On Research Podcast – Understanding Exception from Informed Consent

Mike Linke: The other thing that I think is important to remember is the investigators doing these studies really care about the participants in these studies, and they care about the research and they’re doing it for the right reason, and you’re trying to be able to respect the people who are going to be in these studies.

Justin Osborne: Welcome to On Research with CITI Program, your favorite podcast about the research world where we dive into different aspects of the industry with top experts in our field. I’m your host, Justin Osborne, and I appreciate you joining. Before we jump in, as a reminder, this podcast is for educational purposes only. It is not designed to provide legal advice or legal guidance. You should consult with your organization’s attorneys if you have questions or concerns about the relevant laws and regulations that may be discussed in this podcast. In addition, the views expressed in this podcast are solely those of our guests.

So at the top, you heard a clip from Mike Linke, my guest this episode. Mike is a scientist, a researcher, and an IRB chair, and has been a thought leader in our field for over two decades. One of the most basic tenets of research is informed consent. But what if I told you there’s research happening right now where the participants don’t give their consent before being enrolled in the study? Today, Mike and I discussed the topic of exception from informed consent. This is a growing area of research, and there was an NIH meeting earlier this month with leaders on this topic to discuss current guidance and regulations. Mike spoke at this meeting and he sat down with me afterwards to share his insights and takeaways as well as explaining what exception from informed consent actually means. So without further ado, I hope you enjoy my discussion with Mike. Mike, thank you for joining. Thanks for taking the time to talk to me.

Mike Linke: Hey, Justin. Good to see you.

Justin Osborne: Just to start off, before we dive into the topic, can you kind of give us a little bit about your background, how you got into research, and then what you’re doing now?

Mike Linke: Sure. So I am a microbiologist by training and kind of wormed my way into human subjects research along the way. But I was working at the Cincinnati VA Medical Center in a research lab there for over 30 years studying pneumocystis pneumonia. I finished up a postdoc at the Cincinnati Children’s Medical Center and then took the position at the VA and then continued that career for a long time, investigating the host response to the organism, other aspects of antigen variation.

And while I was at the VA, they asked me to be the VA representative to the UC IRB. At that point, I didn’t know what a UC IRB was. That was about 30 years ago. IRB review was not as involved back then as it is now, but so I was the VA rep to the UC IRB. We met about once a month. I got a free lunch. It was kind of interesting, and the more I spent on looking at human subjects research, the more that it interested me. I felt it was an area where I could really make a contribution. I love basic science and curing pneumocystis in mice and rats, but it seemed like the IRB work had a little more real world application. So I continued along that. And then one thing led to another. I eventually became an IRB vice chair. And then about 20 years ago, I was asked to be one of the UC IRB chairs, and I continued to do that until the end of 2023 when I did retire as the UC IRB chair.

Justin Osborne: Wow. So 30 years in the IRB world. You’ve seen a lot of changes. There’s been a lot of,-

Mike Linke: A lot changes over that time, for sure.

Justin Osborne: So you retired. Congratulations on just retiring.

Mike Linke: Yeah. Thank you.

Justin Osborne: So what roles are you serving now?

Mike Linke: So I’m going to continue my work in the human research protections field. One of my projects is the StrokeNet research group that’s funded through the NIH to run all of their stroke trials, any trials related to stroke funded through the NIH and the University of Cincinnati is the National Coordinating Center for StrokeNet. And as part of that, UC also had to provide a central IRB for the StrokeNet studies. So the UC IRB serves as the StrokeNet central IRB, and I am the chair of that StrokeNet central IRB, and I’m going to continue that work. So I’m going to keep doing that.

Justin Osborne: Nice.

Mike Linke: And then another project that I’m going to continue doing is the SMART IRB project that’s funded through Harvard with Dr. Beer as the PI. Many of you’ll be familiar with SMART IRB for the National Reliance Agreement that’s available through the SMART IRB platform. And then in addition to that, there’s a lot of very good resources in terms of streamlining the single IRB review process, which has really become very common in the IRB world now with the NIH mandate. And then the changes to the common rule and the coming probably FDA requirement for single IRB review. So I am the program director for the education component of SMART IRB. So I’m going to continue that work now also.

Justin Osborne: Wow. Okay. So you put one of your hats down, but you’re still quite active, it sounds like.

Mike Linke: Yes. Yeah. But I will no longer be chairing an IRB meeting every week.

