Five Tips for Informed Consent
1. Keep it simple.
Consent forms should be written “in language understandable to the subject” (45 CFR 46.116). We all know this is not as easy as it sounds. Luckily, decades of adult literacy and patient education research is available to assist us. Readability and information retention can be drastically improved through simple changes to layout, organization, typography, and plain language (see Denzin et al. for a lot of great, simple tips that we should all starting putting into practice immediately). But simplicity and creativity are not mutually exclusive. There’s nothing in the federal regulations that says you can’t use graphics, tables, or even props. We (humans) learn best when things are explained using words and pictures.
Denzin EM, Burton Santibanez ME, Moore H, Foley A, Gersten ID, Gurgol C, Majhail NS, Spellecy R, Horowitz MM, Murphy EA. (2012). Easy-to-read consent forms for hematopoietic cell transplantation clinical trials. Biology of Blood and Marrow Transplantation, 18(2). Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3242929/
2. Writing the consent form should not be an afterthought.
Writing about research in simple language takes practice and effort. Perhaps more importantly, it takes time. As with any written document, you should write several drafts. Whoever writes the first draft must be intimately familiar with the protocol. Avoid cutting and pasting from the protocol. Enlist people unfamiliar with the study to provide fresh eyes. The consent form deserves the time, care, and editorial focus that you would spend on a grant application or peer reviewed journal article. Your participants deserve this as well.
3. Be honest – with participants and with yourself.
The entire process of informed consent is predicated on truth-telling, so this may seem somewhat obvious. The purpose, risks, and benefits (or lack thereof) must be stated clearly. But there may be a temptation to sugar coat or obfuscate some of the details of a given research project – particularly related to the time and effort required by participants. If clear, straightforward statements about research burden make you question why anyone would participate, the problem is likely bigger than your consent form. It may be time to re-think your design – or accept that recruitment will be slow.
4. Consider the process, not just the form.
The consent form covers the “what” and the “why” – but the “when” and the “where” of informed consent are also extremely important. The consent process should not be rushed. Invitation to participate and discussion should take place at a time that is respectful of potential participants’ needs in a quiet, private space. Did the participant just receive a diagnosis a serious illness? Are they facing a risky surgical procedure? Do they need to make other decisions about care? Potential participants should be given enough time to think about, ask questions, and digest the information being presented in order to make a decision that is right for them.
5. Be prepared.
The need for training and preparation will vary based on one’s level of prior knowledge of the study. Depending on the size and scope of a study, there may be one person or many people responsible for obtaining informed consent. In some studies, the investigator who conceived of and developed the protocol may be the sole individual obtaining consent. In others, recruitment and informed consent may be the responsibility of community partners who have no previous background or experience in research.
If graduate research assistants, lay community partners, or medical residents are going to be responsible for obtaining consent, reading the consent form (or even the protocol) is insufficient preparation for the job. Training should include discussion of questions that potential participants may ask, challenges that may arise (e.g., low literacy, lack of decision capacity) and plans for addressing these, and opportunities to practice. Additionally, ongoing support should also be provided to those responsible for obtaining informed consent, as not all questions may be easily anticipated. Staff should also be prepared for the fact that people might say no, or they might not want to hear about a research opportunity. This can be upsetting at first, especially in community-based studies where community partners may be enthusiastic about offering something they view as beneficial.
The CCTS's CIRTification program provides training in human research protections that is tailored to the unique roles of community research partners. The CIRTification curriculum is available for free download or you can access the Informed Consent in Action training video.