Research Non-Compliance Reporting and Management

Transcription

1 I. Research Non-compliance Research non-compliance is a failure by a research team member to follow research related requirements, good clinical practice requirements, GRU requirements, and applicable regulatory requirements and determinations of the reviewing IRB. Some examples of noncompliance include, but are not limited to: Failure to obtain approval for research prior to initiating the research activities, Continuing research activities beyond the expiration date without obtaining continuing review approval, Failure to obtain informed consent when required, Implementing changes to the protocol without prior approval unless made out of immediate concern for research participant safety, Performance of research at an unapproved site, Failure to adhere to the approved protocol, or Failure of the Principal Investigator to properly oversee the conduct of the research Failure to adhere to VA requirements, if applicable Serious Non-compliance is a failure to adhere to the laws, regulations, or policies governing research involving human participants that might reasonably be regarded as: Involving substantive harm, or a genuine risk of substantive harm, to the safety, rights, or welfare of human research participants, research staff, or others If studies conducted at the Charlie Norwood VA Medical Center, it includes substantively compromising the effectiveness of a VA facility s human research protection program Continued Non-compliance is a persistent failure to adhere to the laws, regulations, or policies governing human research. Only the IRB can determine that non-compliance is serious or continuing. Reporting Non-compliance There are five ways to report or initiate a written complaint or allegation of noncompliance and these must be reported within five business days of becoming aware of the non-compliance: The investigator may discover and must self-report an instance of noncompliance to the appropriate IRB; Version Date: Page 1 of 8

2 The IRB may initiate an inquiry based on information available to it gained through the ongoing review of research/monitoring of the informed consent process; Any individual or organization may submit a written complaint or allegation to the Regulatory Compliance Manager, the IRB Chair, or a member of Research Administration leadership Anonymously reporting the non-compliance via the Institutional Compliance Hotline at Information is discovered during the routine audit and compliance process Information identified in any other manner VA Studies: Members of the VA research community must report possible serious or continuing non-compliance with VA or other federal requirements related to human research or with IRB requirements/determinations to the Associate Chief of Staff for VA Research and Development and the IRB in writing within five business days after becoming aware. II. Review by GRU IRB Office/IRB Committee The IRB Office Director/Regulatory Compliance Manager receives the complaint, reviews the initial allegation of non-compliance or harm, initiates an inquiry, and determines if there is merit to the complaint or allegation. During the review process, the IRB Office Director/Regulatory Compliance Manager will communicate directly with the investigator, IRB Chair, other Research Administration leadership, and Legal as appropriate. During the course of the investigation, the IRB Office Director/Regulatory Compliance Manager may request additional information about the allegation from the research team or request a for cause audit of the research by an IRB Office Auditor. For VA studies, the VA Research Compliance Officer is responsible for investigating noncompliance and reporting findings in accordance with VA regulations as indicated in VHA Handbook If the allegation of non-compliance proves to have merit based on the investigation, the IRB Office Director/Regulatory Compliance Manager will notify the IRB Chair and applicable Research Administration leadership. A summary of the non-compliance issue(s) as well as any additional findings from subsequent audits or inquiries will be forwarded to the applicable IRB (internal or external). Review by the GRU IRB Committee: The IRB reviews a report of apparent serious or continuing non-compliance at its next convened meeting. If any of the members have conflicting interests, the member will be recused from the review and discussion. The IRB will determine if the non- Version Date: Page 2 of 8

