Consent document, consent form, whatever you call it—just the mention can send anyone involved in research into a diatribe. Most of those are not glowing praise. Whether you are at a site, a sponsor, an institution, an IRB or a consultant, it’s always a hot topic.
And well it should be, as it is a physical manifestation of the tenuous link between research and the subject. Without that link (or at least an appreciation for when it is not important), we have no research. If that link is corrupt, of course it taints everything. It is really unsurprising that each stakeholder of the complex enterprise we call research would have a vested interest in it. With so much riding on it, there is no wonder why it is in such shape.
Each of those stakeholders has a different use, a different perspective for that poor creature we call the consent document. Legal subtleties, complex and layered medical information, complicated procedures, esoteric risk and benefit percentage calculations and more are stitched together in a gerrymander Frankenstein’s monster. And after creating it, we chase it with pitchforks and torches.
There is evidence that its original, noble intent, to provide information to help the subject make a decision, is not even valid any more. At least today, most people make their decision to be in a study before ever being presented with, much less reading or signing, the consent document. For those that have not made their decision, the document is last, if even on the list of factors in subjects’ decision-making processes. Their underlying personality, their relationship with their doctor, their perspectives on research in general, the availability of treatment options and so on all are more important.
Again, are we surprised? No, not really. Those soft factors, while underappreciated, are fairly well documented with our current understanding of the psychology of human decision making. But well beyond that, we live in the information age. The current role of actual documents is much different than it was 10, much less 30 years ago. “Sign here” has become a one-click reflex instead of the rare and significant ceremony it once was. More and more every day, we are moving away from where we were. Think of yourself—how do you make decisions? If you wanted more information on something, would you a) ask your friend b) google it or c) look it up in a book, the manual that came with it, the agreement you think you remember signing etc. You might do all three: but if you did, you would get 15 answers on-line in 1/10th the time, and would value your friend’s opinion more. You can insert “doctor” for friend, if you want.
As you can see, I have my own pitchfork and torch. However, the problem is not the monster we have created, but the fact that we have created a monster. The link is still as important as it ever was, and stakeholder’s interests are as valid as they ever were. The great new is that most if not all stakeholders agree that a change is needed. There are a lot of really great discussions about and ideas being generated on how to improve the consent document, each with valid points. It’s a very exciting time, and I encourage you to join the conversation.
by Currien MacDonald, MD
Medical Director
Friday, April 8, 2011
Wednesday, March 16, 2011
Undisclosed Future Testing
It is said that the pace of research is increasing. But really, it is the amount of information available to researchers that is increasing. Just as an example, high-throughput and other genomic sequencing advances are producing more information than can be individually examined; data repositories hold vast, never-before seen data, just waiting for someone to connect the dots.
However, we often need to connect those dots with information from living people, as not all advances occur in the clean realm of de-identified data. More importantly, even if gleaned in that realm, all advances come back to living people in some way. Research advances, and so does the understanding of ethical research.
Consent for research assumes the subject understands and is able to determine the risk/benefit ratio of the testing. In these situations, this testing can occur well after the sample collection, making that difficult or impossible. Moreover, research always has the chance of discovering something no one expected. If the researchers cannot predict where their research may lead, then how would the subject be aware of what testing is even possible? Can it be true that the possible risks of future testing are not knowable, and therefore cannot be minimized and balanced?
Clearly, however, there are a realm of risks, and ways to minimize and balance such risks. If de-identification is not possible, then merely appropriate security is required. Risks to community require discussions at the community level; it makes little sense to try to address concerns on a level discordant with the risks. For example, if given the chance individual Havasupai could have allowed their samples to be tested for “tribe origins,” but that would not have changed the community risk.
For some studies, not reporting results to individuals is a tidy solution to the dilemma of potentially harmful results. However, how could researchers report their findings without reporting from whom those findings came? Studying risk factors in populations, i.e., studying the risks of being in a certain population, would require reporting those risks found as being in that population. As the appreciation for those risks may only be known after the sample has been taken, and possibly even after the sample has been de-identified, risk assessment and management is an ongoing process, even just before publication, especially in this kind of research.
Truly, researchers understand these ethical issues, and almost all of the time, need no interference. Moreover, these are just some risks that are to be expected in the daily lives of people in the information age. Nevertheless, there will always be ethical issues, and new ones will emerge.
Currien MacDonald, M.D., CIP
Aspire Medical Director
However, we often need to connect those dots with information from living people, as not all advances occur in the clean realm of de-identified data. More importantly, even if gleaned in that realm, all advances come back to living people in some way. Research advances, and so does the understanding of ethical research.
Consent for research assumes the subject understands and is able to determine the risk/benefit ratio of the testing. In these situations, this testing can occur well after the sample collection, making that difficult or impossible. Moreover, research always has the chance of discovering something no one expected. If the researchers cannot predict where their research may lead, then how would the subject be aware of what testing is even possible? Can it be true that the possible risks of future testing are not knowable, and therefore cannot be minimized and balanced?
Clearly, however, there are a realm of risks, and ways to minimize and balance such risks. If de-identification is not possible, then merely appropriate security is required. Risks to community require discussions at the community level; it makes little sense to try to address concerns on a level discordant with the risks. For example, if given the chance individual Havasupai could have allowed their samples to be tested for “tribe origins,” but that would not have changed the community risk.
For some studies, not reporting results to individuals is a tidy solution to the dilemma of potentially harmful results. However, how could researchers report their findings without reporting from whom those findings came? Studying risk factors in populations, i.e., studying the risks of being in a certain population, would require reporting those risks found as being in that population. As the appreciation for those risks may only be known after the sample has been taken, and possibly even after the sample has been de-identified, risk assessment and management is an ongoing process, even just before publication, especially in this kind of research.
Truly, researchers understand these ethical issues, and almost all of the time, need no interference. Moreover, these are just some risks that are to be expected in the daily lives of people in the information age. Nevertheless, there will always be ethical issues, and new ones will emerge.
Currien MacDonald, M.D., CIP
Aspire Medical Director
Thursday, December 23, 2010
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.
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.
Thursday, November 18, 2010
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
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
Tuesday, September 21, 2010
Welcome to the Blog
We understand that completing IRB paperwork is an involved process, so we offer an integrated web portal for the access and management of your research and study data. Using our ASAP electronic system, multi-center CROs and sponsors can keep track of submitted documents, view scheduled IRB meetings, track missing information and retrieve approved site documents in a few clicks.
At Aspire, it's our mission to protect human subjects while developing a partnership with each client, and we demonstrate this resolution through our full AAHRPP accreditation. Endeavoring to deliver service excellence in all situations, we'll work hand-in-hand with you to bring critical, life-saving drugs and pharmaceutical innovation to the healthcare industry.
At Aspire, the difference truly is service. Together, we'll enhance quality of life through the promotion of ethical research and development.
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