Aspire IRB Appoints New Medical Director
For More Information Contact:
Alycia Huston
Phone: 619-469-0108
Email: alycia@aspire-irb.com
FOR IMMEDIATE RELEASE
September 13, 2011
Aspire IRB Welcomes New Medical Director
SAN DIEGO, Calif. (Sept 13, 2011) - Aspire IRB recently announced the appointment of Jon Holmlund, MD to the company's medical director post. As medical director, Dr. Holmlund is responsible for providing medical and scientific expertise and leadership to ensure the protection of people participating in human research studies reviewed and overseen by Aspire.
"Dr. Holmlund's background is a complementary blend of clinical research and administrative experience," said Alycia Huston, CEO of Aspire. "We're thrilled to have him onboard, and know that we'll benefit from his accomplished background and clear passion for ethics and subject safety."
With over two decades of experience in medical oncology and cancer therapeutics studies, Dr. Holmlund has acquired a broad range of knowledge in the medical testing and research fields. Prior to joining the Aspire team, Dr. Holmlund served as an independent consultant to the biopharmaceutical industry. He has also held the titles of Chief Medical Officer for Ascenta Therapeutics; Vice President of Development for Isis Pharmaceuticals; and Senior Investigator and Project Director for several programs of the National Cancer Institute (NCI).
"Aspire IRB is exceptionally professional-but the staff is also warm and approachable," said Dr. Holmlund. "They have a remarkable handle on the balance between the regulatory and ethical aspects of human subject research, and I look forward to collaborating with them."
Dr. Holmlund received his MD from SUNY-Buffalo in 1984, and completed his postgraduate medical training in Internal Medicine and Oncology at George Washington University Medical Center in Washington, DC. Rather than establishing an office practice after his training, Dr. Holmlund joined the NCI to deliver patient care in the context of therapeutics research. Dedicated to the ongoing pursuit of academic excellence, he is currently working toward an MA in Bioethics at Trinity International University in Deerfield, IL-which he will finish in 2012.
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About Aspire IRB: With over three decades of combined IRB experience, Aspire IRB is certified by the Women's Business Enterprise National Council. The company is also a certified minority-owned business through the National Minority Development Supplier and is committed to growth, quality research and the ethical protection of human subjects. Aspire IRB desires to build lasting client partnerships through timely, efficient service and quality communication.
Tuesday, September 13, 2011
Friday, April 8, 2011
Consent Document
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
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
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
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