Pregnant women lack understanding of research consequences

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[A provisional pdf copy of the article " Optimizing the HIV/AIDS informed consent

process in India is available from the moderator]

Pregnant women in India may be volunteering for HIV research without fully

understanding the benefits or consequences

Posted By: News-Medical in Medical Study News Published: Tuesday, 3-Aug-2004

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 s 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. "

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