Pregnant women may be volunteering to participate in HIV research without fully understanding the benefits or consequences, according to a study published today in BMC Medicine. Volunteers’ comprehension of studies or treatments should be tested to ensure that their consent is truly informed and voluntary, say the study’s authors.
International regulations for ethical conduct of research require that volunteers are presented with detailed scientific and legal information before consenting to take part in a study. However, many funding agencies are unaware of the regulations, and there are no requirements for researchers to check volunteers’ understanding of this information.
The study’s authors, from Johns Hopkins University in Pune, India and Baltimore, USA found that use of visual aids significantly improved volunteers’ understanding of information relating to informed consent. They suggest that, “the current requirements of informed consent procedures are inadequate and that it should be a process that communicates information in an effective manner, allows for reiteration of information, and includes an evaluation of the patients’ knowledge prior to signing the informed consent document.”
Dr. Anita Shankar and her colleagues interviewed pregnant women who had just volunteered for an HIV study being carried out by scientists at an antenatal clinic in a hospital in Pune. Her team tested the patients’ knowledge of the study information that had been given to them during the informed consent process.