Justin Osborne: Got it.

Mike Linke: So that’s a big change.

Justin Osborne: Stepping away from the local IRB. Okay. So the topic that we’re going to talk about, exception from informed consent, I want to just dive in. So instead of saying exception from informed consent, a bunch, I guess we can call it EFIC. Is that the term?

Mike Linke: Yeah. Some people call it ethnic, but I call it EFIC.

Justin Osborne: EFIC.

Mike Linke: So we’ll stick with EFIC.

Justin Osborne: Mike calls it EFIC. If I’m calling it EFIC. All right. So we’ll call it EFIC today. So help us understand, can you define what EFIC is?

Mike Linke: Exception from informed consent is pretty much just what it says. Through the EFIC regulations, the FDA has regulations codified in 50.24, CFR 40, 50.24, that describes how emergency research can be conducted without obtaining prospective informed consent from a potential participant. They’re very strict criteria when these studies can be approved, and there’s a very thorough review both through the FDA and through the local IRBs or the reviewing IRBs for these studies. So any of these EFIC studies conducted through the FDA require a separate IND for the study.

Justin Osborne: Okay.

Mike Linke: So that’s an extra layer of review by the FDA to make sure that it meets the criteria for, some of the main criteria for EFIC is that it needs to be a life-threatening condition for which there are no really acceptable treatments. There has to be a good potential benefit in the study. There has to be preliminary data indicating whatever the investigational agent that’s being studied is. Has a good prospect of working, animal studies, previous maybe clinical studies, those types of things. So there has to be a good scientific merit to whatever the investigational agent is.

Justin Osborne: So in terms of benefit, is that like there has to be anticipated benefit to the individual or at large?

Mike Linke: Yes. To the individuals for these EFIC studies.

Justin Osborne: Okay. Okay.

Mike Linke: Yeah. I mean, taking into consideration also the community benefits, but really there needs to be a specific benefit to the participants that are being enrolled.

Justin Osborne: Okay. So what else? Because obviously the devil’s in the details, right? And when you talk about exception from informed consent, well, consent is sort of the cornerstone of research.

Mike Linke: Kind of the cornerstone of ethical human subjects,-

Justin Osborne: Yeah. Right. Right.

Mike Linke: So we’re now talking about doing research without someone’s informed consent. So there’s the strict criteria, some of those that I just mentioned, there’s some other ones too. But those are the main ones. Life-threatening conditions and no acceptable treatment, and a potential benefit from the investigational agent to the participants. And that some of the other things is there has to be a limited amount of time in order to find a legally authorized representative to provide surrogate consent. So it has to be a situation where it’s unlikely that you’re going to be able to get informed consent from someone to be in a study. So these are really emergency research studies.

Good examples are some of the studies that have been done in the past on seizures. So a person’s out on the street starts having a seizure, the fire department shows up and there’s nobody around, and there’s no good treatment for that. So those are the types of studies. One of the great examples of an EFIC study that was really successful are the external defibrillators now that are available out in public,-

Justin Osborne: Okay.

Mike Linke: In airports and just saw one they put in a park up the street.

Justin Osborne: Yeah.

Mike Linke: Those were shown to be effective through an EFIC study.

Justin Osborne: Very interesting.

Mike Linke: There’s really no other way to do that type of study, so.

Justin Osborne: That is interesting. So question, because that example you just gave, the defibrillator that’s sort of out there. Now that that’s out there, I guess based on the criteria that you gave, if there’s already something approved and available, then you wouldn’t meet the criteria to do an EFIC study in the future on that same type of condition. So is that product out there? There’s really no other way to study that area of research. You know what I mean? I guess there’s no way to test,-

Mike Linke: Yeah, not in that situation. There would not be.

Justin Osborne: Yeah.

Mike Linke: You wouldn’t use EFIC to try to test a different kind of defibrillator.

Justin Osborne: Right, right. Yeah, exactly.

Mike Linke: Right. Defibrillator that’s there works, it’s effective, but if a new one came along, you really couldn’t use EFIC probably to be able to test it.

Justin Osborne: Okay.

Mike Linke: Not that you can’t do EFIC studies on people having a heart attack. That’s different, in a different situation than someone being available to use the defibrillator, so.

Justin Osborne: Got it.

