding and appreciation of consent information when the risks of a study are great enough to justify determining whether people truly understand the information before making a decision to take part.35 Generally, these are studies that involve greater than minimal risk. Assessment may be unnecessarily burdensome when conducting a minimal risk study, such as a one-time survey. As the risk level of a study increases, so will the need to include assessments of understanding and appreciation. When it is determined that the risks of a study warrant assessing capacity, every participant should be assessed on their understanding and appreciation of consent information. This approach has several advantages:
- Ensures that everybody understands and appreciates the research they are participating in, which prevents researchers from wrongly assuming that participants understand the information that was presented to them.
- Helps identify participants who may require additional education or clarification about the research.
- Helps identify weaknesses in the consent process. For example, if many participants misunderstand the same piece of information, perhaps the consent process needs to be modified.
Screening all participants—rather than just certain individuals—also avoids unfairly stigmatizing those with diagnostic labels, such as schizophrenia or dementia, by presuming their capacity is diminished. This also ensure that participants who are undiagnosed are not missed.
The Revised UBACC—A Validated Assessment
The Revised University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) is a validated tool to assess whether a potential participant understands the informed consent information prior to enrollment. Unlike some other assessments of participant understanding, the UBACC specifically assesses understanding of the particular study that the participant is considering. It has been validated and can be used reliably with minimal training. And it can be administered in about 5 minutes.
Administering the UBACC
First, review the consent information with the participant. When you’ve finished reviewing the information, you can administer the Revised UBACC verbally with the participant. There are 10 questions total, and each response is scored 0, 1, or 2 based on how much information the participant understood.
Here’s a sample question using an imaginary clinical trial of a drug to treat memory disorders:
What is the main purpose of the study that was just described to you?
If the participant provides a clearly inaccurate or incomplete response such as “I don’t know” or “I can’t remember” then they score a 0. If the participant provides a partially accurate or partially complete response such as “you’re testing a drug for something” then they score a 1.
If the participant provides a clearly accurate and complete response such as “you’re testing a drug to treat memory disorders” then they score a 2.
Participants can score a maximum of 2 points per question for a total of 20. You can use the information found in the consent form to verify answers. In general, scores of 15 or above indicate that the participant has likely understood the study adequately and has the ability to consent to participation. If a participant scores lower than 15 points, their current level of understanding may need to be questioned. But a score of 15 is only a guide. You might set a lower or higher cutoff depending on the risk level of the particular study. Discuss the appropriate threshold for your study with your research team and the IRB.
In situations where a surrogate or Legally Authorized Representative is providing informed consent, it may be appropriate to assess their understanding of consent information for studies that are greater than minimal risk.
- RESOURCES -
Take a moment now to review three resources that will help you adopt the UBACC in your practice. The first two are downloadable documents of the Revised UBACC, in which you can enter participants’ scores to each question. One is for participants, and one is for Legally Authorized Representatives when they are providing informed consent on a participant’s behalf. Additionally, we provide sample IRB protocol language that can be used in your IRB application to justify the use of the UBACC, along with relevant references.
What to Do with Assessment Results
As previously discussed, there are many reasons why an individual may fail to understand consent information. Thus, when scores are low following an assessment, it is important to first determine whether the potential participant is capable of understanding the consent information by asking the following questions:
- What is causing the lack of understanding?
- Could the specific information that the participant misunderstood be explained or presented in a better way?
It is necessary to use clinical judgement regarding whether to discuss misunderstood information with a participant if scores are low after assessment.
What to do with Low Scores
When the individual can potentially understand the information, then discussing misunderstood information is the best option.
- Try to educate potential participants on information they have misunderstood.
- Help correct factual errors and improve understanding.
- Repeat questions they misunderstood to evaluate whether the participant genuinely understands the information now.
If the participant shows adequate understanding following discussion, they may be allowed to consent. If a participant continues to demonstrate inadequate understanding, then there are several options available:
- Try to obtain informed consent on another day (if you think their cognitive abilities fluctuate).
- Ask the participant to appoint a surrogate decision maker or identify a Legally Authorized Representative (LAR).
- Exclude the participant from participation in the study. It may feel difficult to exclude a participant from research. The participant might feel disappointed, or you might feel pressure to recruit individuals. However, it does not respect patient autonomy, or satisfy Federal research regulations, to enroll participants who do not understand the research or cannot appoint an LAR.
Ensuring that research participants understand consent information respects participant autonomy. Using a validated assessment like the Revised UBACC in appropriate circumstances can help determine if participants understand consent information prior to enrollment. Assessing all individuals when the risk level of a study justifies it can ensure no individuals are missed and avoids unfairly stigmatizing certain groups. When participant scores on a validated assessment are low, there are options available for researchers such as educating, consenting on a different day, appointing a Legally Authorized Representative (LAR), or excluding an individual from participation.
Involving Legally Authorized Representatives (LARs) When Appropriate
Informed consent is foundational to the protection of research participants. The Federal Regulations for the Protection of Human Subjects (45 CFR 46) require that investigators obtain “legally effective informed consent of the subject or the subject’s legally authorized representative” prior to enrolling human subjects in research. This section will provide an overview of:
- The benefits and rationale for appointing a Legally Authorized Representative (LAR)
- Helping participants appoint a Legally Authorized Representative (LAR)
What Is a Legally Authorized Representative (LAR)?
The Federal Regulations for the Protections of Human Subjects (45 CFR 46) define a Legally Authorized Representative (LAR) as:
“An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.”21
The role of an LAR is to provide or maintain ongoing informed consent for a research participant throughout the life of a research study. In this module, we use the terms LAR, surrogate, or proxy to mean the same thing.
