IRB educates community on research, builds trust

IRB member volunteers time to teach

Thanks to the volunteer work and sponsorship of community advocate and IRB member Isaac Hopkins of Plainfield, NJ, there is an inner-city Little League team where the 7- and 8-year-old players wear T-shirts that say, "Do No Harm."

"Kids ask me what it means, and I say, Do no harm’ will take you all through life," he says.

This is just one example of the community outreach, education, and teaching-through-example that has been a hallmark of Hopkins’ 15 years serving as a member of IRB at the University of Medicine and Dentistry of New Jersey (UMDNJ) in Newark.

"Isaac Hopkins is the star of the show," says Barbara LoDico, CIP, BS, executive director of Human Subjects Protection at UMDNJ.

"He’s been in barber shops, schools, churches — pretty much anywhere anyone has asked him to speak," she says.

Inspired by Hopkins’ dedication to inform the public about research and building good will through his volunteer outreach efforts, the IRB has developed a formal community outreach program.

The program’s funding comes from a National Institutes of Health grant that is intended to support human subjects protection programs, LoDico reports.

The program’s goal is to increase public knowledge about research and IRBs and build community trust. Anecdotal evidence suggests its impact has been positive, she says.

"Our calls to the IRB have gone up with people asking more questions," LoDico says.

This suggests that some local citizens who have been recruited for research studies possibly learned about research and IRBs from the community outreach and therefore were comfortable calling the IRB for additional information, she explains.

Hopkins, who has been a community volunteer and member of public boards for more than five decades, has a personal interest in human subjects research and education.

An asthmatic child, he was restricted in his activities and spent many hours in emergency departments, he recalls. "One wish I had was that I could go three days in a row without getting sick, and then it happened."

When Hopkins was nearly 18 years old, medical research led to treatments for asthma that made a major difference in his life, so he has positive feelings about research despite some of the abuses with which he also is familiar.

In 1949, Hopkins served as a chairman of the parole board for the New Jersey State Training Schools for Girls and Boys. He also has worked as a certified crime prevention officer and a parole and hearing officer and drug educator. As a result of his exposure to prisons and prisoners, he learned firsthand about some of the research abuses that occurred in the 1950s, Hopkins recalls.

"I came across a lot of people who were transient and in prisons at one time or another," he says. "I found out some of them were grotesquely disfigured by some of the experiments that occurred before the Belmont Report."

This balanced view of research’s public good and, at times, individual evil have helped Hopkins relate to the fears and concerns many people, including some in Newark’s minority communities, have about participating in human subjects research.

"I usually just present information and I make sure people know that I’m not a research recruiter," Hopkins says. "I explain what the IRB is all about, and I tell people how the IRB board has scientists, ethicists, clergy, and community members."

Calming fears

Hopkins also explains that the IRB has members who are sensitive about cultural issues and who are very concerned about how research participants are treated during the informed consent process.

Usually when he is speaking before the African-American community, people know about the abuses in the Tuskegee (AL) Syphilis Experiment (conducted by the U.S. Public Health Service between 1932 and 1972), so Hopkins will explain how there have been a number of laws passed to better protect people participating in research.

"I talk about the risk-benefit ratio, and I say that the key thing is to make sure that if they participate in any research that they ask all of these questions," Hopkins says. "I tell them that they can wait two or three days until they get the right information and that it’s not necessary for them to participate before they know what’s going on."

The goal for him and the IRB is to build trust in the Newark community where a great deal of research occurs.

"It’s been pretty easy for me to engender trust because I’ve been working with folks for a long time," Hopkins says. "Trust sometimes is based on the person delivering the message rather than what is actually happening."

Another aspect to building trust involves the reputation of the institution that is conducting research, he adds. "We’re the largest and have one of the best trauma centers."

So when Hopkins discusses UMDNJ, he knows people associate it with a competent, technologically advanced institution that they would trust to apply the highest standards to scientific research, Hopkins says.

Hopkins also believes in educating young people about research. Besides his Little League sponsorship, he has helped to establish a faith-based health and disability initiative in which 15-20 students are assigned research projects that will teach them about disabilities and health and give them exposure to research.

"Each one has an assignment to go to a web site and find out about a particular disease, such as tuberculosis, AIDS, hepatitis C, etc.," Hopkins says. "Then at the next meeting, they report back to us."

Although having an IRB member who has decades of community volunteer experience and is considered a community leader is an ideal way to connect with and educate the public, there are several other ways that IRBs and institutions can educate and build public trust.

Outreach efforts

LoDico lists these programs that the institution has started to promote community outreach:

IRB members participate in a medical lecture series. Research education is included in the UMDNJ’s annual medical lecture series for the public.

Attendees may listen to medical school professors discuss issues similar to what they might teach their students. Some of the lectures during this eight-session course may include innovative research techniques, human subjects rights, and ethics, LoDico says.

"One year, we turned the community [attendees] into mini-IRBs and gave them case histories to review," she says. "Another year, we turned them into mini bioethics boards with research questions, and they had to decide how to handle them."

Through this lecture series, people who have volunteered to be community members of the IRB, LoDico adds, have approached the IRB.

"The lecture series exposes the community to the types of discussions that happen when they’re evaluating a research study," she says. "Many people think the medical community acts in a vacuum, but this demonstrates that the community has a voice and the regulations require it."

The IRB’s research brochure has been translated into various languages. The Newark community includes Portuguese, Spanish, and other ethnic groups, so when the IRB’s research brochure has been translated into these languages, as well as Braille, LoDico says.

The brochure often is given out when Hopkins or other IRB members speak before community groups, such as religious organizations. And it’s left in public areas of medical units and is handed out at health fairs.

The brochure discusses human subjects research protection, defining what research is and what the rights are for research participants, LoDico says.

The institution held a workshop on human subjects protection. One of the most successful community educational ventures was a workshop held in May 2001 in which 200 people attended a two-day workshop about IRBs and human subjects protection, LoDico says.

One of the IRB’s goals is to start a lecture series that will cover a variety of IRB and research topics, including adequate consent process, community interest in research with the elderly, and people with the inability to give consent, she says.

"This could be a mentoring program for the community to introduce them to how it is to be an IRB member," LoDico says.

While the series could result in more volunteers for the community member positions on IRBs, its main goal is to educate the public and to give them the information they need to make informed decisions about participating in human subjects research, she says.

"It really bothers me to hear that people are afraid to participate in research," LoDico says. "I think they should say No’ because they want to and not because they’re afraid."