MUNCIE, Ind. -- A recent U.S. Food and Drug Administration (FDA) proposal to include more women in clinical drug and treatment trials is a step in the right direction, says a Ball State University nursing educator.

The September proposal would mandate that women be involved in clinical trials for drugs to treat serious and life-threatening diseases.

"It's been a long, slow process, but people are finally realizing the importance of including women in medical research--and the potential dangers of leaving them out," said Debra Siela, assistant professor of nursing.

Siela's research has looked at differences in how the genders describe symptoms of certain diseases. Understanding such differences may lead to more accurate diagnostic and treatment procedures for both men and women, Siela said.

But according to the FDA, voluntary compliance with 1993 guidelines encouraging participation of women in trials has been insuffecient. One possible reason? Many companies have been hestitant due to the potential of liability concerns, Siela said.

Siela said fear of possible complications with women's health, particularly in their childbearing years, has long been attributed to lack of female involvement in medical research.

However, recommendations from the National Task Force on AIDS Drug Development and the Presidential Advisory Council on HIV/AIDS ask that women with HIV or AIDS not be excluded from trials simply because they are of childbearing age.

"We have to remember that women will not be forced to do something they don't want to. Participating women will be informed of any and all possible risks involved in such studies," Siela said. "And certainly if a woman is pregnant she will not be included in the trials."

Trials designed for men-only diseases will not be affected by the proposal, as long as women-only trials are conducted as well.

A final proposal should be issued before the end of the year.