Veteran volunteers! Ask questions!
Many of my fellow Veterans eagerly volunteer in medical studies sponsored by VA and associated medical institutions.
By Colonel David Earnest, USAFR retired
Thursday, April 8, 2021
After all, it is part of our disposition to want to help our country and fellow Veterans for the greater good. Veterans, in general, are an easily accessible group of candidates; they are a captive audience and willing to be helpful. Often the study includes financial enticements for the Veteran's willingness to volunteer.
I’ve been fortunate to serve as a Veteran on an Ethics Review Committee. Simply put, our mission is to look out for the best interest of the Veteran, and to make certain Veterans are not being put at risk medically or emotionally, and that their privacy is not compromised. In large, it is a thorough review of the Informed Consent Form (ICF) provided to Veterans, designed to educate the individual on the scope of the study, the obligations of the Veteran, and the medical risks associated with being a volunteer.
As I review the ICF, I want to make sure it is easily understood and provides enough detail to well inform the Veteran, but not so complex and lengthy that a Veteran would get lost in detail. Does it use words and descriptions that most anyone would understand? Does it explain the potential risks in easy-to-understand language? Is the Veteran’s personal privacy being protected in perpetuity? If there are specimens taken from the Veteran, are they de-identified?
ICFs primarily focus on the study for which you are enrolling – for example, “the diseases caused by COVID-19” – but additionally may grant the researchers permission to use your bio-specimens for further research or completely unrelated research projects not yet determined. Further, the ICF may ask for permission to perform “Whole Genome Sequencing” (WGS) using your specimens. Terms like these are often not readily understood by the Veteran nor clearly explained in the ICF. Simply put, genome sequencing is like a barcode from the grocery store that provides your genetic makeup but also genetic makeup for your biological relatives.
From my perspective, the ICFs are too complex and difficult to understand. There is no malicious intent or nefarious explanation for this; however, the litigious world requires the researchers to make certain they inform the Veteran from a medical and legal perspective. When the Ethics Review Committee’s goal of making the ICF an easy to read and understandable document is merged with the researchers goal of “covering their bases”, confusion arises.
Yes indeed, the Veteran needs to know the entire picture of what they are volunteering and the implications. How can we accomplish this without compromising the study but providing enough detail to properly inform the Veteran? Here are a few suggestions for the researchers, the Ethics Review Committees, and the Veterans.
Researchers: Provide a list of definitions of all acronyms and scientific terms. Include in the key information section the short version of the purpose of the study, obligations and risks for the Veteran, and any compensation for their time, and whether their personal information will be completely de-identified in all circumstances. If specimens will be stored for future studies, explain to the Veteran the scope of potential use. If Whole Genome Sequencing (WGS) is requested, a complete and separate Informed Consent Form (ICF) should be required, with an easily understood definition and how the information will be used and privacy protected.
Ethics Review Committees: Strive to engage the researchers to reduce and simplify the material provided for the Veteran. Oversee the informed consent process by frequent observations and inquiry. Verify de-identification of materials is completed expeditiously. Follow up with Veterans in studies to make certain they are comfortable in their roles.
Veterans: Make sure you know everything you need to know about the study for which you are volunteering. Understand your obligations and risks. Make certain the specimens you provide will not be used outside of the scope of the study for which you volunteer. If the researchers intend to store your specimens for further study (beyond the scope of the original study), make certain you are in agreement. Most of all, ask questions and make sure you know the full story!
Everyone plays a role in the successful outcomes of research. Research findings often lead to new developments in pharmaceuticals, medical procedures, and ultimately to better outcomes. Generally speaking, it’s my sense that the benefits derived from this scientific research outweigh the risks to the Veterans. It is a noble cause for our Veterans to partake in research and your contributions are appreciated and often overlooked, but because of you, science is advanced for the good of humankind. It is no surprise to me that the Veteran, when asked, steps up to the plate! It’s another opportunity to say, “Thanks for your Service”!