The National Institutes of Health has provided the following guidance on involving Legally Authorized Representatives (LARs) in research:
“When consent capacity could diminish during the course of a study, it may be most appropriate to transition to Legally Authorized Representative (LAR) consent and decision-making. In these cases, involving at the start of the study an individual who could serve as an LAR later on may be most prudent.”38
What Are the Benefits of Appointing an LAR?
There are three main benefits of asking participants to appoint an LAR for research:
- Respect Patient Autonomy: Appointing an LAR helps ensure the participant has a say in who makes research participation decisions on their behalf
- Risk Management: A research team may reduce legal risk by discussing and documenting participant’s wishes regarding an LAR
- Enabling Research Participation: LARs may enable an individual to participate in research even when they are not able to provide informed consent
Appointing an LAR
Individuals with cognitive impairments, caused by Alzheimer’s disease or other neurological conditions, may lack capacity to consent to participate in research.12,32 However, all older adults are at risk of developing cognitive impairments due to a variety of factors, as described previously. Therefore, it is important to be prepared to appoint a Legally Authorized Representative for all older adults in appropriate circumstances, such as multi-year studies where capacity to consent may change over the course of the study.39 Studies indicate that a majority of older adults and adults with mild to moderate Alzheimer’s disease support the idea of letting an LAR make research decisions.24,40
Not all studies will require the use of LARs. A major determinant of whether LARs are necessary is the risk level of the research study. According to the NIH, “a higher level of consent capacity and provision of additional safeguards would be expected in more complex protocols with greater degrees of risk”.38 That is, the risk level of a study should be taken into consideration when determining if LARs are necessary.
Consenting to a complex research study requires learning and retaining a lot of new, complex, and technical information. In contrast, the decision to appoint an LAR is a much simpler cognitive task.41 Evidence indicates that when a participant loses the ability to consent to a complex and high-risk clinical trial, they often retain the ability to appoint a surrogate decision maker, enabling them to take part in research. 42 Appointing an LAR involves trusting someone else to make a decision, “a concept that is already familiar to many” and that is based on existing close relationships.41 In fact, most LARs are family members such as spouses or children, and close friends.40
Currently very few states have laws that specifically address appointing an LAR to consent in research. It is important to first determine if your state has any laws regarding appointing LARs in research settings by asking your IRB or general counsel. You should become familiar with your state specific laws, and if your state has a statute, make sure you know the rules for who can be an LAR.
The Office of Human Research Protections (OHRP) has offered guidance in the absence of state laws. OHRP advises that anyone who can serve as a proxy or surrogate decision maker for healthcare decisions could serve as an LAR for research participation decisions:
“When the laws of the jurisdiction in which the research is being conducted provide a reasonable basis for authorizing an individual to consent on behalf of prospective subjects to their participation in the research procedure(s), OHRP would consider such an individual to be an LAR as defined by HHS regulations at 45 CFR 46. 102(c). IRBs may wish to consult with legal counsel when deciding who can serve as an LAR for subjects’ proposed research.”21
Document Discussions About LARs
It is important to document discussions of the participants’ preferences regarding an LAR in research records. This ensures that there is a record that a discussion took place regarding the participant preferences regarding who they would appoint as an LAR.
Check with your IRB as they may have templates or documentation suggestions for appointing an LAR.
Challenges of Finding an LAR
Finding an LAR may not be easy in certain circumstances. Some patients may be “unbefriended”, that is they may lack decision-making abilities but have no one readily available to serve as an LAR.43 Unbefriended individuals may no longer have any living relatives or friends, they may have lost contact with or been abandoned by family members, or be socially isolated.43
Check with your IRB for guidance on the unbefriended.
Difference Between a Study Partner and an LAR
Study partners are commonly required for Alzheimer’s disease or dementia specific trials. The role of a study partner involves:44
- Assisting a participant with transportation to appointments
- Serving as a collateral source of information for study investigators
Although the role of a study partner may overlap with that of an LAR, they are not the same thing. In many cases, the study partner can also be an LAR, but they may not have officially been appointed as an LAR. The benefits of formally appointing an LAR – to respect patient autonomy and manage risk – still apply when the participant has a study partner. Consider asking study partners to become LARs to clarify their role.
When an individual’s capacity to consent is diminished, or may become diminished, during the course of a study it may be helpful to appoint a Legally Authorized Representative (LAR) as an additional safeguard. Most state laws do not specifically address appointing an LAR to consent in research. The Office of Human Research Protections (OHRP) has offered guidance that in the absence of state laws, anyone who can serve as a proxy or surrogate decision maker for healthcare decisions could serve as an LAR for research participation decisions. Appointing an LAR is a simpler cognitive task than consenting to a complex clinical trial. In addition, most older adults support the use of LARs in research. Check with your IRB to determine your state laws and any guidance they provide on documenting or appointing LARs.
- RESOURCES -
Take a moment now to review three resources that can help you implement the use of LARs into your consent practices when appropriate. The first is a downloadable document containing suggestions on how to broach the LAR conversation with participants, which can be a sensitive subject. The second is a sample note to file template that can be used to document the discussion with participants regarding their preferences for appointing an LAR. Last, we provide sample IRB protocol language that can be used in your IRB application to justify the use of LARs, along with relevant references.
The information in this module is not legal advice and may not pertain to your individual situation or state laws.
This online toolkit was developed by Jessica Mozersky, Erin D. Solomon, and James M. DuBois at the Bioethics Research Center at Washington University School of Medicine in St. Louis with funding from the National Institutes of Aging [R01 AG058254-01, NIA].
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