Human Subjects

3.1 Human Subjects Research

Boston University investigators conducting research involving human subjects, whether externally funded or not, must submit a proposal research plan to the appropriate BUIRB for review and receive approval from the IRB prior to beginning the human subjects research. For Additional Information see: CRCMED

3.1.1 Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security

The HIPAA Privacy Rule protects the privacy of “protected health information” (PHI) at Boston University’s HIPAA-covered components and at BMC, including when personal health information is used or collected in human research. The HIPAA Security Rule safeguards PHI that is in electronic form. Boston University and BMC each have policies and procedures to comply with the HIPAA Privacy Rule and the HIPAA Security Rule with respect to the institution’s PHI. For researchers to gain access to existing PHI that is held by any of Boston University’s “HIPAA-covered components” or by BMC, they must provide written assurances that the health information will be used and protected in compliance with HIPAA policies. Researchers who collect new PHI for research directly from patients of a covered entity/component must collect, use, and protect the information in compliance with HIPAA policies. The research members who will have access to the PHI must receive HIPAA workforce training. The IRB should be consulted to determine whether or not specific research use of PHI constitutes human subjects research that requires IRB review.   For Additional Information see: HIPAA

3.1.2 Project-Specific Conflict of Interest

A Project Specific Disclosure (PSD) form must be filed by every investigator engaged in a research project to disclose at the outset any significant financial interest (as defined in links below) that could reasonably appear to be affected by the design, conduct, or reporting of research. This same form is also used for supplemental disclosure to report any material change in a previously filed disclosure. PI/PDs are responsible for submitting a list of all investigators including those responsible for designing, conducting, or reporting covered research on a project. Applications for research funding will not be submitted until all PSDs are on file.

For Additional Information see: Policy on investigators conflicts of interest and Financial conflict