Table of Contents
1. Introduction
1.1. Mission
1.2. Ethical Principles
1.2.1. IRB Independence from Undue Influence
1.2.2. Institutional Conflict of Interest
1.2.3. Conflicts of Interest Policies for Faculty, Senior Officers and Others
1.3. Applicable Laws
2. Roles and Responsibilities
2.1. Responsibilities of the Institution
2.1.1. Resources for the CHS
2.2. Responsibilities of the Institutional Official
2.3. Responsibilities of the CHS
2.4. Responsibilities of the CHS Office
2.5. Responsibilities of the Investigator
2.6. Responsibilities of Unaffiliated Investigators and Unaffiliated Institutions
2.7. Additional Institutional Support and Responsibility
2.8. Quality Assurance
2.8.1. Monitoring of the CHS
2.8.2. Researcher Grievances, Comments, or Suggestions
3. CHS Member and Staff Policies
3.1. CHS Chair
3.1.1. CHS Chair Qualifications
3.1.2. CHS Chair Training
3.1.3. Expectations for the CHS Chair
3.2. CHS Members
3.2.1. CHS Composition
3.2.2. CHS Member Training
3.2.3. Expectations for CHS Members
3.3. CHS Consultants
3.3.1. CHS Consultant Qualifications
3.3.2. CHS Consultant Training
3.3.3. Expectations for CHS Consultants
3.4. CHS Member Conflict of Interest
3.4.1. Professional/Personal Conflict of Interest
3.4.2. Financial Conflict of Interest
3.5. CHS Member Indemnification
3.6. CHS Primary Reviewer System
3.7. CHS Meeting Schedule
3.8. CHS Quorum
3.9. CHS Staff
4. Initial Review of Research
4.1. Office Procedures for Processing New Applications
4.2. Definitions
4.3. Proposals Not Meeting the Definition of Research Involving Human Subjects in Section 4.2
4.4. Scientific Review
4.4.1. Additional Consultant for Scientific Review
4.5. Ethical Review
4.6. Funding Review
4.7. Investigator/Research Staff Experience
4.7.1. Investigator Conflict of Interest
4.8. Research Meeting Exempt Review Categories
4.8.1. Review of Research Proposals for Exemption Criteria
4.8.2. Unacceptability of Investigator Self-Exemptions
4.8.3. Exemption Criteria
4.8.4. Applicability of Exemption Criteria to Vulnerable Populations (45 CFR § 46 Subparts B, C and D)
4.9. Research Meeting Expedited Review Categories
4.9.1. Review of Research Proposals for Expedited Criteria
4.9.2. Categories of Research that may be Reviewed through an Expedited Review Procedure
4.9.3. Reviewer Determination
4.9.4. When there are Conditions for Expedited Approval
4.9.5. Notification to Investigators
4.9.6. CHS Approvals and Release of Funds for Research
4.10. Research Requiring Full Committee Review
4.10.1. Research Involving More than Minimal Risk
4.10.2. Proposals Not Involving More than Minimal Risk, but that Require Full Committee Review
4.10.3. Document Distribution
4.10.4. CHS Review Procedures
4.10.5. CHS Determinations
4.11. Research Requiring Review More Often than Annually
4.12. Research Monitoring
4.13. International or Off-Site Research and Knowledge of the Local Research Context
5. Continuing Review of Research
5.1. Required Continuation Submission Documentation
5.2. CHS Office Processing of Continuing Review Submissions
5.3. Continuing Review by the Full Committee
5.4. Continuing Review of Research Meeting Expedited Categories
5.5. Lapse in Continuing Review Approval
5.5.1. Investigator Reports for Lapsed Studies
5.5.2. Review of Lapsed Approval of an Expedited Study
5.5.3. Review of Lapsed Approval for a Study Requiring Full-CHS Review
5.5.4. Study Closure of Lapsed Studies
5.5.5. Reporting Study Lapses to OHRP and other Regulatory Agencies
5.5.6. CHS Administrative Functions Resulting in Study Lapses
5.6. CHS Study and Study Closure
6. Amendments to Research Activity
6.1. Amendment Requests
6.2. Required Materials for Amendment Requests
6.3. CHS Procedures for Processing Amendment Requests
6.4. Document Distribution to CHS Members
6.5. Amendment Review by the Convened CHS
6.6. Amendment Review Meeting Expedited Categories
