Researchers who want to conduct experiments on humans, or on viruses and bacteria that infect humans, can face daunting hurdles in the Arab region to get a government’s approval for their plans. But some scientists have found innovative ways to cope.
The regulation of research on human subjects has roots in dark episodes in medical history: the Nazi experiments on prisoners and U.S. government-supported research that studied African American men with syphilis but intentionally left them untreated. In 1964, the World Medical Association established guidelines, known as the Declaration of Helsinki, for human-subjects research that have been regularly updated.
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Under these guidelines, and other ethics rules about working with samples of human tissue, governments need to establish processes to keep the public from being infected by viruses and bacteria and also ensure that participants have knowingly consented to their tissue being used in experiments.
But in some Arab countries, researchers say permission is unreasonably difficult to get, takes more time than it should, and the approval processes aren’t particularly clear. All of this can make it difficult for researchers to plan their work and use their hard-won funding.
Avoiding Working With Human Tissue
Marieh al-Handawi is a chemistry researcher at New York University–Abu Dhabi who is trying to create heat-proof vaccines that don’t need to be refrigerated—this would allow vaccination supplies to reach the most isolated places on earth. (See a related article, “U.A.E. Researcher Joins Quest for Heat-Resistant Vaccines.”)
In the first stages of her research, she decided not to investigate microbes that could infect humans. Instead, she opted to see if she could produce a plant-virus vaccine that could withstand high temperatures. She did this because it meant she wouldn’t need to bother with the paperwork required in working on a human pathogen. “It was just about proving the concept,” she says. “A plant virus meant we could get started right away.”
Now that she’s proven her methods work, al-Handawi wants to push on with her research to see if it would also work for a virus that infects humans. “We would like to try and stabilize a real vaccine,” she says. “But we believe it will be a long process and permissions would be required.”
But she dreads the process so much that that she won’t start it until other aspects of the project are finalized. “Once we get the funding, we will go ahead and figure it out,” she says.
Until then, she’s putting off the paperwork.
Getting Blood Samples
The need for governmental approval doesn’t apply to every kind of scientific investigation that involves humans. Along with clinical trials of treatments, research that involves collecting certain parts of human tissues or experiments that include infectious microorganisms must also be reviewed.
It’s usually a lot easier to do observational studies, which are less invasive.
Jumana Saleh’s work is one such example. She’s a professor in the biochemistry department at Sultan Qaboos University in Oman and is trying to find out why such a high proportion of women die from heart disease. She analyzes patients’ blood for chemical signals of heart disease risk factors. (See a related article, “Researcher in Oman: Why Do So Many Postmenopausal Women Die of Heart Disease?”)
For this kind of research, she says she doesn’t need to seek approval from the government, just the normal university permission. (Universities typically set up committees to review the ethics of research.) The harder part of getting started in her research, she says, is convincing patients in hospitals and members of the general public to consent to be part of the research.
“This is my issue, how to make people understand that this will help them,” she says.
However, she says her gender sometimes helps. “As a woman, I find it easier to be involved with studies where women are participants,” she says. “I have easy access.”
Men on the other hand may find it more difficult to include female patients in their studies because of cultural constraints. (Some female patients in Gulf countries, for example, refuse to be treated by men.)
A Waiting Game
But some research, in particular experiments that seek to test a new product on humans, require permissions from the relevant government authority—along with ethical approval from universities—and this isn’t speedy.
For example, Zainab al-Balushi, a chemistry student at A’Sharqiyah University, in Oman, has developed a skin patch to deliver critically needed nutrients to anorexia sufferers in emergency situations. (See a related article, “Anorexia in the Middle East Is an Overlooked Problem, Say Researchers.”)
This prototype was created through experiments carried out on mouse skin, but al-Balushi now wants to move her product on to the next phase.
“This was done in vitro and we’re currently waiting for approval for clinical use in humans,” she says. The application was submitted more than four months ago, but she is still waiting to hear back.
Researchers often complain about a lack of funding. Boosting financial backing for research could be hard to achieve throughout the region, but researchers believe that when they do win funding, governments could streamline regulatory approval while still protecting both the subjects of research and the general public.