To report a concern, phone the Director at 713-500-7942.

The University of Texas Health Science Center at Houston Committee for the Protection of Human Subjects (IRB) has the responsibility to oversee the safety and welfare of those human participants of research studies conducted in this institution by our faculty, staff and students. This responsibility includes authority under the federal regulations to:

Suspend or terminate IRB approval of research

"An IRB shall have 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. Any suspension or termination of approval shall include a statement for the reasons for the IRB's actions and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head." -45 CFR 46.113.

To exercise this statutory authority, the IRB shall review all allegations of non-compliance with human subjects regulations and review any study that has been associated with unexpected serious harm to research subjects. The IRB will follow these policies and procedures for conducting an inquiry and investigation into such allegations of non-compliance and in reviewing incidents of unexpected serious harm to subjects.

The IRB will take appropriate action to insure the safety and welfare of all human research subjects. These actions may range from corrective or educational measures for the researcher and staff to terminating IRB approval for all active studies of a researcher. In addition, the IRB may suspend approval of research projects at any time during an inquiry or investigation to assure the protection of human subjects.

This policy includes written procedures for reporting actions to appropriate University and federal government officials as required by federal regulation.

• DEFINITIONS
• PROCESS FOR HANDLING ALLEGATIONS OF NON-COMPLIANCE
  • INQUIRY
  • SUSPENSION AND REPORTING
  • INVESTIGATION
  • APPEALS/RECONSIDERATION
  • DISSEMINATION OF FINDINGS

DEFINITIONS

Inquiry Panel shall mean an ad hoc subcommittee, appointed by the Chair and consisting of three members of the IRB whose charge is to review the initial allegation, the response from the researcher and any other appropriate materials and to issue a recommendation to the Executive Committee as to whether an investigation is warranted.

Investigation Panel shall mean an ad hoc subcommittee, appointed by the Chair and consisting of at least five members of the IRB whose charge is to investigate the allegation of non-compliance. To assure continuity and avoid duplication of effort, at least one of these panelists should be a member who served on the Inquiry Panel. The Investigation Panel will issue findings and recommendations to the Executive Committee.

Appeals Panel shall mean an ad hoc subcommittee, appointed by the Chair and consisting of at least three members of the IRB who have not served on any other of the panels involved in the process and whose charge is to review an appeal by the researcher and issue a recommendation to the Executive Committee as to whether reconsideration of the decision is warranted.

Non-compliance shall mean conducting research involving human subjects in a manner that disregards or violates federal and institutional regulations governing such research. This can include, but is not limited to, inadequate or non-existent procedures for informed consent, inadequate supervision of research involving drugs, devices or procedures, failure to follow recommendations made by the IRB to insure the safety of subjects, failure to report adverse events or proposed protocol changes to the IRB, and failure to provide ongoing progress reports.

PROCESS FOR HANDLING ALLEGATIONS OF NON-COMPLIANCE

There are several ways such reports made be submitted to the IRB:

1. An individual or organization may submit a written complaint or allegation of non-compliance to the IRB.
2. The IRB itself may initiate a complaint based on information available (e.g. deficiencies noted in IRB files, or reports from the IRB's clinical monitors).
3. A report may be made to the Ethics hotline.

INQUIRY

1. Purpose
   
   In the inquiry phase, factual information is gathered and expeditiously reviewed to determine if an investigation of the complaint is warranted. An inquiry is not a formal hearing or an in depth analysis of the allegation; it is designed to separate allegations deserving further investigation from those that are frivolous, unjustified or related to minor infractions or misunderstandings.
   
2. Process
   
   Whenever an allegation or complaint of non-compliance is made, the Director will expeditiously bring it to the attention of the Executive Committee. An ad hoc Inquiry Panel will be established. The Director will also send written notice of the allegations to the researcher within 10 working days. If the complaint raises issues of safety and welfare for research subject that are apparent from initial review, the Director also will give the researcher notice of an opportunity to address in his/her response the impact of the immediate suspension of the project(s).
   
