On July 20, 2018, the Office for Human Research Protections (OHRP) made available guidance documents that relate to the three burden-reducing provisions in the revised Common Rule. Institutions may choose to implement these three provisions during the delay period for general compliance with the revised Common Rule (July 19, 2018 through January 20, 2019). The goal of these revisions is to reduce administrative burden and to protect subjects in human trial research.
One of the requirements when the new Common Rule goes into effect, January 21, 2019 is for a revised consent form. Among other requirements, there is to be a key information section that sums up the important elements within the consent form. These sections must adhere to health literacy principles so that the consent form is understandable and readable by the general population.
With our specialization in healthcare translation projects, we also incorporate our knowledge from our experience in Health Literacy and in Plain Language Writing. One of the most important principles in Plain Language Writing is the opening section which tells readers how to use a book, how to navigate the document, why this is important for them.
INFORMED CONSENT AND THE REVISED COMMON RULE
For the Informed consent document in the revised Common Rule, this section needs to be written clearly so that the person understands the research and can decide whether or not to take part. That is called Informed Consent. To make that decisions, this section should contain the following:
- The purpose of this research.
- How this research differs from standard medical care.
- The procedures and the drug(s)/device(s) involved in this research.
- The risks.
- If the possible benefit of taking part in this research is worth the risk.
- The alternatives to taking part in this research.
PURPOSE OF THE RESEARCH AND THE REVISED COMMON RULE
The initial introduction of any document can be so very important. The reader’s first perception on the task is influenced by the way that the topic is introduced and presented. This may be a deciding factor in whether or not the reader will even pay attention…..so really put time into the introduction with that in mind! The patient needs to understand the research and why it is being done.
- Give the most important information first
- Tell them what actions to take
- Explain it is important. The example to the left is the Intro to a book we wrote on Diabetes Management for a Managed Health care plan. A warm welcome section at the beginning tells the reader “HOW” to use the book. A limited literacy reader does not read from start to finish or cover to cover. Good Health Literacy materials allow the reader to skim (subheads at the top of every page or section).
We were recently advising on content that was targeted to Hispanic employees of a company that had a health promotion program. What can you do in the intro when targeting this population with this kind of program? Consider health literacy and the importance on your healthcare communications.
Hispanics are collectivists – health values, beliefs and practices of the individual are linked with those of the family and community. The intended audience for health promotion efforts may need to be the family or community rather than solely the individual. Care must also be taken to define family and community in ways that are in line with the culture of the recipient.ing a culturally and linguistic approach that respects cultural values, beliefs and practices of the intended audience.
An example of doing so would be addressing the health disparities of the different groups. Health Literacy writing also incorporates educational models in the writing. You could research those and that might help you to seek for further answers and incorporate them in your writing. Two models to research would be “self efficacy” and “locus of control.”
We know that as a general rule with the Health Belief Model that people will respond best to messages on health promotion or prevention when they:
- Perceive that they are susceptible (at risk) and that the risk is serious.
- They will receive benefits from a change in their behavior – this is the motivation to change that behavior.
- The barriers (pain, cost, etc.) to changing their behaviors are not too great. They can do it. Show them they can do it and have small successes (education model of self efficacy).