Investigator Guidelines

Additional documentation on human research related issues are located at:

Adults Lacking Capacity to Consentdecisionally-impaired, cognitive capacity, guardian, legally authorized representative, LAR, proxy, durable power of attorney, health care surrogate, incapacitated
Adverse event, deviation, unanticipated problem, and noncompliance reportingAE, SAE, serious, expected, unexpected
Advertising and Recruiting for Research Subjectsads, advertise, advertisement, recruit, recruitment, cold calling,
Alachua County School System ResearchACPS, SBAC, students, secondary, high school, middle school, elementary, education
Ancillary Committees
Animal Research – Use of Animals as Part of a Human Subjects Research Study
Assent of Childrenminor, pregnant, pregnancy, signature, adult
Auditing Research StudiesQA, QI, random, for cause
Bankstissue, data, future use, registry, gatekeeper,
Case Reports
Ceding Review to an External IRBreliance, sIRB, cede, ceded
Certificates of ConfidentialityCoC, NIH
Changes to IRB Approved Research Protocolsamendment, revision, revise
Classroom Activities as Researcheducation
Clinical Consents and Research
Clinical Trials – GCP Obligations (HRP-816)good clinical practice
Closed or Closed to Accrual Studies
Community Based Participatory ResearchCBPR
Compounding Pharmacy
Concerns or Complaints about Research
Consent2Share Study Subject Recruitment
Consenting Subjects Who Cannot Speak or Read EnglishDeaf, illiterate, English, language, translation, fluent, witness, short form consent, cultural considerations, interpreter,
Continuing Review
Data Sharing in Research
Decedent Researchdead, nonliving
Deception in Researchincomplete disclosure, debrief, debriefing
De-identified Human Specimens and/or Data, IRB Pre-reviewcoded, anonymous, de-identifiable
Department of Defense Obligations (HRP-810)DOD
Department of Education Obligations (HRP-813)ED
Department of Justice Obligations (HRP-812)DOJ
Device StudiesFDA, test article, IDE, medical device, significant risk, insignificant risk, SR, NSR, investigational, abbreviated IDE,
DNP Studentsdoctorate of nursing program
Drug StudiesFDA, test article, IND, investigational
Educational Research, normal educational practice, common educational settings — Exempt 1
Exempt 4(i) — publicly available data
Electronic Informed Consent (eConsent)
Enrolling Study SubjectsActive, follow-up, withdraw, withdrawals, screen failures, completed, over-enroll
Environmental Protection Agency Obligations (HRP-814)EPA
Exception from Informed Consent (EFIC) for Emergency Research
Exempt Submissions
Expired Study
Expanded access of a test articleEmergency use, investigational
Expedited Submissions
FDA and DHHS Regulations – Significant Differences
FDA Obligations (HRP-815)
Finders Feespayments, kickbacks, referrals
Foster Children and Researchwards, ward of the state, children
GDSGenomic Data Sharing, NIH, GWAS, DMS
Good Clinical Practice (GCP) Training
Group Consent vs Group Recruitment
GWASGenome Wide Association Studies, NIH
HIPAA and ResearchPrivacy Rule
HIV Testing for Research Purposes
Humanitarian DeviceHUD, HDE
IAPSInternational Affective Picture System Guide, Lang
Incidental Findings
Informed Consent for Minors in Research StudiesChildren
Informed Consents
Informed Consent Form – Which Template Should I Use?
International Organization for Standardization (ISO) (HRP-817)
Investigational MedicationFDA, IND
Investigator Obligations (HRP-800)researcher responsibilities
Investigators BrochureIB
IRB Pre-Reviewed Sources of De-identified Human Specimens and/or Data
Mandatory Abuse Reporting
Mechanical Turk (use of Amazon MTurk for Social/Behavioral Research)
Media Organizations and Researcher Involvement
MRI Standard Language for Consent Forms
Minor Increase over Minimal Risk -- Research involving ChildrenMinor Increase over Minimal Risk, Research on Children
myChart Recruitment
Non-Human Researchnonhuman
New Faculty Joining UF
NetBase Quid
Open Access Databanks
Over Enrolling Study Subjects
Paying Subjects to Participate in Research
Principal Investigator (PI) QualificationsAdjunct, courtesy
Principal Investigator and/or Study Staff Attending IRB Meetings
Probiotics and Clinical Researchsupplements
Quality vs ResearchQIPR
Remote Consenting ProcessTelephonic consent, Zoom Consenting Process
Research Involving Foreign Nationals
Research Involving Student AthletesUAA
Research Rolesmentor, student research
Research Team Responsibilities
Revisionsrevise, amend, amendment
Science Fair Projectshigh school, middle school
Scientific Review and Monitoring Committee (SRMC)
sIRB – Using UF as a Single IRBmulti-institutional
Social Security Numbers and ResearchSSN
Social Security Numbers and the VAMCSSN, VA, NFSG VHS
State Laws and Research
Status Report
Study Staff Attending IRB Meetings
Study Subject Definitions
Subject Screening
Suicide Assessment for Research or Subject Screening
Training Requirements for Conducting Research
Transcranial Magnetic Stimulation (TMS)
Unaffiliated InvestigatorsUIA
Unanticipated ProblemsUPR
Unwed Pregnant Minors and Unwed Minor Mothers
Pregnancy Testing in ResearchMRI pregnancy testing, pregnancy testing in research
Venipuncture – Use of Non-Clinical Space for Research Involving Blood Drawing
Reconsenting Previously Enrolled Subjects -- New Information Provided to Previously Enrolled SubjectsReconsenting Subjects; New Information Provided to Subjects