To establish a corrective action plan and sanctions process in the event of investigator non-compliance.
The CHS IRB may receive information that might lead them to believe that an investigator or study personnel have not complied with the policies of the IRB or Federal regulations/guidelines regarding human subjects research. It is the responsibility of the IRB to investigate allegations, take appropriate actions, and report the findings to the proper persons/authorities.
A. Identification of Serious or Continuing Non-Compliance
The CHS IRB reviews all allegations of non-compliance with research regulations in projects under its purview. For research approved by another IRB, the CHS IRB will notify that IRB of the non-compliance.
Any individual or organization may submit a written complaint or allegation of non-compliance to the IRB. The IRB may also initiate a complaint based on its own available information (deficiencies noted in IRB files, etc.).
Non-compliance can include, but is not limited to:
- Failure to obtain IRB approval for research involving human subjects;
- Failure to follow study protocol;
- Inadequate procedures for informed consent;
- Inadequate supervision of research involving experimental drugs, devices or procedures;
- Failure to follow recommendations made by the IRB to ensure the safety of subjects;
- Failure to report adverse events;
- Failure to act on, or report to the IRB, information from the sponsor which affects subject safety;
- Failure to report proposed protocol or consent form changes to the IRB;
- Failure to solicit IRB approval for proposed recruitment methods and materials prior to use;
- Failure to provide timely continuing review of ongoing studies;
- General non-compliance with IRB policies or research regulations.
The IRB may also review allegations of conflict of interest, financial mismanagement, etc.
The IRB requests that individuals observing investigator non-compliance report to the IRB within 24 hours (or as soon as reasonably possible), any (i) unanticipated problems involving risks to subjects or others; (ii) any serious or continuing noncompliance with Federal Regulations or the requirements or determinations of the IRB; and (iii) any suspension or termination of sponsor approval.
B. IRB Actions
In response to an allegation of non-compliance, the IRB will investigate the allegation and complete the Non-Compliance Report . Documentation of the event will take place on the Non-Compliance Report and in any letters received/sent regarding the report. The documentation will be kept in the IRB office.
If necessary, the IRB will conduct an on-site audit during the investigation. Alternatively, the IRB may audit the investigator at a predetermined future date in order to ensure that the investigator has made efforts to initiate the recommended compliance requests.
Possible IRB actions may include, but are not limited to:
- Dismissing the complaint as unjustified;
- Requiring education of the Principal Investigator (or other investigator or study personnel);
- Imposing specific monitoring of compliance with applicable rules;
- Requiring increased reporting by the Principal Investigator of his/her human subjects research activities;
- Suspending approval for one or more of the Principal Investigator's studies;
- Terminating approval for one or more of the Principal Investigator's studies;
The IRB will send a copy of its final decision to the Principal Investigator. If the allegation involves activities occurring at a non-CHS facility or institution, the IRB will share the information with that site, as appropriate.
C. Suspension or Termination of Research
The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
Suspension or termination of approval includes written documentation of the reasons for the IRB's action that is promptly reported to:
- The investigator;
- The appropriate institutional officials;
- The Food and Drug Administration, if the study is a drug or device study (per regulations set forth at 21 CFR 56.108(b)(3));
- The Office for Human Research Protection (OHRP) if the study is federally funded (per regulations set forth at 45 CFR 46.103(B)(5)(ii));
- The Study Sponsor.
Study Suspension. A study may be temporarily suspended to further enrollment if the IRB feels additional information is needed to ensure the ongoing safety of participants or while awaiting a response from the investigator regarding an initial allegation. Once the investigator has, to the satisfaction of the IRB, provided sufficient information and/or corrected his actions, the IRB may once again allow the study to be open to accrual.
Temporary suspensions to enrollment which are not due to investigator non-compliance (i.e. possible increased risk to subjects, needing investigation and/or clarification) are only reported to the investigator and, if relevant, the appropriate institutional officials.
Reasons for suspension may include:
- Discovery of increased risk to study participants.
- New findings that impact enrolled subjects.
- Failure to report unanticipated problems to the IRB.
- Failure to obtain and document consent which is both informed and effective considering the capacity of the study participants.
- Deficient informed consent documents in general.
- Enrollment procedures that did not minimize the possibility of coercion or undue influence.
- Failure to seek continuing review in a timely manner.
- Other evidence of non-compliance
Study Termination. A study may be terminated if the issues surrounding the suspension of a study cannot be satisfactorily addressed and resolved. Serious issues of investigator non-compliance may lead to the termination of all of an investigator’s active studies. Sufficient and substantive evidence is required to justify the termination of all of an investigator’s studies.
D. Investigator Responses
The investigator must respond to the IRB’s written notice of non-compliance no less than 30 days after receiving such notice. However, the required response time may be immediate (within 24 hours), if patient safety or other urgency is involved.
The investigator’s response must assure the IRB that the issues identified will be taken care of as per the IRB’s request.
Right to a Hearing. The investigator has a right to a hearing, if s/he feels that it would provide a better explanation and substantiation of the event. The hearing may be made to a sub-committee of the IRB or to the Full Board. Determination of whether the hearing will require Full Board attendance or that of a designated sub-committee, will be made by the IRB at the time of the investigator’s request.
Right to an Appeal. If the investigator believes that the allegations are unfounded, have been misrepresented, or if s/he is in any other way in disagreement with the allegations being made in the non-compliance report, s/he may request an appeal.
Such an appeal will be made in writing and will explicitly outline any/all information needed to clarify the issue and state her/his point. The written appeal will be presented to the Full Board for review. If requested, the investigator may be asked to be present at the IRB meeting at the time of the review of the appeal.
Following the appeals process, the IRB may alter its original action. However, decisions made by the IRB at this time will be final.
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