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.
The researchers found that women’s understanding was frequently inadequate, particularly for difficult concepts such as the social risks associated with accepting HIV testing. Adequate understanding of the key subject areas was boosted from 38% to 72% by using simple visual aids during group education sessions. If the same visuals were used again during individual follow-up counselling sessions, the women’s level of understanding rose to 96%.
“This study demonstrates that complex constructs such as informed consent can be conveyed in populations with little education and within busy government hospital settings and that the standard model may not be sufficient to ensure true informed consent,” writes Shankar.
She continues: “As the visuals and this informed consent assessment tool are made available within India, it is hoped that they will be utilized by other government and non-governmental organizations throughout India to improve communication regarding HIV/AIDS.”