Site icon Technology In Human Subjects Research (HSR)

But I Haven’t Killed Anybody…

seatbelt-law-sr22-insurance-helpDr. Perfect, an investigator of Happy Research Institute, submitted a study for IRB review. The study was an adolescent (children) research project focusing on alcohol, drug use, and suicidal ideation. Procedures consisted of several overnight sleep labs, blood work, and extensive surveys asking about sexual abuse, suicidal ideation, and family history of alcohol and drug abuse. Upon review, one of the several IRB concerns was that the IRB wanted to review copies of the questionnaires to be administered to the children.

In response, Dr. Perfect was furious that the IRB would even question his authority to administer surveys. His argument was “I am a very prestigious doctor who has studied this for over 45 years! I have never killed anybody! How dare you question my integrity. I do NOT need to provide you with any questionnaires. You should trust that my research, that has been published for more than 30 years now, is plenty ethical!

While there are several pieces to this study that require careful consideration, the focus on this article is about the IRB’s role in reviewing assessments, surveys, and other parts that are planned to be administered on the study participants.

Federal, national, state, and local regulations are put in place with the purpose of protecting research subjects from potential harms, and ensuring their human rights (among other reasonable purposes, of course).

I like to compare the establishment of these regulations to the establishment of the “Seat Belt Law” with the investigator/research team being the driver of the car. Participants, in this example, are the passengers in the car. Whoever the regulatory oversight entity may be, they are unfortunately seen as the “police” rather than a friend or foe helping “make great research possible”. For easy comprehension purposes, for now we’ll just go with it and call these regulatory people the “police”.

Sometimes a licensed driver gets inspired and asks a bunch of his friends to get in their car and go for an exciting ride somewhere. Sometimes there are police on the lookout, checking to see if the drivers and passengers are wearing their seat belts. Sometimes no one is checking. Whether the driver chooses to wear their seat belt and/or enforce their passengers to wear theirs or not, is up to them. It is entirely possible that no one will die. It is also possible that only one person will die. It is possible that everyone will die. No one knows.

Does that mean that the Seat Belt Law is optional? No. It does not.

What it does mean is that when we choose to ignore the Seat Belt Law, we put not only our own lives at risk, but those who are in the car with us as well. It is true that not wearing a seat belt doesn’t always result in some serious adverse event. It is also true that some states may be more lenient on their own seat belt laws. It is also true that this law used to never even exist. It is also true that regardless of the law, some people choose not to wear their seat belts and never get caught or hurt.

But the fact is, seat belts save lives, and the lack of them has, on too many occasions, killed or seriously hurt people. This is especially important when dealing with children and other vulnerable populations.

You can see that even if the driver is licensed and has been driving for 45 years, the need to obey the law and wear the seat belt is absolutely necessary. Perhaps no one will get hurt in his car ride, but in the unlikely event there is an accident, the institution, the investigator, and the participants can be assured that all protective mechanisms have been checked.

The IRB at Happy Research Institute relayed this information to Dr. Perfect. As a licensed driver of 45 years with no significant accidents (outside a few minor fender benders), Dr. Perfect reluctantly agreed to wear his seat belt and the review was eventually complete.

*All names and institutions have been changed.

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