MinerAlert
MinerAlert
UTEP policy requires training for all faculty, faculty advisors, principal investigators and students who conduct human subject research. This requirement extends to external researchers from other institutions. All people listed as members of the research team that interact with participants must complete human subjects training. To comply with the policy, UTEP affiliates with the Collaborative Institutional Training Initiative (CITI) Program.
All training requirements are updated regularly, as determined by the IRB Chair and AVP of RCRS. Please refer to the IRB website, to review specific training requirements.
Researchers may collaborate with partners from non-academic settings when performing community-engaged research. These partners also need human subjects training, as determined by the IRB Chair and AVP of RCRS. Please refer to the IRB website, to review specific training requirements.
Training compliance will be verified as all submissions are screened and processed. Submissions will not be finalized until training requirements are met.
A vital component of a comprehensive human research protection program is an education program for the IRB Staff, IRB Chair, Vice Chair and members. UTEP is committed to providing training and an on-going educational process for IRB members and the staff of the IRB Office, related to ethical concerns and regulatory and institutional requirements for the protection of human subjects.
IRB members, their alternates, the IRB Chair, and Vice-chair must complete the required CITI Program IRB member training upon being appointed to the IRB and every three years for the duration of their membership.
Initial training consists of completion of modules relating to their service as IRB members. A IRB staff member will schedule an in-person meeting to provide orientation information (meeting schedules, locations, etc.), discuss member duties and meeting processes.
To ensure that oversight of human research is ethically grounded and the decisions made by the IRB are consistent with current regulatory and UTEP policy requirements, training is continuous for IRB members throughout their service on the IRB.
In addition to initial training requirements, the IRB Chair, Vice Chair, Members, and Staff must also satisfy continuing education requirements on an annual basis. UTEP uses the following activities as a means for offering continuing education to IRB members, Research Compliance Manager, and IRB staff:
Staff must document that they have completed the IRB member CITI Program training. Attendance at regional and national meetings (e.g., PRIM&R) is encouraged and supported. IRB staff are encouraged to attend any additional training, such as webinars offered by the Office for Human Research Protections (OHRP) and to obtain IRB Certification (Certified IRB Professional (CIP) as they become eligible.
The following are the PI responsibilities and are not all inclusive:
UTEP requires all research to be conducted under the guidance of a qualified Principal Investigator. Students will be engaged in conducting research as an integral part of their educational experience. Faculty who assumes advisory responsibility for student-led research involving human subjects must be willing to provide oversight for the research activities and assume full responsibility for the conduct of the research. The Faculty Advisor must be actively involved in the research, from protocol design to data analysis and report preparation. In many cases, it may be the student's first experience with formal research. The success of the student's experience will be measured not only in the outcome of their projects, but also in what they learn from the faculty advisor. These experiences will help form their perception of scientific research, and in some cases, determine whether a career in academic research is right for them. The following are the Faculty Advisor responsibilities and are not all inclusive:
The Vice President for Research & Innovation is designated by the University President as the Institutional Official to have responsibility for the Human Research Protection Program with the authority to delegate activities as may be necessary to fulfill the following responsibilities:
IRB main responsibilities in safeguarding the rights and welfare of subjects are as follows and are not all inclusive:
IRB Chair and Vice Chair main responsibilities are as follows and are not all inclusive:
IRB members responsibilities are as follows and are not all inclusive:
If research procedures involve clinical elements and the PI is not qualified in the appropriate clinical area, does not hold an applicable license, or does not have privileges to practice where the research will occur, a licensed and institutionally credentialed clinician appropriately qualified by education, training, experience, and background and appropriate privileges must be designated as the Clinically Responsible Investigator.
The Clinically Responsible Investigator must manage or appropriately delegate all clinical elements of the research such as physical examination, psychological testing, providing counseling services, conducting any drug administration, follow-up examinations, evaluating lab values, test results and reviewing all adverse events.
Clinical elements of a study are considered any event, procedure, test, or intervention that would require performance by a licensed/credentialed professional in a non-research setting.
During review of human subject research, the IRB can determine that a Clinically Responsible Investigator must be identified. The Clinically Responsible Investigator should be noted by name in the research proposal and listed as research personnel in the electronic protocol system. A copy of the Clinically Responsible Investigator’s Curriculum Vitae should be uploaded in “Other Attachments” in the project. The Clinically Responsible Investigator’s contact information should also be included in the informed consent document(s).
In accordance with 21 CFR 56.108(a)(2) (FDA) and 45 CFR 46.109(g) (OHRP), a duty of the IRB is to assure itself, by whatever method it deems appropriate, that the rights and welfare of human subjects are being protected. This applies to transnational research and research taking place in other states and in Texas. The IRB may determine that it is appropriate to use sources other than reports from the investigator to verify that no material changes in the protocols have occurred since their most recent review, and that investigators are conducting the research in compliance with all regulations, laws (domestic and international), policies, and guidelines. Also, the IRB may determine that the consent process for some higher risk protocols should be observed.
