Author: Eva Pastor
Date: 09-09-10 17:46
Source: The Richmond Times Dispatch
URL: http://www2.timesdispatch.com/lifestyles/health/2010/sep/07/stud07-ar-489710/
Date published: September 9th 2010
VCU tries to build trust in research
By Tammie Smith | TIMES-DISPATCH STAFF WRITER
More than 1,900 research studies are under way at Virginia Commonwealth University. Some are lab studies involving cell cultures and research animals. But dozens involve humans and need people willing to be human guinea pigs. Some of the VCU studies seeking people to enroll include 125 cancer studies, two fibromyalgia studies, three heart attack studies, seven seizure studies, five stroke studies, four depression studies and three obesity studies -- just to name a few.
More than 1,900 research studies are under way at Virginia Commonwealth University.
Some are lab studies involving cell cultures and research animals. But dozens involve humans and need people willing to be human guinea pigs.
Some of the VCU studies seeking people to enroll include 125 cancer studies, two fibromyalgia studies, three heart attack studies, seven seizure studies, five stroke studies, four depression studies and three obesity studies -- just to name a few.
"Recruitment is often the life or death of a study," said Dr. Elizabeth B. Ripley, a kidney specialist and senior chairwoman of VCU's Institutional Review Boards. The boards review, approve and monitor university research protocols involving human subjects.
"If you don't fill your study, it's not scientifically accurate," Ripley said. "Let's say you needed 100 people. If you only enroll 20 in that study, you really aren't going to have the answer to whatever it was you were studying."
Ripley has received a two-year grant of close to $1 million from the National Institutes of Health for a project focused on improving community perception and awareness of clinical research studies.
The grants are funded through the American Recovery and Reinvestment Act of 2009. Institutions competed for NIH challenge grants that, in this case, focused on projects that have a high impact in biomedical or behavioral science and/or public health.
Ripley has used the grant to develop a Community Partnership for Ethical Research at VCU, a multipronged effort with a focus on finding the best way to involve people at a grass-roots level in clinical trials. As part of that effort, she and the staff have recruited 10 Richmond-area residents to become research ambassadors, of sorts.
The recruits, who by virtue of their participation are themselves research subjects, are a vital link to the community, Ripley said.
"In the traditional way institutions usually do stuff, we tend to go out in the community when we needed something," she said. "We need participants for a study, we need a site to do it, we need a partner for a grant, whatever it might be. But we haven't always been so good with partnering with the community. To us, that really means we work with our community members. They hear our concerns. We hear their concerns."
Community connections are particularly useful for studies in which obtaining advance informed consent is not feasible. Such studies include those testing emergency treatments in situations where patients or their legal representatives are not in a position to agree to participate.
Federal rules let researchers seek exemptions from individual informed consent for such communitywide studies, but the researchers have to do a broad public information campaign to let members of the community know what's going on.
Two studies at VCU -- one under way and one in planning stages -- are examples of where it helps to have community advocates.
The Rapid Anticonvulsant Medication Prior to Arrival Trial is testing which of two standard treatments for unconscious patients having seizures is most effective at quickly stopping the seizures. Sixteen other universities also are participating in the study.
The Progesterone for the Treatment of Traumatic Brain Injury Protect Trial is testing whether intravenous progesterone started within hours of injury is more effective than a placebo for treating moderate to severe acute head trauma.
"One of the problems with head trauma is we're really good now at taking care of you right after, but your outcome is not always as good as we would hope for," Ripley said. "They are trying to look for ways to improve the long-term outcome.
The brain injury trial is being reviewed by the Institutional Review Boards and still is in the planning process.
The community advocates have helped set up meetings where researchers tell the community about the studies.
Chesterfield County resident Wendy Parker, one of the 10 community advocates for research, became involved through her association with the Epilepsy Foundation of Virginia. An adult son died of a phenomenon called sudden unexplained death in epilepsy. Parker said she never had heard of it.
"I am hopeful that some of the seizure-related projects will lead to new treatments," Parker said.
She helped set up a discussion about research in the Brandermill community where she lives.
"There are lots of precautions that must be taken before a research study even begins," Parker said. "We think that researchers are shut away in their little laboratories and often don't have connections to the outside community. This is a wonderful opportunity both for the community and for the researchers to connect to the people they are helping."
Ripley said there is a lot of give and take. For instance, the community advocates are helping define the role they should play. The advocates don't want to simply help recruit for studies, Ripley said. Nor do the researchers want that.
"We don't want them just to be, 'Call me up and I can give you 10 people,'" Ripley said. "That's not the purpose. One group has been writing the mission statements."
The advocates also are helping to facilitate a series of small group discussions on research ethics. The discussions will use the book "The Immortal Life of Henrietta Lacks," about a woman who died of an aggressive cancer 60 years ago, as a launching point.
Lacks' heirs for years did not know that so-called HeLa cells widely used in cancer research are from the cancer cells from Lacks. A doctor at Johns Hopkins University hospital where Lacks was treated saved the cells and made them available to others.
The book also explores other controversial studies, such as the Tuskegee syphilis study that ran from 1932 to 1972 and the Jewish Chronic Disease Hospital cancer study of 1963, Ripley said.
"Some really unethical things were done," Ripley said. "I think it's really important, though, that we think about the timeframe that it happened. Back in the 1950s you often didn't sign consent for even medical care, much less research care."
|
|
