By James Griffith

>One of the clearest themes of the revisions to the Common Rule was a renewed emphasis on respect for persons. Respect for persons is one of the three major principles promoted in the Belmont Report. For research with humans, the easiest time to express this principle is during the informed consent process and the documentation of informed consent. It is no surprise that much of the renewed emphasis comes from changes and additions to rules about informed consent.

The informed consent process is the research team’s chance to clearly explain what they hope to learn, how they plan to learn it, and what they want from the person that has been invited to volunteer for the study. They should aim to tell that person everything the person might want to know before making a decision about volunteering. A lot of the things people would want to know tend to be the same from study to study. The rules refer to these things as the “basic elements” of informed consent. On the other hand, some things are important to know for many studies, but might not apply to many others. The rules refer to these as… wait… for… it… “additional elements” of informed consent. Catchy, huh?

Before the recent revisions, the Common Rule included eight basic elements of informed consent:

1. Inform the persons that they are being invited to participate in research and summarize how they would participate. Explain the purpose(s) of the research. Explain how they will be involved and how long they will be involved. Explain what procedures will be followed and, if needed, which procedures are experimental.
2. Describe any reasonably foreseeable risks or discomforts.
3. Describe any benefits.
4. Disclose any existing appropriate alternative procedures or treatment.
5. Explain whether and how confidentiality will be maintained.
6. Describe any compensation and/or medical treatments that are available if injury occurs as a result of their involvement in the research.
7. Tell them who to contact in the event of a research-related injury. Also tell them who to contact for answers to questions about the research and their rights as research subjects.
8. Remind the persons that participation is voluntary. Explain that they may refuse or discontinue participation at any time without penalty or loss of benefit.

The revisions to the Common Rule added:

9. Consent forms for research involving collection of identifiable private info or biospecimens must contain one of the following two statements.
   1. Their data might be stripped of identifiers and used for further research.
   2. Even if it is stripped of identifiers, their data will not be used in future research.

Of course, it isn’t enough to just tell people this or hand them a form that includes all of these elements. Respect for persons is expressed by assuring that persons understand the important factors well enough to make a decision that is in their best interests (or in the interests of someone else, if they so choose). Someone from the research team should be ready to answer questions about the study and explain anything potential subjects don’t understand. This review and explanation of the persons’ role in the research is the process of informed consent.

Documentation of informed consent is just what it sounds like. It is making a document, or record, that the person gave consent, or agreed, to be involved in the research in the manner described on the document. Being informed is not the same as being told. The goal of the document should be to help persons understand the study and their role in it. The document should use language that is clear and readable for the person giving consent. The document should explain everything discussed in the process. Unfortunately, informed consent documents often miss this mark. In the U.S., literacy groups recommend writing at no more than the 8th grade reading level for general audiences. The same groups recommend writing at no more than 6th grade level for groups at risk for limited literacy. Assent documents for children should be further adjusted.

Writing at a suitable level is not easy. I made a conscious effort to write simply for this entry. My first attempt was rated as “fairly difficult” to read by one measure. Other measures rated it at the 9th – 11th grade reading level. So I spent another 10-15 minutes revising for more simplicity. The same measures rated the next draft as “fairly easy” and 6th – 8th grade reading level. That’s the version you’re reading now.

The new rules for documenting consent go beyond stressing the overall readability of the document. They also mandate that all consent documents begin with “key information” for the study. Think of “key information” as highlights from, or a brief summary of, the basic elements of informed consent. According to the rules, this includes the following statements.

1. State that you are inviting them to enroll in a research project. Inform them that their participation is voluntary.
2. Briefly summarize the purposes of the research. Describe the procedures the research will use. Give an estimate of about how long their participation would last.
3. Disclose the reasonably foreseeable risks or discomforts.
4. Explain the benefits that can reasonably be expected from the research.
5. Tell them whether there are other suitable procedures or treatments that could help them.

You might have noticed that many of the rules are written from a particular point of view. That point of view assumes the research includes a treatment intended to help the subject. The importance of the rules is more obvious in those contexts. For example, in a clinical trial, the doctor is more concerned about what a treatment does to the group. In contrast, a primary care doctor is more concerned about what the treatment does for the particular patient. It is important that the person understands they are receiving the treatment as a subject and not a patient.

No matter the context, genuine informed consent requires simplicity and clarity, as well as complete disclosure. Our office will be placing greater emphasis on informed consent and on readability. We have developed two new consent form templates that comply with the new rules. Like our old template, one of the new ones has fairly extensive embedded instructions. The other assumes the user is familiar with the purpose of, and rationale for, the elements of consent. In the coming days, we’ll be posting examples of consent forms using this template. In addition, I’ve listed some free readability resources below. I encourage you to test your ability to write simply and to take advantage of these resources when you develop research materials.

http://www.readabilityformulas.com/free-readability-formula-tests.php

https://www.webfx.com/tools/read-able/

https://www.online-utility.org/english/readability_test_and_improve.jsp

MS Word built-in tool

Windows tutorial: https://www.youtube.com/watch?v=YnnB56gziRM)

Mac OS instructions: https://www.techlearning.com/news/determine-fleschkincaid-reading-levels-using-microsoft-word

In the coming weeks, IRBlog will feature a general overview of all the revisions to the Common Rule and we’ll revisit informed consent to discuss Additional Elements and Broad Consent.

Until then, happy investigating!