Marshall University 
Huntington, WV

  

SUBJECT:  Complaints, Non-Compliance, and Regulatory Improprieties

 

PURPOSE:  To provide guidance in handling complaints, non-compliance, and regulatory improprieties in research.

 

POLICY:  To be responsive and sensitive to the complaints of our human subjects and others and to resolve complaints in a positive and timely manner.  This policy preserves the rights of the research subjects to lodge complaints and to be assured that complaints will be taken seriously.  This policy also covers the issues of handling non-compliance and regulatory improprieties.  Non-compliance and improprieties with regulations as well as violations of safety policies will not be tolerated and will be dealt with according to federal regulations.

 

DEFINITIONS:

 

"Non-Compliance" is failure to follow the regulations, the requirements of VA Handbook 1200.5, or the requirements and determinations of the IRB.  Examples of non-compliance include, but are not limited to:

1. Failure to obtain  IRB approval.

2. Inadequate or non-existent procedures for the informed consent process.

3. Failure to report adverse events or protocol changes.

4. Failure to provide ongoing progress reports.

5. Protocol deviations.

"Serious Non-Compliance" is an action or omission in the conduct or oversight of research involving human subjects that affects the rights and welfare of participants, increases risks to participants, decreases potential benefits or compromises the integrity or validity of the research.  Examples of serious non-compliance include, but are not limited to:

1. Conducting non-exempt research without IRB approval.

2. Enrollment of subjects that fail to meet the inclusion or exclusion criteria of the protocol, that in the opinion of the IRB Chair or convened IRB increase the risk to the subject.

3. Enrollment of research subjects while study approval has lapsed.

4. Serious protocol deviations that may place subjects at risk from the research

"Continuing Non-Compliance" is a pattern of non-compliance that, in the judgment of the IRB Chair or convened IRB, indicates a lack of understanding of the regulations or institutional requirements that may affect the rights and welfare of participants, would have been foreseen as compromising the scientific integrity of a study such that important conclusions could no longer be reached, suggests a likelihood that non-compliance will continue without intervention, or frequent instances of minor non-compliance.  Continuing non-compliance also includes failure to respond to a request to resolve an episode of non-compliance.

 

RESPONSIBILITIES: 

The Principal Investigator (PI) and his staff are responsible for complying with all federal regulations concerning their research and their research subjects.  Investigators and research staff must promptly report all non-compliance to the IRB.  They are responsible for the safety of all human subjects enrolled in their studies.  The investigators will hear complaints and try to resolve them prior to the complaint being filed with the IRB Chairman.   

The IRB Chairman is responsible for investigating all human subjects’ complaints, for finding a suitable resolution, and for providing a response to the complaints in a timely manner.  The Chairman and the IRB members are responsible for adhering to all applicable federal regulations, especially in conflict of interest situations.  They are responsible for making investigators aware of their responsibilities of taking human subjects’ complaints seriously and responding to them in a timely manner.  They are also responsible for making investigators aware of the repercussions of non-compliance and improprieties. 

The Director, Office of Research Integrity (ORI) is responsible for investigating all non-compliance issues as well as any improprieties involving IRB members, investigators, or their staff.  These issues will be handled in a timely manner, assuring protection of human subjects is of prime importance, and holding any violators accountable to the applicable regulation.  The Director, ORI will be responsible for providing written documentation of the resolution of the violation. He/she will make a determination for every allegation of non-compliance as to whether the allegation has a basis in fact.  All non-compliance, no matter how minor, will be evaluated by the Director, ORI to determine whether it is serious or continuing.  He/she will evaluate all non-compliance that is neither serious nor continuing to determine whether a management plan is appropriate.

IRB Members are expected to immediately report any instances of undue influence to the Director, ORI.  The Director, ORI is responsible to investigate the allegations and take corrective action.

The IRB Coordinator is responsible for receiving complaints and issues of non-compliance or improprieties.  He/she is responsible for conveying the information to the Director or IRB Chairman in a timely manner.  The IRB Coordinator will maintain a log of all complaints, violations of compliance, and improprieties.  He/she will send, receive, compile, analyze, and report the findings of the complaint survey annually to the IRB.  He/she will also maintain a copy of the complaints as well as the Chairman’s resolution of the complaint.  He/she will maintain a copy of any violations as well as the Director’s written resolution.  He/she is responsible for reporting any non-compliance issues, improprieties, and complaints to the Office of Human Research Protection (OHRP), Food and Drug Administration (FDA), and institutional officials, as appropriate. 

 

PROCEDURE:

 A.  Complaints:

A human subject may lodge a complaint with either the principal investigator (PI) or with the Office of Research Integrity.  If the PI receives the complaint first, he will make every effort to resolve the complaint prior to contacting the Research Office.  However, the research subject may want to address the complaint(s) or inquiries about a research project by telephone, in writing, or in person to the Office of Research Integrity (ORI).  Since each IRB-approved Informed Consent document includes the IRB Chairman’s ORI telephone number (304-696-7320) this may be the subject’s primary contact point.  The ORI staff person receiving the complaint or allegation will establish a complaint file, including the following information:

 

1. Subject’s name, address, and phone number. (NOT MANDATORY: only if the caller is willing to provide this information.  A caller can report an incident anonymously; however, the caller will be advised that a thorough review may not be possible, and that, without this information, follow-up responses to the subject are not feasible.)
2. Study protocol title (or acronym) and Principal Investigator’s name.
3. Date(s) of the incident.
4. An explanation of the complaint.

