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Challenges involving informed consent in bio-medical research

What is an informed consent and how do doctors and researchers communicate with the patients and subjects?

This was one of questions from the participants at the fourth International Conference on Medical and Health Sciences’ preconference session on ethical dilemma in health research in low-income countries.

Head of obstetrics and gynecology department, Dr Phurb Dorji, said that giving or taking informed consent remained a challenge.

Dr Phurb Dorji said that the English version of the patient consent had to be translated into Dzongkha for research for clarity. “As there are lay persons in our review committee, we ask them to read the document. Because they do not have knowledge about the scientific issues, they are asked whether they would be comfortable as participants.”

He said that the informed consent is written in simple language so that the laymen can get an idea of the experiment and potential risks. “Then, we discuss the potential risks beyond the benefits of the study and see if similar studies have not been done and whether the study would contribute to new information.”

He said that there were people who neither understood Dzongkha nor English, which was a challenge. “We don’t have specific guidelines on it, but in the approval we recommend the use of interpreter for better communication. The ideal way may be audio-visual documentation.”

He said that researchers had to question if he or she could conduct the research on his or her spouse, which would answer if the research needs to be done or discarded.

Dr Phurb Dorji said: “It is norms for conduct that differentiates acceptable from the unacceptable in the context of informed environment.”

He said that a person couldn’t be prosecuted by law based on ethics as it is guided by one’s moral sense.

After the research is done and published, it is shared through Bhutan Health Journal. This, he said, was the last ethical concern. “Although Bhutan is at an infant stage, the ground is set firmly.”

Some of the challenges in developing countries include setting research priorities, inadequate capacity of ethical review committee, standard of care, researcher capacities and post research issues, among others.

Dr Phurb Dorji said that it was only in 2010 that the Research Ethics Board of Health (REBH) was established formally to protect the human subjects in bio-medical research. “The board is recognised in Asia pacific region, Europe and in the United States of America because the board is FERCAP certified.”

Potential researchers were trained on research methodology and peer reviewing in the country, he said.

To reduce ethical dilemma in developing countries, the priorities had to be considered by host and the sponsoring countries, he said. “If our students studying abroad need to conduct study on Bhutanese patients, they need consent from the university in addition to consent in Bhutan.”

Rinchen Zangmo 

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