果冻影院

header-logo
Research Microscope Lab
Human Research Protection Program

果冻影院 IRB Policies & Procedures

Learn about all current 果冻影院 IRB policies and procedures for investigators and project teams.

IRB Policies & Procedures

These documents outline the policies and Standard Operating Procedures for conducting human subject research.
all
Advertisement, Recruitment, and Compensation

Advertisements (PDF)

Epic Recruitment Tools Request Form (DOCX)

Recruitment Methods and Compensation (PDF)

Recruitment and Enrollment of Non-English Speaking Subjects (PDF)

Subject Payments for Research Participation (PDF)


Conduct of Research

CareEverywhere for Research (PDF)

Definition and Determination of Human Subjects Research (PDF)

Departmental Review (PDF)

Human Subject Research Protection (HSRP) Training Requirements (PDF)

Requirements & Qualifications to serve as a Principal Investigator (PDF)

Responsibilities for Investigators Conducting Human Subject Research (PDF)

Data and Safety Monitoring Plans (PDF)

Lapsed IRB Approval of Human Subject Research (PDF)

Privacy and Confidentiality (PDF)

Public Data Sets (PDF)


Conflict of Interest

Conflict of Interest for Investigators and Project Team Members (PDF)

Informed Consent

Legally Authorized Representatives (LARs): Who Can Consent on Behalf of an Adult Subject with Decreased Decisional Ability (PDF)

Informed Consent Process for Human Subject Research (PDF)

Informed Consent Document for Human Subject Research (PDF)

Recruitment and Enrollment of non-English or Limited English-Proficient Subjects (PDF)

Research with Subjects likely to Manifest or Develop Decreased Decisional Ability (PDF)

Withdrawal of Informed Consent (PDF)

IRB Submissions and Review

Case Reports and Case Studies (PDF)

Registration Projects: Review under FLEX Criteria (PDF)

Quality Assurance / Quality Improvement Projects (PDF)

Submitting New Studies (PDF)

Amendments (PDF)

Continuing Progress Reports (CPR) (PDF)

6-Year Renewals (PDF)

Study Closure (PDF)

Planned Emergency Research (PDF)

Banking: Accumulating Health Care Data or Biospecimens for Future, Unspecified Research Purposes (PDF)

  • All Investigators & study staff must complete training for Bank Custodians & Key Personnel (Register for D2LTraining module)
  • The activity of collecting and storing data or biospecimens for future, unspecified research purposes is considered a "research activity" subject to IRB review and approval - independently of the IRB review/approval required for specific studies with the same data/biospecimens

Multi-Site Research

Multi-Site Projects and Investigator Responsibilities (PDF)

Reliance Agreements for Multi-Site Studies (PDF)

International Projects (PDF)


Regulatory Compliance

Handling and Reporting of Subject Inquiries or Complaints (PDF)

IRB Actions (PDF)

IRB Records (PDF)

IRB Approval Documents (PDF)

Observation of Research Activities (PDF)

(PDF)

Research Consent Storage: Electronic Copies of Paper ICFs (PDF)

Routine Review Process (PDF)

Reliance and IRB Deferrals

Projects Deferred to National Cancer Institute Central IRB (NCI CIRB) (PDF)

Reliance Agreements for Multi-Site Projects (PDF)


Reporting to the IRB
Requirements for Reporting to the IRB (Reportable Events) (PDF)
Research involving Drugs Devices Biologics or In vitro Diagnostics

Use and Storage of Investigational Devices (PDF) (PDF)

Use and Storage of Investigational Drugs and Biologics (PDF)

Emergency Use of Investigational Drugs and Biologics (PDF)

Emergency Use of Investigational Devices (PDF)

Expanded Access Use of an Investigational Drugs and Biologics (PDF)

Expanded Access Use of Investigational Devices (PDF)

Non-Cancer Human Gene Transfer Scientific Review Committee Instructions and Application Form (PDF)

Vulnerable Populations

Recruitment and Enrollment of Non-English or Limited English Proficient Subjects (PDF)

Research Involving Children (PDF)

Research Involving Department of Defense (DoD) Funding and/or Military Participants (PDF)

Research Involving Economically or Educationally Disadvantaged Persons (PDF)

Research Involving Native American or Alaskan Native Tribes (PDF)

Research Involving Pregnant Women (PDF)

Research Involving Prisoners (PDF)

Research with Subjects Likely to Manifest or Develop Decreased Decisional Ability (PDF)

Use of Human Fetal Tissue in Research (PDF)


IRB Guidance

In addition to policies and SOP's, these documents provide further guidance around the operational functions of human subject research. 

© 2024 果冻影院.  All rights reserved.  | Terms and Privacy 

Non-Discrimination Statement
The 果冻影院 (果冻影院) is committed to fostering a diverse community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the 果冻影院 community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic. 果冻影院’s policy as well as federal and state laws and regulations prohibit unlawful discrimination and harassment.