Understanding Informed Consent | Quorum Review IRB

Informed consent is a crucial component of research with human participants. Numerous incidents of unethical—and oftentimes horrifying—research conducted during the 20th century showed the importance of giving people the opportunity to choose whether they would like to be in a trial. While it seems as if today’s ethical codes and regulations would never allow the forced participation that occurred in the atrocious experiments of Nazi concentration camps, researchers still fumble during the informed consent process.

Following 18-year-old research participant Jesse Gelsinger’s death in a gene therapy trial in 1999, the U.S. Food and Drug Administration (FDA) found that the study’s consent form did not disclose adequate risk information. As a result of lack of informed consent in a standard-of-care surgery to remove a growing non-malignant brain tumor, the Pennsylvania Supreme Court ruled in the 2017 case of Shinal v. Toms that the physician be the one obtaining informed consent when conducting certain clinical procedures or “administering an experimental medication, using an experimental device, or using an approved medication or device in an experimental manner.”

Researchers must remember that informed consent is a process and not simply a consent form. The process begins with the initial contact with the participant and lasts for the duration of the study. This ongoing dialogue between researcher and participant honors The Belmont Report’s basic ethical principle of respect for persons. The FDA Information Sheet “A Guide to Informed Consent” advises that investigators, sponsors, and institutional review boards (IRBs) are all responsible for making sure the informed consent process is adequate.

What Goes Into A Consent Form?

The required contents of a consent form (also called an informed consent form, or “ICF”) depend on the location of a study and applicable regulations and guidelines. State, provincial, and local law may also determine elements of the consent form. No matter the setting of the study, the consent form should be an adequate reflection of the protocol and describe what will happen during the study in language that is understandable to the participant. Core elements of the consent form generally include, among others:

  • An explanation of the study purpose
  • A description of study procedures
  • A description of foreseeable risks to the participant
  • A description of any benefits to the participant or others
  • Alternatives to participation
  • A description of the extent, if any, to which confidentiality of records identifying the participant will be maintained
  • Contact information

If you are submitting a study to Quorum, you are welcome to refer to our sample consent forms and borrow as much language as necessary when drafting your own forms. You can access these forms by contacting Quorum or downloading them from a secure area of our website.

How Can the Consent Form Best Serve the Participant?

While researchers draft a consent form and consult with others for the improvement of that document, they should follow the ancient writerly adage to “know your audience.” The audience is not the sponsoring company’s attorney team or a scientist with years of knowledge about the investigational drug’s risk profile. The audience is the participant—someone who could have multiple advanced degrees or only an elementary school education. There are numerous ways to improve comprehension during consent. Following are some tips for drafting an understandable and highly readable consent form:

Writing a simple consent form can be a challenging task, especially for complex or high-risk studies, such as oncology trials. Quorum offers custom consent form services to create understandable, compliant consent forms on your behalf.

Does the Enrollment of a Vulnerable Population Affect the Informed Consent Process?

Researchers should be especially conscious of applicable regulations, guidelines, and laws when enrolling vulnerable populations—disadvantaged populations that require special considerations or protections in the context of research. Examples of vulnerable populations include minors, incapacitated individuals who rely on legally authorized representatives (LARs) for decision making, individuals who are unable to read (due to low literacy or visual impairment), non-English-speaking individuals, and institutionalized or incarcerated individuals.

The IRB or research ethics board will determine whether enrollment of specific vulnerable populations is acceptable. Below are some things to consider when enrolling certain populations.

Minors

When a study involves minors, the IRB or research ethics board may expect a written assent form to accompany the consent form for parents/guardians. Quorum requires written assent of minors ages 7 and older. In addition, the IRB or research ethics board will determine whether the permission of one or both parents is necessary for the enrollment of the minor.

Legally Authorized Representatives (LARs)

Local laws define who may qualify to serve as an LAR and make decisions for the participant. Depending on the nature of the study and the participant’s condition, an LAR may provide consent for the participant throughout the study or, as is the case with some Alzheimer’s trials, the LAR will only provide consent if the participant eventually loses capacity to consent. Even when Quorum allows the enrollment of this population, we expect investigators to obtain continuing assent of participants whenever possible.

Participants Who Are Unable to Read

If researchers would like to enroll participants who are unable to read, the consent form should generally include a witness statement and signature lines to be completed by an impartial witness on behalf of the participant. (An impartial witness would be an individual who is not directly affiliated with the conduct of the study.) The witness will attest to the completeness of the informed consent discussion and the participant’s voluntary agreement to participate in the study.

Non-English Speaking Participants

In the United States, regulations require the consent form be written in language understandable to the participant (or his/her LAR). When an investigator anticipates enrolling non-English-speaking participants, Quorum requires the investigator provide the non-English-speaking individual with a consent form that is in his/her primary language. In addition, the investigator must ensure a research staff member or other interpreter (other than a family member) who is fluent in the relevant language is available for the informed consent process.

What is the Future of Informed Consent?

In the 21st century, researchers have been experimenting with different means of conducting the informed consent process, from going paperless to adding supplemental documents or media to consent forms. Some more novel approaches include:

  • Tiered consent form, a consent document that includes the most essential information related to a study upfront
  • Animation to communicate study concepts
  • Teach-back method, which involves asking participants questions about what they read in the consent form in order to assess their comprehension of what study participation will involve
  • Electronic informed consent (eConsent), which replaces the hard-copy consent form with digital means of consenting participants (for example, through software or via a website)

As Greek philosopher Heraclitus said, “There is nothing permanent except change.” The informed consent process became mandated and regulated during the latter half of the 20th century. In the coming years, we may see radical changes to the process. Issued by the Department of Health and Human Services (HHS), the revised Common Rule will require that consent forms for federally funded research must be organized and presented in a way that facilitates comprehension. These new regulations also favor the tiered-consent approach, stating that the first portion of the consent form must include a concise and focused presentation of key information that will aid in an informed decision. FDA regulations will eventually harmonize with those of HHS, and we can expect significant changes in the consent forms drafted for all U.S. studies.

No matter what shapes the informed consent process takes in the future, those conducting and reviewing research should keep in mind that participant understanding is at the heart of the process. And, as an individual’s understanding may fluctuate during the course of a trial, the informed consent process should continue until participation is complete.