Rights and Protections for Clinical Research Staff

Clinical research is important to the advancement of medicine, providing knowledge about how best to maintain health and treat disease. Clinical trials require careful planning to safeguard the health and rights of individuals who participate in research. As such, the review and approval of study protocols by relevant authorities before a study commences is critical. A key but often overlooked aspect of this is to ensure consideration is given not only to the needs of research participants, but also to those of study team members. This includes sufficient attention to the rights, interests, and competency of the study staff.

A clinical trial was conducted in a medical center, led by a renowned physician who recruited a trained and experienced staff nurse to be a part of the clinical team that was to conduct the study under the direction of the researcher. Part of the nurse’s role was sample processing, which included working beyond typical hours. This task was not mentioned in the official job description of a nurse at the institution. Before the study began, the lead researcher agreed verbally to compensate the clinical trial staff for all their performed duties; however, the conversation was not memorialized in writing. Upon completion of the study, the researcher did not pay the staff nurse. She felt wronged by this and considered escalating the issue to other more senior members of the institution, but she was conflicted about doing so because the lead researcher was a superior who controlled yearly performance evaluations and assessments for potential promotions.