Function over Form: Assessing Different Consent Form Formats

Informed consent is the cornerstone of conducting research with human participants. Regulations prescribe certain elements and information that must be provided to participants, and that it be in language understandable to the participants.  But there is no guidance or requirements about what the consent process should be or what the consent document should look like. Sponsors and sites have adopted a myriad of styles and formats for consent forms.  In this paper, we will discuss some of the different formats of consent forms as they are using for documenting initial and ongoing consent during clinical studies, and the strengths and challenges of each. 

To draw the distinction, in this paper, the term ‘simple consent form’ is used to denote a word-processed, text-only, standard format informed consent document.

Detailing Study Procedures and Activities in a Table Versus in Paragraphs or Lists

It is fairly common for sites and sponsors to list all of the study procedures and activities in a table, either in the body of the consent form or as an appendix.

Strengths

A table of study procedures

• puts all of the study procedures together and often makes it easier to see what will happen and when. 
• makes consent forms shorter as information does not need to be repeated for each study visit
• can provide the information in an efficient way.
• breaks up the consent form and creates white space which can increase readability and understandability of the consent form as a whole.
• makes it easy to update an entire table, by copy and pasting the table(s) from the protocol.
• helps to reduce copy-paste errors and inconsistent or contrary information between the study visits.
• makes it easier to update the information as it is in one spot on the table as opposed to updating the information for each study visit where the change may occur. 

Challenges

When using a table of study procedures

• some participants may have trouble reading and understanding tables and may not grasp which procedures will be done and when. 
• there may be space limitations for the columns and there may not be sufficient explanations of what the procedures entail, or explanations require complicated footnotes.
• editing or modifying parts of tables can be challenging, particularly when new procedures or study visits are being added.  This will often change how the table appears and may require the table to be reformatted. 
• it is often challenging to format the text in a way that can be easily readable to the participants within the space limitations.

One possible approach would be to describe the research procedures in the consent form and then also include a table as a consent form addendum or additional participant information that can be used as a quick reference.

Using Separate Consent Forms for Different Participant Populations or Cohorts

Sometimes a research study will recruit from multiple different participant populations (e.g., minors consented via parental permission and adults who consent for themselves) or will involve multiple cohorts (e.g., a study comparing different treatment regimens with their own respective risks and procedures) and there could be a different consent form for each group.  

Strengths

The benefits of using multiple separate consent forms include that

• the language in the body of the consent form can be tailored to each participant population. If the procedures, dosages, or compensation offered varies between groups, the consent language can be made specific to that individual participant without including information that does not apply to them.
• the document will require fewer signature lines. If decision-making adult participants have their own consent form, then the document will not also require signature lines for documenting parental permission for the adolescent participants or documenting the signature of a legally authorized representative if the participant is lacking capacity. This approach will help prevent errors that may occur when a participant or study team member signs the wrong section of the consent form.
• if a participant population or cohort completes the research, or if a part of the study completes (e.g, optional first-dose intensive PK sampling, after everyone has completed the first dose) then that consent document will no longer need to be maintained going forward.

Challenges

Some of the challenges of having multiple separate consent forms are that

• having multiple consent forms for different groups means having multiple documents to maintain and revise as the research changes with protocol revisions and amendments. Keeping track of these documents and ensuring they are consistent can be burdensome over time. If the differences between the consent forms for each group are minimal, it might be preferable to use one document and add language that clarifies whether certain sections to apply to a participant.
• using multiple consent forms for the same research study can also introduce the possibility of documentation errors if the study team member obtaining consent uses the wrong consent form. For example: if a participant gives consent for Cohort A, but  later  the research staff inadvertently uses the consent form for Cohort B, to re consent the participant, there is a possibility the participant did not receive the new information that is most pertinent to their participation.

Reconsenting Active Participants Using and Addendum Instead of a Revised Consent Form

The question of whether an active participant should be “reconsented” arises whenever there is a protocol revision, new or updated study risk, or an update to the consent form language. As noted in this WCG White paper, Providing Research Participants with New Information: Is “Re-Consent” Always Necessary?, reconsenting participants should be performed whenever significant new findings may affect a participant’s decision to continue in the research. Reconsenting is most often done in one of two ways: 1) having the participant review the revised consent form in its entirety and consent again, or 2) having the participant review a consent form addendum that outlines the key changes in the research, or that changes that apply to their stage in the study.

Strengths

When using a consent addendum

• it is easier for the participant to understand the key changes without having to re-review information that has not changed since they initially joined the research.
• the consent form addendum will be much shorter than a revised consent form, and the reconsenting process will be take less time for study team members to administer. 

Challenges

When using a consent addendum

• this approach introduces another document that will need to be revised and maintained over the course of a study. If the research is still enrolling, the existing consent form will also need to be updated to incorporate the revised information for new participants. The addendum approach to reconsenting is best suited for situations where enrollment is permanently closed, but there is new information that needs to be communicated to active participants.

Including Optional Components in the Main Consent Form

Sometimes research will involve sub-studies or optional procedures that require separate consent. This information can either be appended to the main consent form or conveyed in a separate consent form addendum.

Strengths

When keeping sub-study information in the main consent form

• there will be fewer documents to maintain and update over the life of the research. This will be easier for study teams, CROs, and IRBs to manage.
• if all decisions related to participation are in one document, it will be easier for the person obtaining consent to ensure all relevant consent has been obtained. There will be fewer consent documentation errors that occur when a study team fails to document one or more of the participant’s choices.

