Swimming with the Sharks—Best Practices in Informed Consent

Clinical Researcher—March 2021 (Volume 35, Issue 2)


Robert King


With more than a million lawyers working in the United States and a quarter million deaths caused by medical malpractice over the past decade, we are awash in litigation.

In assessing medical claims, an attorney will examine the ease of proving fault; the potential range of damages; and whether readily available funds exist, so that winning a case results in quick payment.

Generally, the plaintiff’s lawyers are only compensated when they recover damages. For these lawyers, medical claims are a veritable cornucopia offering potentially huge damages, sympathetic clients who have suffered real trauma, and defendants who maintain robust insurance policies. Clinical trials, which are by their very nature experimental, can add deep-pocketed life science companies to the mix.

One of the best ways to ward off these claims is to have a professionally written and well-executed process for obtaining and preserving a subject’s informed consent. Done properly, the informed consent makes it far more difficult to prove liability. As a result, a counsel faced with going up against a strong informed consent is less likely to accept the case. When a counsel does take on a client who is contesting what appears to be a nearly impregnable informed consent, he or she may moderate the reparations being demanded to reflect the heightened risk of losing in court.

What is Necessary for Effective Informed Consent?

Obtaining valid informed consent requires four things:

Capacity—The subject must have the legal and mental ability to make medical decisions.

Sufficient Information—The medical provider must disclose sufficient information regarding the diagnosis and proposed treatment of the medical condition, as well as have a discussion with the subject on potential alternatives. The provider must also detail the expected benefits and risks, as well as the likelihood that these benefits and risks arising from the various treatment options, so that the subject can make an informed choice regarding his or her own care.

Comprehension—The subject must indicate his or her understanding of the information provided.

Free Will—The subject must voluntarily grant consent without duress. This means that he or she cannot be coerced by anyone or by any aspect of the circumstances under which the informed consent was obtained. For example, obtaining consent immediately prior to a surgical procedure might open the consent to attack if the subject claimed he or she was under undue stress at the time.

If any of these components is weak or missing, then Christmas will come early at the Bar Association.

How Medical Providers Can Protect Informed Consent

When I was growing up in pre-internet Philadelphia, The Daily News had big headlines, short words, and the best sports section. It had a reputation for never using any word with more than three syllables (other than “interception” during football season). The paper’s style reflected its demographics—half the readership was working class and the other half was made up of professionals, so a happy middle ground of readability had to be struck

Drafting an effective informed consent presents identical challenges. Complex information must be conveyed to a varied audience in a thorough, yet understandable manner. Present too much technical information and comprehension fails. Or perhaps, the information will speak to subjects’ fears because they misunderstand the probability of potential adverse events. Keep it too simple and the consent will fail because insufficient information was given.

The best approach is to provide the key information, but in a way that is as understandable to a layperson as possible. To accomplish this:

  • Keep sentences and paragraphs short.
  • Break sections up using clear headings.
  • Avoid medical jargon.
  • Emphasize the voluntary nature of the trial to reduce unjustified fears about trial risks.
  • Proactively throughout the trial obtain feedback allowing concerns to be addressed.

One of the major obstacles to writing effective informed consents is that the legal and medical experts doing so are too familiar with the topic. To succeed, they must write the document so it can be understood by a merely average student at a mediocre junior high school.

The Devil is in the Details

Often, healthcare professionals treat the creation and management of informed consent documents as distasteful chores that need to be gotten through. Further, sloppy compliance with the technical requirements for execution regularly undermine what otherwise would have been effective documents.

Examples include:

  • Relying on administrative personnel, instead of healthcare professionals such as a physician’s assistant, to be present to witness the consent process and to ensure that all necessary information is provided.
  • The principal investigator fails to countersign the document.
  • The person obtaining the consent fails to properly capture the subject’s signature and the date of when it was executed.

Technical errors such as these can loom large in court, so an effective system to ensure strict compliance with the key details of the consent process is paramount.

Google is My Lawyer

Informed consent agreements generated by counsel have been vetted by legal and compliance professionals, which can provide tremendous protection against successful lawsuits.

“Legalese” attaches tremendous importance to the use of particular words or phrases in very specific manners. A single word out of place can have catastrophic results. With so much at risk, cutting and pasting language from the internet into an informed consent is an easy shortcut, but one that can lead to expensive consequences.

The Simple Pleasure of a Nice Conversation

Never present the informed consent as “just” another document. Nothing will undermine confidence in an informed consent than simply handing the form to subjects and telling them to “sign it.”

The informed consent should be part of a give-and-take conversation. Glossing over risks or presenting trial details quickly can boomerang when subjects later claim they did not adequately understand the medical risks of the study they had joined. Having a real conversation regarding the benefits and risks of the trial also allows the medical team to assess a potential subject’s state of mind, encourages recruitment, and helps everyone spot problems before they occur.

The Dog Ate My Homework

Across America, the first sign of spring occurs with millions of people frantically searching for misplaced tax documents to prove their claimed expenses, deductions, and allowances. Clinical trials involving hundreds of subjects and thousands of pages of data are similarly complex, and an informed consent agreement—no matter how good the faith was upon its collection—will be of no assistance if it is lost and problems with the trial arise.

If you want to annoy a judge, few things will raise his or her blood pressure more than “spoilation of evidence.” Missing data and documentation can lead to significant sanctions by the court. Accordingly, preserving access to informed consents, whether digital or hardcopy, is vital.

Do Not Put Off Until April What Should Have Been Done in February

Like a teenager putting out the trash, distasteful chores tend to be put off until the last minute. Too often, developing a consent document that fits the characteristics of a particular trial happens too late.

The informed consent must pass muster with clinical teams, administrators, sponsors, and the institutional review board—all of which takes time. Ramping up at an earlier date drives better outcomes. By developing templates sooner, there is time to develop consensus while avoiding last-minute pressures.


Informed consents represent a vital protection for medical providers, but there is a tendency to treat them as just part of the “routine.” Easily avoided errors result in devastating expenses because medical providers are much too busy to review their existing procedures. Taking a hard look at existing informed consent procedures in the near term is a far more cost-effective and pleasant choice than taking your chances once a lawsuit has been filed.

Robert King (Robert.King@tpclinical.com) is an attorney with more than 20 years of healthcare experience and founder of TakePoint Clinical, a firm whose credo is that “Medical Research is too Important to Wait on Endless Negotiations.” A white paper providing step-by-step instructions on how to speed clinical negotiations is available for download at the firm’s website (www.tpclinical.com).