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
- Human Subjects Research Termination, Termination of IRB Oversight and Activities
- IRB Committee Determinations for Reviewing Research Non-Compliance, Suspending or Terminating Research
- Obtaining Informed Consent and Authorization
- 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
- Revision Procedures to Previously Approved Research Protocols
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
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
- Findings for Waiver or Alteration of Consent Requirements and Waiver of Documentation (waiver of signature) of Consent
- General Requirements for Informed Consent
- Using the Multiple Language Verbal Translation Preparative Forms and Process
- 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
- 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)
- 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
- Exemption from IRB Review Emergency Use of a Test Article
- IRB Research Determination and Exempt Review
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 Oversight
- International Research_ Supplemental Questions for Application to IRB
- Other Federal Agencies - Additional Requirements
- Reliance Agreement Request_IRB Oversight Request Form
- Use of the Single IRB Mechanism for Federally Funded Research Projects