To assess whether there have been no material changes in the protocols as stated above, the IRB may request that members of the IRB and/or IRB staff conduct an observational visit for a specific protocol. This review will help ensure that investigators are not implementing protocol changes prior to IRB review and approval, except when necessary to eliminate apparent immediate hazards to subjects.
As a part of an ongoing Quality Improvement (QI) program, monitoring reviews may be initiated in other ways:
Upon completion of the PAVE visit, the results will be reported to the AVP of RCRS and IRB Chair. The PI will be asked for a response to the findings of the visit, if applicable. The report and, if requested by the IRB, the PI’s responses will be brought to the IRB at a full board meeting for discussion and action.
All questions, comments, complaints, or concerns about the HRPP, IRB, or IRB staff or feel they may have been subjected to or have observed instances of, coercion or undue influence in aspects of human subject research may contact:
IRB Office
Kelly Hall, 4th Floor
Email: irb@utep.edu
Phone: 915-747-6590
Website: https://www.utep.edu/research/human-subjects-research/
All IRB, HRPP or IRB staff questions, comments, complaints, concerns or other input and any allegations of coercion, undue influence or non-compliance are thoroughly investigated, and corrective actions taken when needed.
The AVP of RCRS is responsible to assure that all concerns, complaints, and allegations have been addressed appropriately and that input and suggestions related to the HRPP are considered when reviewing the program. The IRB staff will seek to resolve any complaints, in collaboration with the PI as needed.
Further inquiry will follow procedures in Section 20 if the concern/complaint could be an incident of non-compliance. Unanticipated problems involving risks to subjects or others will be reviewed according to Section 9 of this manual.
The IRB Administrator, with input from the IRB Chair, will periodically review the composition of the IRB and determine whether it is appropriate for the volume and types of research being reviewed to ensure thorough and timely IRB review. Recommendations for the appointment of new members and removal of members will be forwarded to the IO. The AVP of RCRS will annually consider whether the resources and personnel being provided in support of the HRPP are adequate and advise the IO as necessary. Additionally, the AVP of RCRS will evaluate allocated space, personnel resources to support the HRPP, the availability of legal counsel and the process of assuring that all applicable personnel involved in the HRPP have completed the required training and submitted financial interest disclosures.
The AVP of RCRS will periodically review HRPP policies and procedures and adjust as necessary. Comments from research faculty and staff regarding the HRPP will be reviewed as they are received by the IRB Chair, Vice-Chair, AVP of RCRS, and, if necessary, the IO. If applicable, modifications to the HRPP will be made and implemented, and the effectiveness of the implemented changes monitored and discussed at appropriate intervals.
Oversight of the HRPP includes implementation of a quality improvement function to continually assess compliance and effectiveness of the HRPP, and the IRB. The goal of this program is to ensure the HRPP is functioning in full compliance with applicable regulations using processes and procedures that are effective and efficient so that the system facilitates the highest quality of research.
This assessment process includes the following components:
Examples of assessing compliance might include:
The AVP of RCRS and the PAVE Administrator are responsible for identifying objectives and measures for quality assurance and quality improvement (QA/QI). The outcomes of QA/QI (PAVE) efforts are documented and reviewed via QA reports and periodic HRPP progress reports.
The IRB Administrator, in consultation with the IRB Chair, periodically reviews IRB Members, IRB member feedback, and any input from outside the IRB and provides recommendation(s) to the IO regarding the recruitment, retention, or dismissal of members. This review includes examination of attendance, specialty, expertise, education, affiliation, and diversity. A summary of the evaluations and member comments will be submitted through the Associate Vice President of Research Compliance and Regulatory Assurances to the IO.
IRB dedicates a webpage for current and future research participants. This webpage will contain useful research process information for participants and is updated as needed.
To allow a reconstruction of a complete history of IRB actions related to the review and approval of protocols, the IRB records include copies of:
IRB records document all IRB determinations including, but not limited to, those required by laws, regulations, codes, and guidance. IRB records for initial and continuing review of research by the expedited procedure include the justification for using the exempt and expedited procedure and actions taken by the reviewer.
Records are accessible for inspection and copying by authorized representatives of federal agencies or departments at reasonable times and in a reasonable manner.
All research records are retained for at least three years after completion of the research. If a protocol is canceled without participant enrollment, IRB records are maintained for at least three years after cancellation.
UTEP Records Retention Schedule (https://www.utep.edu/purchasing-and-general-services/pgs-departments/records-management/retention-schedule.html) is certified by the Texas State Library and Archives Commission. It has been adopted as an administrative rule of the University. All official state records (paper, microform, electronic, or any other media) listed on the schedule must be retained for the minimum period designated. Once official University records have met their retention periods, they must be disposed of in accordance with the policies and procedures of Records Management.