Informed consent in healthy volunteers: Whom does it protect?

In the next decade, centres for research on the safety, tolerability or bioequivalence of new molecular entities will be confronted with numerous compounds, a narrowing time frame for performing Phase I research activities, and a growing demand for healthy volunteers for participation in non-therapeutic drug studies. A written informed consent (WIC), although required by law for medical investigators, appears to be similar to a contract, but strictly speaking it is not. A WIC is a unilateral statement by a healthy volunteer declaring to take on a number of obligations and to have understood that he has certain rights. The volunteer must accept or reject the statement as a whole because no individual alterations are allowed. Despite this, it is felt that the WIC assists in maintaining a balance between non-exploitation and the struggle for profit by avoiding unrealistic expectations on both sides.