3 compliance is serious and/or continuing in accordance with applicable regulations. VA studies are reviewed according to the VA regulations. In order to make a determination, the fully convened IRB may solicit additional information about the allegation from the study team or request the review of the research by an IRB Office Auditor. The Principal Investigator and/or research team member under investigation will be given an opportunity to submit written comments and to appear before the fully convened IRB. The IRB must reach a determination that serious or continuing non-compliance did (or did not) occur within days after receiving a report of apparent non-compliance. VA Studies An initial report of apparent serious or continuing non-compliance based on a research compliance officer consent document audit, research compliance officer regulatory audit, or other systematic research compliance officer audit is required regardless of whether disposition of the matter has been resolved at the time of the report. Should the IRB determine that the reported incident constitutes serious and/or continuing non-compliance determinations, within five business days after the determination the IRB Chair or designee must provide a written report directly to the following: o Medical center director. o Associate chief of staff for research. o Research and Development Committee o Other relevant research review committee. o The Office of Research and Development, if VA-funded. o The Regional Office of Research Oversight. o The VA Privacy Office, when the report involves unauthorized use, loss, or disclosure of individually identifiable patient information. o The VA Information Security Officer when the report involves violations of VA information security requirements. Unless the non-compliance has already been reported, within 5 business days of receiving notification, the VA medical center director must report the apparent serious or continuing non-compliance to the appropriate Office of Research Oversight research officer, the Veterans Integrated Service Network (VISN) director, and the Office of Research Development. An initial report of an IRB determination that serious non-compliance or continuing compliance occurred is required, even where the determination is preliminary or disposition of the matter has not been resolved at the time of the report. Version Date: Page 3 of 8

4 III. Outcomes of IRB review regarding the non-compliance At the conclusion of the IRB s review, the IRB Chair and the IRB Office Director/Regulatory Compliance Manager will prepare a report summarizing the information it has considered and outlining its conclusion and recommended actions. If the fully convened IRB determines the non-compliance is not serious or continuing, the IRB may: take no action, write to the Principal Investigator describing the concern, and/ or require the Principal Investigator and/or research team member to give an explanation and outline a corrective action to avoid repeating the noncompliance. If investigator s reply is not satisfactory, this is handled as serious or continuing noncompliance. If the fully convened IRB determines the non-compliance is serious and/or continuing, the IRB Chair and the IRB Office Director/Regulatory Compliance Manager will write to the Principal Investigator regarding the findings and actions taken by the IRB and may request a response. Based on the IRB s review and determinations, the following actions may be taken by the IRB: Request for more information before a final decision can be made; Request that the PI implement changes to the research protocol, procedures / informed consent documents; Request that the PI provide a corrective action plan to avoid a repeated occurrence in the future; Suspend or terminate the IRB approval for the study {Refer to IRB Policy: Administrative Holds, Suspensions and Terminations}; Place the study on administrative hold; Review one, some, or all of the investigator s research studies; Revise the frequency of the continuing review process; Limit the types or numbers of studies for which an individual may serve as investigator; Require additional training for the PI and the research staff; Disqualification of the PI or member of the research staff from conducting research at GRU; Disallowance of research use of data collected; Version Date: Page 4 of 8

5 Notification of research participants regarding study problems (required when information may relate to the participants willingness to continue participation) or re-consent of participants; Recommendation to GRU Research Administration leadership that further action be taken Recommend a mentor The review process will be considered as completed once the investigator has completed the requirements and/or responded to the IRB. The IRB Chair and the IRB Office Director/Regulatory Compliance Manager will notify the investigator in writing that the research may continue and no further action is required. If the investigator offers an explanation that the IRB rejects, or if the investigator fails to respond within the specified time period, the IRB may make a recommendation for further action that includes the items listed earlier in section. Remedial actions involving a specific study or research team must be completed within days after the IRB s determination. Remedial actions involving programmatic non-compliance must be completed within days after the IRB s determination unless remediation requires substantial renovation, fiscal expenditure, hiring, or legal negotiations. IV. Appeals There is an appeals process that allows the investigator or research team member the opportunity to seek reconsideration of the determination by the IRB under certain circumstances. The grounds for appeals are limited to the following situations: the respondent has new information that was unavailable at the time of the investigation; the procedures outlined in the policy were not followed; or the sanctions are considered to be excessive The Institutional Official (IO) and a member of the applicable Research Administration leadership will review the written appeal from the investigator or research team member and the final report from the IRB Office Director/Regulatory Compliance Manager and IRB Chair. The decision will be presented in writing to the investigator or research team member within 14 days of the decision and shall be final immediately. The IO will investigate the non-compliance process and, if it is determined that the process was inappropriate, then the IRB will be required reconsider the decision. No other entity within GRU may override a decision by the IRB, or the IO (through the IRB Office Director/Regulatory Compliance Manager and IRB Chair) that limits, imposes Version Date: Page 5 of 8