Mike Linke: The actual condition, having a heart attack still could meet the criteria of a life-threatening disease, and depending on the type of heart attack, there may not be an effective treatment for it.

Justin Osborne: Okay.

Mike Linke: Yeah. Some of the other major parts of the regulation, and a really important part of it is there’s a community called consultation piece and a public disclosure piece. So before these EFIC studies are conducted in a community, the investigators have to go out in that community and tell the community about the study.

Justin Osborne: Wow.

Mike Linke: And get feedback from the community in terms of what they think about the study and whether or not they have any questions or concerns. There is language in the regulation saying that the investigators should take this information to determine whether or not there needs to be any changes to the study based on what the community is saying. In my own experience, I have never really seen that happen, but that’s also asking a lot from a community to kind of comment on a study design that they’re probably not very familiar with clinical research in the first place. But it is a major piece of this study, pretty unique to EFIC research going out. And it’s in the regulations, it’s required prior to starting a study, the community consultation and public disclosure activities first are approved by an IRB, and then the IRB approves the results of those studies.

So when you come back and you report to the IRB what they found from those activities, the IRB can say, “Well, okay. I think you did a good enough job.” Or sometimes IRBs will say, “No, you need to go do more.” Maybe you missed a certain part of your community, certain population that you missed in your community. Or there were questions raised and we need more information to find out whether or not those are really an issue.

Justin Osborne: Yeah.

Mike Linke: So the community consultation is a discussion with the community about the study.

Justin Osborne: So how do you define or I guess interpret community?

Mike Linke: That’s a good question. So there’s the regulation, and as we usually have with regulations, there’s also a nice FDA guidance document on EFIC,-

Justin Osborne: Okay.

Mike Linke: That really does a good job of providing more information on how the regulations should be implemented. And the guidance talks about the community at large, and then also local communities. So the community at large is the catchment area from where your participants are going to come from.

Justin Osborne: Okay.

Mike Linke: So in terms of where, I’m at the University of Cincinnati, we have the University of Cincinnati Medical Center. It’s basically an inner city hospital, level one critical care facility. And it draws from the city of Cincinnati mostly. However, since it’s a level one trauma center, there’s major interstates that run through Cincinnati also. So car accidents, trauma victims are sometimes included in these EFIC studies. So sometimes you have to consider that also. But in general, it’s the community in which your center’s located or from where they draw their patients. And then there’s also the community of people that might be affected with the condition that’s being studied. That’s the second community that you’re supposed to identify.

Justin Osborne: Okay.

Mike Linke: So when we’ve done EFIC studies that involve TBI, we go to bicycle clubs or motorcycle clubs, people who might fall off their bikes and hit their heads and end up with a TBI. So there’s those two communities you’re looking at. And then going back to the issue of Cincinnati having the interstates running through it, for one study that was really kind of going to draw a lot of people from car accidents, we had them include information as part of the public disclosure process at various rest areas or off the interstates around Cincinnati. So community consultation is mainly what I had been talking about.

But the other piece of it is public disclosure, and that’s a one-way notification, newspaper ads, radio ad, those types of things. So public disclosure is the second piece of letting the community know what’s going on. So in terms of what I was talking about with the rest areas, we had them put pamphlets in there as part of their public disclosure process. And there’s public disclosure prior to the study and then there’s ongoing public disclosure during the studies usually. That’s not as clearly mandated in the regulations, but the piece that is, is public disclosure when the study’s over. Once the study’s over, you need to notify the community of what happened.

Justin Osborne: Oh, okay. Like results and everything?

Mike Linke: Yes.

Justin Osborne: Okay.

Mike Linke: Yeah.

Justin Osborne: Interesting.

Mike Linke: And that’s an ongoing issue in human subjects research in general, trying to notify people who participated, what happens. It’s a form of respect, to respect their participation in the study. So there’s various ways people do that, but it’s getting more attention now and going beyond just sending out a PubMed link to the paper, to the manuscript that most people aren’t going to understand. So we’ve seen some really nice lay descriptions that get sent out and,-

Justin Osborne: Nice. With that public disclosure. I’m just thinking about all the avenues. I mean, the rest areas are a good idea. I feel like as time goes on and there’s so many communication avenues now, social media and everything else included over the years that have evolved. How in the world do you get ahead of that? Because like seizures as the example used earlier, right, like a lot of people that have seizures, obviously the cause is unknown. So I could just have a seizure tomorrow. I’m not going to be tagged as a group to disclose an EFIC study to for this population.

