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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: October 2022)

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

University of Massachusetts Amherst

Baystate/UMass Amherst Researcher Affiliation Procedures

Questions?

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

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