CPHS has assembled supplemental guidance information to assist investigators and study teams to become fully aware and alleviate ambiguities regarding IRB submissions, the review process implemented by CPHS, common questions regarding recruitment and consenting activities, and ongoing management of approved studies.

This information is intended to be used in conjunction with the Investigator’s Handbook and Standard Operating Procedures of CPHS.  

General Guidance

• Categories of Research Activities Exempt from Review
• Classroom Projects
• "Compassionate Use" - Investigational Drug
• "Compassionate Use" - Unapproved Medical Device
• Expedited Review
• Genetic Research
• Human Fetal Tissue
• International Research
• iRIS Documentation
• Materials Requiring IRB Review
• Medical Device Risk Categories
• Noncompliance
• Payment for Research-Related Injury
• Pediatric Populations - Blood Draws
• Research Intermediary
• Risk/Benefit Assessment
• Trial Phases

Ongoing Study Management

• Adverse Event Reporting
• Continuing Review Application
• FDA Inspections
• Monitoring Program
• Protocol Deviations
• Revisions/Amendments to Approved Studies

Recruitment / Consulting

• Children/Adolescents as Subjects
• Deception in Research
• Emergency Department Patients
• Emergency Research Waiver of Consent
• Flyers, Ads, Posters & Brochures
• Finder's Fees
• Repeated Contacts of Subjects
• Telephone Consent
• Translations of Informed Consent Documents
• UT Employees and Students as Subjects

New Protocol Submission

• Conflict of Interest
• Fee for IRB Review of Protocols
• Inclusion of Women and Minorities
• Medical Record Review for Research Purposes
• New Protocol Submissions
• Protocol Approval Types
• Reimbursement of Research Subjects
• Submission and Review Process

Confidentiality

• Certificate of Confidentiality
• Confidential Follow-Up Forms
• HIPAA

All studies and their informed consent documents must have been reviewed and approved by the CPHS prior to enrolling of any human subjects.

If you feel that your project is an exception to these guidelines, or if you are not certain whether they apply to you, please contact the CPHS to discuss the matter.