Policies and Procedures

The Human Research Protection Program Standard Operating Procedures has 17 sections. Click a link 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 (September 2023)
• Research Related Injury Language (March 2023)
• Withdrawal of Consent/ Revocation of Authorization (March 2023)
• Managing Training and Credentials in IRBNet, Standard Operating Procedure (October 2023)

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

• Baystate/UMass Amherst Researcher Affiliation Procedures

Questions?

Please contact HumanResearch@baystatehealth.org for any questions about our Policies and Procedures.