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Did a study of Indonesian people who spend most of their days under water violate ethical rules?

Did a study of Indonesian people who spend most of their days under water violate ethical rules? ...

Did a study of Indonesian people who spend most of their days under water violate ethical rules?

A controversial study showed that the Bajau are good divers thanks in part to an enlarged spleen.

In April, a paper showing why Indonesia's Bajau people are such great divers drew worldwide attention as a striking example of recent human evolution. But the study, published in Cell, has created a different kind of stir in Indonesia, where some say it is an example of "helicopter research" carried out by scientists from rich countries with little consideration for local regulations and needs.

"Too many mistakes were made here," says geneticist Herawati Sudoyo, who heads the Eijkman Institute for Molecular Biology in Jakarta. Indonesian officials say the research team failed to obtain ethical approval from a local review board and took DNA samples out of the country without the proper paperwork. And some Indonesian scientists complain that the only local researcher involved in the study had no expertise in evolution or genetics. But Eske Willerslev, director of the University of Copenhagen's (KU's) Centre for GeoGenetics, says the team he headed had a permit from the Indonesian government and worked hard to follow the rules. "I would never participate in research that I felt was unethical," Willerslev says. The government hasn't informed him about problems, he says, but, "If we have made an error that violates national or international guidelines, we would like to apologize for that."

The issue escalated in late May, when Pradiptajati Kusuma, a geneticist at the Eijkman Institute who has also studied the Bajau, suggested in a tweet that the team could have faced prosecution under strict new rules on foreign research, proposed by the Indonesian government and now under debate. "Jail? Possible," Kusuma wrote. He later deleted the tweet, but Melissa Ilardo, the Cell study's first author, says she was so rattled that she canceled a July trip to Indonesia during which she planned to inform the Bajau about her study. "I did everything I could to conduct this research ethically and properly, and this is breaking my heart," says Ilardo, a Ph.D. student at KU at the time of the fieldwork and now at the University of Utah in Salt Lake City.

Sometimes called sea nomads, the Bajau have lived off the ocean for centuries; men spend much of the day underwater to spear fish and harvest sea cucumbers. In 2015, Ilardo took saliva samples from 59 Bajau individuals in Central Sulawesi and measu red their spleen size. The team found that, compared with controls, the Bajau have bigger spleens, which may help prevent hypoxia during long dives by releasing extra blood cells. The researchers also identified a gene variant that may be responsible.

Willerslev's group received a permit for the study from Indonesia's Ministry of Research, Technology and Higher Education, commonly known as RISTEK, in Jakarta and ethical clearance from the Danish National Committee on Health Research Ethics. "We were told that RISTEK permit included local ethical approval as well, thus there was no ethical violation," Willerslev says.

Sadjuga, secretary of RISTEK's Foreign Research Permit Coordinating Team, disputes that account. "We always request ethical clearance from at least one Indonesian research ethics commission," Sadjuga says. (Like many Indonesians, he uses only one name.) Triono Soendoro, who heads the Ethical Commission for National Heal th Research and Development at the Indonesian Ministry of Health in Jakarta, confirms that the team should have had approval from an ethical panel in Indonesia; guidelines from the Council for International Organizations of Medical Sciences also call for local approval.

The team may also have run afoul of regulations when it shipped DNA samples to Copenhagen for analysis. Ilardo says she filed a material transfer agreement (MTA)â€"a contract governing the shipment of research samplesâ€"with her application to RISTEK. But for the transfer of human DNA, she should have sought approval from the National Institute of Health Research and Development in Jakarta, says Siswanto, who chairs that institute. "If this was a requirement, I would have expected that RISTEK would have told me if my MTA was invalid when I submitted it," Ilardo says.

Some Indonesian scientists, meanwhile, are miffed that the only Indonesian name on the paper is that of Suhartini Salingkat, a n education researcher at Tompotika Luwuk Banggai University, a small private institution in Central Sulawesi; according to the paper, she "provided logistical support." Foreign teams "should involve Indonesian scientists in all stages of research," says Mohamad Belaffif, an Indonesian bioinformatician at the HudsonAlpha Institute for Biotechnology in Huntsville, Alabama.

Ilardo says she did try to collaborate with scientists at the Eijkman Institute after RISTEK requested she do so. An email exchange between Ilardo and Sudoyo, provided to Science by Willerslev, shows Sudoyo didn't respond to several requests for a meeting in October 2015, before fieldwork began, and later effectively declined a partnership. "As far as I understand, you have your own partner already in the Bajau project, therefore we are not needed," she wrote. (Sudoyo declined to answer Science's questions on this matter.) Given Ilardo's overtures to the Eijkman Institute, "I would love to understand what went wrong and why they suddenly are so angry," says Rasmus Nielsen of the University of California, Berkeley, another senior author on the paper.

Ilardo says she shared her genetic expertise with Tompotika students in an informal seminar, and made the partnership worthwhile for Salingkat by helping her with a research paper. In Ilardo's application to RISTEK, she also promised to organize a meeting with the Bajau people to tell them about the results of the study. But even if she hadn't abandoned that plan following Kusuma's tweet, some argue it would have been too late. "In general, the return [of research results] should coincide with or slightly precede publication so that the participants are not the last to know," says Conrad Fernandez, a bioethicist at Dalhousie University in Halifax, Canada.

Berry Juliandi, a biologist at Bogor Agricultural University in Indonesia, says the country 's "tangled" system of permits can be hard to navigate for foreign researchers. "The root of this problem is the weak management of foreign research permits in Indonesia," he says. "How could RISTEK approve Ilardo's permit proposal [when] she doesn't have a valid MTA and ethical clearance from an Indonesian institution?" Working with a bigger, more experienced local institution than Tompotika might have helped the researchers avoid pitfalls, he says.

The case comes at a sensitive time, when Indonesian and foreign scientists are debating rules, proposed in 2017, that would strengthen MTA regulations, compel foreign researchers to include Indonesian colleagues as "equal partners" on projects, and include them as authors on every peer-reviewed paper about the work. Outside researchers would also have to submit raw data to the country's research ministry; some violations would carry prison sentences. Some scientists, bo th in Indonesia and abroad, say the law is unworkable and could stifle scientific progress. At the same time, RISTEK says it wants to promote research collaborations, and on 5 July, it launched an online system that makes the paperwork easier and less time-consuming for foreign researchers.

Neither RISTEK nor the Ministry of Health has taken action against the researchers over the Bajau study. A spokesperson for Cell says the journal is satisfied by the researchers' explanation. "The authors sent us documentation indicating that they received consent from the Indonesian government to conduct this research," he says. "We have no evidence that further investigation of this matter is warranted."

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Source: Google News Indonesia | Netizen 24 Indonesia

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