The Consent Process
Consenting to participate in a clinical trial involves learning about the purpose, activities, risks, and benefits of the trial.
What Happens during Consent
People talked about getting paper or electronic copies of consent forms with information about the trial. Some consented in person and others did it virtually, over Zoom or other platforms. In Jim’s trial, the clinical trial team read the consent forms aloud to him. Ashley said her son’s doctor showed her “everything that was inside the binder, the chemicals, the time periods we would be at the hospital, when we would be home.” Debbie found a “user-friendly” synopsis of the trial to be helpful.
Going over the trial information multiple times gave Alejandro “peace of mind.”
Going over the trial information multiple times gave Alejandro “peace of mind.”
So, I had a first visit and a phone call. Once I got the protocol and the details of what it was, then they had a list of the things that I would have to consent to and it's like, you're committing to this, if you are going to be working with us.
We went over it once and then weeks right before we actually got the schedule done. And then, when we got the schedule done, and I got the schedule, we also went over it over the phone—like, these are the things that you're going to be agreeing to. And we went over the things I still— you need to confirm before you do MRIs and the things you needed to confirm before the lumbar puncture. So, we did all that, including COVID, making sure that I didn't have COVID. But then, when I thought I had done everything, and I was ready to get my dose, then we went over the form again and just a reminder of all the things that I was committing to and also, what the program was—so again and with a person, and with the person waiting for me to nod and acknowledge every single part of it, before we move into the next section, which is all welcome. Because there were things there that I had read about, but it was a good reminder. So, when I signed up, before I got my dose, I was like—I said, yeah. I have the information I need. It was not a matter of, oh, I forgot to ask this, I forgot to ask that. I felt pretty good that I had information that I needed. And so that gave me peace of mind, too. And so, I signed it. And I got my first dose.
After learning more about the trial, people sign forms agreeing to participate or sometimes, as Tiffany did, consent verbally while being audio-recorded. Debra N. recalled, “I said right away, you can use my DNA. I gave all of that up for the study.” Other people, such as Mia, took paper copies home and “went over them.” A few people talked about reading through and discussing the forms with their spouses. For younger children or people who need assistance with writing, a parent or other family member signed the forms for them. Some people kept hard copies of the forms they signed to look back at in the future.
Rhonda reviewed the consent form with her clinical trial team.
Rhonda reviewed the consent form with her clinical trial team.
They sent it to me through DocuSign, something like that. And it was very, very long, a lot of reading. And I'll be honest, I didn't read it all because my eyes will not focus for that long. And they explained it to me, separately, over the phone. And I signed it, and then we went over it again the first day that I'm there for that four-trip one.
Kara appreciated having time to review information before signing.
Kara appreciated having time to review information before signing.
A lot, a lot, a lot, a lot of information. And they would like give you the information, and they would send you home with it for a few days, you know, to really look over it, really make a decision. And they were-, very-, wanted you to really, like, invest in it and take a look at it, and make sure this was what you wanted to do. And the information itself had just like a bunch of—it was very—a lot of statistics. And, very medical, as well, as it had a bunch of information that I thought was good, like the, you know, side effects, percentage of the side effects—and, based out of, like, out of this X amount of people; so, you can see, like the mean, median, mode of it. You could see it all lumped together and how, how it’s affected people and stuff. But it was a lot, a lot, a lot. And the information you take home, is for-, well, you know, it’s for you. So, whenever I would go back in, I would get fresh stuff. And I would go over everything with my neurologist, like, with her. I wouldn’t just willy nilly sign anything. But it was very good—like, if I needed more time, I could absolutely have it. There was no rush from the clinical trial people or my neurologist. If it was like, if you want more time, you could have more time, and they were very pleasant about it.
Many Forms
Most people we interviewed spoke about consent involving a large number of forms. As Julia puts it, the consent process was “signing lots and lots of papers.” Jean, a participant in several clinical trials, noted that consent forms can be “a little bit different. But in the long run, it’s basically pretty much the same.” Elaine said, “I just know it was a lot of pages, and I had to sign them and initial them. I can’t tell you what they all said.” Some people we spoke with confirmed their consent again before certain tests or treatments or signed consent forms multiple times over the course of a long clinical trial.
Fred says the consent form was for his trial “was huge.”
Fred says the consent form was for his trial “was huge.”
So, the consent form was like 50 pages long. Ok, this consent form for this thing. It was huge. It was huge. We probably did eight of them. Every couple of years, oh, we had to take these two lines out, stuff like that. So, I had to sign in like six or eight places, and initial and date every page. So, listen then, I bet it's eight of them. I've got most of them, so I kept them. I have them in a stack just there. But it's almost as bad as when I was in the army. It was terrible. In the army, flew over to Germany. When I go to leave Germany, you have to get signed out by every place you could have gone to in the army…. It was like, oh my gosh, what do you need so much paperwork? So, when I got the first couple of consent forms, oh yeah, it's like the army.
