Protecting the Rights, Safety, and Welfare of Study Subjects
Investigators are responsible for protecting the rights, safety, and welfare of subjects who participate and enroll in their studies. This responsibility includes adhering to the protocol so that study subjects are not exposed to unreasonable risks. The IRB can not approve research when the protocol does not describe the study procedures in sufficient detail to ensure compliance during study execution. See the IRB's webpages on Protocols and Writing a Protocol and the IRB's Protocol Templates webpage which explain the CHOP IRB's expectations regarding protocols submitted for review and approval.
Oversight of Study Staff
It is common practice for investigators to delegate certain study-related tasks to their study staff and colleagues listed as members of the investigative team. When tasks are delegated by an investigator, the investigator is still responsible for those tasks and for providing the necessary level of supervision of those to whom tasks are delegated. The investigator is accountable for regulatory violations resulting from failure to adequately supervise the conduct of the clinical study.
The investigator should ensure that any individual to whom a task is delegated, is qualified by education, training, and experience (and state licensing or hospital certification where relevant) to perform the delegated task. Appropriate delegation is exceedingly important for tasks considered to be clinical or medical in nature, such as evaluating study subjects to assess clinical response to an investigational therapy (e.g., global assessment scales, vital signs) or providing medical care to subjects during the course of the study. However, all study procedures are ultimately the PI's responsibility.
The investigator should maintain a list of all appropriately qualified persons to whom significant research-related duties have been delegated. This list should also describe the delegated tasks, identify the training that individuals have received that qualifies them to perform delegated tasks (e.g., can refer to an individual's CV on file), and identify the dates of involvement in the study. An investigator should maintain separate lists for each study conducted by the investigator.
The investigator should ensure that there is adequate training for all staff participating in the conduct of the study, including any new staff hired after the study has begun to meet unanticipated workload or to replace staff who have left. The investigator should ensure that staff:
- Are familiar with the purpose of the study and the protocol
- Have an adequate understanding of the specific details of the protocol;
- Are aware of all applicable regulatory requirements and accepted standards for the conduct of the study and the protection of human subjects;
- Are competent, experienced, certified and licensed to perform the delegated tasks;
- Are informed of any pertinent changes during the conduct of the study and receive additional training as appropriate.
When the sponsor provides training for investigators in the conduct of the study, the investigator should ensure that staff receive the sponsor's training, or any relevant information (e.g., training materials) from that training that pertains to their role as a member of the study team.