6 conditions or in any way restricts the respondent s privileges, or imposes conditions or restriction upon the respondent s research protocols. V. Reporting to Regulatory Authorities If the fully convened IRB makes a determination of non-compliance that is serious and/or continued, the IRB Office Director/Regulatory Compliance Manager will ensure that proper documentation is provided in the minutes to include the IRB determinations and corrective actions. If not properly documented, the non-compliance issue will be presented at the next IRB meeting to be addressed. If all items are addressed in minutes, the IRB Office Director/Regulatory Compliance Manager will promptly prepare a letter to the appropriate regulatory authority (DHHS OHRP, FDA, etc.) that contains 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 Research project number 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 decision of the IRB Actions the institution is taking or plan of action to address the problem: Suspending enrollment on the study Suspending any activity on the study as long as subject on active treatment are adequately cared for Asking the IRB Office to audit the study or all of the studies under this investigator Requiring continuing review more often than annually Requiring a change in principal investigator (PI) Requiring the addition of a mentor for the PI Requiring additional education and training for the PI and research team Requiring monthly or quarterly reports on the activity of the study Terminating the IRB approval for the study Requesting confirmation from outside experts or consultants related to the activity of the study Requiring additional information from the PI Revise the informed consent document Inform enrolled subjects Version Date: Page 6 of 8

7 Increase monitoring of subjects to include observation of the informed consent process Plans, if any, to send a follow-up or formal report by the earlier of: 1. A specific date 2. When an investigation is completed or a corrective action plan is implemented The IRB Chair, Institutional Official, applicable Research Administration leadership, and the Office of Legal Affairs will review the letter and modify as needed. The IRB Chair and IRB Office Director will sign the letter. The IRB Office Director or designee will send a copy of the report to: IRB by including the letter in the next agenda packet as an information item Institutional Official DHHS OHRP, if the study is subject to DHHS regulations or subject to a DHHS federal wide assurance FDA, if the study is subject to FDA regulations. If the study is conducted or funded by any Federal Agency other than DHHS that is subject to "The Common Rule", the report is sent to OHRP or the head of the agency as required by the agency 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. Department of Defense (DoD) Human Research Protection Officer, if DoD regulated Principal investigator Sponsor, if the study is sponsored Contract research organization, if the study is overseen by a contract research organization Department Chair or supervisor of the principal investigator 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 Office of Risk Management of MCGHI, if applicable Office of Legal Affairs Others as deemed appropriate by the Institutional Official If the GRU IRB makes a determination of serious and/or continuing non-compliance for VA regulated studies, the following individuals at the VA will be notified: Version Date: Page 7 of 8

8 Medical Center Director Associate Chief of Staff for Research Research and Development Committee The Office of Research and Development, if VA funded The Regional Office of Research Oversight The VA Privacy Office, when the report involves unauthorized use, loss, or disclosure of individually identifiable patient information The WHA Information Security Officer when the report involves violations of VA information security requirements. The IRB Office Director/Regulatory Compliance Manager will ensure that all the required elements have been addressed by the IRB and will report to within 15 business days of the IRB determination. For more serious actions, the IRB Office Director will expedite reporting. VI. Studies under External IRB For studies in which GRU is not the IRB of record, research non-compliance must be reported to the external IRB for the study in accordance with the external IRB s policies and procedures. The IRB of record is responsible for reviewing and making determination of serious and/or continuing non-compliance. The external IRB will notify the GRU IRB Office of any serious and/or continuing noncompliance determination. This notification is shared with the appropriate Research Administration leadership and other GRU individuals as needed (ie: Institutional Compliance, Legal Office, etc.). This may result in institutional level actions. Version Date: Page 8 of 8