UConn

• UConn Health – Human Subjects Protection Office
• UConn ClinicalTrials.gov
• Office of University Compliance
• UConn Qualtrics Online Survey Information
• Policy on the Security Requirements for Protecting University Data at Rest
• UConn Family Educational Rights and Privacy Act (FERPA)
• UConn Health Insurance Portability & Accountability Act (HIPAA)
• UConn REDCap

Connecticut Educational Institutions

• Central Connecticut State University IRB
• Eastern Connecticut State University IRB
• Southern Connecticut State University IRB
• Hartford Public Schools
• New Haven Public Schools
• The University of Hartford IRB
• Yale University IRBs

State of Connecticut

• Department of Developmental Services
• Department of Mental Health and Addiction Services (DHMAS)
• Department of Public Health Human Investigations Committee
  • Department of Public Health Genomics
• Connecticut Office of Early Childhood
• Department of Correction Organizational Development Unit (includes Research and Evaluation)

Greater Hartford Area Hospitals and Medical Centers

• Hartford Hospital IRB
• St. Francis Hospital and Medical Center IRB
• Connecticut Children’s Medical Center IRB
• The Hospital of Central Connecticut IRB

The Jackson Laboratory

• Institutional Review Board

Federal Government

• Office for Human Research Protections (OHRP)
  • OHRP Human Subject Regulations Decision Charts
  • 45CFR46 (2018 Requirements)
  • OHRP International Standards and National Policies
  • OHRP IRB Guidebook
• U.S. Food and Drug Administration (Guidance for IRBs, etc.)
  • 21 CFR Parts 50 and 56
  • FDA Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects 
  • Frequently Asked Questions on Botanical Drug Product Development (Addresses Dietary Supplements and INDs)
  • Development & Approval Process (Drugs)
  • Information Sheet Guidances for Institutional Review Boards, Clinical Investigators, and Sponsors.
  • Medical Devices
  • Mobile Medical Applications
  • Informed Consent Guidance for IRBs, Clinical Investigators and Sponsors
• Department of Health and Human Services – HIPAA
• National Institutes of Health (NIH) Office of Research Integrity (ORI) Research Involving Human Subjects
  • NIH Certificates of Confidentiality Kiosk
  • NIMH Human Subject Research Issues
  • NIH Scientific Data Sharing
• ClinicalTrials.gov
• Department of Energy – Human Subjects Protection Program
• NASA Human Research Program
• National Science Foundation (NSF)
• U.S. Department of Education Protection of Human Subjects in Research
  • Family Policy Compliance Office (FPCO) – Information about FERPA and PPRA
• U.S. Department of Energy Human Subject Protection Program
• U.S. Department of Veterans Affairs Program for Research Integrity Development & Education (PRIDE)
• Walter Reed Army Institute of Research Human Subject Protection Branch (HSPB)
• Department of the Navy – Human Research Protection Program
• National Institute of Justice – Human Subjects and Privacy Protection
• Department of Education
  • Protection of Human Subjects
  • Us Department of Education (FERPA)
  • Protection of Pupil Rights Amendment (PPRA)

Training for Research with Human Participants

• Collaborative IRB Training Initiative (CITI)

IRB Professional Organizations/Forums/Accreditation

• Public Responsibility in Medicine and Research (PRIM&R)
• Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)
• IRB Discussion and News Forum

IRB/Bioethics

• The Hastings Center
• DHHS – Office of Research Integrity

International Research Ethics Guidelines

• Council for  International Organizations of Medical Sciences (CIOMS) International Ethical  Guidelines for Biomedical Research Involving Human Subjects
• Nuffield Council on  Bioethics (UK)
• World Health Organization (WHO) Ethics Publications
• Listing of  International Bioethics Organizations
• General Data Protection Regulation (GDPR)

Recruitment

• ResearchMatch at UConn – Information about UConn and UConn Health’s participation in Research Match.
• ResearchMatch – National volunteer registry used by over 120 institutions to match volunteers with active research studies.

Resources

• The Center for Health Studies – Project to Review and Improve Study Materials (PRISM)
• The Researcher’s Guide provides investigators and students with information that will be helpful for meeting the standards set by the UConn IRB policies and by the Federal Regulations for the protection of human subjects in research.
  • Download the entire Researcher’s Guide

  Or go to each section in the guide:

  • Secondary Data Analysis
    Guidance on analysis of existing data sets.
  • Data Security and Internet-Based Research
    Protecting and securing data on devices and during transmission over the internet.  Conducting research on the web.
  • Closure of Human Subjects Research Studies
    Guidance on study closure procedures, record retention, and adverse events learned after study closure
  • Consent Process
    Informed consent is more than the form.
  • Deception/Debriefing
    Guidance for use of deception in research and debriefing requirements.
  • Documentation
    Good research documentation habits are essential to reliable research data.
  • Does Evaluation Require IRB Review?
    The decision about whether review is required should be made in concert with the IRB.
  • Ethnographic/Naturalistic Research
    Guidelines for submission of ethnographic/naturalistic research protocols.
  • Focus Groups
    Guidance on when research involves focus groups to obtain data.
  • Investigator Responsibilities
    Your part in the compliance partnership.
  • Normal Educational Practice
    What type of educational research may or may not qualify for review under the exempt criteria?
  • OHRP Guidance
    A brief introduction to the Federal office that oversees research with human participants.
  • Oral Histories
    When are oral histories “human subject research” under the federal rules definition?
  • PI Mentoring of Student Researchers Conducting Research with Human Participants
    Guidance regarding the importance of mentoring student researchers and the responsibilities of mentorship.
  • Recruitment and Advertising Guidance
    Guidance for recruitment and advertising, including a recruitment flyer template.
  • Student Athlete Involvement in Research Studies
    Guidance regarding recruitment and compensation.
  • Study Design and Scientific Review
    How design is related to participant protection.
  • Wording Tips
    Need to simplify language for participants? The PRISM Toolkit Word List and full PRISM Readability Toolkit are available for free download on the Kaiser Permanente PRISM website.