The federal regulations governing the conduct of human subject research are 45 CFR Part 46 and 21 CFR Parts 50 and 56, on which our IRB program is based, along with the ethical principles of the Belmont Report.
Other Regulatory Considerations
In addition to the FDA and the OHRP, the Institutional Review Board (IRB) must comply with other regulatory agencies at the Federal level. Two other agencies will be of interest to you as you conduct or participate in research:
The Office of Research Integrity / Misconduct in Research
The Western Connecticut Health Network IRB is required to report any cases or issues of research misconduct or fraud to the Office of Research Integrity (ORI) and to file an assurance of compliance each year. Our institution is committed to fostering an environment in which research is conducted in accordance with the highest professional, ethical, and legal standards.
Misconduct of any nature in research undermines the fundamental concepts of scientific research, and the public’s trust and confidence in our organization. Our Misconduct in Research policy outlines the process of reporting, inquiry, and investigation of alleged misconduct in research. To date no misconduct issues have been reported.
The Office of Civil Rights / HIPAA
The Office of Civil Rights is the overseeing authority of HIPAA standards or regulations. HIPAA stands for the Health Insurance Portability and Accountability Act, and is often referred to as the Privacy Rule, which better describes its purpose. HIPAA establishes minimum Federal standards to safeguard the privacy of individually identifiable health information, also called Protected Health Information (PHI).
Covered entities, which must comply with the Privacy Rule, are health plans, health care clearinghouses, and health care providers such as Western Connecticut Health Network. We may not use or disclose PHI except as permitted under the provisions of the Privacy Rule. We are committed to this responsibility.
The Privacy Rule also gives certain rights to individuals, including rights to access and amend certain health information and to obtain a record of when and how their PHI has been shared with others for certain purposes.
The Privacy Rule recognizes that the research community has legitimate need to use, access, and disclose individually identifiable health information to carry out a wide range of health research studies with the intent to improve medical science and patient care. In conducting approved research, researchers may create, use, and/or disclose individually identifiable health information within strict parameters.
The Privacy Rule protects the privacy of such information while at the same time allowing researchers some access and use of the information. Acting as the Privacy Board for Research, the IRB looks out for individuals who participate in or are the subject of research. We do this by strictly complying with HIPAA and the Privacy Rule, and by educating and assisting our researchers how to do the same.
We are committed to ensuring that individual rights and privacy are protected to the full extent of the law and consistent with our sound ethical practices and respect for persons.
For More Information
Please contact the Institutional Review Board if you have questions or would like more information about the IRB.