Altruism

It’s the holidays, gifts are being exchanged and we look to the New Year. At the same time, there are flurries of investigations and mudslinging. I started thinking about how it all fits together. Without sponsors and institutions, research wouldn’t get started. Without sites, it would never get done. Without investigators, it wouldn’t get done safely. And so on. IRBs, OHRP, the FDA, monitors, auditors, coordinators, on and on, it is a really big project. I’m glad we have a really great team. However, at the center of it all, and I think we all agree, are the subjects. Without them, there is no research. The fact is that they ARE the gift; they are giving, literally, of themselves so research can progress.

Looking at it from that perspective, I saw subjects also know the secret to research. The answer to the big Why. Why do research at all? A good start is why do most people volunteer for research?

The cynical-minded note the large sums offered to volunteers in some studies. Others point out research offers the chance at treatments not otherwise available. Just plain self-interest, they say. They look the same way at sponsors and institutions: they just want to make money. Sites too. (Don’t we all?)

But let’s go back to our subjects—the ones who are getting the “large sums” and the “new treatments.” Sure, those are on their lists of answers. But there is one item that is at the top of all of their lists. The lists of those subjects, and the ones who are not compensated, and the ones who really know this study will not benefit them--they all have one item in common. They are doing it for the future. To help others, to add knowledge, even a little, so someone else can have it a little better. A New Year’s resolution in every study, in every subject.

It’s true for us, too. We could be working for a bank, or dot-com, or a million other jobs. Probably making as much money, if not more, yet we chose this. Why? To help people. What’s more, if it’s true for the subjects, and its true for us, it’s probably true for you, too. You know what else? It’s probably true for that ___ (insert sponsor, site, IRB, monitor, etc.) that just annoys you to no end, too.

Altruism is a key reason people enroll as subjects in research. To make the world a better place. It’s why we are all doing this, really. Sure, there are some, umm, misguided individuals getting a lot of attention. But the grand majority of us are here for the same reason. To help people. I guess at this time of year, I thought it was just nice to draw some attention to it.

Blood Volume Sampling

A simple question has a simple answer, right? Of course, I would argue there is no such thing as a simple question. Take blood sampling, for example. A common question, if not simple, goes like this: what is an acceptable amount of blood to be taken in a study?

There is not a volume of blood that is “acceptable” or not acceptable. There is risk. The numbers that are used as benchmarks (and for qualifications for approval by the expedited process) come from blood donation amounts. This is related to the routine experiences of healthy people, who donate blood in their everyday lives, i.e., minimal risk. Although probably not necessary, let’s be clear on our definitions. Blood donation is usually defined as up to 550 mL from a healthy person (who has been medically screened), no more than every 8 weeks. Changing any of those (health status, including age and screening results, amount and time from last blood collection, etc.) voids the comparison.

So, any blood collection is a risk. Less than about 500 mL in a healthy person is minimal risk, but still a risk. More blood than that or pretty much any sampling in someone who is not “healthy” has at least possibly more risk. To be acceptable, all risk must be minimized (to the extent possible) and then balanced by benefit. There is no upper limit of acceptable risk, theoretically, but in reality there obviously is.

Risk and benefit is almost always the key. What is an acceptable amount of blood to be taken? The amount that produces a risk (after being minimized) that is less than the benefit of the study. If the study needs every drop of blood to be able to reach its objectives, and the possible benefits of those objectives are more than the total minimized risks, that amount is acceptable. Let’s look at it from the other perspective. One drop less than the study needs to reach those objectives is too little. If the whole study fails because there was not enough blood collected, there was no benefit.

So, please propose to draw as much blood as your objectives require. Plan for errors and possible missed collections if you choose. Be ambitious or cautious. But whatever you do, be clear. Think transparency, think open lines of communication. Be simple and redundant when you note what you are doing with the blood and why you need each drop.

How much blood is too much? One drop more than you need.

Currien MacDonald, MD, CIP
Medical Director
Aspire IRB

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