Internal IRB Concerns Policy and Procedures

No employee, committee member, or investigator shall be discriminated against or be subject to any reprisal for reporting suspected or actual violations of any regulation or standards relating to human subject research under the Common Rule(45 CFR Part 46)

REPORTING HUMAN SUBJECT RESEARCH CONCERNS

Issues of violations or suspected violations relating to human subject research activities must be reported in writing, using the Human Subjects Concern Reporting Form.

Reports can be emailed to [email protected] or mailed anonymously to:
IRB Office, 1010 Campus Drive, FLITE 410, Big Rapids, MI 49307

POLICY

It is the responsibility of the Ferris State University Institutional Review Board (IRB) to protect the safeguards and rights of humans involved in research and to ensure that human subjects' research complies with applicable ethical principals, laws, and regulations. The IRB has the right to decline, withdraw, or suspend approval at any time of any proposed or ongoing human subjects' research.

Investigators may not initiate research until a written formal IRB approval has been received. Unapproved conduct of human subjects' research activities or unauthorized deviation from an approved IRB protocol will constitute research misconduct, and investigators will be subject to Ferris' Research Misconduct Policy & Procedures.

Investigators are responsible to conduct their research in accordance with the approval terms and conditions, sound ethical principles and applicable federal, state and local regulations, and university policies, including but not limited to Conflict of Interest, Research Misconduct, Information Technology (IT) Security, Health and Safety, Public Safety, Financial Policies and Procedures, the Health Insurance Portability and Accountability Act (HIPAA), and the Family Educational Rights and Privacy Act (FERPA).

Investigators, IRB members, and members of the Ferris campus community, must promptly report any suspected or actual wrongful conduct associated with human subject research to the IRB. Reports of noncompliance with 45 CFR Part 46 or the policies of Ferris will be directed to the appropriate individual(s) for investigation and corrective action to protect subjects and the University. Investigators must promptly report unanticipated problems and/or adverse events to the IRB using the Unanticipated Problems Form. Reports should be completed and submitted within a week from the day the event which may cause risk to human subjects/others occurs. Investigators are responsible to understand these terms.

Descriptions of planned and approved research must not significantly conflict with or deviate from the information provided to external funding agencies or other university committees. At any time, the IRB may consult with the appropriate external funding agencies or other university committees to ensure compliance of approval dates and protocol procedures. Inquires may occur without investigator knowledge.

As needed to determine compliance with applicable policy and procedures, the IRB may randomly audit any approved research protocols in their entirety. An audit committee of at least two people will be selected among IRB membership and include at least one person who reviewed the initial application and include a subject matter expert, when possible. In serious situations, the Institutional Official (IO) and/or the Provost & VP for Academic Affairs will have the authority to terminate or suspend a project immediately. In all other cases, the IRB will convene for a Full Review prior to suspension or termination of any protocol; a quorum must be met and vote to determine further action.

PROCESSING CONCERNS

Step 1: The concern reporting form is completed and logged in the IRB record.

Step 2: The concern goes before the Full IRB Committee and it is determined if it is an IRB matter or a University Level Matter. If the former, the IRB investigates. If the latter, it is sent to the Office of Research and Sponsored Programs (ORSP) to handle at the University level. If both, it is a joint investigation between ORSP and IRB.

Step 3: The IRB continues the investigation to determine the accuracy of the concern through necessary means, while maintaining confidentiality.

  • Within ten (10) working days, the IRB Chair makes an initial investigation regarding the concern to determine the severity of the violation(s), and possible harms posed by the situation. When appropriate, the Chair will notify the PI of a protocol review and will ask the PI to immediately take corrective action or suspend the protocol in order to minimize any harms posed by the research project, pending further investigation.

  • Based on the concern and any investigational data gathered, the IRB will discuss and vote to indicate its stance on the concern and/or any related issues arising from the investigation. A quorum is necessary for a vote and a 2/3 majority is required to approve any motion(s) related to the committee stance on the concern and/or related issues.

  • If the IRB motion indicates that there is NO reason to move forward, the issue is considered closed.

  • However, when the IRB feels that the concern and/or related issues require further action, the IRB may additionally vote to take corrective action(s) or propose sanctions

Step 4: In situations where the IRB motion(s) indicates that the concern and/or related issues require further action(s), the Chair and as appropriate, other reviewers and/or member(s) of the ORSP will meet with the PI to communicate the IRB decision(s) to the PI, while maintaining confidentiality. The IRB Chair will work with the investigator to bring the research back into compliance with the protocol. If an impasse is reached, the protocol is suspended and sent to the ORSP for a final determination.

Step 5: Research is brought into Protocol Compliance or is permanently suspended; granting agency is notified as needed.