Program educates parents about pediatric research

Award for best practice in human subjects protection

A web site designed by Boston's Children's Hospital to better educate parents about pediatric research has won the top award for best practice in human subjects protection by the Health Improvement Institute.

The institute, which annually recognizes exemplary efforts in protection of research subjects, announced its awards in December.

Susan Kornetsky, MHP, CIP, director of clinical research compliance at Children's Hospital, says the development of the site was among improvements at the hospital funded by a human subjects research enhancement grant from the National Institutes of Health.

She says the project was spurred by a fruitless search for existing unbiased information about research that was tailored toward parents of patients.

"We noticed that there was some information — web sites, books — geared toward participating in clinical research, and the things we found seemed very pro-clinical research," Kornetsky says. "We also didn't find anything that was geared specifically toward pediatrics. It's a different decision when you're deciding for yourself to participate in research, versus deciding for your child.

"So we decided there was a need for something that was very unbiased, that would give parents the opportunity to think about the questions they should be asking before they allow their child to participate in research," she says. "Our hope would be that after someone reviewed the materials or parts of it, some [parents] would decide yes, and some would decide no — that it was really unbiased."

Worked with consultant

The team at Children's that worked on the project was led by James Mandell, MD, the president and chief executive officer of the hospital. Kornetsky says the content was developed on-site, but for video and graphics to help convey the information, the team turned to a company which had previously worked on a similar web site for the hospital's informed consent process.

"The content, the actual script, was developed here at the hospital," Kornetsky says. "We had a consultant who worked with us and developed the content, and we had that reviewed by several ethics advisory people here at the hospital. Then the content was turned over to [the company], who actually put it together — they hired the actors and did all the graphics."

The finished project includes basic information about clinical research, along with deeper discussions about the issues involved in making decisions about participating. The text is sprinkled with links to glossary entries for such terms as "clinical trial," "principal investigator," and "placebo."

Parents get practical information, such as what would be required of them if their child were enrolled in a study, as well as questions they can ask to evaluate whether a study is a good choice for their child.

Video clips feature actors portraying parents speaking with research staff in order to explain research concepts. Another feature on the site helps parents create a list of questions they can print out and take with them to a meeting with the research team.

The site also includes a "family journal," with comments by families who have gone through the decision whether to enroll a child in research.

"We wanted to include people who had made the decision and what went into that decision," Kornetsky says. "Another area that we had not seen any site deal with was a little section on conflict of interest, since we thought that was important for people to be aware of so they can ask the right questions."

Input from families

In addition to having the content reviewed by an ethics board, the hospital also enlisted the help of a committee at Children's Hospital made up of families whose children have been treated at the hospital. While that step didn't lead to major changes in the content, Kornetsky says, "it helped us make sure that it was on target and that it was understandable and used appropriate lay language."

The site took about 18 months to develop and was launched in 2004. Kornetsky says she's noticed that the site is being linked to by other research organizations, including government sites and research subjects advocacy groups.

"We tried to make it so it would not be specifically about research at Children's," Kornetsky says. "You will see the Children's Hospital logo in the back, but we tried very hard to make it about research with children and pediatrics in general. And I think we succeeded."

She notes that the site focuses on biomedical research, even though Children's does conduct social-behavioral studies. "We had to make a decision really early on to put some parameters around it," Kornetsky says.

But the site is set up so modules can be added later, if time and funding permit.

"We could add a section: 'If you're being asked to participate in educational research or behavioral research,'" she says. "Those are the types of things we hope to someday do — that and get it translated into Spanish."

Kornetsky says institutions considering a similar project should focus on presenting the information as simply as possible.

"You don't want to make it seem as if people are stupid, but you also don't want to make it so that it's technically very difficult to understand," she says. "And you want to try to make it as engaging as you can. We tried to make it interactive and multimedia — there are words and phrases that come up, but also people and graphics and areas where you can stop and ask questions."

She warns that the process takes a serious commitment of resources.

"By resources, I'm not just talking about dollars," Kornetsky says. "I think that's the easy part. But it's the time and manpower. You write it, you review it, then you see the video of it, and it comes out differently than you thought it would. So we learned how to work with that."

Kornetsky is happy that the web site appears to be useful to others outside the Children's Hospital research community.

"When we submitted the grant [to the NIH], we saw that a lot of people were using it for infrastructure and databases," she says. "It was funded, but I remember getting a comment back that they thought we were a little off the mark on what we intended to do with it."

"But I think we've had much more impact than we would have buying computers and building a database," Kornetsky says.

The Health Improvement Institute, based in Bethesda, MD, is a nonprofit organization dedicated to improving the quality of America's health care. It began giving awards for excellence in human research protection in 2002.

To view Children's Hospital's parent education Web site, go to www.researchchildren.org.