Dani says she didn’t read all of the consent forms.
Dani says she didn’t read all of the consent forms.
A lot of forms. And I mean, of them, but I knew it wasn't a drug trial. And then I figured they weren't going to do anything to me, so I just kind of signed. And I guess I probably should read more, should have read more. I also remember her going through some of the forms with me. And if I can remember, it reminds me--you in The Peanuts, the parents are like. That's what it feels like she was saying. And I remember just being like, OK, look smart, [NAME] and smile and it's great. So, I don't know. That's sad and awful, but I don't read it. I didn't read it all.
Karen keeps hard copies to track what trials she has been in.
Karen keeps hard copies to track what trials she has been in.
I always got a written, I always got like a hard copy, even if I signed something online, for me to have. And I actually have a whole file. I keep a record of everything that I’ve been part of. I have a whole file on studies because, you know, I like to go back and see which ones I’ve done and then sometimes go back and look for the results of the study.
What Consent Includes
People learned about and agreed to various things during the consent process. For Mia, it was an opportunity to learn about the “point of the study and who they intend to help.” Debbie emphasized that the consent process helps you to “understand your obligations” around tests and treatments during the trial. Debra C. talked about learning how her information would be shared within the trial as part of consent. Several people noted that consent forms include the option to stop or leave the trial at any point. Some peoples’ consent forms included information about not getting results back from the trial.
Liz describes what she consented to as a participant.
Liz describes what she consented to as a participant.
So, in signing up for the study, it was all laid out. There was a whole chart about, week one, you get the MRI. You have to do certain blood work. You have to do all these different tests and so forth. And then, say, week six, you get these other tests done and so forth. So, the whole study was laid out as far as what was required of me and where these tests and things would be conducted. So, I knew up front whether or not I was going to be able to hold up my end of the study or not
Jennifer A. says she found it helpful to learn how the trial would protect her personal data.
Jennifer A. says she found it helpful to learn how the trial would protect her personal data.
I think it helps to know that they do respect your privacy. You are, in a lot of these studies, really giving them personal data. Whether it's your biological data from blood results, or your words, and your thoughts, and your experiences. So, I think it is nice, and they go the extra mile to let you know all of the efforts and safeguards they're going through to make sure that your data is used the way that it's supposed to be used and kept in the right hands of the people. And if they are going to share it, just making sure you understand. And I think that just makes me feel comfortable with the organization in the study, that they care about me and not just the data that I'm going to provide.
Susan describes what she looked for in the consent forms.
Susan describes what she looked for in the consent forms.
I don't– I don’t know. I knew that– I knew from the beginning that when you sign the forms, you don't have legal grounds to anything. You can't ask for your stuff. And I also knew that any time you wanted to quit, you could quit. So that– that was– that was really all you needed to know. I didn't care if they used my data somewhere. It didn't bother me at all. I knew that I wasn't going to get any of my data back. I wasn't going to get any results on anything. I knew that they would let me know if there was something serious about my condition that they were just– not that they would. And that's the one thing I asked. What if something is– you see something and it’s like– needs to be addressed? Are you going to just let me go and not tell me that I need to address something? And they said that was a no. So, I knew that if something really happened and they found something in my blood work or whatever, that they would– that they had an ethical– they had to tell me. And just let it go and say, well, guess what? You know, so that I knew, and I knew you could quit any time. So that's really all that really mattered.
Clarity and Confusion
Some people felt the consent process was “very straightforward” and “pretty easy to understand.” Fred says his clinical trial team “did actually spell out pretty much everything,” and his experience ended up being “pretty close to the way they said.” Jim “understood how [the clinical trial] worked.” Susan, in contrast, was left with questions because “we can't read the whole forms. They're fine–fine print, and are you all going to understand everything?”
Several people said they didn’t know the purpose of the trial until it ended. Others were unsure if the forms they signed were for a trial. A few people did not remember the consent process. As Bianca described, “I'm probably blocking this out. I'm sure I signed consent forms. I totally don't remember.” Marquita said she didn’t remember the consent process because “it’s [all] been so much.” David S. learned more about the dangers associated with his trial after the consent process, when he did more reading on his own.
Mercedes says the consent process was straight forward.
Mercedes says the consent process was straight forward.
It was pretty easy and straightforward in your options to vacate the study at your will whenever without reason or rationale. It's pretty straightforward like I said, but you do have a duty to read. You need to read all the fine print, et cetera. So that was it.
Lori describes how the consent process could be more clear.
Lori describes how the consent process could be more clear.
And every disease isn't like that, every study isn't like that. But where there's a possibility to take it from science land into parent land would be really, really helpful--and it was still--it was very sciency, there was probably two-thirds of the pages I didn't know what it was, but it was like, "That doesn't matter, this doesn't matter, you look here, focus on this part," and that's the way that should be." And it was great, and I could question people.