6.7. Modifications to Research Resulting from Emergency Procedure/Process
6.8. Amendment Review of Studies Meeting Exemption Criteria
7. Ceding Review
7.1. Definitions
7.1.1. Cooperative Agreements and Reliance Agreements
7.1.2. IRB Authorization Agreements (IAA)
7.2. Conditions for Ceded Review
7.2.1. Accepting Review Responsibilities for another Institution
7.2.2. Ceding Review to other Institutions
7.2.3. Harvard Clinical and Translational Science Center (CTSC)
7.3. Required Documentation for Ceded Review
7.4. Procedures for Ceded Review
7.4.1. Initial Approval
7.4.2. Continuing Approval
7.4.3. Amendments, Non-Compliance, and Unanticipated Problem Reporting
7.4.4. Study Closure
8. Multi-Site Studies
8.1. Where the Faculty of Medicine is the recipient of the primary funding award (regardless of the source), and the research is conducted at HMS or HSDM (with additional sites coordinated by the HMS/HSDM Investigator)
8.2. Where the Faculty of Medicine is the recipient of a primary funding award and the Principal Investigator is an HMS/HSDM faculty member who is based at a Harvard-affiliated institution where the research will be taking place
8.3. Where the Faculty of Medicine is the recipient of a subcontract funding award and the research is taking place at HMS or HSDM
8.4. Where an HMS/HSDM Investigator who is based at a Harvard-affiliated institution is the recipient of a subcontract funding award from the Faculty of Medicine and the research is taking place at the Harvard-affiliated institution
8.5. Where there is no external funding to the Faculty of Medicine and the HMS/HSDM Investigator is the Principal Investigator and additional sites are coordinated by the Investigator
8.6. Where an HMS/HSDM Investigator who is based at a Harvard-affiliated institution receives no external funding through the Faculty of Medicine and the research is taking place at the Harvard-affiliated institution
8.7. Where the primary research funds are awarded to the Faculty of Medicine and may or may not include a subcontract to the Institution where the research is taking place and where the HMS/HSDM Investigator has no affiliation
8.8. Where the subcontract research funds are awarded to Faculty of Medicine and the research is taking place at an Institution where the Investigator has no affiliation
9. Research by Faculty of Medicine Students
9.1. Mentors
9.1.1. Mentor Letters/Letters of Support
9.1.2. HSDM Faculty Advisors
9.2. Funding for Student Research
9.2.1.
Faculty of Medicine Scholars in Medicine Office (SMO)
9.2.2. Fellowship Monies
9.2.3. Extramural Funding
9.3. CHS Student Submission Requirements
9.4. Communication
9.5. Institutional Approvals
9.5.1. CHS Approval
9.5.2. Research Site Approvals
9.5.3. Ceded Review of Student Research
10. Policies and Criteria for IRB Approval
10.1. Participation Review
10.1.1. Equitable Selection of Participants
10.1.2. Risks vs. Benefits
10.1.3. Data Safety Monitoring
10.1.4. Privacy
10.1.5. Confidentiality of Data
10.1.6. Certificates of Confidentiality
10.1.7. Remuneration Guidelines
10.2. Recruitment
10.2.1. Recruitment Guidelines
10.2.2. Recruitment Materials
10.2.3. CHS Review of Recruitment Materials
10.3. Informed Consent Guidelines
10.3.1. Informed Consent Form
10.3.2. Guidelines for Waiver or Alteration of Consent Requirements
10.4. Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
10.5. CHS Review of HIPAA Waivers of Patient Authorization
11. Vulnerable Populations and Special Protections
11.1. Pregnant Women, Neonates, and Fetuses
11.1.1. Pregnant Women and Fetuses
11.1.2. Neonates
11.1.3. Research Involving, After Delivery, the Placenta, the Dead Fetus or Fetal Material
11.1.4. Research not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates
11.2. Prisoners
11.2.1. Additional CHS Composition Requirements
11.2.2. Additional Issues for Consideration by the CHS
