By Andy Burman, PRIM&R Blog Squad
PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.
At home when people ask me what about my job title and I reply, "research program coordinator", it is not uncommon for people’s eyes to glaze over. That’s when things get awkward, because the subsequent question becomes, "What does that mean?"
Despite my three years looking at consents with my institution’s IRB, I haven’t been able to develop "clear, concise language" explaining this side effects of my job. Is there language that I could use that most people would easily understand?
It is my job to support a committee of people whose focus is to balance the need to conduct research with the needs of protecting human research participants.
Oh, crud. That has a Flesch Kincaid Grade level score of 13.03. Not below an eighth grade reading level, still too complex. I better try again.
My job is to assist a group of people. These people balance the need to conduct research with the needs of protecting those enrolled in the research.
That’s better, a score of 5.41.
The things we, humans, choose to care about.
An overarching theme of the AER Conference this year has been informed consent.
"Most informed consent reading levels are too high."
"They are too long and legal."
"God save the trees!!"
It seems to me that we are all looking for a magic bullet when it comes to the consent of research subjects. We aren’t happy with the way things are, therefore there must be a better, all-encompassing solution that will work for everyone in all circumstances. But simply to say that informed consent forms are the problem, and to say that verbal consent would more fully inform subjects, is to ignore a huge source of the problem:
We are human and we don’t all think, act, or behave in the same way. We are different by nature. It is these differences that make the process of informed consent difficult. After all, being "informed" to one person, may not equate to "informed" to the next. Being informed is subjective.
Can we do better consenting? I believe we can. However, as long subjectivity and humans are involved, then we can never expect to reach an all-inclusive solution or perfection of the informed consent process. It just isn’t a reasonable expectation.
Meaning between the linesTags:
By Andy Burman, PRIM&R Blog Squad
What I find so frustrating is that we gather every year and talk about this. I also go to ACRP and we talk about it there. And of course we talk about it at IRB meetings. But nothing changes. When will we reach the tipping point and actual change the way we do this?
Thanks for your comment. This was my first AER meeting and I feel your frustration. Obviously, there is no clear and certainly no easy answer.
I believe a combination of factors of ethicism, compassion, trust, and (God forbid) a high degree of communication with each individual research participant is paramont in order to acheive true informed consent. It is not a process that should be rushed and a process that should be handeled with compassion.
It takes time. It takes training.
To answer the question when will we reach the tipping point?
I don't know. But I don't want to be the one who experiences tragedy at my institution and causes it to tip for everyone else. That's why we all need to go home and carefully consider our IC process for ourselves. All we as individuals can do is make the best within the realm of our control.