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.

More informationcan be found in the Investigator’s Handbook and Standard Operating Procedures of CPHS.  

Submissions to CPHS

• What needs CPHS review?
• Materials Requiring IRB Review
• New Submissions
• Entries into iRIS
• Continuing Review
• Protocol Deviations
• Change Request or Protocol Amendments
• Adverse Event and Unanticipated Problems
• Conflict of Interest Disclosures
• "Compassionate Use" - Investigational Drug
• "Compassionate Use" - Unapproved Medical Device

IRB Review Process

• Exempt
• Expedited Review
• Full Board Review
• Risk/Benefit Assessment
• Review Process
• Fee for IRB Review
• Review Outcome
• Medical Device Risk Categories

Informed Consent

• Telephone Consent
• Repeated Contacts of Subjects
• Emergency Research Waiver of Consent
• Translations of Informed Consent Documents
• Research Intermediary
• Recruitment
• Finders Fees
• English Consent Template
• Spanish Consent Template
• Updated Child Assent Form

Payment

• Reimbursement of Research Subjects
• Payment for Research-Related Injury

Study Populations

• Children/Adolescents as Subjects
• Emergency Department Patients
• UT Employees and Students as Subjects
• Pediatric Populations - Blood Draws
• Inclusion of Women and Minorities

Special Types of Research

• Deception in Research
• Clinical Trials - Trial Phases
• Genetic Research
• Research Involving Human Fetal Tissue
• International Research

Oversight

• Reporting Non-Compliance
• Review of Non-Compliance
• Appeal Process
• Responding to Subject Concerns
• FDA Inspections
• CPHS Monitoring Program

Confidentiality

• Certificate of Confidentiality
• Confidential Follow-Up Forms
• HIPAA Guidelines
• HIPAA Template Forms
• HIPAA Privacy Rule and Documents
• Providing Patient/Subject Initials to Study Sponsors

Investigator Responsibilities

• Investigator Responsibilities
• Investigator Training
• Additional responsibilities for Studies under an IND
• Additional Responsibilities for Studies under an IDE

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.

UTHealth’s Compliance Hotline (1-888-472-9868)
For other questions, please call us at 713-500-7943.