Resources For Researchers

Announcements

• September 28, 2011 (pdf)
• October 7, 2011 (pdf)
• December 15, 2011 (pdf)
• Baystate Health & UMass Amherst IRB Collaboration (pdf)

IRBNet

• Read Me First: IRB (pdf)
• IRBNet Training Energizer - Researcher 1 (pdf)
• IRBNet Training Energizer - Researcher 2 (pdf)
• IRBNet 5 Steps of the Researcher (pdf)
• IRBNet Notes - Subsequent packages 1 (pdf)

Current IRB Forms

• Ancillary Services Worksheet 
• Basic Application Part 2 
• Conflict of Interest and Conflict of Commitment Questionnaire
• Continuing Review Report
• Modification Request Form
• Other Reportable Events
• Pathology Services Application
• Protocol Deviation Report
• Report of an Unanticipated Problem
• Request to Open a Closed Study
• Study Closure Report
• Supp A Human Subjects Research Determination
• Supp B Preparatory to Research
• Supp C Emergency Use  Report
• Supp D Request for Determination of Exempt Status
• Supp E Request for Expedited Review
• Supp F CIRB Facilitated Review (COG, RTOG)
• Supp G Collaborative Research
• Supp H Research Involving Children
• Supp I Research Involving Prisoners
• Supp J Rearch Involving Pregnant Women, Fetuses or Neonates
• Supp K Research Involving Subjects with Impaired Decision Making Capacity
• Supp L Request for Waiver or Alteration of Consent or HIPAA Authorization
• Supp M Establishment of a Data Repository
• Supp Mm Use of Data Obtained from a Repository
• Supp N Establishment of a Tissue Repository
• Supp Nn Use of Specimens Obtained from a Repository
• Supp O Research Using the Internet
• Supp P Investigational Drugs or Devices
• Supp Q In Vitro Diagnostic Devices
• Supp R Humanitarian Use Devices

Human Research Protection Program (HRPP)

• Applicability of ICH GCP to Human Subjects Research (pdf)
• Effective October 3, 2001: Revised HRPP/IRB Policy & Procedures Manual (pdf)
• Consent Checklist (pdf)
• Consent Template (Word doc)
• Guidance on Special Considerations for Oversight of Research Protocols Using an FDA Regulated Product (pdf)
• Guidance to Requirements of the Sponsor and the Investigator as Sponsor (pdf)
• HRPP 1.03 EMR Access for External Visitors (pdf)
• HRPP 1.04 Research Lab Processing (pdf)
• HRPP 1.05 3601 Main Freezer Storage (pdf)
• Intellectual Property Agreement (pdf)
• Letter re: IRB and Translation Fees (pdf)
• NCI Cooperative Group Consent Checklist (Word doc)
• Protocol Template for Experimental Studies (pdf)
• Protocol Template for Non-experimental Studies (pdf)
• Research Participant's Bill of Rights
• Translations and Use of Interpreters (Word doc)

Recruitment

• Recruitment Guidelines (pdf)
• About ResearchMatch (pdf)
• Investigator FAQs About ResearchMatch (pdf)
• ResearchMatch Overview for Baystate Participants