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Responsible Conduct of Research

Responsible Conduct of Research (RCR) is defined by the National Institutes of Health (NIH) 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”.

Responsible Conduct of Research (RCR) provides the foundation for conducting sound, ethical research and reinforcing public trust. Rush promotes RCR within the research community by providing educational opportunities for initial and continuing education relevant to a broad spectrum of research matters.

NIH requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, and dissertation research grant must receive instruction in responsible conduct of research.  This policy will take effect with all new and renewal applications submitted on or after January 25, 2010, and for all continuation (Type 5) applications with deadlines on or after January 1, 2011.  This Notice applies to the following programs:  D43, D71, F05, F30, F31, F32, F33, F34, F37, F38, K01, K02, K05, K07, K08, K12, K18, K22, K23, K24, K25, K26, K30, K99/R00, KL1, KL2, R25, R36, T15, T32, T34, T35, T36, T37, T90/R90, TL1, TU2, and U2R.   This policy also applies to any other NIH-funded programs supporting research training, career development, or research education that require instruction in responsible conduct of research as stated in the relevant funding opportunity announcements.

The NIH RCR requirement is two fold:

  • Electronic RCR training obtained through CITI Program
  • Didactic in-house training

ORC offers the didactic in-house training every year in the Spring and Fall. For information on this training, contact Tiffany Bailey.

RCR includes the following:

  • Conflict of Interest 
  • Protection of Human Subjects
  • Animal Welfare and Use
  • Research Misconduct
  • Mentor/Mentee Responsibilities and Relationships
  • Safe Research Environments
  • Collaborative Research
  • Peer Review
  • Data Analysis and Tools for Recordkeeping Practices and Lab Safety
  • Secure and Ethical Data Use, Data Confidentiality, Management, Sharing and Ownership
  • Authorship and Publication
  • Intellectual Property and Commercialization 

The following content outlined below is to provide resources to enhance and compliment the CITI program coursework on RCR.

ORI RCR Resources

Research Misconduct
This course provides information to researchers about what constitutes research misconduct and how to report it. In addition, it identifies some practices that might decrease the risk of unwitting or deliberate research misconduct. Offered by the Columbia University Responsible Conduct of Research Education Committee, the course is appropriate for faculty, researchers and students engaged in any type of research.  Research Misconduct Policy for Review and Reporting Allegations

Protection of Human Subjects

Human Participant Protections Education for Research Teams
This course satisfies the National Institutes of Health human subjects training requirement for obtaining federal funds. You will have the option of printing a certificate of completion from your computer upon completing the course. The course is offered by the National Cancer Institute and is appropriate for faculty, researchers, students, administrators and others who engage in human subject research.

NIH Complete Informed Consent Process
This presentation should be reviewed by anyone who participates in human subjects research and wants a better understanding of the informed consent process and different approaches for facilitating better informed decision making by subjects. The Elements of a Successful Informed Consent training video was created by the Human Subjects Protection Team of the National Institute of Mental Health Office of the Clinical Director. In the video, actors portray a clinical investigator and a potential research participant engaged in an informed consent discussion about a clinical research protocol. A narrator introduces the required elements of an effective informed consent discussion.

These additional videos can be reviewed by anyone who conducts human subject research and wants a better understanding of the informed consent process and different approaches for facilitating better informed decision making by subjects. SoCRA Obtaining an Informed Consent, Emory University Informed Consent Process

Data Acquisition, Management, Sharing and Ownership

Data Acquisition and Management
Obtaining important and unbiased data and using proper methods of data collection that do not waste resources requires methodical and conscientious data management. This course talks about these issues and the data manager responsibilities for sharing information. This course is offered by the Columbia University Responsible Conduct of Research Education Committee. It is appropriate for faculty, researchers and students engaged in any type of research. The Department of Health and Human Services’ Office of Research Integrity has published these guidelines. Guidelines for Responsible Data Management in Scientific Research. Rush's Research Data - Access, Ownership and Retention policy

Data Management
This course discusses data integrity, the usefulness of the research it supports and the need for careful attention to detail for collection of information. This approach must be practiced from initial planning through final publication. It is offered by Clinical Tools, Inc., and funded by the ORI. The course is appropriate for faculty, researchers and students engaged in any type of research.

