Sanford Health recently was recognized by the Association for the Accreditation of Human Research Protection Programs for its rigorous standards. To be fully accredited, institutions must go beyond the federal government requirements for how to treat human research subjects. Sanford Health is the only accredited health care system in eastern South Dakota and all of North Dakota. Find out if an organization is accredited here.
We caught up with David Pearce, Ph.D., the executive vice president of research and innovation at Sanford Health, to better understand what human research is and why the AAHRPP accreditation matters.
What is human research?
Human research is any kind of work with real people or their data.
Those are the two types – therapeutic, which means there’s some sort of intervention to try to improve a condition or disease, and nontherapeutic, which means gathering data through surveys or questionnaires. One example is the work that a team is doing surveying people on teen pregnancy. Once we have sufficient information, we can try to come up with strategies to prevent, diagnose or treat different issues.
One thing to remember is that all clinical trials involve people. Animals such as mice are used in pre-clinical work.
Clinical trials don’t involve random experiments or stopping treatments that are working. Instead, they build on the standard of care already in place by trying something that we believe has the potential to make a difference.
What are the regulations like?
Research is very highly regulated. We have to track everything because we’re dealing with human beings in these trials. We also know through history that when it isn’t regulated, it can become unethical.
Think about the atrocities of World War II and what happened in Nazi Germany. Or the Tuskegee study, where men with syphilis were misled into thinking they were receiving treatment. In the U.S., we use the Belmont Report as our ethical foundation.
We as an institution and as individual researchers want to be ethical and effective in the work we do. We’re in this to learn, to discover and, ultimately, to find solutions.
We take regulation so seriously that fully a third of our research team is devoted to just making sure we meet all requirements.
What does it look like at Sanford Health?
An organization must use an institutional review board, or IRB, to examine anything that’s deemed human research. Sanford maintains three IRB panels. The IRB and investigators are regulated by the Food and Drug Administration and the Department of Health and Human Services. Sanford applies additional protections and procedures beyond what is required.
It’s an enormous amount of accountability – from the initial training to the execution to the reporting.
For example, if a physician wants to research something, he or she needs to take a course that explains the principles of research and the ethics of it – such as why you might treat a vulnerable population like children differently.
Then, once a trial launches, there’s an enormous amount of reporting that goes along with every participant, even if it seems unrelated to the trial. We need to make sure that any outcomes or results we report are clean – so if a participant takes a different medication than usual, we need to track that to determine how it influences our results.
What are the other ethical considerations of human research?
Well, the biggest one is it can’t be of benefit to the institution or the physician. We aren’t doing this kind of research to incentivize our organization or employees. And we have to make sure we’re clear in our discussions and materials that the trial is to investigate whether a therapy works or doesn’t – we can’t promise that it will, or that it won’t.
This is another way the IRB comes into play – to make sure we clearly explain what we’re doing to those who participate. And to ensure what we’re doing is for the greater good, not to take advantage of a population.
How did Sanford Health go above and beyond the requirements to earn AAHRPP accreditation?
We consistently don’t have violations. (To see a list of institutions and violations, go here.)
We listed all our studies, and our physicians were randomly interviewed to make sure they truly understand the ethical implications of what clinical or human subject research is all about. And I’m proud to say they do.
This accreditation is a big deal to us, and to me, personally. Two years ago, we set out to earn it, and we did. That’s a testament to how seriously we take our work, and how important it is to us to do it right.
Sanford Health currently has nearly 300 active clinical trials. To find more information, go here.
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