Congruency is evaluated for several parts of the grant application and the protocol. Information to be reviewed includes, but is not limited to:

Key personnel

• As listed on the proposal

General scope of work

• Specific aims/protocol objectives

Human Subjects

• Participant population (number of subjects, age, gender, inclusion/exclusion criteria) 
• Intervention (surveys, interviews, focus groups, etc.)
• Recruitment and informed consent process o Subject compensation (feasibility of financial commitments made to subjects)
• Protection of human subjects - Potential risks and benefits
• Privacy and confidentiality - Protection of personally identifiable and/or protected health information
• Source of materials (e.g., Database or collaborator – is a DUA needed?)
• Data and safety monitoring plan
• Collaborators and performance sites
  • Reliance agreements (external IRBs), multiple IRBs, sIRB
  • Letters of cooperation

Animal Research

• Species/strains
• Animal numbers and age/sex proposed
• Procedures (e.g., surgeries, tumors, agents administered (route, dosage), etc.)
• Additional sites for animal experiments – is a Memorandum of Understanding (MOU) needed?

Biosafety/Radiation Safety/Chemicals

(Reviewed by EHS directly)

• Are you using rDNA, synthetic nucleic acids or biological materials (e.g., cancer cells, biological toxins, microorganisms)? – Make sure to submit or update your MUA.
• Do you have up-to-date sublicenses, registrations for radioisotopes, x-rays, lasers?
• Are you working with controlled substances, hazardous chemicals, select agents, …?

Additional Examples

Information that may be requested if not readily available to RIO include:

• Full submitted proposal, including specific aims of the research and budget
• Approved or submitted IRB, IACUC, or Biosafety committee protocol number(s)
• Animal or Human Subjects Research work scope
• For collaborations, a clarification of the work scope with respect to the University of Houston’s role in the project
• For collaborations with subrecipients, where the University of Houston is the primary award recipient, if the Animal/Human Subject Research is taking place at another University or entity, then the appropriate approval letter(s) will be requested
• Additional research project clarifications as necessary