BU researchers are responsible for the ethical conduct of research with human subjects. An institutional review board (IRB) is the committee that reviews, monitors, and approves human subject research. The purpose of the IRB is to protect the rights and welfare of human subjects and to assure clinical research is conducted according to federal regulations, state law, and IRB policies.
FOR BUMC RESEARCHERS
FOR BU CRC RESEARCHERS
NEWInitial Submissions
Guidance
- Determining if IRB approval is needed
- Submitting an IRB proposal
- IRB Review of Exempt Human Research Policy
- IRB Review of Human Subjects Research using Expedited Procedures Policy
- Researcher Financial Conflicts of Interest Policy
- Subject Payments Policy
- Waiver or Alteration of Informed Consent Policy
Forms
Recruitment & Informed Consent
Continuing Review & Annual Check-ins
Guidance
Amendments & Modifications
Reporting Incidents
Guidance
Reliance Agreements for Multisite Studies
Guidance
Supplemental Forms
Guidance
- Additional Requirements for Federal Agency Funded Research
- International Research Policy
- Research Involving Children Policy
- Research Involving Cognitively Impaired Adults Policy
- Research Involving Investigational Devices Policy
- Research Involving Investigational Drugs Policy
- Research Involving Pregnant Women Policy
- Research Involving Prisoners Policy
Forms
- Appendices A – International
- Appendices B – Drugs
- Appendices C – Device
- Appendices D – Samples
- Appendices E – Genetics
- Individual Investigator Agreement Form
- Attestation Form for Translation of Study Documents
- Attestation Form for Translation of the Consent Form
- Final Report Form
- Request for Modification Response Form
- CRC IRB Engagement Checklist
- Supplemental Form – Enrollment of Adult Participants with LARs
- Research Data Repository New Application
Quality Improvement & Post Approval Resources
Topic Index
- WEB Amendments and Modifications Updated June 10, 2016
- WEB Annual IRB Review Updated June 10, 2016
- WEB Compliance Updated June 10, 2016
- WEB COVID-19 Guidance Updated June 26, 2020
- WEB Determination of Research and Research Involving Human Subjects Updated May 10, 2020
- WEB For CRC IRB Members: Meeting Documents Updated September 26, 2016
- WEB HIPAA Updated November 28, 2016
- WEB Human Subjects Updated May 10, 2019
- WEB Human Subjects Training Updated July 28, 2016
- WEB Initial Submissions Updated June 13, 2016
- WEB IRB Members Updated June 22, 2016
- WEB IRB Office & Services Updated June 10, 2016
- WEB IRB Submission Timelines Updated October 22, 2019
- WEB Material Transfer Agreements Updated August 1, 2016
- WEB Quality Improvement and Post Approval Resources Updated June 10, 2016
- WEB Research Participation Updated July 14, 2016
- WEB Responding to the IRB Updated June 10, 2016
- WEB Responsibilities, Ethics, and Regulations Updated June 13, 2016
- WEB RIMS Training Updated August 18, 2016
- WEB Tips for Creating a Consent Document Updated August 29, 2016
- WEB Virtual Office Hours – RSVP Updated May 26, 2020
Below are the forms and policies you will likely need. To quickly find a form or policy in this list please use the Find Function: command+f (mac) or control+f (pc). Or view the full forms and policies libraries under Forms & Policies in the main navigation. Please download and fill out PDFs using Adobe—Acrobat Reader DC is available for free.
- DOCX 118 Determination Form Updated August 5, 2020
- WEB Additional Requirements for Federal Agency Funded Research Updated May 31, 2016
- WEB Amendments/Modifications to Previously Approved Research Updated October 30, 2014
- DOCX Appendices A – International Updated August 15, 2016
- DOCX Appendices B – Drugs Updated August 15, 2016
- DOCX Appendices C – Device Updated February 27, 2017
- DOCX Appendices D – Samples Updated May 16, 2016
- DOCX Appendices E – Genetics Updated August 15, 2016
- DOCX Attestation Form for Translation of Study Documents Updated August 15, 2016
- DOCX Attestation Form for Translation of the Consent Form Updated August 15, 2016
- DOC Clarification Form (for Exempt Studies Only) Updated August 15, 2016
- WEB Clinical Trials Registration and Results Reporting Updated January 20, 2019
- WEB Community Outreach Updated December 30, 2019
- WEB Convened Meeting Updated January 20, 2019
- DOCX COVID-19 Consent Form Supplement Updated August 10, 2020
- DOCX CRC IRB Engagement Checklist Updated August 5, 2020
- WEB Determination of Research and Research Involving Human Subjects Updated June 23, 2020
- WEB Documentation of Informed Consent Updated February 1, 2019
- WEB Exception & Deviation Policy Updated January 20, 2019
