Institutional Review Board (IRB)
Federal-Wide Assurance 00004634
All research involving human participants conducted under the auspices of UMass Boston requires prospective review and approval of the Institutional Review Board (IRB). The IRB reviews human subject research in accordance with current U.S. Department of Health and Human Services as well Food and Drug Administration regulations and guidelines.
The IRB also serves as a privacy board to ensure compliance with the privacy rules defined in the Health Insurance Portability and Accountability Act (HIPAA). As such, it acts upon requests for waivers or alterations of the Authorization requirement under the Privacy Rule for uses and disclosures of protected health information (PHI) for research purposes.
The main purpose of the IRB is to protect the rights and welfare of human subjects who take part in research. All UMass Boston faculty, staff, and students who propose to conduct research involving human subjects are required to successfully complete the web-based CITI training (for complete information, carefully review the provost's memo of 23/2/11). In its review of proposed research activities involving human subjects the IRB seeks to ensure that:
- Risks to subjects are minimized by evaluating whether procedures performed on subjects are consistent with sound research design and do not unnecessarily expose subjects to risk.
- Risks to subjects are reasonable in relation to any benefits that might be derived from taking part in a research study and to the importance of the knowledge that may result.
- Selection of subjects is fair and equitable. The IRB seeks to determine that no eligible individuals are denied the opportunity to take part in any study, particularly those from which they may benefit, based on an arbitrary criterion such as gender, age or language barriers.
- Planned recruitment and consent procedures allow for voluntary participation and that informed consent will be obtained from each prospective subject or where appropriate, or from the subject's legally authorized representative.
- The research plan provides for monitoring the data collected to ensure the safety of subjects.
- There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data collected on research participants.
Questions regarding the IRB or the conduct of research involving human participants may be directed to Kristen Kenny, IRB administrator, at 617.287.5374 or firstname.lastname@example.org.