Maintaining high ethical standards in education, patient care and research is vital to upholding WMed's mission, vision and values. Ethics, compliance and integrity in regards to research ensure compliance with all federal, state and university policies. Most of these regulations are put in place to protect people, animals, even institutional integrity, and cover a broad range of activity from general guidelines to specific regulations like financial conflict of interest. Student, residents, faculty and staff are all obligated, along with the guidance of the research compliance department, to understand their role in upholding these research standards in advancing knowledge through innovation and discovery.
FDA Audit Assistance
The purpose of the FDA audit processes is to help formalize organizational and communication tasks for responding to either an unannounced or scheduled Food and Drug Administration (FDA) audit. The FDA audit may be for the WMed IRB, a clinical trial under the oversight of the WMed IRB, or for a clinical trial being conducted at a WMed site, but under the oversight of an External IRB. These processes also describe activities that are done to prepare for, facilitate, and follow up on the audit of the WMed IRB and/or a clinical trial.
- FDA Audit Guidance for WMed Staff
- FDA Audit Process for WMed IRB
- FDA Audit Process for a Clinical Trial Under Oversight of WMed IRB
- FDA Audit Process for a Clinical Trial Under Oversight of External IRB
Research Compliance Violation Reporting
WMed relies on you to speak up if you believe that you have observed unethical, illegal or suspicious behavior. When you speak up, you provide the information necessary to investigate and remedy a potentially damaging situation. Every report will be acted on in a confidential manner, with notification to other appropriate individuals made on a need-to-know basis. If anonymity is desired, it will be protected to the extent possible.
- How can I report a possible violation?
- Research Compliance Violation Report: Completing the form provides the Chief Compliance Officer with the information needed to conduct a thorough and timely investigation into the research concern or violation reported. The ability to privately and confidentially discuss a compliance concern with the submitter by the Chief Compliance Officer can be vital to conduct a proper and thorough investigation.
- Research Compliance Hotline (269.337.6505): You may call the Compliance Hotline at any time during the day or night, seven days a week, 365 days a year and leave a recording. Only the Chief Compliance Officer is authorized to listen to the recorded message. Under normal circumstances the hotline will be checked for messages on a weekly basis.
Research participants are encouraged to share their concerns or complaints regarding their involvement in a research study with the investigator or study staff. However, research participants may also report their concerns to the WMed IRB at 269.337.4345, or by completing the Compliance Violation Report or by contacting the Compliance Hotline at 269.337.6505.
- Who should use the Research Compliance Violation Report form or Research Compliance Hotline?
Research participants, employees, students or anyone with concerns that research is not being conducted in accordance with WMed policies, with external sponsor requirements, or with federal and state regulations. Research concerns can be reported confidentially and or anonymously and without fear of retaliation against individuals who report them in good faith.
- When should the Research Compliance Violation Report form or Research Compliance Hotline number be used?
If you believe that you have observed unethical, illegal or suspicious behavior and suspect that a research compliance issue has occurred.
- What about protection from retaliation?
Employees, students or research participants who call the hotline will not be retaliated against. If an employee perceives that they are being retaliated against after making a call or submitting a concern, the employee is referred to the appropriate office to file an administrative grievance procedure.
- May I report anonymously?
Yes, you may choose to make your report anonymously by completing the online (written) report and forwarding to the Chief Compliance Officer. We ask that if you choose to file anonymously you provide as much detailed information as possible for the review.
- What happens if I submit a report or contact the Compliance hotline?
Once a report is submitted, or a call is received, it is promptly reviewed to determine what further steps should be taken. The scope of the review, and which officials(s) will be involved, will depend on the facts and nature of the case. Hotline reports are handled with the utmost care and in a timely manner.
The Research Compliance Hotline is not intended for reporting criminal or medical emergencies (for emergency assistance, please call 911), nor is it intended to handle employee grievances such as work conditions, performance evaluations, hours of work etc., (please use non-research “Compliance Hotline” form located under WMed Directory). The Research Compliance Hotline has been established for complaints related to research activities.