- WEB HHS and FDA Regulations Compared Updated March 10, 2009
- WEB HIPAA Health Care Providers Policy 5: Authorizations and When They Are Necessary Updated November 13, 2017
- WEB Human Research Protection Program Quality Improvement and Assessment Updated November 7, 2014
- WEB Human Subject Payments (PAFO) Updated August 1, 2017
- DOCX Individual Investigator Agreement Form Updated December 14, 2020
- WEB Institutional Official’s Authority and Responsibilities Updated May 31, 2016
- WEB Institutional Review Board (IRB) Policies and Procedures Updated December 2, 2015
- WEB International Research Updated May 31, 2016
- WEB IRB Composition and IRB Member Roles and Responsibilities Updated December 2, 2015
- WEB IRB Continuing Review Policy Updated June 27, 2016
- WEB IRB Member and Consultant Conflict of Interest Updated November 7, 2014
- WEB IRB Recordkeeping Updated January 20, 2019
- WEB IRB Review of Exempt Human Research Updated January 20, 2019
- WEB IRB Review of Grants and Contracts Supporting Human Subjects Research Updated January 13, 2020
- WEB IRB Review of Human Subjects Research using Expedited Procedures Updated January 20, 2019
- DOCX IRB-CRC Amendment Request Updated January 20, 2019
- DOCX IRB-CRC Assent Form Template Updated August 15, 2016
- DOCX IRB-CRC Continuing Review/Annual Report Application Updated January 25, 2017
- DOCX IRB-CRC Event Form (Replaces the Deviation & Unanticipated Problems Forms) Updated August 15, 2016
- DOCX IRB-CRC Exempt New Application Updated January 20, 2019
- DOCX IRB-CRC Expedited/Full Review Board New Application Updated November 25, 2019
- DOCX IRB-CRC Final Report Form Updated August 15, 2016
- DOCX IRB-CRC Informed Consent Template Updated November 20, 2019
- DOC IRB-CRC Request for Modification Response Form Updated August 15, 2016
- DOCX IRB-CRC Study Staff Amendment Form Updated January 25, 2017
- WEB Noncompliance in Human Subjects Research Updated June 27, 2016
- WEB Principal Investigator Responsibilities Updated May 11, 2016
- WEB Privacy and Confidentiality Updated February 13, 2019
- WEB Recruitment and Advertising Updated January 20, 2019
- WEB Reliance Process Updated March 3, 2019
- WEB Reporting Incidents to Institutional Officials and Regulatory Agencies Updated March 19, 2019
- DOCX Research Data Repository New Application Updated August 15, 2016
- WEB Research Involving Children Updated March 24, 2015
- WEB Research Involving Human Subjects Updated January 20, 2019
- WEB Research Involving Investigational Devices Updated October 9, 2015
- WEB Research Involving Investigational Drugs Updated May 31, 2016
- WEB Research Involving Persons with Limited Decision-Making Capacity to Provide Informed Consent Updated December 20, 2019
- WEB Research Involving Pregnant Women Updated November 7, 2014
- WEB Research Involving Prisoners Updated November 7, 2014
- DOCX Research with Human Subjects Determination Form Updated August 5, 2020
- WEB Researcher Financial Conflicts of Interest (CRC IRB) Updated October 9, 2015
- WEB Reviewer Assignment Updated October 30, 2014
- WEB Scientific Review Updated October 30, 2015
- DOCX Single IRB FAQs Updated September 11, 2020
- DOCX Single IRB Policy Updated September 11, 2020
- DOCX Single IRB Request Updated September 11, 2020
- WEB Subject Payments (CRC IRB) Updated September 23, 2014
- DOCX Supplemental Form – Enrollment of Adult Participants with LARs Updated July 28, 2020
- WEB Suspension or Termination of Research by the IRB Updated October 30, 2014
- WEB Training Requirements Updated November 7, 2014
- WEB Unanticipated Problems Involving Risks to Subject or Others & Adverse Events Updated May 31, 2016
- DOCX Video Use Consent Form Updated August 15, 2016
- WEB Waiver or Alteration of Informed Consent Updated January 20, 2019
Due to COVID-19, the CRC IRB staff are working remotely. If you have any questions, the IRB staff are available via Microsoft Teams, email and phone. Please note that office phone numbers are currently being forwarded to staff personal phones. If you call, please be sure to leave a message with your name and phone number so that we know how to call you back!
Primary Contacts
Additional Contacts
-
SD
Shayne C. Deal
Senior IRB Analyst
617-358-6116
Email Me -
PH
Paul Hart
IRB Analyst
617-358-6117
Email Me -
SH
Savannah Holmes-Farley
Coordinator Charles River Campus, Institutional Review Board (IRB)
617-358-6115
Email Me -
DL
Diane Lindquist
Director of Health Privacy and Compliance; BU HIPAA Privacy Officer
617-358-3124
Email Me -
MM
Mary McCabe
Senior IRB Analyst and Reliance Specialist
617-358-6922
Email Me -
LT
LaNeia Thomas
Assistant IRB Director
617-358-6346
Email Me