The primary mission of the Saint Joseph's University IRB is to ensure the protection of rights, privacy and welfare of all human participants in research programs conducted by SJU and associated faculty, professional staff, and students. Along with participant protection is the goal of providing quality service to enhance the conduct of research. To achieve this goal, the IRB has the authority to review, approve, modify or disapprove research protocols submitted by faculty, staff and student investigators. The IRB review process is guided by federal rules and regulations, and is based on the Protection of Human Subject Code of Federal Regulations, the Belmont Report, and provisions of 45 CFR 46 – Protection of Human Subjects requiring institutions receiving federal funds to have all research involving human participants be approved by an IRB.
Statement of Principles
Saint Joseph’s University is committed to excellence in teaching and research. Further, the University is committed to the conduct of these activities with the highest possible ethical standards. Saint Joseph’s University has established an Institutional Review Board (IRB) which will review for approval research involving human subjects. The purpose of the IRB is to protect human subjects and to assist faculty, students, and staff in the pursuit of knowledge through research that reflects the ethical standards of Saint Joseph’s University.
The Institutional Review Board is guided by the ethical principles regarding all research involving humans as subjects set forth by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral in Ethical Principles and Guidelines for the Protection of Human Subjects of Research: The Belmont Report. The Belmont Report includes such principles as respect for autonomy, beneficence, and justice to guide research involving human subjects. In addition, the IRB will attempt to assure compliance with the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations and those required by OHRP (Office of Human ReResearchsearch Protection).
Saint Joseph's University is a Catholic and Jesuit university that instills in each member of its academic community: a love of learning and of the highest intellectual and professional achievement; moral discernment reflecting Christian values; and a transforming commitment to social justice. These principles and convictions ground a living tradition of personal and social ethics, which, along with the Belmont Report, provide the IRB with a basis for the protection of human subjects in research.
The following broad principles are the basis for the development of Saint Joseph’s University’s policies concerning review of research involving humans:
- The direct or potential benefits to the subject, and/or the importance of the knowledge gained, must outweigh the inherent risks to the individual.
- Participation in the project must be voluntary and informed consent must be obtained from all subjects, unless the Institutional Review Board waives the requirement.
- A subject has the right to withdraw from a research project at any time or may refuse to participate without loss of benefits to which the subject would be otherwise entitled.
- Safeguarding information about an individual that has been obtained in the course of an investigation is a primary obligation of the investigator.
- No distinctions in the approval and monitoring of projects will be drawn between funded and non-funded projects, sponsored and unsponsored projects, or on-campus or off-campus projects, except for requirements concerning reporting information to a funding agency.
SJU Policy on Research Involving Human Subjects
In accordance with its abiding concern for human dignity, individual freedom and integrity, and the civil rights of all citizens, Saint Joseph’s University has adopted a policy that monitors and controls procedures that should be used in research involving the participation of human respondents or subjects. The Institutional Review Board (IRB) was established in accordance with federal regulations governing the use of human subjects in research. The IRB is charged with the responsibility for review, approval and surveillance of all research involving human subjects conducted in connection with SJU. The ethical principles which guide the IRB are consistent with The Belmont Report. The IRB policies and procedures comply with the rules and regulations of The Federal Policy for the Protection of Human Subjects as stated by the Department of Health and Human Services (DHHS) in the Federal Code, 45 CFR Part 46.
The SJU IRB operates under the University’s Federalwide Assurance (FWA 00000064), negotiated with the Office of Human Research Protections (OHRP). The OHRP is the division of the Department of Health and Human Services (HHS) which regulates Human Subjects research. This Assurance provides Saint Joseph’s University with the authorization to conduct human subject research. Administrative responsibility for overseeing these functions has been delegated to the Office of Research Services.
This policy applies to all faculty, staff and students whenever they are supervising or conducting any research activity involving human subjects, regardless of whether the research is funded, and regardless of whether the subjects are members of the University community. This policy applies to research conducted at other institutions by faculty, staff, and students, even if that institution has its own review process. The University cannot accept responsibility for research conducted in violation of University policy and without required approval.
Human Subjects Research is defined as any investigative activity involving interviews, questionnaires, or treatments of any kind requiring the participation of human subjects or respondents, whether conducted on or off campus. Certain classroom or research exercises that involve data collection or presentation of research results outside the classroom may also require IRB review. This policy is designed to insure the health, safety, privacy and dignity of all persons participating in research under the auspices of the University.
The SJU IRB reviews research that involves human subjects. The types of research that are covered include social-behavioral research, survey research, outcomes research, educational research, oral histories, and psychological research. In addition, some quality assurance and classroom activities may or may not be research.
How the results will be used affects whether or not a project is research. If there is any intent to publish or otherwise make known the results, the project should be submitted to the IRB. For example, if the project is being undertaken with the notion that a paper or journal article may be published, or that a poster or paper may be presented at a conference or community gathering, the project most likely will qualify as research and thus is subject to review by the Institutional Review Board.
Any faculty member or student preparing proposals for research or class projects involving human respondents or subjects should arrange to have his/her proposal or class project protocol reviewed by the IRB prior to initiation any data collection for the project.
The Research Compliance Coordinator can be contacted by telephone at (610)660-1298, or e-mailed at email@example.com for consultation on any research projects.