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 Standard Operating Policies and Procedures that monitors 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 IRB Standard Operating 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 Standard Operating Policies and Procedures (SOPP) listed below 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.

These SOPPs are designed to ensure the health, safety, privacy, and dignity of all persons participating in research under the auspices of the University.

  • SOPP 1: DETERMINATION OF NEED FOR IRB REVIEW & APPROVAL
  • SOPP 2: SUBMISSION REQUIREMENTS & PROCEDURES FOR RESEARCH THAT IS EXEMPT FROM IRB REVIEW
  • SOPP 3: RESEARCH PERSONNEL ROLES & RESPONSIBILITIES
  • SOPP 4: INITIAL AND CONTINUING REVIEW BY THE IRB: REQUIREMENTS FOR SUBMISSION OF APPLICATIONS, APPROVAL CRITERIA, EXPEDITED AND CONVENED COMMITTEE REVIEW & POST-APPROVAL PROCEDURES
  • SOPP 5: NONCOMPLIANCE
  • SOPP 6: ADVERSE EVENTS & UNANTICIPATED PROBLEMS
  • SOPP 7: INFORMED CONSENT
  • SOPP 8: RESEARCH INVOLVING SJU STUDENTS
  • SOPP 9: INTERNATIONAL RESEARCH
  • SOPP 10: USE OF INTERNET/SOCIAL MEDIA FOR HUMAN SUBJECT RESEARCH
  • SOPP 11: RECRUITMENT & PAYMENT OF HUMAN SUBJECTS