Adverse events and discomfort in studies on healthy subjects: the volunteer's perspective

Abstract

Adverse events and inconveniences are inherent to nontherapeutic studies in healthy subjects. From the volunteer's perspective it appears that the incidence of adverse experiences in such studies exceeds the reported frequencies from investigators considerably. This finding suggests that investigators are usually not aware or able to ascertain the true incidence of adverse events. The present survey also confirms that pertinent information on the personal history may be unreliable. Volunteers are reluctant to answer questions regarding, in particular, their smoking habits, caffeine and alcohol consumption. Regarding the matter of informed consent, a noteworthy contradiction between the volunteers' attitude and behaviour became apparent. Although the volunteers admit that even rather minor adverse events ordinarily would discourage them, they still consent to enrollment. In view of this apparent contradiction, there is no alternative to the investigator's personal responsibility to counsel and protect the subject. Surveys such as this one may contribute to the awareness that the explicitness of GCP guidelines merely define the format, but not the content quality of these fundamental ethical values, which remain the unique burden and challenge of the investigator.

Healthy participants in phase I clinical trials: the quality of their decision to take part

“…Admittedly, the importance displayed regarding the monetary compensation was no surprise, as these results concur with those found in other studies (Hasser et al , 1977; Bigorra & Banos 1990, Hermann et al. 1997).…”

More than the money: A review of the literature examining healthy volunteer motivations

“…Of the twelve 13-24 studies identified, six were conducted in the United States, 15-17, 19, 22, 24 five in Europe, 13, 14, 20, 21, 23 and one in Malawi. 18 The Mtunthama study, which took place in Malawi, was the only published research on this topic from a developing country identified by our review.…”

“…13-16, 21-24 Access to healthcare was the main reported motivation in the Mtunthama study, 18 as well as the main incentive for the elderly volunteers studied by van Gelderen et al 20 Helping to contribute to science and medicine, 13, 15, 19, 21, 23 helping others, 15-17, 19-23 meeting people, 17 relaxing 17 or wanting to participate in something important, 19 learning more about science and medicine, 14, 16, 17 and curiosity 13, 14, 16, 18, 19 were other reported motivations for participation (Table 2, Table 4). …”

“…18 Hermann et al found that while 53% of volunteers said their main motivation was money, many had secondary social motivations—many saw studies as a good way to meet people and make friends. 23 While money may be necessary to attract healthy research volunteers to participate in studies, healthy volunteer motivations are not simple or one-dimensional. Instead, these studies suggest that although money might interest healthy volunteers in seeking information about study participation, there are other important factors involved in motivating volunteers to enroll or remain in research.…”

“…13 Herman et al reported that volunteers consider staff behavior, their relationship with other volunteers, and other aspects of the study environment to have a large impact on their well-being while participating in the study. 23 A personal approach to recruitment and interacting with research volunteers may have an effect on recruiting repeat volunteers, and could even have an impact on recruitment of naïve volunteers, especially if word-of-mouth is a major source of information about research projects. This facet of volunteers’ experiences may influence decision making and have an impact on overall interest in research participation, enrollment, and retention of volunteers.…”