Data Use Agreement (DUA) and Material Transfer Agreement (MTA) Requirement

When working with community members, other university/hospital personnel (when a subaward on a grant is not in place), or with collaborators (without a subcontract or agreement with Rush in place) or when there is a person with the status of Visiting or Observer on a research project, a Data Use Agreement may be required.  If materials (animals, specimen, etc.) are being transferred to these same types of entities, a Material Transfer Agreement may be required.

A Data Use Agreement (DUA) is an agreement that governs the sharing of data between research collaborators who are covered entities under the HIPAA privacy rule. A DUA establishes the ways in which the information in a limited data set may be used by the intended recipient, and how it is protected. Applies whenever Rush research data is shared or contact with Rush patients/patient data will be realize.

A Material Transfer Agreement (MTA) is a contract that governs the transfer of tangible research materials between two organizations, when the recipient intends to use it for his or her own research purposes. Applies whenever Rush materials are shared with an outside entity/person for research purposes.

For additional information, please contact Rush Legal: Jessica Fenton (jessica_fenton@rush.edu) or Olivia Ness (Olivia_Ness@rush.edu).

Collaborative Science
This course examines the benefits and potential problems that researchers face when engaging in collaborative and multidisciplinary research. It is offered by the Columbia University Responsible Conduct of Research Education Committee and is appropriate for faculty, researchers and students engaged in any type of research.

Collaborative Research

This course examines the benefits and potential problems that researchers face when engaging in collaborative and multidisciplinary research. It is offered by Northern Illinois University, funded by the Department of Health and Human Services' Office of Research Integrity (ORI). It is appropriate for faculty, researchers and students engaged in any type of research.

Publication practices, responsible authorship and peer review

Responsible Authorship and Peer Review
This course addresses some of the issues that authors and peer reviewers face as they attempt to maintain the quality of shared information. It is offered by the Columbia University Responsible Conduct of Research Education Committee and is appropriate for faculty, researchers and students engaged in any type of research.

Scholarly integrity and the responsible conduct and reporting of research are essential for maintaining public trust in the research enterprise and for community benefit from research discovery.

Scholarly publications include (and are not limited to) books, articles, abstracts, presentations at professional meetings, and grant applications. This includes other dissemination of written findings, thoughts and analyses. Authorship Policy

Avoiding Plagiarism, Self-Plagiarism, and Other Questionable Writing Practices: A Guide to Ethical Writing

The guide’s purpose is to help students and professionals identify and prevent questionable writing practices and to develop an awareness of ethical writing. Offered by Miguel Roig of St. John’s University (funded by ORI), it is appropriate for faculty, researchers and students engaged in any type of research.

Mentoring Responsibilities: Rush Mentoring Program

Mentoring
This course addresses the central role of mentoring to the entire field of responsible conduct of research. Mentoring is both a core element of responsible research and an essential means for transmitting professional standards. Offered by the Columbia University Responsible Conduct of Research Education Committee, this course is for all those involved at various levels of research including graduate students, post docs, junior faculty, senior researchers, as well as department and research administrators.

Adviser, Teacher, Role Model, Friend: On Being a Mentor to Students in Science and Engineering
This guide discusses practices common to successful mentoring relationships and encourages mentoring activities that are in the best interests of both parties. It is offered by the National Academy of Sciences, National Academy of Engineering and the Institute of Medicine. This guide from 1997 is intended for faculty members, teachers, administrators and others who advise and mentor students in science.

Mentoring Case Studies
The cases and role play demonstrate a variety of issues that can arise among mentors and trainees. The scenarios deal with common pitfalls and how to manage or avoid them when they occur. These cases are part of the ORI’s Responsible Conduct of Research Casebook.