Mike Linke: Yeah, that’s a great point. I think one thing that we need to stress is it’s not a community consent process. So we’re not going out there and asking consent from everybody to be in these studies. It’s been shown to be very rare. Very few people relatively are enrolled in these studies, but it’s very rare to enroll someone in this study who had actually been part of the community consultation process.

Justin Osborne: Oh, interesting.

Mike Linke: Yeah. The odds that you’re going to go through this and then you’re going to have this condition and you’re going to be in the right place and you’re going to meet all the inclusion exclusion criterion end of this study doesn’t really happen.

Justin Osborne: Yeah.

Mike Linke: Now, public disclosure, maybe they would’ve seen a billboard or bus ad or something like that. But you raised a good point about social media because prior to Covid, a lot of these community consultation activities were done in person. One of the big locations was community meetings, neighborhood types of meetings. And they would go and they would get on the agenda, the investigators, and tell people about the studies. They would go out to various events such as in Cincinnati, the Flying Pig Marathon.

Justin Osborne: Okay.

Mike Linke: They’d set up a table and they’d have information and they’d talk to people about it. But now since Covid, there has been a big movement to more remote community consultation activities using social media, Facebook platforms, Zoom meetings. When they first started that, they got a lot of scrutiny like they always do, I think when you’re switching things up. But I think that they’ve become much more well accepted. And as we all know, the remote options offer a lot of possibilities for people who may not be able to attend in person. You might be able to get a wider audience signing onto these things, so you might be reaching out to more people and then being able to obtain feedback through those. You also need to obtain feedback back from the community. So being able to do that through social media is also probably improving the responses you’re getting, at least the number of responses. So that’s been a real change. And a lot of the community consultation activities now are done remote through social media.

Justin Osborne: Yeah. I think that’s a good idea. We’re evolving with the times here with research, trying to keep up.

Mike Linke: Right.

Justin Osborne: So, okay. So then you’ve kind of gone through the requirements. There are very specific stipulations laid out in the regulations to be in an EFIC study and to run one, right, to get this exception in place. You enroll a patient. Right. So a patient’s enrolled in a study, say a seizure study, they wake up in the hospital, and what does the rest of the process look like?

Mike Linke: Yeah, that’s an important piece of it. So after enrollment, there has to be a notification either of the participant or their legally authorized representatives as soon as possible after being in the study. You’re not getting informed consent because the person’s already been in the study, but you’re notifying them about being in the study. And then usually there’s some type of follow-up that you need to continue to follow the person who was enrolled and that you can then obtain informed consent to stay in the study. So at that point, you could say, no, don’t collect any more information.

Justin Osborne: Okay.

Mike Linke: Don’t call me anymore, don’t whatever. So there is a requirement that you have to notify people that they were enrolled. One piece that’s hard, but it happens because a lot of times patients who are eligible for these studies are very sick. They’ve had a very bad medical action, and they may pass away. Well, there’s a requirement that you notify the family that they were in the study.

Justin Osborne: In the study.

Mike Linke: And that letter that’s used has to be approved as part of the initial approval package for the protocol.

Justin Osborne: Oh, that’s part of the requirements for an EFIC study? Okay.

Mike Linke: Yeah. Yeah.

Justin Osborne: Interesting.

Mike Linke: No, in general though, just may be a good point to say that there’s been studies, and for the most part, the public supports these EFIC studies. They’re well-designed. They’re really testing investigational agents that can improve the outcomes for lots of people, and there’s no other way to do it.

Justin Osborne: Right.

Mike Linke: So,-

Justin Osborne: That’s the key.

Mike Linke: There has not been a huge pushback against these studies.

Justin Osborne: Yeah, like you said, there’s no other way to do it.

Mike Linke: The general feedback they get from community consultation is that for the most part, people are okay with it. Acceptance rates of 70, 80%.

Justin Osborne: Meaning patients that are enrolled?

Mike Linke: There’s various types of questions they ask, would you be enrolled in the study? Would you be okay if a family member was enrolled? And usually the yeses are in the 70 to 80% range and always over 50% from what I’ve seen, so.

Justin Osborne: That’s good. That’s good. So then question, if somebody is enrolled in an EFIC study, you’ve already collected the data, you’ve already administered whatever the product is. When you approach them after the fact, are they able to withdraw their data from the study at that point?

