This document is to serve as a guide for Edgewood College faculty, staff, and students engaged in research projects involving human participants. These guidelines have been prepared with the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations (45 CFR Part 46), known as the "Common Rule," as a guide. These guidelines provide for and direct the activities of the Edgewood College Institutional Review Board (IRB). The guidelines are housed in the Edgewood College Oscar Rennebohm Library, can be obtained from the IRB Chairperson, or can be found at https://www.edgewood.edu/irb.
The Edgewood College Institutional Review Board (IRB) will be responsible for reviewing all Edgewood College research proposals involving the use of human participants. The IRB shall review, approve or disapprove, and/or request changes in submitted projects brought before it based on the policies stated herein.
1. The IRB will keep the following records for at least three (3) years after closure of the research study:
1. Copies of research study proposals, informed consent documents, and progress reports;
2. Copies of correspondence between the IRB and principal investigators;
3. Adverse reaction reports.
2. IRB will permanently maintain IRB membership records, IRB policies and procedures, and minutes of IRB meetings.
3. The work of the Board and appropriate supporting documents will be submitted to the Vice President of Academic Affairs at the end of each semester.
4. The IRB Chair will promptly provide written notice of suspension or early termination of the IRB’s approval of a research study to the investigator, the Vice President of Academic Affairs and, if appropriate, the Department of Health and Human Services (DHHS), the head of any supporting federal agency and the Office of Human Research Protections (OHRP).
5. If the IRB becomes aware of any unanticipated problems involving risks to participants or any serious or continuing noncompliance with the federal regulations governing research, the IRB Chair will notify the head of the appropriate supporting federal agency and, if appropriate, OHRP. A copy of the report will be simultaneously delivered to the Vice President of Academic Affairs and to the investigator.
6. The IRB Chair will report to the Office for Research Integrity any occurrence of scientific misconduct in a Public Health Service-sponsored research study that involves fabrication, plagiarism or other practices that are not accepted within the scientific community for proposing, conducting or reporting research.