Challenges

• Including optional components in the main consent form can introduce the possibility of other errors. For example, this approach can lead to situations where a study team member fails to obtain a signature or participant decision on one of the optional sections.
• It can also lead to situations during reconsenting where a participant makes a different choice than they originally did. If this discrepancy is not noticed or resolved, it can make it difficult to determine whether the participant meant to change their prior consent or simply forgot the choice they made earlier. If a single consent form for all procedures, both required and optional, is used, it is a good practice for the study team member to have the participant’s prior choices available to reference during the reconsenting process.

Electronic Consent (eConsent)

The term electronic consent (often abbreviated as “eConsent”) can mean multiple things, including uploading an approved consent document onto a platform that can be viewed on a tablet , phone, or computerror the use of electronic platforms that incorporate the consent form with dictionaries, storyboards, animation, videos, graphics, and/or images.  Since these involve two different processes, we will discuss the strengths and challenges of them separately.

Uploaded Consent Document

Strengths

When uploading a simple consent document to be used electronically

• once the IRB has approved the simple consent form it is generally very easy to upload into an electronic document. If there are no changes to the consent form, uploading it does not require any additional review by the IRB.
• the research site will not need to have printed versions of the consent form available for each participant; rather the site would be using the same file on the tablet each time and saving it as a separate file once the participant has signed the form.
• the site may not need to keep paper copies of the signed consent form which could help in decreasing the space needed to store study records, as well as reducing the risk that the consent forms get lost, or inadvertently destroyed, particularly if the data system is backed up.
• if the data system is searchable, then it could also be quicker and easier to determine if a particular participant has signed the consent form(s), and when.

Challenges

When uploading a simple consent document to be used electronically

• the system used to obtain consent and store the electronic consent forms must be compliant with 21 CFR Part 11 for any clinical trials regulated by the FDA¹. Note that if participants are physically signing the consent form using a stylus or their finger, rather than typing a “signature”, this is considered to be a “wet signature” and the system does not need to be compliant with 21 CFR Part 11.
• the site will likely still need to print off the signed consent form to provide the signed version to the participants (per ICH GCP )², but this would be the case even if the site was using paper based consent forms.
• if the electronic form gets corrupted or inadvertently deleted, the site may not have a usable consent form

The site should maintain at least one current copy of the simple consent form to serve as a back-up in case there are technical issues or the electronic version can’t be used.

Electronic platforms incorporating dictionaries, animation, storyboards, and/or videos

Increasingly sites and sponsors are using consent processes that are incorporated into an electronic platform and will include embedded dictionaries, animation, videos, storyboards, and other visual information to help explain the study.  The text of the consent form is also generally incorporated as part of the electronic platform and the participants may digitally or physically sign the consent form as part of the electronic platform.

Strengths

When using multi-format electronic platforms for the informed consent process

• this format may improve participant satisfaction with the consent process, and help increases the participants’ comprehension of the study and the associated procedures, risks, benefits, and alternatives by providing an interactive learning approach.³
• electronic platforms make it easy for the participants to go back to specific sections to re-review information if they have questions.
• the multi-modality platforms help people with different learning styles, such as auditory and visual learners understand the consent form as opposed to simply relying on reading the consent form.
• When consent information needs to be updated during a study, once changes have been approved by the central IRB, they could be pushed out to all of the sites simultaneously. This helps to make sure all of the sites are always using the most current version of the consent form.
• the integration of videos, images and other tools may make it easier to visualize complex ideas or procedures

Challenges

When using multi-format electronic platforms for the informed consent process

• they are expensive, compared to paper-based forms or simple electronic forms
• they can be time-consuming to develop initially and to change when needed
• consent incorporating tools such as voice-overs, videos, or animations will generally require a second IRB review (following initial review of the simple consent document) as the content is different than what is included in the simple consent document.
• if using both a simple consent document and the multi-modality electronic format, the site and sponsor may need to update multiple documents when there are changes, including the simple consent document and the consent form provided as part of the electronic platform.
• this electronic platform will need to comply with 21 CFR Part 11 and the site will still need to provide a printed copy of the consent form to the participants.

Concluding Thoughts

There are many formatting options to consider when drafting an informed consent form, each with their own advantages and disadvantages. The format of the ideal consent form may vary by situation and study. When drafting an informed consent form, the sponsor and study team should evaluate their needs and constraints to design an informed consent form that will be easy to understand for potential participants and efficient to implement for study teams. The IRB can be a resource for discussing options and implications on the review and implementation process.

References

1. 21 CFR § 11.1
2. See Integrated Addendum To ICH E6(R1):Guideline For Good Clinical Practice Section 4.8.11, https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
3. See for example Abudjarad, et al, Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial, JMIR Form Res. 2021 Oct 19;5(10):e20458. doi: 10.2196/20458. PMID: 34665142; PMCID: PMC8564662. (https://pubmed.ncbi.nlm.nih.gov/34665142/ Accessed 02-16-2023) and Gesualdo F, et al. Digital tools in the informed consent process: a systematic review. BMC Med Ethics. 2021 Feb 27;22(1):18. doi: 10.1186/s12910-021-00585-8. PMID: 33639926; PMCID: PMC7913441. (https://pubmed.ncbi.nlm.nih.gov/33639926/ Accessed 02-16-2023)