PHRP launches public education campaign
PHRP launches public education campaign
Info is available free to trial sites
A new campaign aimed at improving public trust and knowledge of clinical trial research was launched in May by the Partnership for Human Research Protection Inc. (PHRP) based in Washington, DC.
Called "What You Should Know About Research Studies," the campaign includes a brochure that can be distributed to patients at hospitals, clinics, clinical trial sites, and other places across the country. PHRP is sending the brochures to more than 5,000 hospitals and other organizations and has made them available for a free download from its web site at www.phrp.org.
"Every year, thousands of people volunteer for clinical trials that help to advance medical science and contribute to breakthroughs," said Karen Timmons, president of PHRP, who spoke at a media conference about the new campaign.
"As we conduct important clinical trials, we must be sensitive to the needs of volunteers participating in this research, and that’s why we launched the educational campaign," she added.
PHRP’s brochure tells the public, including potential research subjects, what questions they should ask their physicians or the research conducting a study.
Among the questions the brochure suggested are these:
- Why is this experiment being conducted?
- Will I be able to continue to see my own doctor?
- Is there any cost to me, or will I be paid to participate in this study?
- What other options or choices do I have if I decide not to take part in this study?
- Could my condition get worse during the study? What will happen if it does? If my condition worsens, will I be notified? How?
- Who pays for my care if I’m injured during the study?
- What will happen to me at the end of the study? Will I be told the results of the study?
- Who stands to benefit financially from the results of this study? Is there a conflict of interest with the researcher? If so, how is it managed?
These are the kinds of questions Paul Gelsinger, father of Jesse Gelsinger, who died in 1999 four days after participating in a clinical trial involving gene therapy work, said he wishes he’d known to ask six years ago. Gelsinger, who has worked with PHRP for several years as they developed their human research accreditation program, also spoke at the media conference about the patient education initiative.
"When we got involved in this clinical trial, we trusted that the system was impeccable, that there were no problems with it," he pointed out. "I didn’t know the questions to ask; I asked what I thought were appropriate questions, but I didn’t delve into conflict of interest with the researchers."
For example, Gelsinger said he had no idea the head researcher of his son’s clinical trial had a 30% ownership of a biotech company that held the patent rights to the researcher’s work.
"I had no understanding of how that could impact his impartiality in the research," he added. "Unfortunately, in our experiences, the system is not trustworthy. There are too many influences that are unseen from the patient perspective, and they just have to be revealed; and this brochure gets into a lot of those questions."
Potential subjects who read the brochure and use it to guide their questions during the informed consent process or prior to becoming involved in a clinical trial will be better informed and prepared than the typical research subject, Gelsinger and Timmons said.
"It will put investigators on the spot and make them have to answer them and give people the courage to ask the questions," Gelsinger noted.
Clinical research professionals have the obligation of informing the public and potential subjects about human subjects protection in research, and the PHRP campaign will assist them with this task, said Lori Roesch, CIM, CIP, manager of the research subject protection program at Aurora Health Care in Milwaukee. Roesch also spoke at the media conference.
"The more information a person has, the better equipped he can be to ask questions and make decisions," she said.
"I often hear people refer to themselves as guinea pigs when they participate in research," Roesch added. "It’s our goal at Aurora to dispel that myth."
Aurora Health Care will make the brochure available to research staff for their trial volunteers, and they’ll pass them out at community education events, she explained.
"I think it will help to raise people’s awareness of research, much like the Terri Schiavo case raised awareness of advanced directives," Roesch added.
The brochure has a section titled, "What you need to know about participating in a clinical research study," and in that section, there are 10 main points, including the following:
- At the time you sign up for the study, it will not be known if the experimental drug, medical device, or treatment will help you more than the standard treatment.
- Ask for a copy of the study protocol. Look for a description of potential side effects of the treatment.
- The costs of participating in a research study are not always covered or paid for by health insurance. Talk to the doctor conducting the research and your insurance provider to determine if there will be any extra expense to you.
- You will be asked to sign an informed consent form, which explains the nature of the study, the risks involved, and what may happen to participants. Take the informed consent document home, read it thoroughly, and review it with your family.
- For help in understanding the informed consent or study protocol, seek out expert advice from a family physician, a patient advocate, or a specialist who treats your disorder.
PHRP also explained in the brochure how some IRBs and human subject research programs are accredited and where research volunteers can find out more information about accreditation.
While the accreditation process doesn’t alter the regulatory framework, it does build in safeguards by providing a prospective independent review of an organization’s performance, says Jessica Briefer French, an assistant vice president of PHRP.
For example, the regulations are limited in their guidance for conflict of interest management, French said. "Conflict of interest was not a major issue 30 years ago when the Common Rule was written," she added. "But as more and more research is funded by industry, conflict of interest has become a much more important issue."
PHRP requires accredited organizations to have specific requirements or policies for the management of conflicts of interest, including the collection of data about potential conflicts of interest and policies for taking actions to mitigate or eliminate the conflicts, French explained.
The main purpose of the education campaign and brochure is for these to serve as a vehicle that involves potential research participants more in the process, Timmons said.
"They can take the brochure home to their families and discuss its potential implication before making the decision," he added. "This really is a nice way for an individual to understand the implications and ask the right questions prior to signing the informed consent."
A new campaign aimed at improving public trust and knowledge of clinical trial research was launched in May by the Partnership for Human Research Protection Inc. (PHRP) based in Washington, DC.Subscribe Now for Access
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