Human Research Protection Program
The MD Anderson Human Research Protection Program (HRPP) is an institution-wide program that encompasses every aspect of human subjects research where each component is collectively responsible for protecting the rights and welfare of human research participants.
The components of our HRPP include: Institutional Review Board, Scientific Review Committees, Data Safety Monitoring Board, Institutional Animal Care and Use Committee, Radiation Safety, Information Technology, Compliance, Legal, researchers and research teams, pharmacy, and research participants and the community.
Each of these components is in part responsible for ensuring that:
- The rights and welfare of human research participants are protected in all MD Anderson research.
- All MD Anderson research is guided by the ethical principles of respect for persons, beneficence, and justice as set forth in the Belmont Report.
- All MD Anderson research is conducted with the highest level of expertise and integrity.
- All MD Anderson research complies with applicable laws.
Human Research Protection Program Manual
HRPP Manual
The Office of Human Subjects Protection maintains the HRPP Manual, which is a reference tool that contains all the links to the policies, procedures, forms, and templates related to human subjects research.
Chapters in the manual include:
- Chapter 1. The Human Research Protection Program (HRPP)
- Chapter 6. Structure and Composition of the IRB
- Chapter 7. Systematic Review
- Chapter 12. Informed Consent and Assent
- Chapter 14. Principal Investigator Responsibilities
The documents referenced in the manual can be found below.
If you have any questions about the HRPP manual, please contact IRBHelp@mdanderson.org.
Policies
- Advertising and Recruiting for a Research Study
- Certificate of Confidentiality
- Clinical Trials Registration and Reporting Requirements
- Continuing Review of Research
- Designated Individuals
- Human Subjects Research Termination, Termination of IRB Oversight and Activities
- Inclusion of Pharmacokineitc and Pharmacodynamic Testing in Clinical Research
- IRB Committee Determinations for Reviewing Research Non-Compliance, Suspending or Terminating Research
- Obtaining Informed Consent and Authorization
- Preparation and Publication of Case Reports and Case Series
- Single Patient Use of an Investigational Agent or Device _Compassionate Use of an Investigational or Label Drug
- Remuneration in Research Studies
- Reporting Adverse Events for Drugs and Devices
- Reporting Protocol Deviations, Protocol Violations and Unanticipated Problems
- Return of Unused Study Medication to Pharmacy
- Revision Procedures to Previously Approved Research Protocols
- Submission of Investigator's Brochures
Guidance
Authorizations and Agreements
- IRB Authorization Agreement Tip Sheet
- Responsibilities Matrix for Utilizing a Single or External IRB Mechanism and an IRB Authorization Agreement
- Utilizing an IRB Agreement or Authorization and Definitions
Data Safety Monitoring
Devices
- Humanitarian Use Device
- Significant Risk and Nonsignificant Risk Medical Device Studies
- Unanticipated Adverse Device Effect (UADE)
Exempt Research & Emergency Use
- New and Revised Exemption Categories and Examples
- Exempt Review Categories Common Rule, FDA, and MD Anderson Policy
- Expanded Access to Investigational Drugs and Devices
- Expedited Review Categories
- Emergency Use of a Test Article
Informed Consent
- Annotated MD Anderson ICD – Essential and Additional Elements
- Considerations for Re-Consent of Participants Tool
- Findings for Waiver or Alteration of Consent Requirements and Waiver of Documentation (waiver of signature) of Consent
- General Requirements for Informed Consent
- IRB Guidance on Re-Consenting Participants on a Research Protocol
- Side Effect Glossary
- Using the Consent Statement for Questionnaires
- Using the Multiple Language Verbal Translation Preparative Forms and Process
Payment, Reimbursement, & Conflict of Interest
- How to Determine which Remuneration Form to Use
- Payment Ethical Considerations
- Conflict of Interest COI Annual Certification FAQ
- Guidelines for IRB Members on Conflicting Interests
Recruiting
Review of Research
- Confidentiality of Institutional Review Board Proceedings
- Criteria for IRB Approval of Research
- Determining What Qualifies as a Protocol Specific Procedure
- Does My Project Need IRB Review
- Events and Information that Require Prompt Reporting to the IRB
- Evaluating Sound Study Design
- Glossary of Clinical Trials Terms and Commonly Used Acronyms
- Guidance for Obtaining Additional Expertise or an Expert Consultant
- HIPAA and PHI
- MD Anderson HRPP Components
- Supervisory Responsibilities of Investigators
- Scientific Reviewer Guidelines for Preparing Written Comments
- What Qualifies as Human Subject Research
Vulnerable Populations
- Additional Protections for Inclusion of Children in Research (OHRP)
- Additional Safeguards for Children in Clinical Investigations (FDA)
