WASHINGTON, United States (CMC) — The Pan American Health Organisation (PAHO) says that after years of scientific research involving thousands of children who lost their lives to childhood lukemia – treatments are now available and this can be attributed to research.

According to the regional health organisation, the vast majority of children with childhood leukemia today survives.

“Doing research is the only way to discover the cure for a disease or the solution to a health problem,” said Carla Saenz, PAHO’s regional advisor on bioethics. “But the research is not done by researchers alone; it requires the generous contribution of people as participants. So, we have an obligation to ensure they are always treated ethically.”

PAHO said all research that involves people must be reviewed and approved in advance by a committee that ensures that the proposed research is ethical.

But PAHO said it is not always easy to determine what it means to treat people who participate in research in an ethical way, especially in low-resource settings.

The Council for International Organizations of Medical Sciences (CIOMS), founded under the auspices of the World Health Organization (WHO) and the United Nations Educational, Scientific and Cultural Organization (UNESCO), recently published a new edition of its International Ethical Guidelines for Health-related Research Involving Humans.

PAHO said these are the most comprehensive, up-to-date and detailed international consensus guidelines for human research.

The first edition of CIOMS’ ethical guidelines for research dates back to 1982, PAHO said.

Before that, it said CIOMS had ethical guidelines for biomedical research and others for epidemiological research.

“However, the new edition of the guidelines covers all areas of health-related research involving human beings, whether they are directly involved—for example, in a clinical trial or study where the health of pregnant women in areas with Zika is monitored of pregnant women in areas where there was Zika—or because the research uses clinical histories or tissues with individually identifiable data,” PAHO said.

It said the new edition provides 25 guidelines and specific explanations that facilitate the understanding and implementation of each one.

There are a number of significant changes compared with the previous 2009 edition, PAHO said.

For example, it said the new guidelines: Require that all research with human subjects have social and scientific value.

“If a study does not have the potential to generate knowledge that would help improve the health and well-being of people, then it is not ethical,” PAHO said.

It said the new guidelines emphasize low-resource settings, with the aim of facilitating an analysis that ensures that research is always fair towards the populations living in those contexts, for example, by providing them with medicines or interventions that result from the research.

The guidelines specify that these conditions are not limited to low-income countries but can be found even in high-resource countries.

The new guidelines introduce the concept of broad informed consent, “so that those who participate in research can authorize the use of their biological materials and related data in future research.

“The importance of being able to give informed consent for future studies arose in the context of the Ebola outbreak,” PAHO said urging the use of broad informed consent during the Zika outbreak in the Americas, including the Caribbean.

PAHO said the new guidelines also include “a guideline for community engagement, that is, a way to ensure the relevance of the proposed research to the affected community, as well as to show respect to communities, their traditions and norms and to gain their acceptance.”

Additionally, the new guidelines redefine the concept of vulnerability, “so that it is not a simple label for entire groups of people but rather facilitates an analysis of the specific characteristics that can make people or populations more vulnerable to harm when they participate in research,” PAHO said.

It said this approach to vulnerability allows ethics review committees to make a “more detailed analysis and to be better able to protect vulnerable people, rather than simply excluding them categorically from research, as has traditionally been done with the aim of protecting groups that are considered vulnerable (such as children and pregnant women).”

PAHO said these categorical exclusions have led to a scarcity of evidence on the diagnosis, prevention and treatment of diseases that affect these groups; the CIOMS guidelines emphasize that this inequity must change.

The new guidelines revise the approach to research with pregnant women to allow a more detailed analysis of the conditions needed to protect pregnant women, while also promoting research that involves them, PAHO said.

“These guidelines show the way the right way to conduct ethical research in health, the only acceptable way to produce discoveries that improve people’s health and well-being,” said Saenz, who was among the bioethics experts who contributed to the revision of the new guidelines.