Ethical and cultural concerns in sexual function assessment.

The ethical and cultural issues accompanying sex research methods are rarely discussed. The present remarks briefly examine three previously described ethical principles--respect for people, beneficence and justice--as they might relate to sexual dysfunction assessment in clinical trials. Given the fact that sexuality is a social behavior and the outcome measures are reliant on some form of self report, there are specific pressures on investigators to conduct research assessment that respects ethical principles and cultural values. Examples with respect to screening criteria and participant selection are discussed. Recommendations include: (a) excluding participants with selected sexual and non-sexual diagnoses, psychosocial behaviors and habits; (b) including proportional ethnic groups as well as non-heterosexual participants; and (c) considering the couple, rather than just an individual, as study subjects who each require medical and psychosocial screening, assessment, and informed consent.