   The Inquiry Panel will review the allegation of non-compliance, the response from the researcher, and any other information necessary to determine whether an investigation is warranted. The Inquiry Panel may interview the researcher and others, but is not obligated to do so. It may be necessary to secure critical data or materials at the outset of the inquiry to protect the integrity of those data. The IRB maintains the authority to secure such materials at any time during an inquiry or investigation.
   
3. Recommendations and Outcome
   
   At the conclusion of the inquiry phase, the Panel will make a recommendation to the Chair and Vice-Chair. Possible recommendations include:
   1. Dismissal of the allegation or complaint as unjustified
   2. Referral of the matter to another more appropriate university office for resolution (e.g. grievance, student affairs, academic misconduct, animal care).
   3. Resolution through corrective or educational measures where the violation of human subjects regulations is minor or inadvertent
   4. A formal IRB investigation where the allegation or complaint appears founded and is of a serious nature.
   The report of the Inquiry Panel will initiate a report to the PI regarding the outcome. This report will include a statement of the reasons for the decisions. Depending on the nature of the allegation and the extent of the review required, the inquiry phase is expected to be completed within 30 days. An extension of this time frame may be granted if warranted.

SUSPENSION AND REPORTING

At any time during the inquiry or investigation process, the CPHS may determine the necessity to suspend accrual of research subjects or suspend approval of research project(s) to assure the protection of human subjects. The authority to suspend research rests with the Chair, Vice-Chair and Director. Except in cases of imminent harm to research subjects, approval will not be suspended until the researcher has had an opportunity to respond to the initial allegation of non-compliance.

When a decision has been made to suspend approval of research, CPHS will notify the EVP for Research and other appropriate University and hospital officials as well as the PI's department chair. The authorized institutional official (the I.O. for the assurance document) will send written notice to the following entities, as required under federal regulations:

1. Federal Office of Human Research Protection (OHRP)*
2. Federal Food & Drug Administration (FDA)* {for drug and device studies}
3. External and internal sponsors funding a study, which is placed under suspension.

* OHRP and FDA as applicable if the matter involves the non-submission of a project which should have been reviewed by the CPHS, and the PI's failure to do so has resulted in unanticipated risks to human subjects - or, serious or continuing non-compliance with CPHS requirements.

Reports will be filed within 5 working days of suspension.

If reports are necessary to professional licensing boards or state agencies, they will be made by other appropriate University officials.

INVESTIGATION

1. Purpose
   
   The purpose of the investigation is to explore the allegations by assembling and examining relevant information. The Investigation Panel's charge is to generate a report that summarizes the information considered, conclusions regarding as to where there was non-compliance with regulations, and recommendations for action. During an investigation, additional information may emerge that justifies broadening the scope beyond the initial allegations. The PI shall be informed if new and different allegations are discovered during the course of the investigation.
   
2. Process
   
   An ad hoc subcommittee of at least 3 members of the CPHS will conduct the investigation. These members will have areas of expertise suited to reviewing the complaint. Depending on the nature and scope of the complaint, CPHS members may be relieved of their regular IRB duties during the investigation.
   
   The Investigation Panel may use any and all materials and reports gathered during the inquiry phase but are not limited to actions or conclusions of the Inquiry Panel. The Investigation Panel may obtain documents and other records relevant to the investigation (e.g. researcher's records, medical charts, grant applications, etc.). The Panel may interview any persons who may have information relevant to the complaint. The Panel may draw on the resources of the institution or external consultants to assist in the review of issues that require expertise beyond or in addition to that available on the Panel.
   
   The PI under investigation will be given an opportunity to submit written comments and to appear before the Panel on at least one occasion prior to the Panel issuing its report. The PI may offer relevant information to the Panel and suggest other individuals to be interviewed. An attorney may also accompany the PI at any time he/she appears before the Panel. The PI shall give the Panel notice of the attorney's participation at least 48 hours prior to any interview.
   
