Ethics & Regulations

One of the talks that I often do is entitled, "Ethics & Regulations in Human Subjects Research". Once, when I was about to start the talk, a researcher yelled out, "That's an oxymoron. Regulation doesn't have anything to do with ethics." Well, I can't talk for all regulation, but, with regard to the human subjects regulations, that's not true.

The basic ethical principles underlying research involving human subjects are contained in the "Belmont Report" and they are Respect for Persons, Beneficence, and Justice. Although some argue that these principles are not applicable to all research, I don't agree. I've been involved in the human research protections field for almost 30 years and have seen all kinds of research and I am absolutely convinced that these principles apply to all research, if not to life in general. I challenge anyone to explain to me how they might not apply.

However, these are abstract principles. How do we apply them to the review of research to help ensure that the research is being conducted ethically? That was the challenge facing the drafters of the regulations. The solution was Section 111 of the regulations (45 CFR 46.111 and 21 CFR 56.111) - The Criteria for IRB Approval of Research. The "111 Criteria", as they are called, take the abstract principles of the Belmont Report and turn them into criteria that can be used to evaluate whether research is being done ethically. The criteria in Section 111 include: risks are minimized, risks are reasonable in relation to benefits, subject selection is equitable, informed consent is appropriately obtained, informed consent is appropriately documented, data monitored to ensure subject safety, privacy and confidentiality are protected, and additional protections are in place for vulnerable subjects. These criteria are directly related to the Belmont Principles: risk/benefit analysis and subject safety - Beneficence, equitable subject selection - Justice, informed consent, privacy/confidentiality, and protection of vulnerable subjects - Respect for Persons.

So, by applying the 111 Criteria, IRBs are implementing the Belmont Principles and conducting ethical review of research.

Human Nature

Many of the critics of IRB review in the social sciences argue that they don't need IRB review because individual researchers are ethical and will make sure that their research meets the appropriate ethical standards. The flaw in this argument is human nature. One of the things that we know about human nature is that no one can be totally objective about their own work. We can and must try to be objective about the risks and benefits of our research, but we can't be totally objective. One way that we're not objective is that we all tend to underestimate the risks of things with which we are most familiar. I often use the example of the time I got in a cab to go to the airport and the cab was in a minor accident. I hit the plastic behind the driver, banged my nose and bit my lip. I wasn't wearing a seat belt. Why? Because I was underestimating the risk of that part of my trip. Living in New York City, I take cabs all the time and it was that familiarity which led me to underestimate the risks. It's the same in research. We can't be objective about the risks in the procedures or situations that are most familiar to us. We also overestimate the benefits of our work. If we didn't think that what we were doing was important, we wouldn't get out of bed in the morning to do it.

As I said in my previous post, ethical research requires that the risks of the research are identified, that the risks are minimized, and that the risks are reasonable in relation to the potential benefits of the research. Although researchers have the primary responsibility to make that analysis, since they can't be totally objective about the risks and benefits, every research activity needs an independent, objective review. That is what the IRB is supposed to provide. The IRB, however, must also be objective and have the necessary expertise to make this risk/benefit analysis.