The Research Plan is a narrative of the study and is a living document to be maintained over the life of the protocol. A Research Plan is required for every protocol submitted for IRB review.
A. Introduction and Background
B. Specific Aims/Study Objectives
C. Methods, Materials and Analysis
D. Research Population, Recruitment Methods, and Compensation
E. Informed Consent Process
F. Participant Privacy, Data Disposition, and Data Confidentiality
G. Potential Research Risks or Discomforts to Participants
H. Potential Benefits of the Research
I. Investigator Qualifications, Roles, and Training
Appendicies to the Research Plan
Complete applicable appendices and attach to the Research Plan. If the following appendices do not apply to the research, do not include. Applicable appendices become part of the Research Plan and are required with each subsequent submission.
Appendix A - Drugs: for research involving the use of any drug, substances, or biologics.
Appendix B - Medical Devices: for research involving the use of a medical device.
Appendix C - Ionizing Radiation: for research involving the use of ionizing radiation (X-ray, DEXA scan, etc.).
Appendix D - HIPAA: for research involving the use of Protected Health Information.
Appendix E - Genetic Materials: for research involving coded or identifiable DNA samples/genetic information.