Recognition, appreciation, communication key to informed consent
Engage volunteers as partners in process
The informed consent process is more challenging because of the public's lack of understanding and trust of research.
This leads to poor morale among clinical research (CR) professionals and impedes trial recruitment. But this cycle can be broken by CR coordinators and investigators who learn to improve their own communication skills, an expert says.
"Most professionals have noticed that the public has so little understanding of the clinical research enterprise, and the little they do know reflects a level of distrust and a lack of rudimentary facts and information," says Ken Getz, MBA, MS, a senior research fellow at the Tufts Center for the Study of Drug Development at Tufts University in Boston, MA. Getz also is the chair of The Center for Information and Study on Clinical Research Participation, a nonprofit group that educates the public and develops outreach initiatives.
"What this has translated into is increasing difficulty in recruiting volunteers in studies, and this affects morale because the people they interact with don't have a basic appreciation of the importance of research in advancing public health," Getz says.
"Right now the only time people typically learn about a clinical trial is when they sit in an informed consent meeting," Getz says. "It's a sad state of affairs that people don't know about clinical research."
Research professionals are so close to the research enterprise that they have forgotten how to communicate with and educate the public, Getz says.
To reverse this trend, according to Getz, CR coordinators and investigators need to focus on recognition, appreciation, and communication.1
Participation is a gift
"It starts with recognition and appreciation," Getz explains. "It has to be explained on a very personal level, and by that I mean the gift of participation has to be perceived as a gift that matters to me personally."
CR professionals need to convey to each volunteer that they are grateful for the volunteer's gift of time and participation because this gift benefits the CR industry, public health, and society.
"Every medicine I take and every therapy that has helped me or a loved one has come about because of thousands of people giving the gift of volunteering in clinical trials," Getz says.
Education is next, but it has to be communicated to potential research participants before they actually participate in a clinical trial, Getz says.
"Education should take place before people find themselves in that window of time where they're desperate to find a treatment alternative, which is where 90% of volunteers come from today," Getz says.
Too often CR volunteers decide to participate in a research trial at a time when they're very sick and not well equipped to be educated about how a trial works, he notes.
So CR education should start on a public level, engaging people who are not volunteers yet, but might one day decide to participate in a study.
"They need to be informed about clinical research and think about their health care options," Getz adds. "Once you have persuaded the individual to recognize and appreciate what volunteerism has done for them personally, the next step is to arm them with facts and information to help them construct an educated viewed of clinical research."
Since this type of public education is not routinely done by CR sites, institutions, and the research industry, the public's only knowledge and information about clinical research comes from the media and popular culture, he says.
The key to improving communication and education about clinical research is to reach out to people before they need a research therapy.
Anticipate participants' questions
CR sites could provide potential study volunteers with information about questions they might ask an investigator and CR coordinator. Questions might include the following:
- What is the phase of the research study, and what does that mean?
- How many people will participate in the study?
- What is the purpose of the trial?
- What is expected of me?
- What kind of procedures will be performed?
- What other kinds of treatment for my condition are available if I'm not interested in the investigational drug?
- What can you tell me about the company sponsoring this drug?
- What if I receive the treatment and there's an adverse event? Who will pay for my follow-up care?
- What do I need to do to inform my insurance provider?
- Will my information be shared with other people?
- Will my identity be disclosed?
Communicate potential risk
CR sites also need to improve the way they communicate risks to trial participants.
"This is one of the hardest areas to communicate in the informed consent form," Getz says.
"While the informed consent form that the patient reads is very explicit, the research professional typically is somewhat uncomfortable handling this issue," Getz says. "The research professional might say that the patient can drop out of the trial at any time, but he usually is not comfortable discussing the risks, and the patient doesn't ask enough questions."
One way CR professionals could improve their ability to communicate risk information is by taking some standard questions on the topic and writing down answers that can be practiced before they sit down with potential participants.
For instance, they could pull together some statements about how the CR site will mitigate risks and what regulations, reforms, policies, and procedures are in place to improve CR safety.
Also, CR sites could let participants know about any unexpected adverse events that crop up, Getz says.
"Research centers that are most committed to volunteers will put in place mechanisms to remind volunteers of fully disclosed information on the risk profile as it changes and evolves," Getz explains. "They'll answer and anticipate certain questions, even if patients don't ask them."
Also, some CR sites will create a mechanism in which they can revisit the trial's risk profile and review it with volunteers if it's changed, Getz adds.
This type of practice keeps within the spirit of federal research ethics regulations, and it continues the informed consent process.
Follow-up after trial completion
Communication about clinical research and a particular trial should continue even after the study has ended.
"That's an area that is in dire need of attention," Getz says. "There is little to no follow-up after the volunteer has completed a trial."
In one study conducted by the Tufts Center for the Study of Drug Development, more than 80% of volunteers said that after the trial was over they never heard from the research center again, Getz says.
Close to 90% of the people who responded said they would volunteer for clinical research again if the trial were appropriate and if they were asked, Getz says.
"Most people have a positive experience with research," Getz says. "The message here is that these are important ambassadors, and people need to stay in touch with them if at all possible."
The study volunteers want to know that their participation in research has mattered, and post-study communication is a way to keep volunteers feeling positive. It may increase the chances the participants will volunteer again or recommend research participation to friends and family, Getz adds.
"Those good feelings die down quickly if there's no contact, so this is an opportunity," he says.
- Getz K. The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial. Bar Harbor, ME: Jerian Publishing; 2007.