Two researchers from University of Pennsylvania, Department of Medical Ethics and Policy, Perelman School of Medicine, set out to evaluate the nature of informed consent associated with the rapidly developed, accelerated COVID-19 vaccines in the United States. Authorized under emergency use authorization at unprecedented speed, the fundamentals of ethical research center on proper informed consent. But how did this process turn out? With enormous built up government-sponsored public-private messaging about the importance of the vaccines, are study participants and those getting inoculated with the emergency jab informed on terms that they can understand regarding the experimental vaccine? As it turns out, all talk of patient engagement was sort of chucked aside when it came to informed consent, according to the latest study results published in Jama Network. Dr. Ezekiel J. Emanuel and Connor W. Boyle set out to better understand just how clear and concise vaccine sponsors were communicating to participants of studies. How straightforward and informative was informed consent? As it turns out, volunteers would have had to be specialized attorneys in this specific field to have a clue. Informed consent documents ended up far lengthier and more complex than need be, included ancillary information, and appeared more as a legal tome. Although they may or may not be subject to the particular law, are sponsors and sites falling short of the intent of the Common Rule, 45 C.F.R. 46?
TrialSite News shares the study and provides a brief breakdown for the community to understand these findings and subsequent possible implications. In what is a concerning set of findings, not only are sponsors and research centers overwhelming COVID-19 vaccine subjects with overly complex legal tomes for informed consent documentation, they’re also adding irrelevant content seemingly to perhaps prioritize sponsor legal protection over following their duty under the Common Rule to ensure subjects substantially understand what the study is about, including its material risks.
What are the rules?
Importantly, the horrors of prisoner of war and concentration camps of World War 2 also involved human experimentation. During the war trials and thereafter, the concept of informed consent congealed and ultimately led to the “Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects.”
The Common Rule (45 C.F.R. 46) was set up to protect people who volunteer as clinical research participants (subjects) from undue harm. Informed consent is the document or other communication form, such as video or presentation that helps protect volunteers rights—that is, they have a right to informed consent and a right to truly understand the nature of the risk of a biomedical research endeavor.
Changes during Obama Era
During the Obama presidency, the study’s co-author, Dr. Ezekiel J. Emanuel participated in the Common Rule rewrite while serving as a White House advisor. A key driver of the overhaul centered on ensuring that the informed consent process was streamlined, simpler and more empowering to volunteers or what is known as subjects.
Does the Common Rule apply to all research?
No. They apply to federally funded research. But many of the vaccine studies were in fact federally funded with money from Operation Warp Speed, HHS/BARD, and the NIH, and this could be a factor in influencing the interpretation. While the Common Rule applies to federal research, the revised Common Rule doesn’t apply to the U.S. Food and Drug Administration (FDA).
However, many experts in the field suggest it prudent to consider new key information and consent elements in their informed consent forms. Just the inclusion of such information doesn’t trigger transition to the Common Rule.
So what is Informed Consent?
Well, it’s a response to the tragedies of the human condition associated with involuntary human experiments. Based on the historical precedent and the subsequent rules leading to the Common Rule, study subjects (volunteers) must give their informed consent to the sponsor/site conducting the trial. Documents conveying the risks and possibilities of the particular study are designed to protect the subject from undue harm.
Despite ongoing industry chatter about patient engagement and patient-centricity, when it comes to legal boilerplate, the sponsors and trial sites often produce ever more complex and incomprehensible legal documents. The majority of research ethicists believe industry has gone too far.
What is the key issue here?
The movement for patient-centricity calls for more patient-friendly engagement and dissemination of information in such a manner and form as to provide patients with a fair chance to fully understand the implications of the investigational product.
What are some key findings?
On average, the documents were over 21 pages and took 35 minutes to read. The authors noted that one would at least have to have a high school reading comprehension level despite the fact that several federal guidelines recommend that informed consent be edited so that areading comprehension level of eight grade or lower would be sufficient.
Does this indicate Pharma is not living up to its Commitment?
Yes. The pharma industry is failing to live up to its commitment to better engage patients/participants in the research process. That is making the informed consent process more simple, straightforward, and easy to understand. Volunteers must truly understand the risks on terms they get; and Pfizer, Moderna and Johnson and Johnson failed to do this.
According to study co-author and bioethicist Dr. Ezekiel J. Emanuel, “Informed consent documents are really bad. And it’s not hard to improve them. But it does require a mindset, which is ‘We’re going to try to make it as short as possible, as simple as possible.”
Do NIH and Ethics Committees/IRBs have responsibility here?
Yes, TrialSite believes so. Especially the IRBs. In the USA, they must authorize the IRB. In many of these studies, the National Institute of Health, National Institute of Allergy and Infectious Disease (NIAID) were co-sponsors and are supposed to represent the people. Shouldn’t they ensure that informed consent is more engaging and informative in the mission-critical studies they help fund?
Hasn’t the government focused on improving this process?
Yes. There is often discussion and even updates to rules. But little has changed. Few can truly read and understand these informed consent (IC) documents for such mission-critical clinical trials.
Are there examples of informed consent language to study?
Yes. Although there is no formal OHRP guidance, an HHS advisory panel has offered tips on how to write this section and can be found at the following Regulations.gov website by earing the following document IDs: HHS-OPHS-2020-0003-0007 and HHS-OPHS-2020-0003-0008
Connor W. Boyle, Research Administrative Coordinator
Call to Action: Sponsors, consider making the informed consent easier for participants to understand.