Mike Linke: Yeah, probably not.

Justin Osborne: Okay.

Mike Linke: I think as you know, the FDA regulations require for FDA regulated studies that that data stay in or any data already collected would stay in.

Justin Osborne: Yeah. So then their choice, like you said, is do I continue or not? They could say, I’m out right now, or I can move.

Mike Linke: Yes.

Justin Osborne: Okay.

Mike Linke: Yeah. Right. Which is the same as basically any FDA regulated study.

Justin Osborne: Sure.

Mike Linke: You can withdraw any time you want, but any data that’s already been collected, it’s going to be used.

Justin Osborne: Right, right. Absolutely. So, okay. I understand that there was an NIH meeting yesterday that took place. Can you share A, what drove this meeting to take place about EFIC, what it was about? And then we can go from there.

Mike Linke: Yeah. NIH hosted this meeting in Washington DC for investigators, IRBs, federal agencies were in attendance, FDA, OHRP, there was someone from the DOD there. So it was all of the players that are involved in these EFIC studies to get together to kind of just review the process, talk about some options for improvement. They’ve definitely become more common over the past few years. So it was just thought that it was a good time to get everybody together and kind of review how they were being implemented, whether there were any suggestions for improving the process, maybe making it more accessible. So it was an all day meeting. The regulators, FDA and OHRP gave presentations, and then investigators gave presentations in terms of the types of studies that they’ve done and the types of studies that meet this criteria. And then IRBs spoke about reviewing these studies and the difficulties and challenges with reviewing EFIC studies.

Justin Osborne: Very interesting. So when is the last time that guidance or regulations were updated for EFIC?

Mike Linke: The regulation was initially put out in 1986 and really hasn’t been changed since then.

Justin Osborne: Wow.

Mike Linke: The guidance came out after that, and I’m not completely sure of the exact date of when the guidance came out, but the guidance is newer in terms of the regulations, but there’s been no changes to the regulation since then.

Justin Osborne: Okay. So this was sort of a meeting of the minds yesterday to just sort of open up discussions on, Hey, this is becoming more and more popular. It’s maybe been a minute since we’ve looked at this. Let’s have a discussion.

Mike Linke: Yeah. Meeting of the leaders in the field trying to get everybody on the same page in terms of where we are with it.

Justin Osborne: So what is your sense after the meeting? And I know you’re obviously one of the leaders in this area being invited to this stuff. What is your sense after the meeting? Where is this going to go from here?

Mike Linke: I don’t see a real quick regulatory change or anything. I think it’s just a matter of getting people to understand the situations where it’s appropriate to use this, to use the EFIC process to conduct human research. And then there’s the other option for waiver of informed consent. And FDA now has also approved that in terms of studies that involve no more than minimal risk. So some of the really interesting discussions yesterday was how you put those two together. When should a study be considered no more than minimal risk, and maybe meet the criteria for waiver of informed consent based on those criteria? Or when does it cross the line and actually need to become an EFIC study, if it involves more than minimal risks? So those were some of the really interesting questions. And then you get into this question of what is minimal risk?

That involves a lot, getting into pragmatic studies, comparative effectiveness studies, when do those maybe constitute minimal risk and could meet that criteria for waiver under that regulation? So those were some of the interesting discussions. And then another piece of it is the issue that only life-threatening conditions may be studied under EFIC and what is actually a life-threatening condition? There was one study discussed that involved treating pain, and the FDA did determine that that based on shock related to the trauma that the patient had occurred and was in pain, that they were treating a life-threatening condition. And it met the criteria for EFIC. But there are a lot of situations out there that may not be immediately life-threatening, but still very difficult to obtain informed consent and no really satisfactory treatments. So kind of looking at how the criteria for EFIC could be interpreted to maybe allow study of some other really important conditions that may not actually specifically fit the criteria.

Justin Osborne: Yeah. Expanding the scope of when EFIC is used.

Mike Linke: Yeah. But right now, there’s no changes in that direction.

Justin Osborne: Yeah.

Mike Linke: There’s no regulatory changes.

Justin Osborne: Yeah.

Mike Linke: And at least for the FDA regulated research, the FDA considers these on a case by case basis in terms of whether or not they meet EFIC.

Justin Osborne: Got it.

