 I'm a policy analyst here at NHGRI and I focus on issues around and the appropriate ways to do genomic data sharing. My name is Julie Sapp. I'm a genetic counselor also with NHGRI and I am part of lots of different research protocols, all involving human volunteer participants. So Julie, let's get started with a pretty foundational or basic question. What is informed consent? So informed consent is a process where a volunteer participant and a researcher talk about the goals of a research study and what being in the study might mean for the prospective volunteer. It's an opportunity for a research scientist to explain why they're doing this research and why it's important and why we need people to be in the study. And to ask the volunteer to make a decision about whether or not being in a research study is right for them and for the prospective volunteer to ask questions to make sure that they are getting the information they need to make that decision. I think part of what's important here is that being in a research study is different from getting clinical care in the sense that the purpose of research is to come up with or generate generalizable knowledge that we hope will benefit everyone. But in clinical care, when you're talking with a doctor or thinking about undergoing a medical procedure, for example, the goal is really to make you as an individual better or to do something that will benefit you. And that's one key way where research is different than clinical care. So informed consent is a really important part of that process. And as I'm sure you are very well aware, Elena, this whole idea of getting informed consent from prospective research participants is kind of new. And it certainly hasn't always been the case that we've thought about this carefully and tried to secure that kind of permission, right? Right. It might surprise people to know that these regulations and expectations of researchers are relatively new. I think as a society, we started to learn about studies where people didn't know that they weren't patients or people were treated in ways that today we would deem definitely unethical because there wasn't sort of an infrastructure around how we did research in an way where we're obtaining permission from prospective participants. And so there are a number of, you know, sort of historical documents from recent times that have laid a framework for many of the regulations that exist in the US today and policies for obtaining informed consent from prospective participants. Yeah. And again, I totally agree with you that I think a lot of people might find that really surprising. And it's really great, I think now that we're in an era and a situation where we have all of these different supports to ensure that the research that we conduct is done again in an ethical way, exactly like you said. Right. So part of that support for ethical research is the institutional review board and they do play a role in the informed consent process informed. So can you talk a little bit about what they do, how they're constructed and what they serve? Yeah, absolutely. So the institutional review board or IRB is a group of people that review research proposals before the research starts and on an ongoing basis to make sure that the research that includes human volunteer participants is in line with these regulations and standards that you mentioned earlier essentially that the research has been being conducted in an ethical way. And I think one thing that's really important to note about IRBs about these groups of people is that they include both scientists and non-scientists. So there's always representation on these committees, these groups of people from people who are not scientists that are members of the community. In addition to kind of reviewing research before it starts and on an ongoing basis, one of the things that they pay careful attention to is both the informed consent document. So what it says about the research and also the process by which the researcher plans to obtain informed consent from their prospective research participants to be sure that both of those things are understandable and that they cover important points like the potential risks and benefits of being in the study and also, you know, ongoing and future use of participants data and information. What do you think are some of the ongoing challenges for obtaining informed consent today? Yeah, that's a great question. You know, I think a lot of people really think of informed consent as, you know, a document that two people sign after they read it. And that's really only part of it. You know, informed consent, I really think of again as this ongoing process where researchers explain really key elements of the research study and what it could mean for participants both now and in the future. Research participants are engaged and ask questions and carefully consider if being in the study is the right decision for them. And so making both that document and the conversation clear and accessible and convenient for everybody for both the research scientist and for the participant is tough. Another ongoing challenge that we're meeting is this idea of that research studies now maybe involve more than, you know, just trying a new drug or something like that. Right in the era of genomics, we can generate all kinds of data sets and very big data sets and how we handle that data, I think is certainly an ongoing challenge and I'm sure you have some thoughts about that. And kind of think of data as more so a forever thing that many researchers can can utilize in their work and so explaining the nuances of that to research participants can be I think a bit of a challenge, especially if genomics is one part of a study and there are other aspects to it so I totally agree that that's a challenge that we're trying to meet is being more clear about how the data will be used who will be used by in the future and those sorts of things. Absolutely. As someone who's a bit closer to the practice of obtaining informed consent, what would you say it looks like for there to be a successful informed consent dialogue with a participant. I think that's a really, really great question. You know, on the surface of it I think that a successful informed consent session looks like two people having a conversation in a way that it's clearly understandable and accessible to both people who are involved in the conversation. So there's really an exchange of information rather than the information flowing in just one direction like from the researcher to the prospective participant. So that means doing things like actively inviting people to ask questions about, you know, different parts of the study, checking in for understanding to make sure that what you're saying is clear and understandable. And I think also another thing that I think of when I'm consenting participants is I'm kind of expecting at least some people to just decline participation. In, you know, the length of a study, right, because we know that being in a research study is not for everyone. And we also know that some people may, you know, come into the idea of being in a research study with a set of understanding. And it's actually, you know, different from maybe what they might hear from a researcher or read in the consent form and maybe the answer to one of those questions that they've asked is something that will make them change their minds. So I think successful informed consent does include occasionally people declining participation, because it's just not right for them, and they've gotten the information and asked the questions that they need to be able to make that decision from the beginning. So in your opinion, what do you think the future looks like for informed consent in what ways do you think it might get better over time. Yeah, you know, I think I hope that in the future informed consent feels more like an ongoing conversation than a form to sign, you know, both for participants and scientists I think that, you know, we need to continue to think creatively about how we communicate with perspective participants, you know, things like electronic portals and other ways that we can use technology to connect researchers and participants is great. On the other hand, I also hope that, you know, communication or improving communication doesn't just mean more technology. I really think we need to meet prospective research participants where they are in really as many senses of the word as possible, you know, sharing information about the research that we do and why we think it's important for people to consider joining our research studies in lots of different languages and in lots of different ways, you know just generally trying to lower barriers to participation. I think it's something that I hope we continue to think about in the future. What do you think Elena. Yeah, hearkening back to the issues or challenges with communicating about the uses of genomic data I do hope that we will get better at being clear about what people's data will be used for and that participants feel empowered to change their preferences over time potentially, given that it can be used for a very long time. So I think that engaging participants on that issue as a group and then individually would be really a great thing to see in the future.