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Compliance and Complaints


Complaintant Protection Policy

The IRB is required to review allegations of misconduct and to take action to protect human subjects. Please call the IRB at 413-585-3914 or file a Participant Complaint Form if you have a concern about a research project.

Reviewing complaints and allegations of non-compliance is critical to the IRB's ability to protect human subjects. A climate free of fear of sanction is required to foster appropriate reports and ensure a fair review of allegations. Retaliation against good faith “whistle blowers” is illegal and will not be tolerated at this institution.

Investigator Noncompliance

The IRB is required to review allegations of investigator noncompliance with IRB-approved proposals as well as Federal regulations and College policy pertaining to HSR. The IRB also reviews allegations of misconduct that violate the rights of research subjects. Incidents of noncompliance will be reviewed by the IRB for corrective action appropriate to the incident. In all cases the IRB's primary concern will be to protect the welfare of the research subjects.

The IRB will report to the federal Office for Human Research Protections (OHRP), and any other sponsoring Federal department or agency head:

  • any serious or continuing noncompliance with the regulations or requirements of the IRB
  • any injuries to human subjects or other unanticipated problems involving risks to subjects or others, and any suspension or termination of IRB approval for research to appropriate institutional officials.

Investigator Conflict of Interest

The Smith College Board of Trustees will in the future approve a policy on Conflict of Interest in Research. Under such a policy, the IRB will determine whether the conflict is permissible in the context of the research and, if so, whether the conflict warrants disclosure to subjects as part of the informed consent process.

 
 
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