Mike Linke: EFIC can also be conducted under HHS regulations by a secretarial waiver letter that was issued, and that basically follows the FDA regulations.

Justin Osborne: Okay.

Mike Linke: So for federally funded research.

Justin Osborne: So they match.

Mike Linke: The big difference is you cannot enroll children or prisoners in EFIC studies funded by the HHS.

Justin Osborne: Okay. Okay. Yeah. Which matches their vulnerable populations regulations. So comparing EFIC studies or thinking about EFIC studies and waivers, in your experience, do you see researchers trying to go the waiver route, but it should go, it sounds like the bar for EFIC is much higher. I mean, you have to do a lot more work.

Mike Linke: Yeah. The bar for EFIC is much higher, and if a study involves more than minimal risk, you either need to get consent or go the EFIC route if it fits the EFIC criteria. So the no more than minimal risk route for obtaining waiver of informed consent is potentially easier.

Justin Osborne: Yeah.

Mike Linke: But it also has to be not practical to conduct the study without the waiver. It can’t negatively affect the rights and welfare of participants. So that’s a high level to go over too, to get the waiver for informed consent. And then the issue of what is no more than minimal risk is a real tough topic. And there’s a lot of variability on what people think is no more than minimal risk. So that either it is something though, the other way to conduct studies with a waiver.

Justin Osborne: Yeah.

Mike Linke: The big difference I suppose, and this came up yesterday, is that there’s no community consultation process or public disclosure process when you’re doing the standard waiver of inform consent.

Justin Osborne: Right. Right. And that to me seems like a pretty big lift, right? I mean, there’s no, because for every study, it would have to be a completely different plan and design. You can’t reproduce that.

Mike Linke: There was some discussion about being able to use those community consultation activities across studies, but right now they need to be done for every study.

Justin Osborne: Yeah. Interesting. Well, anything else that I’m not thinking about, about EFIC that you think is worth mentioning in this little niche part of the research world?

Mike Linke: We’re focused on the exception from informed consent, but it’s not like 100% of the eligible participants, patients for these studies are not capable of providing informed consent, or there might be an LAR available. So there has to be a plan included in the submission for how you’re going to obtain consent when it’s possible to obtain consent.

Justin Osborne: Okay.

Mike Linke: And one of the big pieces that plays into that is that for these studies, the sponsors or investigators have to define a therapeutic window. So the therapeutic window is the time in which you need to administer the test agent where it has the best possibility of working.

Justin Osborne: Okay. Got it.

Mike Linke: So there’s no sense in waiting two hours to give someone a drug that really needs to be given within a half an hour.

Justin Osborne: Sure.

Mike Linke: So these protocols have to define this therapeutic window, and then during that therapeutic window, say it’s an hour or two hours, there needs to be a plan in place for how you’re going to try to identify if the person is truly cognitively impaired and unable to give informed consent, how you might be able to identify an LAR to provide surrogate consent. So that needs to be part of the plan too. So it’s not, and that’s changed since I first started looking at these EFIC studies 10, probably 20 years ago, where IRBs for the most part felt that in order to qualify for an EFIC study, no one eligible for the study should be able to provide informed consent or surrogate consent because then why you doing EFIC,-

Justin Osborne: Right.

Mike Linke: There’s some people, but now it’s become more accepted that there could be a certain percentage of people where it is possible. And if it’s possible, you need to respect that and try to get informed consent. And it’s not a deal breaker for EFIC, because you still wouldn’t be able to conduct a study with the number of participants who are able to provide informed consent. So that’s changed a lot because we had those discussions on some of our early studies where they said, well, we might be able to get informed consent from some people. Well, then why don’t you just conduct the study with those people?

Justin Osborne: Right.

Mike Linke: But you run into problems of not having enough people to get an answer quickly enough. And then the other thing that comes up is bias. So the patients who are able to get informed consent probably aren’t as sick as the other patients. So if you’re only enrolling those people who aren’t as sick, how generalizable are the results you then get from the study.

Justin Osborne: True. True. But two things with that. I imagine that the therapeutic window that you talked about, that would create challenges I could see where if that window is short enough, how do you, the whole determining whether or not they’re capable takes time.

Mike Linke: Yeah.

Justin Osborne: So creating that in the protocol.