   At the conclusion of its investigation, the Investigation Panel will prepare a report summarizing the information it has considered and outlining its conclusion and recommended actions. A copy will be sent to the PI who will be given 10 working days in which to submit comments. The Panel will review any such comments and decide whether to modify the preliminary report. When completed, the Investigation Panel will distribute its report as appropriate. The investigation phase is expected to be completed within 60 working days with an extension possible if warranted.
   
3. Outcome
   
   The Executive Committee will base its decision on the report of the Investigation Panel. Appropriate actions to be taken include but are not limited to:
   
   1. Dismissal of the complaint as unjustified
   2. Remediation or educational measures
   3. Increased reporting by the PI of human subject research activity
   4. Restrictions on research practice such as limiting the privilege to minimal risk or supervised projects
   5. Suspension of approval for one or more of the PI's studies
   6. Termination of approval for one or more of the PI's studies
   7. Referral to other University officials or committees for possible action by those bodies.
      
   The Executive Committee will issue the final investigative report and send it to the researcher. Its decision becomes final within 5 working days of release unless the PI files a written statement of appeal within that time.

APPEALS/RECONSIDERATION

1. Purpose
   
   The purpose of an appeal is to give the PI an opportunity to request reconsideration of the decision reached by the Executive Committee. Grounds for appeal are limited to:
   1. new information not available during the investigation
   2. sanction exceeds the severity of the violations
   3. failure of the panels to follow these policies and procedure
      
2. Process
   
   An ad hoc subcommittee of the CPHS, which includes members who have not served on either the Inquiry or Investigation Panels, will consider the appeal. The Appeals Panel will review the written statement of appeal and make a recommendation as to whether there should be a reconsideration of any aspect of decisions made. In reaching this recommendation, the Appeals Panel may ask for a response from the Investigation Panel.
   
   If the Appeals Panel denies the appeal, the Executive Committee's prior decision becomes final. If the Appeals Panel recommends reconsideration, the Executive Committee will reopen the case. When this is done, the Executive Committee may choose to reconvene the Investigation Panel or reconsider the matter on its own. Either the Executive Committee or the Investigation Panel will offer the PI the opportunity to appear personally to present the appeal.
   
   Upon reconsideration, the Executive Committee will determine whether to modify or uphold the original decision reached. This action is final. Consistent with the CPHS' regulatory authority, no other entity within the University may override such a decision.
   
   The reconsideration phase is expected to be completed within 30 working days.

DISSEMINATION OF FINDINGS

At the time when the Executive Committee's decision becomes final, the Committee will release its findings to the PI and to appropriate University and governmental officials as required under federal regulations. The same guidelines as set forth for reporting suspensions will apply. The CPHS will not initiate any public disclosure of findings.

1. Resources
   
   The Executive Committee as well as the Inquiry, Investigation, and Appeals Panels shall have access to the necessary resources and staff to conduct a thorough and fair review of allegations. Internal and external consultants may be called to assist in the review.
   
2. Coordination with Other Investigative Processes
   
   Some complicated cases require review by other institutional or external entities. The CPHS will cooperate in the review of allegations of academic misconduct, financial mismanagement, FDA inspections, etc. to avoid duplication of effort and to minimize competing use of resources.
   
3. Conflict of Interest/Commitment
   
   As with all CPHS processes, any CPHS panel member or Executive Committee member who has a conflict of interest or commitment relating to the matter under review will excuse him/herself from the proceedings. It is permissible to allow substitution of non-Executive Committee members for such concerns at any stage in the proceedings.
   
4. Confidentiality for Complainants and Witnesses
   
   In general, the PI under review should have access to the identity of complainant(s) and others who provide information. However, if such individuals request anonymity, the CPHS will make every effort to protect their identities while at the same time affording the PI access to the substance of the allegations. The CPHS cannot guarantee absolute anonymity.
   
5. Retaliation
   
   Reviewing complaints and allegations of non-compliance is critical to the ability of the CPHS to protect human subjects. A climate free from fear of sanction is required to foster appropriate reports and ensure a fair review of allegations. Retaliation against good faith "whistle blowers" is illegal and will not be tolerated at this institution. Whistle blowers who report CPHS related concerns may use other mechanisms at the University for protection against retaliation.