Investigator-initiated clinical research requires the development of a protocol. The protocol is a document that describes how a research study will be conducted: the objective(s), design, methodology, statistical considerations and organization of a study, and a plan to ensure the safety of the research subjects and the integrity of the data collected. Seton provides the Topics to Address in a Research Proposal as a guide for investigators to follow when organizing their clinical research project. According to the ICH Good Clinical Practice guidelines, a protocol should include the following components:
- Title page (general information)
- Background information
- Study design
- Selection and exclusion of subjects
- Treatment of subjects
- Assessment of efficacy
- Assessment of safety
- Adverse events
- Discontinuation of the study
- Quality control and assurance
- Data handling and record keeping
- Publication policy
- Project timetable/flowchart
The NIH also provides many resources for protocol development to assist investigators in writing and developing clinical research protocols that are in compliance with regulatory/GCP requirements. Some NIH institutes have a mandatory requirement for using their protocol template. Studies conducted at Seton must also follow guidelines for developing the Informed Consent that will be used in their study to enroll research subjects. As a Catholic institution, Seton is required to conduct research in compliance with Ethical Religious Directives.
Ethical and Religious Directives for Catholic Healthcare Services
The purpose of the Ethical and Religious Directives is two-fold: first, to reaffirm the ethical standards of behavior in healthcare that flow from the Church’s teaching about the dignity of the human person; second, to provide authoritative guidance on certain moral issues that face Catholic healthcare today.
All research within the Seton Family of Hospitals must follow the ethical standards set forth in the Ethical and Religious Directives. Any questions regarding these Directives should be addressed with Seton Research Administration.