Vaccinated vs. Unvaccinated Part 4 - The Legal Perspective

This is the final installment of the vaccinated vs. unvaccinated series. If you haven't read the other articles, in part 1 I discussed the general shape of prospective, randomized, placebo-controlled study to answer the question of whether or not vaccines play a causative role in autism. In part 2, I provided an overview of the history of ethics in medical research, particularly discussing three key documents: the Nuremberg Code, the Declaration of Helsinki and the Belmont Report. And in part 3, I examined whether or not the study would be ethical. In this post, I will look at whether the study could legally be conducted. Before continuing, please go read the first three parts. The full series can be found here.

The primary reference I'll use for this post is 45 CFR 46, the set of regulations that governs research involving human subjects. In particular, I will refer to subparts B and D (sections 46.201-46.207 and 46.401-46.409), which provides for special protections for research involving newborns and children.

In part 3, I established that our study would be greater than minimal risk. While that does not preclude conducting it, it does mean that certain additional legal requirements must be satisfied before the study can be approved and move forward. I also showed that regardless of legalities, the study would be unethical. Only by some strange, alternate sense of ethics could one argue that it would be okay to go ahead with the study. But, supposing that we live in bizzaro world and the ethics are not a hindrance, could our study be conducted legally? Let's take a look.

Vaccinated vs. Unvaccinated Part 3 - Ethical Evaluation

In part 1 of this series, I went over the general description of a prospective randomized, placebo-controlled clinical trial (RCT) to study vaccinated vs. unvaccinated children. In part 2, I reviewed some of the history of medical research ethics, including three foundational documents that have helped to shape the current human research landscape: the Nuremberg Code, the Declaration of Helsinki and the Belmont Report. If you have not yet read those posts, I strongly encourage you to do so now. They should provide a decent basis for understanding part 3. The full series of posts can be found here.

Just to recap certain aspects of the design of a prospective vaccinated vs. unvaccinated RCT to determine whether or not vaccines cause or contribute to autism, we would need to follow the subjects from birth through at least 4 or 5 years of age. In order for the results to be clear and show a definite cause, several thousand children would need to be enrolled in both the group receiving vaccines and the group not receiving any vaccines (who would get a saline shot instead, to keep it blinded). Subjects in the vaccinated group would need to be matched to the placebo group as closely as possible on a range of factors, such as parental age, ethnicity, birth order/# siblings and so on - in short, any factors which may play a confounding role in the analysis and outcomes of the study.

In the remainder of this post, I will apply the ethical considerations and regulations introduced in part 2 to some of the specifics of the type of study discussed in part 1. Since I am most familiar with U.S. regulations, when discussing legalities, I will be referring in large part to 45 CFR 46, the set of regulations that govern research involving human subjects. This is probably going to be pretty long, so bear with me.

Vaccinated vs. Unvaccinated Part 2 - A History of Medical Research Ethics

In my last post, I provided a basic overview of what a vaccinated vs. unvaccinated study would look like. The general form would be a prospective, double-blind, randomized, placebo-controlled trial. The big question that I asked in my previous post was what is stopping someone from conducting a trial like this in children, and my short answer was ethics.

Within the context of scientific research involving humans, ethical protections of subjects is a relatively recent thing. For most of human history, the systematic investigation of some question involving humans has taken the attitude that the answer being sought was of the utmost importance. The well-being of the people being experimented upon was secondary, if it was thought of at all. Compounding matters was the dehumanizing view that certain populations were viewed in the same way that we tend to view animals: chattel to be exploited. Criminals, the mentally incompetent, even women and children in some cases, were viewed as a means to an end.

So, what changed?

Vaccinated vs. Unvaccinated Part 1 - An RCT Overview

This article is something I've been thinking about writing for quite a while, now. In discussions about vaccines, the question of whether they relate to autism (they don't) and research, the idea of a study looking at vaccinated vs. unvaccinated children often comes up. Typically, the call for such research comes from those who are opposed to vaccines or who are scared or uncertain about vaccines, either completely or just in terms of how they are currently administered. Certainly, such a study would pretty definitively answer the question once and for all. Granted, there would still be some die-hards who, if the study were to show that vaccines do not cause autism, would come up with some excuse. They may say that the study was flawed in some unspecified manner. Perhaps they would assert some conflict of interest that may or may not be real. And I've already heard some state, before such a study has even been done, that the vaccines that the parents received are to blame. That last one could potentially go on and on ("well, it must be the vaccines the grandparents/great-grandparents/etc. received!").

At any rate, there are two basic ways to go about such a study. First, there is a retrospective epidemiological study. This kind of study would look at populations that already received or did not receive vaccines, taking the form of case-control studies or cohort studies. There likely would be no randomization. There would be no placebo control. Individuals would probably be matched by age and a host of other factors. There are a lot of potential variables, though, that could confound the results. As I'm not an epidemiologist, I won't get into the difficulties involved in this sort of study. René Najera over at The Epi Times has a series of posts [Unfortunately, an anti-vaccine activist's actions forced René to take his site down] on epidemiology that may help inform readers of the considerations involved in this kind of research. Prometheus also wrote about vaxed vs. unvaxed over at Photon in the Darkness [Sadly, Prometheus took down his site for financial reasons.] back in 2008, touching on the logistical nightmare of finding enough subjects to enroll.

The second approach would be to conduct a prospective, double-blind, randomized, placebo-controlled trial.