- Determining Socioeconomic Status for a Research Participant
- Enrollment of Pediatric Patients in Phase 1 Adult Studies
- Involvement of Prisoners in Research (OHRP)
- Non-English Speaking Research Participants
- Parental Permission
- Research Involving Pregnant Women, Fetuses, and Neonates
Forms & Templates
Adverse Events
Deviations, Violations, & Unanticipated Problems
- Protocol Deviation Log
- Protocol Violation Tracking Form IRB
- PI Override Form
- Unanticipated Problems Form
Exemptions
- Exemption from IRB Review Emergency Use of a Test Article
- IRB Research Determination and Exempt Review
- New PA Protocol Exempt Memo
Informed Consent
- Informed Consent Template – Clinical
- Informed Consent Template – PA
- Informed Consent Template – Psychosocial
- Informed Consent Tempate - Abbreviated Informed Reconsent Document
- Verbal Translation Preparative Sheet (VTPS) Form - Spanish
- VTPS Request - Other Languages
- Authorization for the Use and Disclosure of Protected Health Information
IRB Members
- Annual Evaluation of IRB Members
- Consultant Conflict of Interest Declaration
- Determining if IRB Members are Nonscientists
- Determining if IRB Members are Unaffiliated
- IRB Member Conflict of Interest Declaration
IRB Oversight
- International Research_ Supplemental Questions for Application to IRB
- Other Federal Agencies - Additional Requirements
- Reliance Agreement Request_IRB Oversight Request Form
- Annual Institutional Worksheet
- Study Specific Worksheet
- Use of the Single IRB Mechanism for Federally Funded Research Projects
Scientific Review
- Department Chair's Protocol Review and Prioritization
- Institutional Approval to Utilize Departmental Review Option for SRC Studies Approval
Reimbursement
- Patient Disclosure Acknowledgement for Reimbursement Form (Abbreviated_not Bank of America)
- Patient Disclosure Acknowledgement for Reimbursement Form (Bank of America)
Termination
Use of the Single IRB Mechanism for Federally Funded Research Projects
Use of the Single IRB Mechanism for Federally Funded Research Projects
SOPs, Workflows, & Checklists
Standard Operating Procedures
- Activating Research Protocols (Clinical, PBHSR, and Protocol Applications)
- Consent Process Observation
- Consenting Non-English Speaking Participants
- Data Safety Monitoring Board (DSMB)
- ePAAC
- External Data and Safety Monitoring Board (EDSMB)
- External IRB Submissions for Studies with an Institutional Conflict of Interest
- External IRB Submissions
- Evaluating and Monitoring Planned Emergency Research
- Guidelines for Monitoring MD Anderson IND Sponsored
- Handling Revocation of Consent or Other Participant Complaints
- IND_IDE Information for Supporting Companies
- Multicenter Subject Confidentiality
- Multicenter Subject Registrations
- Multicenter Subject Serious Adverse Event Reporting
- Multicenter PI Override Process
- Multicenter Verifying Protocol Eligibility
- Multicenter Protocol Response Verification
- Multicenter Deviation-Violation-Unanticipated Problems Reporting
- Multicenter Protocol Compliance Assessment
- Multicenter Query Submission and Tracking
- Multicenter Electronic Research Applications
- Multicenter Note to File Guidance
Standard Operating Procedures
- NIH Policy on Single IRB Review for NIH Funded Research
- Participant Remuneration
- Psychosocial, Behavioral, and Health Services Research Committee
- Reimbursement
- Scientific Review Committee
- Study Drug Accountability
- Utilizing a Single or External IRB Mechanism
Checklists
- Informed Consent Checklist for Investigators
- Protocol Activation
- Sponsored Research Agreement
- Vulnerable Populations_ Children
- Waiver of Written Documentation of Consent
- Waiver or Alteration of Consent Process
Workflows
- Addressing Allegations and Findings of Non-Compliance
- CIRB Amendments
- CIRB New Submission
- Data Safety Monitoring Plans and Data Safety Monitoring Committees
- How to Consent Non-English Speaking Patients
- Process for Handling Reports
- Process for Internal and External Reporting
Worksheets
- Annual Institutional Worksheet
- Criteria for Approval
- Engagement Determination
- Expedited Review
- Human Research Determination
Engagement Determination
Regulatory Documents
Regulatory Documents
- Charge to the Institutional Review Boards on Human Subjects In Medical Research
- Charge to the Institutional Review Board on Human Subjects in Nonmedical Research
- Charge to the Executive Institutional Review Board on Human Subjects in Medical and Nonmedical Research
- Statement of Compliance
- Federalwide Assurance
- Delegation of Authority for the Human Research Protection Program
- iConsent Data Integrity Review
- Vice President Position Description
By-Laws & Charters
- Data Safety Monitoring Board By-Laws
- Executive IRB By-Laws
- External Data and Safety Monitoring Board (EDSMB) By-Laws
- Internal Audit Activity Charter
- Psychosocial, Behavioral, and Health Services Research Committee By-Laws
- Radiation Safety Committee By-Laws
- Scientific Review Committee By-Laws
IRB Appointment Memos