Non-Compliance Policy

Policies and Procedures of the Institutional Review Board

According to the United States Department of Health and Human Services Office for Human Research Protections (OHRP), "The IRB Committee is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated." The IRB process applies to all Webster University faculty, staff and students conducting research involving human subjects on or off campus, as well as those requesting to do research at Webster University.


Definitions

OHRP defines research as “a systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge”.

Further the OHRP defines human subjects as:

“Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under the federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information.”

Non-compliance is the failure to follow federal IRB guidelines and the policy of Webster University for the protection of human subjects.

Policy

This policy applies to:

• University faculty members engaging in data collection involving human subjects, e.g. archival research, surveys, interviews, clinical trials, or experimental research.

• All student initiated research projects utilizing human subjects which are conducted outside the University classroom setting.

A research project must be reviewed if:

• it involves human subjects;

• it is research as defined by the OHRP;

• the possibility of publishing or disseminating results exists.

In addition, all Webster University students must have a faculty mentor/advisor (not a committee) who will oversee the execution of the research project.

It is expected that students engaged in the following research endeavors will submit an IRB application:

• all master's, post master's,  and doctoral projects utilizing human subjects;

• research methods classes that require students to collect data outside the classroom; and

• any Individualized Learning Experiences involving human subject research.

Additional information on determining who must complete the IRB application can be found on the Webster University IRB website www.webster.edu/irb

Research activities that fall under any of the federally defined exempt categories may not be subject to IRB requirements (e.g., annual reviews, informed consent requirements). However, it is strongly suggested that informed consent always be used. An IRB application must be completed since the IRB is the only body that can determine if a research project requires limited review or is exempt. Additional information on exempt research can be found at http://www.hhs.gov/ohrp/policy/#exempt

Incidents of noncompliance must be reported to ensure protection of human subjects and adherence to University policy. Unapproved research involving human subjects may place those subjects and the researcher at risk. All incidents of suspected non-compliance must be reported to the Chair of the IRB Committee.

Procedure

The Chair of IRB will convene a meeting of the members of the IRB Committee and a representative of the Faculty Senate to determine if there is an issue of non-compliance. Approval of the research may be suspended while the investigation is conducted. The following steps are taken:

• The Chair will notify the project investigator (PI) (s) that a non-compliance review has been initiated.

• The PI(s) are invited to submit a written explanation of the possible non-compliance.

• The PI(s) may also be asked to appear before the IRB committee.

• If after deliberation, the Committee determines that non-compliance has not occurred, the PI(s) will be notified in writing.


If the IRB determines that there has been an issue of noncompliance:

• appropriate action to protect human subjects will be taken; 

• action can be remedial and may include education for the PI(s) on protection of human subjects;

• and/or follow up reports to the IRB Committee related to the particular issue may be required.

If the Committee determines there is a serious issue of non-compliance:

• the PI(s) will be notified, and

• a Committee consisting of the Chair of IRB, the Chair of the department of the particular faculty PI(s), the Dean of the school/college of the faculty PI(s), Provost and Senior VP,  and Chair of Faculty Senate will be convened to further review the incident.

• If it is determined that there are serious issues of non-compliance, disciplinary action will be taken. 

o     For faculty this may include suspension of the research and/or constraints on presenting or publishing the research.

o     For students this may include suspension of the research or not accepting the thesis.

• The PI(s) will be notified in writing the decision of the Committee.

o     If the PI(s) believes that the IRB has erred in the decision, the University Grievance Procedure may be initiated.  Refer to the handbook for additional information. http://www.webster.edu//student-handbook/grievance.html