Suffolk University is a teaching and research institution committed to promoting the ethical conduct of human subjects research in accordance with the guiding principles outlined in the Belmont Report, the Nuremberg Code and federal regulations codified in the 45 CFR 46 Common Rule under the auspices of the Department of Health and Human Services (DHHS). Suffolk University holds a Federal-wide Assurance (FWA) with the Office of Human Research Protections (OHRP) that articulates the institution’s commitment to complying with government, state and local policies governing human subject research.
All research involving human participants conducted under the auspices of Suffolk University requires the independent and prospective review and approval by the Institutional Review Board (IRB). The IRB is comprised of faculty, staff, and non-affiliated members who are charged with reviewing all human subjects research conducted by Suffolk University faculty, staff and students in accordance with current HHS and FDA regulations and guidelines. The IRB is charged with ensuring the protection of research participants through the integrity of the informed consent process as well as safeguarding the confidentiality of personally identifiable information associated with the collection of data on research participants.
Suffolk University offers the Collaborative Institutional Training Initiative (CITI) program as its human subjects research ethics training curriculum. All individuals working directly with human subjects or data that can be linked back to individual subjects must complete human subjects research training requirements every two years. Research protocols will not be reviewed prior to the completion of training by all study team personnel. To complete CITI you must first register by visiting the training log-in webpage, clicking on the ‘Register Here’ link and affiliating yourself with Suffolk University as the Participating Institution. Initial training requirements can be met by completing the Basic Course for Social and Behavioral Research Investigators.
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 ensure the ethical conduct of human subject research by protecting the rights and welfare of human subjects who take part in such research. In its review of proposed research activities involving human subjects the IRB seeks to ensure that:
- Risks to subjects are minimized. The IRB evaluates 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 expected 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 will result in voluntary participation and that informed consent will be obtained from each prospective subject or where appropriate, 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.