Policies & Procedures
Standard Operating Procedures
The Human Research Protection Program Standard Operating Procedures has 17 sections. Click below to review a particular section or download the HRPP Standard Operating Procedures here. (Last updated: February 2024)
- Section 1. Human Research Protection Program
- Section 2. Institutional Review Board (IRB)
- Section 3. IRB Review Process
- Section 4. Documentation of Records
- Section 5. Obtaining Informed Consent from Research Subjects
- Section 6. Vulnerable Subjects in Research
- Section 7. FDA-Regulated Research
- Section 8. Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
- Section 9. Protocol Exceptions and Deviations
- Section 10. Complaints or Concerns
- Section 11. Non-Compliance
- Section 12. Reporting to Regulatory Agencies and Institutional Officials
- Section 13. Investigator Responsibilities
- Section 14. Sponsored Research
- Section 15. Participant Outreach
- Section 16. Health Insurance Portability and Accountability Act (HIPAA)
- Section 17. Special Topics
- Collaborative Research Standard Operating Procedures
Policies
- Baystate IRB General Compliance Letter
- Research Related Injury Language
- Withdrawal of Consent/ Revocation of Authorization
- Managing Training and Credentials in IRBNet, Standard Operating Procedure
- Research Supported by a Department of Defense Component
Unaffiliated Investigator and Associate in Research
An Unaffiliated Investigator (“UI”) is an individual who is not employed by Baystate Health, is not a member of the Baystate Health Medical Staff or Associate Professional, and is not a student enrolled in an academic program affiliated with Baystate Health. An Associate in Research is a student enrolled in an academic program affiliated with Baystate Health who participates in research without salary, stipend, or other compensation from Baystate Health.
- Unaffiliated Investigator Agreement
- Unaffiliated Investigator Policy
- Unaffiliated Investigators Information Sheet
- Unaffiliated Investigator Checklist
- Associate in Research - Standard Operating Procedures
- Associates in Research Agreement - Policy BHS-AA 5.0
- Attestation Template - Health and Background
- Badge Photo Recommendations
- CORI Acknowledgement Form for Students
- Medical Provider - Health Attestation
- Online Training Modules - AIR and UI
- Security Form - Fillable
University of Massachusetts Amherst
Conflict of Interest
If you have questions regarding Conflict of Interest or wish to report suspected misconduct at a Baystate Health facility, including the UMass Chan - Baystate campus, please contact Research Compliance Officer, Jennifer Pacheco via Jennifer.Pacheco@baystatehealth.org, phone 413-794-3458 or anonymously through the Corporate Compliance Hotline at 877-874-7444.
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