As a kid, I was brimming with research questions begging to be answered. I implemented weird, and often inadvertently cruel, “experiments,” most of which involved my family’s beloved Labrador retriever as unwitting test subject. Would the perpetually hungry dog eat anything, even with hot sauce? (Yes. Then he’d shake his head vigorously as if trying to loose a biting insect from his snout.) Was he capable of navigating the living room with a paper bag over his head? (No. He sprung rapidly in reverse at high risk of backing down a flight of stairs). Science is based on replication, so my experiments were repeated over and over again to increase confidence that initial results had not occurred merely by chance.
I loved that animal with my whole heart and, looking back, I am not proud of my experiments. However, I was young and curious with little regard for the relative risks and benefits of such activities. None of what the dog and I learned together made either of our lives any better. My parents—good people with a mature sense of ethics—always put a stop to my inane canine studies before someone got hurt.
In real, grown-up research, an Institutional Review Board (IRB) functions like a parent in a household with a curious child. Essentially the IRB is an ethics committee responsible for making sure that the proposed research meets certain standards. The IRB reads through the plans for a study and determines whether the human subjects in the study will be adequately protected from harm. The IRB also decides whether the benefits of answering a particular research question are worth the risks involved. Needless to say, my Labrador studies would never have made it past an IRB.
The truth is that researchers dread the IRB, not because they want to harm research participants, but because it’s like being asked to clean your room and take out the trash before being allowed to play outside. (In case you’ve lost the analogy: curious child=researcher, parent=IRB, and household=the institution). Researchers do their best to explain the proposed study and assemble all of the necessary documents, but it seems like the IRB always comes back with a request for more information. When all you want to do is start your research, this feels like being told that now you also need to sweep the floor before you can go play.
In addition to letting the IRB know about the research, researchers absolutely must inform research participants. Human subjects have a fundamental right to know about the risks and benefits of the study before freely choosing whether or not to participate. This is called “informed consent” and the researcher’s description of this process must be submitted to the IRB along with other materials. The informed consent document is therefore a core piece of the IRB application and the overall research process. [If you are curious about the actual U.S. regulatory language on consent, it can be found at Department of Health and Human Services (DHHS) at 45 CFR 46 and the Food and Drug Administration (FDA) at 21 CFR 50.]
There are three parts to informed consent:
- Giving information to the individual study candidates;
- Making sure these candidates understand the study and have an opportunity to ask questions; and
- Obtaining their voluntary agreement (consent) to participate in the research.
The informed consent form—the paper or online document that participants read and sign—is required by law to say that the study is part of a research project and to describe the aims of the research. It must also include the following information (key items are underlined for emphasis):
- Expected length of time the person will be expected to participate in the study
- Overview of any treatments or procedures that are considered experimental
- Expected risks and benefits to the person participating in the study
- Treatment or procedure alternatives that the person could choose, if applicable
- How confidentiality of records will be maintained and the fact that the FDA may inspect the records
- Compensation if the research involves more than minimal risk, if applicable
- Medical treatments that are available if the person is injured as a result of participation in the study, if applicable
- Name and contact information for questions about the research and the person’s rights as a research subject
Finally, the informed consent form must clearly state that participation in the research is entirely voluntary and that the person may withdraw from the study at any time without penalty or loss of benefits and services to which the person is entitled. [The above framework for consent forms can be found at 45 CFR 46.116(a) and 21 CFR Part 50.25(a).]
Returning to my childhood for a moment, imagine that the family dog was a person and I wanted to conduct the same experiments. I would need to explain to him the research I was doing, allow him to ask questions, make sure that he understood, and then get his signed consent that he was willing to participate. Only then could I bring out the hot sauce. Before all of this, of course, the IRB committee (of my institution/household) would have had to approve my research plans and proposed consent form. A long shot.
The reason that informed consent matters so much is that there are many examples of abuses—instances where research subjects, especially those who are most vulnerable (children, older adults, prisoners, etc.), were taken advantage of. These examples are widely available online and are far more painful to read about than my dog backing down the stairs. The other reason it matters so much is that the more that people understand research, the quicker we can find solutions to problems. Answers are found more rapidly when everyone is working together on the same research questions. Informed consent is an ongoing part of that process.
We at CreakyJoints have observed that when subjects in arthritis studies really understand what the research is about, everyone benefits. As CreakyJoints works with academic rheumatologists to build the Arthritis Power* registry for arthritis research, informed consent is a priority that goes beyond a single form or a signature that satisfies legal requirements. It is a process that will involve regular updates to CreakyJoints members about how arthritis works and which treatments and behaviors are most effective based on what the research reveals. And the informed consent process allows individual participants to choose at any time whether to continue to participate in the research. If you have questions about informed consent or your participation in arthritis research, please contact me at [email protected]
*Arthritis Partnership With Comparative Effectiveness Researchers (AR-PoWER), nicknamed “Arthritis Power” is a Patient-Powered Research Network supported by the Patient-Centered Outcomes Research Institute (PCORI)