UNIVERSITY PARK, Pa. — How research is conducted is an important topic. Scientists must balance several principles when conducting research with humans. According to the National Institutes of Health, these principles include scientific validity, independent review of the research, and making sure that participants are properly informed before participating. Answers to the scientist's research question should contribute to the understanding of health or improve how to prevent or treat medical conditions. The exposure of research participants to the risk and burden of the research process must be justified. Research ethicists like Jen McCormick with Penn State Clinical and Translational Science Institute study the balancing of research principles.
A full interview with McCormick about research ethics is available in episode 5 of Penn State Clinical and Translational Science Institute’s Engage podcast. Each episode aims to help listeners learn about the research process and how Penn State helps improve our neighbors' and communities' health. Below are a few of the questions McCormick addresses in the podcast.
Q: What is research ethics?
McCormick: Research ethics is conducting research in an ethically and socially responsible way. Research ethics can be referred to as responsible conduct of research but ethical research actually takes it one step further than responsible conduct. Responsible conduct of research is following the rules and the regulations — which is very important, and that's part of ethics — but ethical research is taking a step beyond that and thinking about how the research fits into social values.
Q: Is ethics a matter of what is right or wrong?
McCormick: There's a little bit more nuance to what happens because sometimes, in ethics, there's a gray area. People, like myself, help researchers navigate that gray area. So, some of what research ethics is about is what's right or wrong. For instance, the experiments during the Holocaust, those where Nazi scientists used Jewish prisoners and other prisoners in the concentration camps in their science, that was wrong.
But there are other things that are a little bit more nuanced, and you have to think about who benefits? Is there any social good that can come out of this? And in particular, when humans are participating in the research, are people adequately informed? There's an element of what's right and wrong, but there is a huge gray area.
Q: How is the increase in available data affecting research ethics?
McCormick: Personal health information, medical record information, genomic information and public perceptions around those are some things that I am personally interested in. It’s a really important ethical issue to make certain that researchers are using appropriate mechanisms to access and use that information, and to determine whether they're able to share it or not share it. I'm really interested in this idea of data sharing and data use and access. When people are participating in research, a lot of times, researchers want to share that information broadly. So, it's really important to have language within the consent document that reflects that these data will be shared broadly.
I'm big about transparency. Another important thing about research ethics is that it's essential to be very transparent about what we're doing as researchers.
Q: You provide research ethics consultations through Penn State Clinical and Translational Science Institute. How can you help Penn State faculty?
McCormick: I've helped a number of researchers think through authorship issues. I've helped them think through informed consent documents.
I have a fair amount of experience in genetics and genomics. I can help investigators think about the ethical issues that come up when doing that type of research.
Another thing I can think about is the return of research result — whether a research finding should be returned to a participant or whether it's still too much research and doesn't have clinical utility or usefulness. And if that research finding should be returned, I can help the investigator think about how it should be returned.
Editor's note: Penn State faculty and staff can request a consultation with McCormick by completing a Penn State Clinical and Translational Science Institute service request form.
Q: What kind of collaborations are you open to as a researcher?
McCormick: Any and all — I like to think of myself as a collaborative scientist, and I think that there are a lot of fun things that probably can be done where you might have a scientist — someone who's doing either translational, clinical or even basic science — coupling with someone who does the type of work that I do, which is in a research ethics and ethical, legal, social implication scholarship. One of the things that I'm keen to do is work with investigators and think about how there may be an embedded ethics study within a larger research project; how we could incorporate a really interesting ethical or social implications research question and collect some data.
About Penn State Clinical and Translational Science Institute
Penn State Clinical and Translational Science Institute provides tools, services, and training to make health research more efficient at Penn State. It is an advocate for translational science atg the University and is a bridge between basic scientists and clinical researchers. The institute encourages collaboration to discover new treatments, medical procedures and way to diagnose disease. Learn more at ctsi.psu.edu.