A. Protocol Information Title of Protocol IRB protocol number* *will be assigned upon submission B. Principal Investigator (PI) Name Degree/Title Dept. & College at RFUMS Email Phone Most recent CITI training* C. If this is a postdoctoral or student project (supervised and sponsored by the faculty PI) provide name of the trainee: D. List all members of the research team (add rows as needed): Name & Title Email RFUMS Dept. & College; Work Address (if non-RFUMS) Role in project Date of recent CITI training* * Include pdfs of all training certificates with application E. Funding information Federal funding agency (direct grant award) Federal flow-through funds (subcontract/collaborator) Non-federal grant or sponsor Other None External funding agency/sponsor information including Grant or Sponsor’s Project ID number: Part II: Self-Assessment of Exemption Criteria Even though the IRB may determine that some research is exempt from continuing review per federal regulations, adequate provisions still need to be in place to protect research participants. In making its consideration of exempt status, the IRB asks that the PI provide a self-assessment that this research project qualifies for exempt status. The IRB must agree with this assessment and also must determine that: a) The research involves no more than minimal risk to participants. b) Selection of participants is equitable.
B. Will identifiable data be available to anyone other than the PI? If yes, explain who will have access to the data and why access is required C. Where will the data for this study be stored? D. What security provisions will be taken to protect and maintain confidential data (password protection, encryption, etc.)? E. How long will the data be stored? F. Will you be returning individual research results to participants? Yes No Part VII: Research Collaborations and Other Approvals A. Does this research project involve collaborations with any personnel or sites outside of Rosalind Franklin University? If yes*, briefly describe the collaboration (with whom and for what purpose): B. Is this research proposal being reviewed by any other institution’s IRB? If yes*, please provide information below: *Additional requirements for ensuring appropriate IRB oversight may apply. These requirements are often dependent on whether or not the site/personnel is considered “engaged” in human subjects research according to federal definitions. For example, the IRB may require a signed individual investigator agreement (IIA) or an institutional authorization agreement (IAA). Contact the IRB office (irb@rosalindfranklin.edu) to determine how IRB oversight of the research activity with the external site/personnel should be addressed. C. Does this research proposal require approvals from any other committee at RFUMS (for example, Biosafety, Conflict of Interest, OSR) or any other outside entity (for example a site requiring a data use agreement or a certificate of confidentiality)? If yes, please specify below and provide documentation. Part VIII: Conflict of Interest (COI) Disclosure Rosalind Franklin University Policy requires that personnel conducting research involving human participants at Rosalind Franklin University disclose any significant personal conflict of interest that would reasonably appear to be affected by, or potentially influence the research project. A personal interest is any interest held by the individual that is not associated with employment or affiliation with the