The 8 Common Informed Consent Form Mistakes on IRB Audits

The IRB and its approval process for biomedical research protects the rights and welfare of human participants. In this capacity, the IRB serves an important role in keeping the clinical research community in compliance with laws and regulations, as well as participants educated, informed, and aware of the risks and benefits of a particular clinical trial.

When performing an audit, the IRB is responsible for reviewing the protocols that were pre-approved for clinical trials, documenting errors and omissions, and reporting on their findings. It is a very detailed, rigorous process and the stakes are high for all invested parties. Finding that a clinical trial is not being conducted in accordance with regulations or IRB requirements will support their authority to suspend or terminate it.

Outlined below are 8 common Informed Consent Form (ICF) mistakes that are often identified through IRB audits:

1. Inadequate disclosure of the procedure, risks and discomforts

An informed consent form can fall short of its purpose due to a lack of clarity in its description.

As a rule of thumb, there are five elements that must be included in every ICF used in clinical trials:

  • A statement that the project is for research purposes only and that participation is completely voluntary
  • A summary of the research: purpose, duration and list of procedures involved
  • Reasonable risks that a participant may experience
  • Reasonable and expected benefits
  • Any alternative treatments or approaches

With such a large array of information on the table, the onus lies with the investigator to communicate everything in detail with the subject.

To avoid misinterpretation and unnecessary risk, doctors and researchers must have a detailed discussion to make sure the patient understands the full implications of the clinical trial.

2. Rushing through the consent process

Informed consent is a very important step in the process of enlisting participants for clinical trials. There is rigor around the development and execution of the informed process and the IRB does pay attention to how the ICFs are presented and understood by subjects.

Two common mistakes noted by the IRB: 1) Non-approved personnel reviewing the consent, and 2) A tendency of rushing subjects through the IC process.

Technology solutions such as eConsent, or electronic informed consent forms that can document every step of the IC process help organizations produce documentation to the IRB that address these concerns.

3. Less than adequate confidentiality and voluntary participation

An informed consent form must ensure there is no coercion or undue influence compelling a person’s participation in a research or clinical trial. This isn’t just reserved for language that limits the individual’s right to participate or withdraw from the investigation at any time they want. The protection of rights and welfare of human subjects can be hampered in many subtle ways, so there are other measures to be on the lookout for.

Ultimately, it’s unacceptable to maintain an environment that’s less than conducive to privacy, which prevents subjects from freely evaluating whether they can voluntarily participate. To minimize the possibility of coercion, the process should be conducted in an atmosphere that gives the subject or family enough time alone to review the informed consent form.

4. Spoliation of evidence, especially through lost forms

This is a risk with administering informed consent forms on paper. Information stored on paper can and does get misplaced and/or lost from time to time. Failure to obtain and keep signatures and records is a red flag that may lead IRB auditors to question whether valid consent was ever obtained. Digitizing ICFs is the best way to maintain, and produce valid informed consent documentation to the IRB in audits.

5. Not submitting revisions for modification and approval

Revisions of ICFs happen all the time in clinical research. The IRB requires approval for all revisions, big or small. Unfortunately, sometimes forgetting to obtain approval for revisions happens and is picked up in IRB audits. Having a well documented revision approval process is essential to passing audits with flying colors. Best practice is to have one person in the organization responsible for all ICF modifications and to documenting approval in a central location.

6. Failure to re-consent on a revised form

Understandably, the ongoing relationship with subjects sometimes necessitates new developments, which in turn requires ICF forms to be updated. Whenever a form is modified or updated, subjects need to reaffirm their decision to participate by reviewing and re-consenting/signing the new document. Unfortunately, failure to obtain IC from revisions is a reality and can be avoided with the right technology, processes/procedures in place.

7. Lack of attention to detail

The devil really is in the details and details matter tremendously if you want to avoid the risk of malpractice. Acts of negligence can manifest in several ways, such as:

  • Failure to correctly initial and date the ICF
  • Failure to secure the witness’s signature from the relevant healthcare professional
  • Allowing the subject to consent on an expired form
  • Failure to conduct the discussion in the presence of a witness (if required)
  • Missing required HIPAA language

Furthermore, there have been situations where sponsors want to include additional elements on an ICF after it’s already gone through the rigorous IRB approval process. Once these changes are deemed necessary, it not only needs to go through another IRB review, but also needs to be presented for re-consent to previously enrolled subjects.

Having monitors review informed consents early in the approval process may help alleviate this potential issue.

8. Failure to use an 8th-grade readability level or lower in the consent form

Layman’s terms have to be used in both ICFs and communicated discussions. When creating paper-based or electronic ICFs, sponsors and CROs must follow the rules around language, and ensure that readability not exceed 8th grade levels. This also holds true in verbal communication with subjects who are deciding to participate in the clinical trial. Clear, concise, 8th-grade level communication is something IRB auditors look for in their review. Failure to communicate in a way subjects can understand and comprehend could cause your study to not be approved by the IRB.

Wrap up

IRB audits happen everyday. Generally speaking, clinical researchers have a good grasp on the rules and guidelines they must follow as it pertains to the ICF process. Of course, with manual workflows, mistakes and oversights come with the territory. Many stakeholders are adopting technology to help them manage their clinical trials with better accuracy and today, there are over 30 eConsent solutions that are built specifically for clinical trials. Do your research, look for companies that are dedicated to building functionality for decentralized clinical trials and schedule demos to understand how they help manage the front and back-end processes.