1. Purpose
This SOP describes the process WVU follows to comply with all applicable local, state,
and federal regulations in the conduct of research and to communicate certain actions
to entities that may have an interest in the status of the research being conducted.
The IRB will notify institutional officials, funding sources, regulatory agencies
as appropriate. When the IRB determines: that an event represents an unanticipated
problem involving risks to participants or others, that an event meets serious
or continuing non-compliance criteria, or suspends or terminates approval of research.
2. AAHRPP Reporting Requirements
The IRB must report to the Association for Accreditation of Human Research Protection
Programs (AAHRPP) within 48 hours after West Virginia University officials or any
researchers (if the researcher is notified rather than WVU) becomes aware of:
- Any negative actions taken by a government oversight office, including, but not
limited to, federal OHRP determination letters, FDA warning letters, FDA 483
inspection reports with official action indicated, FDA restrictions placed
on IRBs or researchers.
- Any litigation, arbitration, or settlements initiated related to human research
protections.
- Any press coverage (including but not limited to radio, TV, newspaper, online
publications) of a negative nature regarding the WVU human research protections
program.
The IRB Director, IRB Chair, or Vice Chair will report allegations of research misconduct
to the WVU Institutional Official, who will coordinate the inquiry, investigation,
and hearing phases as needed. All investigations and reporting to appropriate officials
will be conducted according to WVU’s Policy for Research Misconduct. (See SOP 049:
Non-Compliance and Research Misconduct.)
3. Procedures
After the IRB makes a determination necessitating reporting to external agencies
(See SOP 031: Research Related Event Reporting), a WVU OHRP administrator or designee
prepares a letter containing the following information:
- The nature of the event (unanticipated problem involving risks to participants
or others, serious or continuing non-compliance, suspension or termination
of approval of research);
- Name of the institution conducting the research;
- Title of the research project and/or grant proposal in which the problem occurred;
- Name of the principal investigator on the protocol;
- Number of the research project assigned by the IRB and the number of any applicable
federal award(s)
(grant, contract, or cooperative agreement);
- A detailed description of the problem, including the findings of the organization
and the reasons for
the IRB’s decision;
- Corrective actions and/or sanctions the institution is taking or plans to take
to address the problem
(e.g., revise the protocol, suspend participant enrollment, terminate the research,
revise the informed
consent document, inform enrolled participants, increase monitoring of participants,
etc.);
- Plans, if any, to send a follow-up or final report by a specific date or when
an investigation has been
completed, or a corrective action plan has been implemented;
- For suspensions or terminations of IRB approval of FDA-regulated research, the
letter will also
include:
- The name of the drug, biologic, or device;
- The IND number, or IDE number/non-significant risk (NSR) status of the device;
- The address(es) of the clinical investigator(s)
3.1. The IRB Chair, Vice Chair, or designee reviews the letter and modifies the letter
as needed.
3.2. The IRB Chair, Vice Chair, or designee electronically approves (and, if possible,
electronically signs) the letter.
3.3. The IRB administrator or designee sends a copy of the report to the following
as applicable. Reporting to a regulatory agency is not required if the event occurred
at a site that was not subject to the direct oversight of the organization, and
the agency has been notified of the event by the investigator, sponsor, another
organization, or other mechanisms.
- Principal investigator;
- Sponsor, if the research is sponsored;
- The Institutional Official at WVU and, when appropriate, Officials of the institutions
that have a Memorandum of Understanding (MOU) with the WVU IRB;
- Chairman or supervisor of the principal investigator and/or offending investigator;
- The IRB, by providing the determination letter;
- The Institutional Representative(s) identified in a relevant reliance agreement
if the WVU IRB is responsible for review and oversight of the research;
- The Privacy Officer of a covered entity, if the event involved unauthorized use,
loss, or disclosure of individually identifiable patient information from that
covered entity;
- The Information Security Officer of an organization if the event involved violations
of information security requirements of that organization;
- WVU Office of Risk Management (if applicable);
- The federal OHRP, if the research is subject to DHHS regulations or subject to
a DHHS Federal Wide Assurance;
- Other federal agencies when those agencies oversee the research, if they require
reporting separate from that to the federal OHRP;
- FDA, if the research is subject to FDA regulations;
- The Department of Defense, if the research is conducted under the terms of the
Department of Defense Addendum Federal Wide Assurance;
- The WVU OHRP administrator or designee can provide copies to others as deemed
appropriate by the WVU OHRP Director, Institutional Official, IRB Chair, or
designee.
4. References
WVU Policies:
SOP 031: Research Related Event Reporting
SOP 049: Non-Compliance and Research Misconduct
Federal Regulations:
21 CFR 56.108
45 CFR 46.108
AAHRPP:
Standard I-9
Element II.2.G
Element II.2.H
Element II.2.I
