IRB Policies & Procedures

Below are links to the IRB related policies and procedures.  If you have any additional questions, please contact Cherie Bilbie, Director of the Human Research Protections Program (HRPP), at 860-972-2893.

HRPP Program (100's)
Research Community Responsibilities (200's)
Collaborative Research (300's)
Education/Training (400's)
Conflict of Interest (COI) (500's)
IRB REVIEW (600's)
Vulnerable Populations (700's)
Informed Consent (800's)
Reporting/Regulatory Compliance (900's)
Research Involving Drugs, Devices or Biologics (1000's)
Research Using Coded Specimens or Coded Private Information (2000's)
Genetics Research (3000's)
HIPAA as it Relates to Research (4000's)
Conduct of Research / Guidance Topics (5000's)
State Law Considerations (6000's)
Grants & Contracts (7000's)

HRPP Program (100's)
# 105 - Policy Statement Regarding Institutional Oversight of Human Research
# 120 - HRPP:  Organization, Roles, Responsibilities, & Evaluation (UPDATED 1/28/13)
# 125 - Statement of IRB Compliance with ICH/GCP and Federal Regulation
# 135 - Hartford HealthCare Human Research Protection Program Participant Outreach Activities
# 140 - Hartford HealthCare Human Research Protection Program Conduct of Quality Assurance/Quality Improvement Activities

Research Community Responsibilities (200's)
# 200 - Principal Investigator Responsibilities
# 205 - Research Staff Responsibilities
# 210 - Who May Serve as a Principal Investigator in the HH HRPP

# 220 - Protocol/Study Design Requirements

# 225 - Community Consultation to Assess and Minimize Group Harms

Collaborative Research (300's)
# 300 - Reliance on the IRB of Another Institution, Organization, or an Independent IRB
# 305 - Research Involving Multiple Sites

Education/Training (400's)
# 400 - Collaborative Institutional Training Initiative (CITI) Module Requirements for Human Subject Protection (HSP) and Responsible Conduct of Research (RCR)

Conflict of Interest (COI) (500's)
# 500 - Conflict of Interest (UPDATED 8/24/12)

IRB REVIEW (600's)
# 600 - Engagement in Research
# 602 - Research for Which Review by the HH HRPP Is Required (UPDATED 10/13/11)
# 606 - Single Case Reports and Case Series
# 608 - IRB Membership (UPDATED 1/28/13)
# 610 - Use of Consultants/Ad Hoc Members in IRB Review
# 614 - Exemptions:  Review and Determinations
# 616 – Review by the IRB (UPDATED 5/24/13) -This policy encompasses the following topics:

(1) Review and Approval by Other (Specialty) Committees
(2) Review:  Full Board Convened Meeting (Initial and Continuing)
(3) Criteria for Approval of Research                                                  
(4) Distribution of Information for Review                                        
(5) Review:  Expedited (Initial and Continuing)                                    
(6) Studies Needing Verification from Sources Other than the Investigator
(7) Determining the Frequency of Continuing Review                    
(8) Modifications Processing Procedure - IRB-requested revisions by Investigator
(9) Review of Proposed Modifications to Previously Approved Research

# 620 - Risk Assessment
# 622 - Assessing the Data and Safety Monitoring Plan
# 623 - Protecting the Privacy and Confidentiality Interests of Human Research Data (UPDATED 2/2/13)
# 624 - Conduct of a Convened IRB Meeting (UPDATED 10/13/11)
# 626 - IRB Minutes
# 628 - Continuing Review Notification
# 630 - Planned Emergency Research

# 636 - Review and Processing of Problems, Complaints, Concerns, and Questions from Research Subjects

# 638 - International Research

# 642 - IRB Review Fees (coming soon)

# 644 - Retention of IRB Records

Vulnerable Populations (700's)
# 700 - Research Involving the Participation of Individuals with Impaired Decision-making Capacity
# 705 - Research Involving Pregnant Women, Human Fetuses, and Neonates
# 710 - Research Involving Prisoners
# 715 - Research Involving Children

Informed Consent (800's)
# 800 - Informed Consent Process and Its Documentation
# 805 - Consent Monitoring
# 810 - IRB Approval Stamp on Consent Forms
# 820 - Research Involving Non-English-Speaking Subjects and Use of the Short-Form Consent
# 830 - Waiver and Alteration of Informed Consent and Authorization for Research (UPDATED 10/13/11)
# 840 - Certificates of Confidentiality

Reporting/Regulatory Compliance (900's)
# 900 - Protocol Deviations and Violations
# 905 - Protocol Exceptions
# 910 - Adverse Events/Unanticipated Problems Involving Risks to Subjects or Others - Prompt Reporting
# 915 - Administrative Holds, Suspensions and Terminations of Research
# 925 - Handling of Non-Compliance
# 930 - Reporting To Institutional Officials and Regulatory Agencies
# 935 - Clinical Trials Registration and Reporting of Results

Research Involving Drugs, Devices or Biologics (1000's)

# 1000 - Clinical Investigations of Investigational New Drugs (INDs) or Marketed Drugs
# 1050 - Review of Research Involving Medical Devices
# 1100 - Medical Devices: Significant Risk, Non-significant Risk and Exempt
# 1150 - Humanitarian Use Devices and Their Review
# 1200 - Emergency (Compassionate) Use of an Investigational Drug, Device, or Biologic
# 1450 - Off-Label and Investigational Use of Pharmaceuticals and Medical Devices

Research Using Coded Specimens or Coded Private Information (2000's) (coming soon)
# 2000 - Research Databases, Specimen Repositories, and the Use of Existing Data or Specimens in Retrospective Research

Genetics Research (3000's) (coming soon)
Genetic Non-Discrimination Act (GINA)
Genome-Wide Association Study (GWAS)
          o Guidelines
          o DNA For Dummies

HIPAA as it Relates to Research (4000's) (coming soon)
# 4000 - Requirements for Use/Disclosure of PHI for Research Purposes
# 4050 - Individual Rights in the Research Context
# 4100 - Determining if Research is Subject to or Exempt from the Privacy Rule (HIPAA) and Conducting Research with De-identified Information
# 4150 - Minimum Necessary Standard: Research Activities
# 4200 - Review of Activities Preparatory to Research
# 4250 - Access to Health Information of Decedents for Research
# 4300 - Limited Data Sets in Research
# 4350 - Database Review
# 4400 - Waiver and Alteration of Informed Consent and Authorization for Research
# 4450 - Accounting of Disclosures
# 4500 - Record Retention Dictated by the Privacy Rule
# 4550 - Sponsor Access to Protected Health Information (PHI) - Onsite
# 4600 - Data Security Requirements and Safeguarding Electronic Communications

Conduct of Research / Guidance Topics (5000's)

# 5000 - Advertising, Recruitment, & Pre-Screening of Research Participants

State Law Considerations (6000's)
# 6000 – Applicability of State and Federal Laws Related to Research

Grants & Contracts (7000's)
# 7000 - Written Agreements for Externally Funded Research Involving Human Subjects