Handbook of Operating Procedures > Series 300 Faculty and Academic Policies > 3.8.7 Responsible Conduct of Research (RCR) Training and Responsibilities

3.8.7 Responsible Conduct of Research (RCR) Training and Responsibilities

A. Purpose

The purpose of this policy is to foster an environment of research integrity comporting with Responsible Conduct of Research (RCR) and complying with requirements from funding agencies such as the National Institutes of Health (NIH), the National Science Foundation (NSF), and other funding agencies.

B. Persons Affected

This policy applies to all faculty, post docs, lab assistants, technicians, undergraduate or graduate students who are engaged in research on the University of Texas at Tyler (UT Tyler) and the University of Texas Health Science Center at Tyler (UTHSCT) campuses.

C. Definitions

1. Responsible Conduct of Research: The National Institutes of Health defines Responsible Conduct of Research as “The practice of scientific investigation with integrity. It involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research.”

2. CITI: Online RCR training is provided by the Collaborative Institutional Training Initiative (CITI).

D. Policy

The University of Texas at Tyler is committed to maintaining a research environment that promotes attention to the highest ethical standards for all sponsored and non-sponsored research.

Conducting research with integrity involves more than the scientific or technical expertise required to conduct a research study. Acting with integrity in research requires the ability to identify and respond appropriately to ethical questions that inevitably arise throughout the research process.

All personnel involved in research are required to complete the Responsible Conduct of Research training modules within the Collaborative Institutional Training Initiative (CITI) online course. RCR courses specific to various disciplines are available to those working in biomedical research, humanities, physical sciences, engineering, and social/behavioral research.

E. Responsibilities

The major institutional components involved in the maintenance and oversight of the Responsible Conduct of Research (RCR) training programs are the Principal Investigator (PI), Research Team, Human Research Protections Program/Institutional Review Board (HRPP/IRB) and the Center for Clinical Research (CCR), the Office of Research, Scholarship, and Sponsored Programs (ORSSP), and Research Compliance. The main responsibilities and functions of each of these components are as follows:

1. Principal Investigator (PI): A significant burden of responsibility rests with the PI when engaging in any kind of research. The PI’s responsibilities include but are not limited to

   1. Ensuring appropriate conduct of all aspects of a research project, including review of the primary data generated by all team members and maintenance of a complete, auditable record of the research. Publication of fully validated and appropriately presented data is the responsibility of the PI, usually the communicating author submitting a manuscript for review (or shared with another communicating author).
   2. Completing proposals for funding in accordance with requirements of the funding agencies.
   3. Assuring projects are performed in accordance with funded proposals and approved protocols by appropriate research compliance committee.
   4. Ensuring any required institutional approvals have been obtained.
   5. Providing annual updates to the research compliance committees when required.
   6. Ensuring changes to protocols have been approved by the research compliance committees in accordance with their policies.
   7. Ensuring that all personnel involved with a research project completed the Responsible Conduct of Research (RCR) training and are trained in other research areas as required by the research compliance committees.
2. Research Team (including PI):

   a. To properly perform assigned tasks, prepare data for review.

   b. To fully record, date and archive all of the methods and data for ready review by the PI or other institutional or external parties authorized to review the data.

   c. To report suspected  infractions of the responsible conduct of research to the Research Integrity Officer or administrative superiors.                         

3. Human Research Protections Program/ Institutional Review Board (HRPP/IRB): The HRPP/IRB is responsible for protecting the rights and welfare of participants who take part in UT Tyler research as well as ensure that scientific research is conducted ethically and in compliance with all federal, state, local regulations, and institutional policies. These comprise the assignment and oversight of required training including RCR. The latter is accomplished in collaboration with Research Compliance.
4. The Office of Research, Scholarship, and Sponsored Programs (ORSSP): The ORSSP assists Investigators in the preparation and submission of research grant applications for federal and non-federal funding agencies. Once a proposal is funded, the ORSSP monitors reporting compliance of the award and financial oversight of the project. The ORSSP S also assist with preparing and submitting necessary progress reports to funding agencies per required deadlines. Many funding agencies require implementation of the extended RCR training program, and this is achieved by working with Research Compliance.
5. Center for Clinical Research (CCR): The CCR is responsible for assisting Investigators in the preparation of research proposals including the review for feasibility, budgets, and clinical trial agreements. The CCR’s services include ensuring standardized training and appropriate certifications for the investigators and research staff. The CCR provides operational support for all industry sponsored research. The CCR provides internal compliance monitoring and feedback to PI’s conducting human subjects’ research according to policies and procedures of the IRB, CCR, OSP/ORS, and the Institutional Research Compliance Committee, and partners with Research Compliance to assure completion of the RCR training.
6. Research Compliance: Research Compliance is responsible for coordinating training in RCR, including assignment, monitoring and enforcement of training.

F. Procedures

Research Compliance Standard Operating Procedures.

G. Review

The Divisional Head for this policy is the Senior Vice President for Research and this policy shall be reviewed every five years or sooner, if necessary, by the following Stakeholders or their current equivalent:

1. Senior Vice President for Research
2. Associate Vice Presidents for Research/Research Compliance
3. Medical Director of Clinical Research
4. Director-Human Research Protections Program
5. Director-Office of Sponsored Programs
6. Legal Counsel

H. Added, Amended, Reviewed On, and Next Review Dates

Some language was adopted from the Governance of Human Subjects Research Policy