RESEARCH ETHICS AND THE IRB

A brief history of modern research ethics and the IRB

Zoltan BokaDirector of Research Compliance and Bioethics

Lehman College

Experiments and People

Testing ideas and hypotheses by performing experiments involving people has a long history but much of that time has been marred by abuse

For example, in 1718, King George I of England offered a pardon to any prisoner in Newgate Prison who agreed to be injected with the smallpox virus as part of an experiment to find a vaccine. (Huth, 2006)

The Problem of Consent

You’re a prisoner in England in 1718: The King offers you a choice- get out now and be infected with the smallpox virus, or be free of the virus but remain in jail.

Is that really a choice?

The first task of IRB is to ensure that consent is freely given. This is more complicated than it sounds.

Who Can Consent?

The Nuremberg Code was developed in the aftermath of the discovery that Nazis conducted human experimentation on prisoners in concentration camps.

The Code has three requirements for consent: That one have a) the capacity to consent, b) a freedom from coercion, and c) comprehension of the risks and benefits involved

The Three Elements in Practice

King George has an idea: He would like to try out the vaccine for smallpox on prisoners and gives you two scenarios:

1) A prisoner who consents to a trial gets a pardon and one who does not consent stays in jail.

2) Every prisoner gets an injection and will be told that it is to help advance science but not told what it is.

What do you think?

Modern Deception

Between 1932 and 1972, the U.S. Health Service told poor African-American men in Alabama that they were receiving free medical care when in actuality, they were not being treated at all as physicians watched the disease progress and individuals infect others.

In 1974, Congress established 45 CFR Part 46, which discusses the process by which institutions obtain informed consent.

What do I have to do?

First, you need to ask yourself whether what you’re doing is human research:

Are you conducting human research or clinical investigations on human participants?

Scenario: You are interested in how life expectancy has grown between 1800 and 1900. You look up death records to compile a list of how long people in Bronx County lived before dying between 1800 and 1900. Is this human research?

Now that you know

Once you know that you need IRB approval for human research, you need certification.

A certificate is generally good for up to three years. Anyone who wants to work on human subject research must have one.

Once you are armed with a certificate, you have to think about the design of your study.

First, Do No Harm

“The third experiment…took such an extraordinary course that I called an SS physician of the camp as witness, since I had worked on these experiments all by myself. It was a continuous experiment without oxygen at a height of 12 kilometers conducted on a 37year–old Jew in good general condition. Breathing continued up to 30 minutes. After 4 minutes the experimental subject began to perspire and wiggle his head, after 5 minutes cramps occurred, between 6 and 10 minutes breathing increased in speed and the experimental subject became unconscious; from 11 to 30 minutes breathing slowed down to three breaths per minute, finally stopping altogether.” (Katz, 1992)

Issues to Consider

These slides are just a primer. As you do research, you will find yourself in many situations where you have questions: The IRB office can answer most of these issues.

Once you’ve decided that a) you are going to do research and b) involving human beings, you must ask yourself: What, who and why?

What

What procedures will you use?

What equipment will you need?

What space will you conduct your experiments in? (If you are use more than one space, sometimes you will need more than one approval.)

Who

Who are you? What makes you qualified?

Who will you be working with? (Even assistants who are students will need to be certified.)

Who is the population you’ll be studying? If you are working with sick people, children, prisoners or a specific vulnerable segment of the population, you’ll face more scrutiny.

Ask yourself who will be participating in your study.

Why

For IRB this is the most important question and it permeates everything:

Why will you be performing this test instead of something else?

Why will you be looking at this population?

Why do you need a certain number of participants?

The Scouts Offer Good Advice

Are you someone who “thought out beforehand any accident or situation that might occur, so that you know the right thing to do at the right moment, and are willing to do it”?

Spend twice as much time planning and thinking as you do writing.

Never assume that something can’t happen.

Examples

I’m studying stress in athletes. I’m looking at how their heart rate changes as they undergo more difficult exercises.

What should I do?

I’m considering studying a disease and how it effects the spine. The disease can show up in rats and people and effect the spine the same way.

What is your advice?

Closing thoughts

It is always a good idea to get input from another person; Even better if s/he from outside your field or department.

References:

Huth, E. (2006). Quantitative evidence for judgments on the efficacy of inoculation for the prevention of smallpox: England and New England in the 1700s. Journal of the Royal Society of Medicine, 99(5), 262-266.

Katz, J. (1992). Abuse of human beings for the sake of science. In When medicine went mad (pp. 233-270). Humana Press.