1. Purpose
This SOP describes the process WVU follows to address both allegations and confirmed
reports of any non-compliance in accordance with 45 CFR Part 46 and 21 CFR Part
50. This policy applies to the research investigative team (for research misconduct
allegations), the IRB, and WVU OHRP staff. WVU encourages members of the research
community to report apparent non-compliance to the IRB. The determination that
non-compliance is serious or continuing rests with the IRB.
2. Procedures for Addressing Allegations of Non-Compliance
2.1. Allegations of non-compliance are investigated by the WVU OHRP Director (or
designee), the IRB Chair, or a designated IRB Vice Chair.
2.2. The WVU OHRP Director (or designee) conducts a pre-inquiry review for preliminary
informal checking of the facts to determine if there is a reasonable basis for
the allegation and if the allegation can be supported or provided by evidence.
- If the allegation of non-compliance is determined by the WVU OHRP Director (or
designee) not to be a credible confirmed report of non-compliance, in fact
by definition, the inquiry stops, and no further action is taken.
- If the allegation of non-compliance is determined by the WVU OHRP Director (or
designee) to be a credible, confirmed report of non-compliance, in fact by
definition, the inquiry proceeds as outlined in this policy. The allegation
of non-compliance is considered a confirmed report of non-compliance by definition.
3. Procedures for Addressing Confirmed Reports of Non-Compliance
3.1. The WVU OHRP Director (or designee) forwards the confirmed report of non-compliance
to the IRB Chair or IRB Vice Chair for review. The IRB Chair or Vice Chair determines
whether the confirmed report of non-compliance either does not represent serious
or continuing non-compliance or might represent serious or continuing non-compliance
as defined in this policy.
3.1.1. If the IRB Chair or IRB Vice Chair determines that the confirmed report of
non-compliance is neither serious nor continuing non-compliance, as defined by
this policy, IRB Chair, or IRB Vice Chair consider but are not limited to the following
actions:
- Acknowledgement of the problems, requiring no sanctions but with instructions
regarding the necessity to establish procedures and policies to avoid further
infractions.
- Require additional education and training applicable to human research participant
protections of the investigator and/or staff.
- Request a corrective action plan from the investigator.
- No further action.
3.2. When issues of non-compliance are reviewed by the convened IRB, the WVU OHRP
Staff prepares the documents listed below, if they apply, and makes them available
to all members of the convened IRB for review at least one week before the convened
meeting. All members are expected to review the information and be prepared to
discuss it at the meeting.
- The current IRB application;
- The informed consent document;
-
The Investigator Brochure;
- The confirmed report of non-compliance;
- The audit report (investigation report) including a list of witnesses and documents
reviewed;
- Previous reports of non-compliance and the past record of the investigator and
his/her study team;
- All additional pertinent documents or portions thereof; (e.g. primary data)
3.3. A WVU OHRP staff member assigns a primary reviewer based on scientific expertise
to perform an in-depth review of the documents. The primary reviewer will present
his/her findings at the convened meeting. The primary reviewer and the IRB Chair
or IRB Vice Chair will lead the discussion during the meeting.
3.4. The convened IRB votes on whether the confirmed report of non-compliance represents
serious non-compliance and/or continuing non-compliance as defined by this policy.
WVU OHRP staff record the discussion and rationale for any action and vote in the
minutes.
3.5. If the convened IRB votes on whether the confirmed report of non-compliance
represents serious non-compliance and/or continuing non-compliance as defined by
this policy. The IRB considers but is not limited to the following actions:
- Acknowledgement of the problems, requiring no sanctions but with instructions
regarding the necessity to establish procedures and policies to avoid further
infractions.
- Require additional education and training applicable to human research participant
protections of the investigator and/or staff.
- Request a corrective action plan from the investigator.
- No further action
3.6. If the convened IRB determines the confirmed report of non-compliance represents
serious non-compliance or continuing non-compliance, as defined by this policy,
the IRB considers but is not limited to the following actions:
-
Verification that participant selection is appropriate.
- Observation of the research and the informed consent process by a WVU OHRP administrator
or IRB member.
- Modifications of the protocol.
- Request an increase in monitoring of the research activity via an independent
data safety monitor or board
- Safety intervention as necessary such as visits to the activity site and continuing evaluation of the site by a WVU OHRP administrator or IRB member.
- Request audit and progress reports from the sponsor monitor or CRO.
- Request a directed audit of targeted areas of concern by a WVU OHRP administrator and/or IRB member.
- Request a status report after each participant receives intervention from the investigator.
- Modify the frequency of the continuing review cycle.
- Request additional PI and research project team education focused on human research protections from appropriate available sources (e.g., GCP Training, OHRP conferences, NIH tutorials, human research protections seminars).
- Notify current subjects if the information about the non-compliance might affect their willingness to continue participation.
- Provide additional information to past participants
- Suspend IRB approval of the respective research protocol pending a written plan for the correction and/or prevention of the non-compliance.
- Remove the Principal Investigator of the research project.
- Suspend or terminate some or all of the research protocol and possibly other research being conducted by the Principal Investigator as well. (See SOP 029: Suspension, Administrative Hold, Early Termination and SOP 034: Reporting to External Agencies.)
3.7. If the IRB determines that the confirmed report of non-compliance was either serious non-compliance or continuing non-compliance, as defined by this policy, the matter is referred to the WVU OHRP staff to handle according to SOP 034: Reporting to External Agencies.
4. References
WVU Policies:
SOP 029: Suspension, Administrative Hold, Early Termination
SOP 034: Reporting to External Agencies
Federal Regulations:
45 CFR 46.103 (a)
45 CFR 46.103 (b)
45 CFR 56.108 (b)
AAHRPP:
Element I.5.D
