Rethinking the process of informed consent

By Sylvia Baedorf Kassis, MPH, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.

Are a good informed consent form and a good informed consent process really mutually exclusive?

Whether you attended yesterday’s Great Debate at the AER Conference, you are undoubtedly aware of the criticisms of informed consent forms used in research. You may have even complained yourself: The forms are too long; the forms have too much legal jargon; the grade level of language is too high; and on and on…

In an effort to address some of these issues, yesterday’s Great Debate was ambitiously titled, Be it Resolved that Consent Forms are an Obstacle to Informed Consent and Should be Abolished. Leonard Glantz, JD, and Jerry Menikoff, MD, JD, took on the topic with gusto and, respectively, debated the pros and cons.

In his arguments supporting abolishment, Mr. Glantz stated that consent forms have nothing to do with ethics or protecting human subjects. Rather, the forms are devised to protect the researchers (and their institutions), and detract from what should be the real focus: the consent process. Mr. Glantz’s argument culminated in the point that consent should involve a discussion that is audio taped, so that meaningful documentation of the process would exist (as opposed to a “meaningless” signature).

In contrast, Dr. Menikoff argued that consent forms are necessary to provide a cheap and efficient method for researchers to cover the key information that subjects should know. The forms should be clear and brief. He closed by stating the consent process is irrelevant if the message isn’t clear.

After listening to rebuttals and audience comments, it seemed to me that the debaters’ arguments had more in common than not. Although the philosophical issue was abolishing the consent form in its entirety, both Mr. Glantz and Dr. Menikoff discussed the need for a meaningful discussion between the person obtaining consent and the potential participant. And really, regardless of whether there is a consent form, both seemed to agree that the entire process of informed consent is what needs to be refined and improved.

I would be surprised if consent forms are abolished any time soon, so I leave you to consider several suggestions of ways to improve the consent process

  • Don’t assume that researchers or their staff members are educated in engaging in an appropriate informed consent process. Offer consent training to all members of the research team.
  • Administer an assessment of understanding or “teach-back” method to all potential participants before they agree to participate.
  • Utilize impartial parties, such as nurses or health educators, to engage in the informed consent process with potential research participants.
  • Limit the length of consent forms.
  • Permit researchers to decide the key 5-10 points that they want potential participants to know about the research studies, accompanied by a standard research fact sheet that lists the regulatory elements.