Mike Linke: Yeah. And the regulations do talk about in the guidance that you don’t need to exhaust the whole therapeutic window in terms of trying to obtain informed consent or surrogate consent. FDA recognizes that in some situations, really, there is no time,-

Justin Osborne: Sure.

Mike Linke: To do that.

Justin Osborne: Yeah, I mean, car accident and side of the road kind of stuff.

Mike Linke: Right.

Justin Osborne: That would be tough.

Mike Linke: Yes.

Justin Osborne: And just stopping to ask around, anybody in LAR for this? That would be,-

Mike Linke: Right. And then identifying a proper LAR.

Justin Osborne: Yeah.

Mike Linke: And how do you really know they’re the LAR?

Justin Osborne: Right.

Mike Linke: And it’s process.

Justin Osborne: That would be complicated.

Mike Linke: But there needs to be a plan in place to do it when possible.

Justin Osborne: Sure.

Mike Linke: The other thing that I thinks important to remember is the investigators doing these studies really care about the participants in these studies, and they care about the research, and they’re doing it for the right reason. And you’re trying to be able to respect the people who are going to be in these studies.

Justin Osborne: Yeah, no, that’s important. That’s important. And like you said earlier, you can’t do this kind of research without this mechanism in place, so.

Mike Linke: Yes. Yeah.

Justin Osborne: That’s important. Well, Mike, this has been fantastic. I really appreciate you diving into the EFIC world for us and helping us understand it a little bit better.

Mike Linke: You’re welcome. Yeah. I think it’s important for people to know about and hopefully provide feedback on and get involved. And if there’s opportunities for being involved in the community consultation process, take those up and be part of it.

Justin Osborne: Yeah, that’s great. And we’ll put links in the show notes here of this episode with more information about EFIC. Maybe people can do some digging on their own.

Mike Linke: We need more community involvement in these studies.

Justin Osborne: Always, always. Well, I appreciate it. Good talking to you.

Mike Linke: Yeah, good to see you.

Justin Osborne: Hello again, and welcome back to our new segment called Same Team. This is where I ask my guest to reflect on their own careers and connect us all back to our shared mission in the industry. I’m still with Mike Linke here, and Mike, it’s easy, as we all know, to get bogged down in the weeds of our jobs and the specific roles in the research industry. But I do think, again, that most of us stay in this industry because we genuinely believe in doing our part to help move healthcare forward for our friends and family. So I’m wondering, can you share a story or experience from your career that helps connect you with this idea that we’re all in this industry to help?

Mike Linke: Well, thanks, Justin. And I think there are a couple areas that would answer that question, but the first thing that came to my mind when you brought it up is that, as I mentioned before, my background as a scientist, I was a researcher. I did a lot of basic research, and as I became more involved in the IRB world and then as an IRB chair interacting more with investigators, I think that scientific background that I had really made it easier for investigators to talk to me. We have great conversations. When I first started this 20 or so years ago, there was a much more adversarial relationship between IRBs and investigators. And you probably remember that early in your career, Justin. So as we moved forward, as investigators would call and they might be upset about something, but when I would be able to understand what they were telling me and know where they were coming from and know that they want to do the right thing, they were just frustrated with the administrative hurdles and the changing roles.

And so to have these conversations with investigators has really been the most rewarding part of me being involved in the IRB world as an IRB chair. I’ve learned a lot. I’ve been able to interact with them and really help them get protocols written and implemented that were done ethically and met the regulatory requirements and ended up with really good results that changed outcomes and really changed practice. So I think that’s probably the most rewarding piece of being the IRB chair, was being able to improve this relationship and a more collegial relationship between the IRB and investigators, knowing that we’re all working together to try to help people and develop better treatments.

Justin Osborne: That’s fantastic. And I am sure, as you said from the researcher side, I mean, they had to have really appreciated an IRB chair whose part of their world, right, and understands not just the regulation side and all that stuff, but really understands the science and what’s driving them to do their work. That’s really important.

Mike Linke: Yeah, I think that helped a lot.

Justin Osborne: That’s great, Mike. And again, we are on the same team, right? We’re all here to help. So that’s perfect.

Mike Linke: And you and I have been on the same team for a long time.

Justin Osborne: We sure have. It’s a good team to be on.

Mike Linke: It is.

Justin Osborne: I really appreciate all your insights and knowledge. As always, it’s great to talk to you. Great to see you again.

Mike Linke: Well, thank you for having me. I enjoyed it.

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