Creative IC tool is a user-friendly newsletter

Add color, bullet points, boxes, pictures

In Caroline Knight's 20 years of experience, working as a research coordinator, the size of informed consent forms has grown from an average of four pages to about 18 pages. In her estimation, the additional pages have not made it easier to fully inform potential research participants of what to expect in a clinical trial.

"It's ridiculous," says Knight, who is a clinical research specialist for Pen Bay Medical Center in Rockport, ME.

"These are not written for the patients; they're written by attorneys for attorneys," she says. "I'm embarrassed every time I have to hand one to a patient."

Everyone agrees informed consent forms are too long, have too many legal words, and are not readable for most potential research participants. Yet the problem continues, Knight notes.

So Knight decided to create an informed consent tool that would give subjects the necessary information, including required elements of consent, in a reader-friendly format. It would not replace the standard form used by sponsors, investigators, and research institutions, but it would supplement that information and improve the informed consent process.

She has a generic informed consent newsletter that can be adapted to each new study in about two hours, Knight says.

"It helps with patient education," Knight adds. "And the act of creating helps me learn the study better and think it through from a patient's perspective."

Study participants and the IRB have embraced the informed consent tool and sponsors have approved it, as well.

Knight goes over the informed consent newsletter with subjects, reading the headlines, and summarizing what it says.

"Then I leave study participants alone with the newsletter and the full informed consent document," Knight says. "I say, 'Because the informed consent form is difficult to read, this is a supplement to help you. But you should still read the big form; this is a take-away message.'"

Here's how Knight created the informed consent tool:

• Select a reader-friendly format: After some research online, she found that a newsletter format was flexible and reader friendly and provided an opportunity for inserting graphics and photos.

"I got access to Microsoft Publisher and used one of their templates for the newsletter, which I created for one of my studies," Knight says.

A newsletter can have color, varying font sizes, boxes, shading, indexes, and other textual and graphical features that make it appealing to the eye and easier to read and understand.

"I made a generic template of the newsletter and can plug in the information from a new study," Knight says.

• Include most important elements first: The newsletter's table of contents shares the front page with a brief discussion of the study and its risks. Also, the bottom part of the page has in a bold, large font the words, "Who to Call?

The numbers listed include "911" for emergencies, plus the study doctor's number at both the research and regular clinic; the research clinic's seven-day-a-week phone number, and the IRB's number in case the subject has any questions about his or her rights.

There also are contact phone numbers on every page, Knight says.

All subject headers are in boldface, larger print and are stated as a question. For instance, the generic form lists this information about risks at the top of the first page of the newsletter:

• "Are there any Risks? All medications have the possibility of complications and side effects. For a detailed list of these, please see page 9 of the informed consent form you will receive. Other risks:

— You might get a bruise where your blood is taken;

— The MRI machine uses a powerful magnet. If you have any metal in your body, this could be a big problem. This will be discussed with you before each MRI is done;

— During the X-ray you will be exposed to some radiation;

— The risks to unborn babies is very big. Therefore, you may not participate in this study if there is any chance of you getting pregnant."

The brief and simplified list of risks is not designed to take the place of informed consent, Knight notes.

"It's a sort of Cliff Notes to the informed consent document," she adds.

• Give subjects answers to anticipated questions: The generic newsletter includes a page that talks about what is expected of study participants, using bullet points to cover such items as "Take your study medication exactly as directed" and "Tell the study coordinator about all illnesses and changes in your health."

This section also explains what it means to say study participation is voluntary, saying, "Just because you consent to a research study, doesn't mean you have to finish it. You may discontinue study drug if you don't like the way it makes you feel, if the schedule is not working for you or for no reason at all. You don't even have to give us a reason. However, we do ask that you come in for one last visit. We need to make sure you discontinue the medication in the safest way. We also need for you to return any unused study medication."

Knight also included information in the newsletter about other reasons a study participant might not finish a study, such as if the study doctor decides the study is not in the person's best interest or if there is a problem that crops up in a lab report.

And there even are small sections addressing alternatives to the study, what will happen if new information is learned about the drug, and how subject privacy and confidentiality are handled.

"I put a section in there called, 'Are you just a number?'" Knight says. "It says, 'Well, in a research study, yes, you are just a number! We never submit any documentation about you to the sponsor that has any personal identifiers.'"

Knight said this to study participants for years and thought it would be helpful to include it in the informed consent newsletter.

• Summarize study events: The informed consent newsletter has a page that details the visit schedule and procedures performed. It also features an x-ray picture, but could include any photo or drawing pertaining to study procedures.

The schedule might read:

— Screening – up to 21 days before start of study medication

— Day 1 – start of study medication

— Day 14 – this visit can be done any day between 14 and 19 days after day 1.

The key to answering the section header of "What procedures will be done?" is to keep the list simple with single words or short phrases. In Knight's generic newsletter, there is plenty of white space between the bullet point descriptions of procedures.

One example of the list is called "During the screening period," and it includes these items:

— Learn about the study and ask questions

— Medical history

— Physical exam

— Blood draw

— ECG

— MRI and x-ray.

• Address other issues participants often ask about: The fourth and last page of the newsletter addresses the study's costs and whether — or how much — participants are paid.

For instance, under the header, 'How much will this study cost you?' the answer given in the generic newsletter is "Nothing. Any medication or procedure required for the study will be provided by the sponsor to you for no charge. Your insurance will not be billed. For any other medical conditions you might have or any other problems that come up during the study, you will be responsible for those costs the same as before the study."

And Knight includes at the very end of the newsletter a boxed section, titled, "You are contributing to the advancement of medical science."

This part lists a brief reason why research is important: "Research has led to important discoveries that make our lives better." And it has a few bullet-point examples, including new drugs to treat cancer, diabetes, and other diseases, and vaccines.

"We end it by telling them how important they are and the contributions they are making to medical science, and we thank them," Knight says.