Nokea
The nurse, assisting with Phase I drug studies, is talking with a woman who asks, Why can't I participate in this study? What would be the nurse's best response?
Correct Answer: A
Rationale: Phase I drug trials usually involve healthy male volunteers because chemicals may exert an unknown and harmful effect on ova in women which could result in fetal damage when the woman becomes pregnant. Drugs are tested on both men and women, but women must be fully informed of risks and sign a consent stating they understand the potential for birth defects. Women are not more prone to adverse effects of medications. Although some drugs may affect women differently than men, this is a rationale for why drugs need to be tested on women, not an explanation of why women are not included in a phase I study.