Research Volunteers: The Heart of HIV Science
Research volunteers offer a profoundly personal gift that is essential to the scientific process. Their heroism is valued highly by scientists, who work diligently to protect the health and safety of study participants.
“We are not looking for guinea pigs or human Petri dishes,” says Dr. Stephen J. Brown, Medical Director of AIDS Research Alliance. “In fact, how a new drug or vaccine will affect human blood and tissue has been tested long before it is given to research volunteers.”
“Research volunteers tell us how a promising new treatment or vaccine will work in the real world—where people eat and drink vastly different foods, get colds and flus, consume over-the-counter drugs, and maintain their health in completely different ways due to gender, race, fitness, lifestyle, culture, or sexual orientation,” Dr. Brown explains.
Carneka Grant, a community educator with AIDS Research Alliance, tells potential volunteers: “It all boils down to this: If you want a world without AIDS, then you can help. Indeed, HIV science will never find a cure or a vaccine without you.”
“Because of AIDS research, I have treatment options. Because of
AIDS research, I am still alive. Because of AIDS research,
I have been given 23 years to pursue my dreams.
Because of AIDS research, I have hope.”
—Brian Glover, Research Volunteer
Why Are Research Volunteers Needed?
Every year, thousands of Americans—and millions worldwide—still die of AIDS. Today’s HIV treatments—which AIDS Research Alliance helped to develop—are not a cure. Rather, current therapies can only suppress the virus and slow the progression of HIV disease. While current anti-HIV drugs (“antiretrovirals”) have saved millions of people from an early death, no existing HIV treatment eradicates the virus from the body.
HIV expresses itself differently in women and people of color, and those differences may affect the therapeutic choices available to them. For others, some anti-HIV drugs cause serious, long-term side effects, which can shorten patients’ lives. Still other HIV patients have developed a resistance to the only antiretroviral drugs that are effective against the strain of the virus in their bodies. Finding improved treatments, as well as a cure, continues to be a top research priority that requires dedicated research volunteers.
For every two people who access HIV treatment, another five become infected worldwide. At that rate, we will never be able to “treat our way out” of the AIDS epidemic. Instead, HIV researchers must find a vaccine and a cure. Imagine if AIDS Research Alliance could protect HIV-negative people from ever becoming infected.
Because most people at risk of HIV/AIDS worldwide are heterosexual women of color, researchers are trying to develop an effective microbicide, which is a special lubricant that can halt the sexual transmission of HIV. Once found, an effective microbicide could be used privately by women without the knowledge or consent of their sexual partners so they can take control of their own health. HIV scientists will need research volunteers to help develop and test HIV microbicide candidates.
“As a research volunteer, I helped scientists develop a test to protect the blood supply from HIV. That means a lot to me. That HIV antibody test has had a lasting impact on the world.”
—C. Novak, Research Volunteer
Who Should Volunteer for HIV Research?
Anyone can volunteer for AIDS research. AIDS affects the young and old, women and men of every race, as well as rich and poor alike. Yet, AIDS affects the African-American and Latino communities disproportionately more than it does whites. Consequently, scientists need research volunteers from each of these groups. Volunteer pools that are gender diverse and multi-racial ensure that every community will benefit from promising new drugs.
Each clinical trial is different and requires different types of volunteers. Even when a study ends unsuccessfully, scientists still learn information that will improve future studies. In this way, research volunteers stand on the shoulders of those volunteers who came before them, and each volunteer makes a valuable contribution to scientific progress.
Some studies require only one clinic visit, other studies require several visits or years of follow-up. While some studies involve answering questions on a survey, others may involve taking pills. Often studies offer patients without health insurance a good way to gain access to vital drugs. Some studies offer volunteers financial compensation, while other studies do not.
The best way to learn if a research study is right for you is to ask a few questions:
1. What exactly is being studied?
2. What procedures will be done and how long will the study last?
3. What are the known risks and benefits of study participation?
4. Will I be compensated for participating?
5. Will I receive help to get to and from the research clinic?
6. Once the study is complete, can I learn any results of the study?
People who volunteer for research usually have their own reasons for doing so. Whatever their reason, they are heroes and heroines, doing vital work that will eventually make a cure for AIDS and an effective HIV vaccine possible.
Is Volunteering for Research Risky?
