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Costa Rica approves legislation to regulate scientific research on humans

November 20, 2013

A majority of lawmakers on Tuesday evening approved a new piece of legislation that outlines the parameters for conducting scientific research on humans for health purposes, an action ordered three years ago by the Constitutional Chamber of the Supreme Court, or Sala IV. 

At the time, the Sala IV suspended all such research until a law to regulate it was approved. The ruling halted 124 clinical experiments and 235 epidemiological studies.

The bill, No. 17,777 and now known as the Biomedical Research Regulatory Law, establishes regulations that must be followed by both public and private researchers.

It states that biomedical research in Costa Rica must be designed for developing or contributing to knowledge on human health, and that it must be guided by the principles of respect for human dignity.

It also stipulates that participation in a biomedical investigation must be voluntary and, therefore, participants must not be paid for it. Participants only would be reimbursed for costs associated with participation.

As a requirement, volunteers must consent to participation by signing every page of a written authorization.

“The approval of this bill is a milestone for the country. The government greatly thanks lawmakers of all parties for reaching an agreement to pass this legislation that will enhance scientific and business growth in the country,” Presidency Minister Carlos Ricardo Benavides said in a press release on Tuesday.

The bill was approved in a first round of debate by 37 lawmakers, while eight voted against it.

Accessibility Without Exclusion Party lawmaker Víctor Emilio Granados voted against the bill arguing he believes that “this new legislation authorizes the participation of underage volunteers or those with some level of mental disability,” as the drafting states that these people can participate “as long as the research results may produce direct health benefits, or when comparable results in older individuals or in those incapable of consenting cannot be obtained.”

Granados argued that the International Convention on the Rights of Persons with Disabilities ensures that persons with severe mental disabilities should not be subjected to biomedical research. Lawmakers agreed to send the approved draft to the Sala IV for consultation.

On her Twitter account, President Laura Chinchilla criticized the delay that the consultation would generate, saying, “Despite the urgency to vote in a second debate the Biomedical Research Law, and after years of debate, lawmakers now will consult with Sala IV.”

The law also would stipulate that the government must guarantee the rights and safety of research participants, and ensure compliance with ethical standards.

The bill would create a new agency called the National Health Research Council (CONIS), which would form part of the Health Ministry and have the responsibility of “ensuring the quality of all research and its strict adherence to human rights.”

Although the draft must receive the Sala IV’s approval, lawmakers expect to vote it into law during a second round of debate on Thursday.

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