11.2.3. DHHS-Funded Research Involving Prisoners
11.2.4. Expedited Review Procedures
11.2.5. Exempt Research with Prisoners
11.3. Children
11.3.1. Research Not Involving Greater than Minimal Risk
11.3.2. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual child participants
11.3.3. Research involving greater than minimal risk and no prospect of direct benefit to the individual child participants, but likely to yield generalizable knowledge about the participant’s disorder or condition
11.3.4. Research not otherwise approvable that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children
11.3.5. Requirements for Permission by Parents or Guardians
11.3.6. Requirements for Assent by Children
11.3.7. Additional Requirements for Wards and Foster Children
11.3.8. Child Abuse Reporting
11.3.9. Confidential Birth Information
11.4. Embryonic Stem Cell Research
11.5. Participants with Cognitive Impairments
11.5.1. Research outside the jurisdiction of the Massachusetts Department of Mental Health (DMH)
11.5.2. Research within the Jurisdiction of the DMH
11.5.3. Research Protocol Considerations
11.5.4. Assent, Consent, and Legally Authorized Representatives and Proxy Consent
11.6. Participants with Limited Capacity to Speak English
11.7. Participants with Economic Disadvantages
11.8. Participants with Educational Disadvantages
11.9. Participants with Stigmatizing Conditions
11.10. Participants who are Students, Fellows, or Employees of Harvard University
11.10.1. Curriculum Studies and Studies Specifically Recruiting Students
11.11. Investigator Self-Experimentation
12. Clinical Research
12.1. Studies Involving Drugs in Research
12.1.1. Massachusetts Requirements
12.1.2. Use of FDA-Approved Drugs in Research
12.2. Use of Devices in Research
12.2.1. Significant/Non-Significant Device Determinations by the CHS
12.2.2. Exemption from the Requirement for an IDE
12.2.3. Requirements for Investigators using Drugs or Devices in Research
12.2.4. Clinical Research Requirements for Sponsored Programs Administrators (including Grant and Contract Officers and CHS Administrators)
13. Adverse Events and Unanticipated Problems
13.1. When and How to Report Events to the CHS
13.1.1. When there is a Data Safety Monitoring Board or Committee (DSMB/C)
13.2. CHS Review of Reported Problems
13.3. Document Distribution
13.3.1. Notification of CHS Determinations to Investigator, Institutional Officials, and Regulatory Agencies
14. Non-compliance with 45 CFR § 46, HU or CHS Policies/Procedures
14.1. Definitions
14.2. Investigator Reports of Protocol Deviations and Non-Compliance
14.2.1. What to Report to the CHS
14.2.2. When to Report to the CHS
14.2.3. Other Allegations or Reports of Non-Compliance
14.2.4. Initial Inquiry
14.3. Further Investigation by the CHS
14.4. Confidentiality
14.5. Coordination with Other Investigative Process
14.6. Action Prior to Decision
14.7. Decision (including suspension or termination of approval)
14.8. Notification of CHS Determinations to Investigator, Institutional Officials, and Regulatory Agencies
14.9. Retaliation
15. Suspension or Termination of Research
15.1. Notification to Participants
15.2. Notification of CHS Determinations to Investigator, Institutional Officials, and Regulatory Agencies
16. CHS Records
16.1. Active Study Files
16.2. Study Record Retention Policy
16.2.1. Investigator’s Study Records
16.2.2. CHS Study Records
16.2.3. Other Study Records
16.2.4. CHS Meeting Packets
16.3. Minutes of a Convened CHS Meeting
16.4. Membership Rosters
16.5. Policies and Procedures
17. Sponsored Research
17.1. Organizational Structure
17.2. Ethical Assurances
17.3. Additional Requirements for Clinical Trials
17.4. Requirements for Social/Behavioral Research
18. Participant Outreach
18.1. Consent form Requirements
18.2. CHS Contact Information and Procedures
18.3. HMS and CHS Websites