Scientists take every precaution to protect research volunteers from harm and to respect their privacy. One way the U.S Food & Drug Administration [FDA] protects research volunteers is to place in-human clinical trials—where a new drug is given to research volunteers for the first time—at the very end of a long process of laboratory tests and pre-clinical studies in test tubes and in animals. While these pre-clinical studies cannot rule out all potential complications, they rule out harmful or toxic drugs long before humans are exposed to them.
Scientists also protect trial participants by establishing strict rules about who can—and who cannot—participate in a clinical trial. These rules are called inclusion or exclusion criteria. For example, a particular study may seek only men within a certain age range, who are HIV-negative and sexually active. Inclusion and exclusion criteria not only help scientists answer specific research questions, but they also exclude anyone who might be harmed by the study.
Even with all of these safeguards, some unexpected side effects are still possible, which is why studies typically require volunteers to undergo regular physical examinations and blood tests so that researchers can look for and identify unusual symptoms or side effects. Volunteers usually receive compensation for travel back and forth to the clinic so that these check-ups are not a burden.
More importantly, if any study participant experiences a medical problem related to the drug being studied, he or she receives free medical care until the problem is resolved. By law, this follow-up care is offered in exchange for the volunteer’s participation in the study. Given all of these safeguards, only a tiny fraction of volunteers ever experience serious or long-term problems associated with a clinical trial.
How Researchers Keep Volunteers Safe
The National Research Act of 1974 establishes the legal rights of research volunteers, as well as the ethical responsibilities of researchers. All medical research conducted in the United States must follow the strict regulations established by this law. Research volunteers appreciate two items required by this law: (1) “informed consent”; and (2) independent medical review boards that protect the interests of study volunteers.
Every research volunteer must give his or her “informed consent” prior to participation in a research study. This means that every volunteer must sign a document, declaring that he or she understands what the study seeks to discover, what is likely to happen over the course of the study, and what is expected of research volunteers. Before signing this document, every step of the trial must be explained in the language the volunteer prefers. Often a volunteer’s first visit to a research clinic involves private discussions with several healthcare professionals to review this document in detail.
Volunteers cannot participate in a study until they give their informed consent, but researchers often review each volunteer’s consent documents several times over the course of the study. This helps volunteers remember their rights, such as a right to privacy and confidentiality. There is a good reason why study participants are called “volunteers,” because trial participation is completely voluntary and every participant has the right to withdraw from the study at any time for any reason.
Before a clinical trial can begin, an Institutional Review Board (IRB) must first approve the study’s “protocol.” A protocol describes every step of the study and how it will be accomplished. It also details the type of volunteers that will be required, how they will be treated over time, and how the researchers will protect the safety and rights of research volunteers. In this way, IRBs protect research volunteers before and during every study.
IRBs are autonomous bodies that are not paid or supervised by the researchers conducting the study. IRBs typically include scientists, physicians, lawyers, psychologists, and interested members of the general public. Because IRBs are autonomous, they hold the power to approve or reject a study’s research protocol.
In addition to IRBs, every large-scale research study also creates an independent and separate Data and Safety Monitoring Board (DSMB). Members of a DSMB are the only ones allowed to take “sneak peeks” at the data being collected in a clinical trial. No one else—not even the lead researcher—is allowed access to the data being collected. DSMBs can—and sometimes do—stop research studies early, if they think continuing the study could be harmful to research volunteers.
Volunteers, the Heart of HIV Research
When asked directly, most people say they would like to join a research study, but only about 15% of people in the United States actually volunteer for medical research. So medical research volunteers continue to be a special breed of people who enjoy helping others.
While there may be risk involved, most research volunteers stay focused on how their altruism will benefit others in the future. In fact, surveys conducted among America’s research volunteers reveal that most volunteers liked their experience, and felt that they benefited significantly from study participation. Most say they would agree to volunteer again.
Our ability to treat HIV today is due entirely to research volunteers who stepped forward years ago. Today’s research volunteers—standing at the heart of HIV science—will eventually help researchers find a cure for AIDS and an HIV vaccine.
To join a current study:
• Interested in joining a future clinical trial
• Interested in helping us recruit study volunteers, or
• A former research volunteer, who wants to stay involved
“A donor may give AIDS Research Alliance $5.00 or $1,000,000
and ask, ‘What does my money do exactly?’ Well,
it changes peoples’ lives forever, and I’m still here to prove it.”
—John Paul Valdez, Research Volunteer
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