Walden University ensures compliance with research integrity policies via a three-part compliance program:
-Preventive components include researcher education, researcher self-assessment, faculty supervision of student researchers, and IRB submission support as well as outreach within the various communities with which Walden researchers engage.
-Monitoring components include checking IRB-approved studies for compliance through staff/faculty supervision and audits (i.e., comparing completed studies to check that they did not deviate from IRB-approved procedures or involve any other type of research misconduct).
-Reactive components include investigating and resolving reported ethics violations, Serious Adverse Events (SAEs), and research misconduct.
Models Underpinning the Compliance Program
Quality Assurance is the more traditional model for compliance programs. It is typically reactive and retrospective with the tasks of policing, finding mistakes, and assigning post hoc consequences.
Quality Improvement involves both prospective and retrospective work. The main tasks are supporting self-assessment among researchers and continuously improving the research support system to prevent problems. Toward this end, the compliance staff puts significant effort toward identification and resolution of barriers to compliance.
Walden University’s Office of Research Ethics and Compliance has combined both quality assurance and quality improvement best practices into its preventive, monitoring, and reactive work to ensure compliance with all of the following:
federal, state, local, and international laws and regulations (as applicable);
requirements of funders;
requirements of any community research partners who might be assisting the researcher regarding needs assessment, identifying potential participants, recruiting potential participants, data collection, or results dissemination;
provisions for participant safety;
data integrity standards; and
the specific participant recruitment and data collection procedures that are approved by the IRB (which typically subsumes the standards listed above).
Walden University’s Office of Research Ethics and Compliance (OREC) is responsible for upholding the research ethics standards of the Institutional Review Board (IRB) and U.S. federal regulations regarding the protection of human research participants as well as the research-related aspects of the codes of conduct articulated in the Student Handbook and Faculty Handbook regarding accurate representation of researchers, research activities, datasets, analyses, and research products. This office is also responsible for upholding the research ethics standards stipulated by research partner organizations and funding agencies sponsoring research at the university.
These various sources of research ethics standards are each tied to policies that mandate a fair, evidence-based, timely institutional response to allegations of research misconduct. Please click on the links above to view each of those policies.
Research misconduct includes fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. At any stage of research development, publication, or dissemination, the university requires students and staff to report any concerns regarding research integrity to Walden's Office of Research Ethics and Compliance (OREC) within 5 business days of any event, communication, or work submission that suggests possible research misconduct. This report can be made by contacting the OREC director in person; by writing to 100 Washington Avenue South, Suite 1210, Minneapolis, MN 55401; via email@example.com; or by calling 612-312-1210. Confidentiality of the reporter’s identity will be maintained if requested.
As the Research Integrity Officer for the university, the director of OREC will contact the researcher and collect all relevant information and materials. These communications will follow the university's general procedures for research misconduct inquiry, in compliance with 42 CFR Part 93.
Responding to Allegations of Research Misconduct
OREC receives all reports of suspected misconduct. Essentially, Program Directors review and adjudicate any allegations of research misconduct that solely violate the researcher’s code of conduct while OREC supports the Program Director via collection of evidence. The IRB staff reviews and adjudicates non-compliance with IRB policies. All other research misconduct allegations are handled by OREC staff and are externally reported as mandated by funder requirements.