Advice to improve informed consent

Three different approaches outlined

There are a number of ways clinical trial (CT) sites and investigators could improve the informed consent process, and CT experts offer a variety of suggestions for how to make this happen.

Here are some of their ideas:

  • Make certain potential participants do not harbor therapeutic misconception;
  • Check consent forms for the eight basic elements included in the federal mandate of 45CFR46.116;
  • Use the consent form as a tool to assist with a lengthy informed consent discussion.

"The whole notion of informed consent is so important, yet so difficult to figure out," says Robyn Shapiro, JD, a partner who specializes in health law at Drinker Biddle & Reath in Milwaukee, WI.

Principal investigators and CT staff struggle with how to meet all of the informed consent requirements and how to provide IC effectively, Shapiro notes.

"Part of the challenge has to do with the complexity of the research, and part of it has to do with the difficulty of counteracting the therapeutic misconception," Shapiro explains. "Therapeutic misconception is most prevalent in cases where you have desperately-ill patients who are thinking about very early phase trials when not a lot of other options are available, and the procedure is complex."

To some extent, therapeutic misconception is always an issue because a patient might benefit, but then, again, might not because this is research and not clinical treatment, she adds.

With a little discipline and extra time, CT sites can make certain all informed consent documents include the eight federally-mandated basic requirements.

It's a good strategy to create a template or checklist listing those eight requirements, says Judi Kuhl, CIP, BS, quality improvement coordinator in the office of research integrity at the University of Kentucky in Lexington, KY.

True to the code

According to the Code of Federal Regulations (45CFR46.116), the eight mandatory elements of informed consent are listed verbatim below:

  1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
  2. A description of any reasonably foreseeable risks or discomforts to the subject;
  3. A description of any benefits to the subject or to others which may reasonably be expected from the research;
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
  7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
  8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

One challenge for some investigators is including these eight elements in less formal informed consent documents, such as letters that are mailed out with surveys when the waiver of documentation of informed consent has been approved by an IRB, Kuhl says.

"A survey cover letter is a little different than an informed consent form for diabetes research," Kuhl notes. "The most effective cover letters are the ones that are like a conversation between a person and less technical."

So it's difficult to include the eight mandatory elements while writing the letter in this conversational tone, she adds.

This is why the University of Kentucky is working on a template for a cover letter that could be used with research and in the event of a waiver of documentation, Kuhl says.

Sometimes it's difficult for investigators and CT staff to view the informed consent document as a tool to facilitate the informed consent process and not as an end to the discussion.

"The consent form is really nothing more than a tool, and it's used in the context of what is supposed to be a discussion between an investigator and the subject," says Stewart A. Laidlaw, PhD, an associate vice president for compliance at the Los Angeles Biomedical Research Institute at the Harbor-UCLA Medical Center (LA BioMed) in Torrance, CA.

"The investigator should explain what's involved in the study and do it at a much lower level than what's in the consent form language," Laidlaw says. "Conscientious investigators will spend considerable time with each individual subject, attempting to communicate what's involved in the study."