All research involving humans (including their tissue, data, or medical records) that is conducted (1) at UF, Shands, or NF/SG VAMC facilities, or (2) by faculty, staff, or students from UF, Shands, or the NF/SG VAMC, must be approved by a UF IRB before the research is conducted.

• Introductory Questionnaire - NonHuman/Exempt studies
  NOTE: to qualify you can never have contact with (a) the living individual or (b) their identifiable information. Coded data or tissue can qualify provided you also have a confidentiality agreement.
  NOTE: only the IRB can determine if research is nonhuman.

• Introductory Questionnaire - NonHuman/Exempt studies
  NOTE: retrospective review of medical records that includes the recording or use of any identifiable information (name, medical record number, date of birth) or a code key which links to identifiable information may NOT be considered exempt.
  NOTE: only the IRB can determine if research is exempt.

• Introductory Questionnaire for Full Board and Expedited Studies

  IQ Addenda:	A: Researcher Assurance	J: Vulnerable Subjects
  	B: Banking	K: Children
  	C: Drugs	L: Conflict of Interest
  	D: Devices	M: Expedited Review
  	E: Experimental Procedures	N: Data Safety Monitoring Plan
  	F: Radiation or Radioactive Materials	P: Prisoners
  	G: Gene Therapy or Genetic Testing	S: Behavioral or Psychological Research
  	H: Informed Consent Waiver to Enroll Subjects	V: VA
  	I: Deception or Placebo	W: Pregnant Women, Fetuses, and Neonates

• Protocol (read Protocol Template Guidelines before completing the protocol form)

Unless you request a waiver or modification of Informed Consent in the Introductory Questionnaire, you must also complete at least one of the following Informed Consent forms. If you are collecting, creating, or using health information you must use the HIPAA versions of the form.

• Informed Consent Forms

Other forms:

• Confidentiality Agreement for Specimens
• Unaffiliated Investigator Agreement

Click here for HIPAA forms.

Please read our standardized text if your protocol includes the use of blood draws, employee subjects, MRIs, placebos, randomization, women (pregnancy risk info), tissue storage, student subjects, or videotaping.

• Introductory Questionnaire - Tissue/Data Bank only
• UF/Shands Informed Consent with HIPAA - Tissue/Data Bank only
• Confidentiality Agreement for Specimens - optional, if receiving coded samples from other institutions.

• HDE - new submission - Treatment only - no research involved. If research involved, use Full Board paperwork.