Informed consent is the foundation of ethical research; ensuring participants are fully aware of what they’re agreeing to before participating in a study. After reviewing consent forms for the past decade, here are the 5 most common errors that we (an IRB) encounter.
1. Acronyms, Technical Jargon, and Overly Complicated Language
A frequent issue is the use of acronyms and technical language in consent forms. As researchers, it is easy to become mired in a topic and forget your audience. The audience (and IRB) are likely not as versed on the topic, and require more explanation, in addition to fewer technical details. Participants should understand the study’s purpose, procedures, risks, and benefits in clear, straightforward terms. Using complex terminology can confuse participants and undermine their ability to make an informed decision.
2. “What am I risking? What am I getting?”
At the heart of the informed consent process is the participants comprehension of risk and reward. Many forms underexplain the risks and rewards in relation to the participant. Consent forms should detail both the anticipated benefits of the research and any possible risks, including long-term or indirect effects. Instead of quoting the regulations, and simply stating that “the risk of participation is no more than what would occur in everyday life”, put more thought and effort into the risk/benefit calculation. Failing to provide a comprehensive risk assessment can lead to participants being unprepared for potential outcomes.
3. “You have the right to remain silent…”
Too often we see the “participation is voluntary” wording inserted somewhere near the bottom of the consent form- shouldn’t this be more important?! That’s the whole point! Participation is voluntary, and that point that should be made early and often. When dealing with vulnerable populations, this point cannot be made clear enough. While malintent is certainly not intended, as a research community we can do better.
4. Updates to Consent Forms
Researchers sometimes overlook the importance of updating consent forms as the study progresses. If significant changes occur in the study protocol or new risks are identified, participants must be informed and provide renewed consent. If not forgotten, the implications can often be overlooked. For example: enrollment is low, and the study team decides to offer 20% more compensation to participants. Well, what is to be done with the individuals who have already completed participation? Are they reconsented and paid the additional amount? Are they left out, and their early participation was simply “bad luck”? What is fair and equitable? What risks are associated with recontacting participants? All are things to consider when altering the consent forms.
5. The Consent Process– Not Just a Form
Finally, the IRB must consider the consent process as a holistic endeavor, not just a form to be signed. The process of obtaining consent should be conducted in a way that ensures participants are making decisions free from coercion or undue influence. Researchers must provide adequate time for participants to consider their involvement, ask questions, and decide on their own accord. The researchers who are taking consents, and where consent is being taken, can greatly affect the level of pressure felt by participants to join the study. No one appreciates being put on the spot, and it is imperative that researchers cultivate a consent process that frees prospective participants from pressure.
By addressing these common errors, researchers can help ensure that the informed consent process is genuinely effective, transparent, and respectful of participants’ autonomy.
The tips listed above may seem obvious to seasoned authors, however we often become blinded to the items with which we are most comfortable. To those less experienced authors, we hope that this short list has left you with a few things to think about during your next IRB submission. As always if you require any assistance with IRB or its’ associated services, please feel free to reach out to Pearl IRB at 317-899-9341.