What Are the IRB Noncompliance Regulations?

An Institutional Review Board (IRB) is a committee that is mandated by the federal government for any health care or research facility that does scientific research on human subjects and is supported by the federal government. The committee protects the rights and welfare of human subjects taking part in clinical research conducted at that facility and has the responsibility to approve, disapprove, review, require modifications to and provide monitoring of research proposals and methodologies involving humans alongside federal and state regulations. The federal government sets the standards for IRB compliance; noncompliance with IRB regulations may invoke various penalties upon the faculty, staff and students.

Responsibilities of the IRB

• The IRB has multiple responsibilities and powers to ensure that human subjects are protected. They may approve, modify and reject scientific research that involves human subjects. Furthermore, they can monitor the conduct of research, demand progress reports, impose a hold on some aspect of research, oversee the human subject consent process, require human subjects to re-consent in order to participate in research, issue letters of reprimand and impose penalties on students, faculty and staff found responsible for noncompliance.

Use of Human Subjects

• Human volunteers must make an informed decision to participate voluntarily before being used in scientific research. During scientific research, people are considered human subjects when any bodily materials such as hair, blood and tissue are used and when information is gained from them through interview, examination or observation.

Definition of IRB Noncompliance

• Noncompliance involves one or more of the following: harm to research subjects, exposure of research subjects to risk of harm, significant risk to privacy of subjects, willful misconduct on behalf of investigators and a negative impact on ethical principles.

Policy

• Incidents of IRB noncompliance must be reported to the IRB immediately. Contacting any member of the IRB is considered adequate. The IRB will investigate allegations of noncompliance, take action to protect subjects, report serious or continuing noncompliance to government authorities and suspend or terminate research activities.

Penalties of IRB Noncompliance

• Students found to be responsible for IRB noncompliance may face any of the following: school credit may be withheld, dissertation or thesis work will be rejected, articles may be banned from publication and funding will be withheld. Furthermore, staff and faculty will face any or all of the following penalties: school funding may be withheld, sponsors may withdraw funding, articles may not be published, only approved research may be allowed and all current research may be suspended.