 

The subject will be reassured that all means will be taken to inquire into the circumstances and appropriate measures will be taken to address the issue.  Furthermore, the subject will be informed that a response to him or her will be forthcoming as rapidly as possible (providing that contact information is given) but no later than 14 days from the receipt of the complaint.

 A copy of the complaint is forwarded to the IRB Chairman.  Within three working days after receipt, the Chairman or his/her designee will explore the allegation and identify the IRB member(s) most appropriate to review the allegations or concerns.  The identified IRB member(s) will investigate the allegation(s) and prepare a written report addressing the allegation and making recommendation(s) for resolution or remedial action.  The final report will be submitted to both the IRB Chairman and Director ORI within 10 working days after receiving the assignment, who will ensure that an appropriate response to each complaint or allegation is prepared.  The Chairman will report at the following IRB meeting the action(s) taken and, if necessary, submit a report to the appropriate officials and agencies.  Within 30 days of submission of the complaint/allegation, a survey questionnaire will be given to the individual who submitted the complaint or allegation and request it be returned within 7 working days.  The questionnaire will determine the level of satisfaction achieved and allow additional comments.  The questionnaires will be compiled and analyzed on an annual basis and reported to the IRB.

The complaints will be handled in a confidential manner.  Access is limited to only those employees with a responsibility that requires knowledge of the complaint.  (Further action is outlined in Section D.) 

All complaints will be reviewed by the IRB Chair under the policy and procedures for unanticipated problems involving risks to participants or others for a determination as to whether the complaint is an unanticipated problem involving risks to participants or others, and if so, will require review by the convened IRB.

 

B.  Compliance/Non-compliance:

 

All Non-Compliance determined to be serious or continuing will be reviewed by the convened IRB.  Each IRB member will receive a copy of the complete IRB study file for that particular study along with all correspondence related to the non-compliance.  The range of actions that can be taken by the IRB are as follows:

• Modification of the research protocol

• Modification of the information disclosed during the consent process

• Providing additional information to past participants

• Notification of current participants when such information may relate to participants' willingness to continue to take part in the research

• Requiring current participants to re-consent to participation

• Modification of the continuing review schedule

• Monitoring of the research

• Monitoring of the consent

• Suspension of the research

• Termination of the research

• Referral to other organizational entities

The IRB will monitor performance of specific compliance issues and any non-compliance issues brought to the IRB’s attention.  Periodic audits will be conducted through a random sampling of the specific compliance issue being monitored.

When investigator non-compliance issues are identified, the Director of Office of Research Integrity will be notified and he/she will receive a copy of the non-compliance allegation.  The Director or his/her designee will promptly investigate the allegation of non-compliance and corrective action will be taken.  The Director will make every effort to correct the issue(s) at the administrative level.    Within three working days after receipt, the Director or his/her designee will explore the allegation and identify the individual(s) most appropriate to respond to the allegations/concerns.  The identified responsible individual(s) will investigate the allegation(s) and prepare a written report addressing the allegation(s) and making recommendation(s) for resolution/remedial action or disciplinary action, if appropriate.  The final report will be submitted to the Director within 10 working days after receiving the assignment.  The Director or his/her designee will ensure appropriate response to each complaint/allegation is taken.  The Director will report at the following IRB meeting the action(s) taken and if necessary, submit a report to the appropriate officials and agencies.

 Allegations of serious non-compliance will be reported immediately to the IRB Chairman, to the Director ORI, and to the Vice President for Research. 

 

The IRB Coordinator promptly reports allegations of non-compliance with the governing regulations and to the Director ORI  and other appropriate organizations as indicated in Appendix A.  (Further action is outlined in Section D.)  

 

C.  Regulatory Improprieties in Research

 All instances of improprieties in research will be reported to the Director, ORI.  Each instance of alleged impropriety will be evaluated on a case-by-case basis.  All effort will be made to correct the impropriety at the administrative level.   If the impropriety involves potential harm to others or significant property damage, the appropriate institution officials will be notified for immediate action pending formal inquiry. (Further action is outlined in Section D.) 

 D. Further Actions:

 

The ORI Director or the designee, as appropriate, will conduct an initial review to determine the nature of the complaint, non-compliance issue, or impropriety.  During this review, every effort will be exercised to maintain the confidentiality of all parties involved.  The Director will evaluate the facts gathered and take appropriate action.  Dependent upon the nature of the event or circumstances, certain actions may occur:

 

            1.   Further inquiry may be initiated.

2.      Administrative action may be taken (i.e. suspension or termination of the study).

3.      Details and recommendations forwarded to the appropriate committee Chairpersons (e.g., IRB, Radiation, or Safety) for consideration in their committees, and action.

4.      Details and recommendations forwarded to the appropriate Department Chairman for action.

5.      Details and recommendations forwarded to the Vice President for Research, Provost, University General Counsel, or the President for action.

6.      Details and recommendations forwarded to the appropriate officials at affiliated institutions for notification, action, and follow-up, if applicable.

7.      Other actions as deemed appropriate.

 

The final course of action is entirely dependant upon the nature, severity, and degree of seriousness of the findings.  For example, the IRB may require special monitoring of the consent process by an impartial observer (consent monitor) to reduce the possibility of coercion and undue influence by an investigator or his staff. 

 

The Director, ORI will report to institutional officials and regulatory agencies in accordance with the Reporting Policy SOP.

 

 

FOLLOW-UP RESPONSIBILITY:  Director, Office of Research Integrity

 

 

APPENDIX    A
 

 INFORMS/NOTIFIES/REPORTS TO [ONE OF THESE ENTITIES] ON