Clinician Scientists

UCSF Clinical and Translational Science Institute (CTSI)
Responsible Conduct of Research Course

The CTSI RCR course helps clinician scientists learn how to address the ethical issues that inevitably arise in research. The course addresses requirements and regulations for human-subjects research, including IRB approval and consent, conflicts of interest, research misconduct, authorship, and ethical challenges related to research in resource-poor countries.

CTSI's RCR course is a hybrid online, 7-week course, with required weekly 1-hour facilitated WebEx live discussion sessions. Participants are expected to devote at least four hours per week to individual work and online peer interaction. Topics include:

  • Assessment of Risks and Benefits in IRB Review
  • Practical Issues in IRB Review
  • Informed Consent
  • Conflicts of Interest
  • What is Research Misconduct and Why Does It Matter?
  • Authorship
  • Research in Resource-Poor Countries

Collaborative Institutional Training Initiative (CITI)
Responsible Conduct of Research Series

The CITI RCR online training program addresses core norms, principles, regulations, and rules governing the practice of research. The National Institutes of Health (NIH), the National Science Foundation (NSF), and the U.S. Department of Agriculture (USDA) require certain categories of researchers to receive RCR training. RCR is increasingly viewed as an essential component of training, regardless of a researcher's source of funding.

The CITI online RCR series consists of a basic course, complemented with a set of additional modules of interest, and a refresher course.

The CITI Human Subjects Research (HSR) series covers the historical development of human subject protections, as well as current regulatory information and ethical issues.  The HSR series consists of modules from two basic tracks, Biomedical (Biomed) and Social-Behavioral-Educational (SBE), and a set of Additional Modules of Interest. Many of the basic modules have corresponding sets of refresher modules that are intended to provide learners with a highlighted review of what was covered in the basic modules.

The CITI Program's biomedical HSR content was expanded significantly in 2004 to include content for social and behavioral researchers (SBR).  The CITI Program joined the Biomedical Research Alliance of New York (BRANY) in May 2016 in order to better address the educational needs of investigators, staff and students, in the global research community.

Basic HSR modules are suitable for all persons involved in research studies involving human subjects, or who have responsibilities for setting policies and procedures with respect to such research, including Institutional Review Boards (IRBs).

Content and Audience

The CITI RCR courses are suitable for any person involved in research, ranging from upper-level undergraduates to senior faculty. Particular emphasis is given to the educational needs of graduate students and postdoctoral scholars. NIH requires at least some categories of trainees to have in-person discussions about RCR; CITI's courses can be used to complement these activities. CITI's courses may also be used independently of a classroom or other in-person settings.

The CITI RCR basic course covers essential topics to be a responsible researcher: authorship, collaborative research, conflicts of interest, data management, financial responsibility, mentoring, peer review, plagiarism, research misconduct, and research involving humans and animals. CITI also goes beyond the standard core and offers modules on topics such as export controls, social and environmental issues relating to engineering research, and social responsibilities as a researcher.

 

What does NIH say is required and sufficient for RCR training program content and structure?

The UCSF CTSI online hybrid course and CITI RCR and Human Subjects Research training are a necessary, but not always sufficient, component of RCR training. Please be sure to contact your funder to inquire about additional requirements beyond current course offerings.

In general, however, NIH requires several components of training in RCR including:

  • Formal RCR and Human Subjects Research training
  • Refresher RCR instruction at each stage of training (e.g., graduate, postdoc, etc)
  • Continuing informal or formal training in research ethics throughout the year
  • The involvement of departmental research faculty in supplemental and continuing instruction in research ethics.

 

Instructional Components:

Format

NIH highly encourages multiple forms of RCR training, including formal courses (such as the UCSF CTSI course), small-group discussions, and instruction by faculty members.

Applicants will also need to describe the format they will use to provide continuing and ongoing training and instruction in research ethics/RCR (using their own faculty) throughout the year for each year of the trainees’ fellowship. These may be lectures, panel discussions, or colloquia providing refreshers on topics covered in UCSF in-person course offerings such as RCR-PS or BMS 214 (see Subject Matter), but they may also cover topics of specific ethical concern in the trainees’ field not covered by RCR-PS or BMS 214.

Subject Matter

The NIH lists several topics they strongly suggest RCR programs to cover, the majority of which are covered in the CTSI online hybrid course, RCR-PS, and BMS 214:

  • Conflict of interest
  • Policies regarding human subjects
  • Mentor/mentee responsibilities
  • Collaborative research
  • Peer review
  • Data acquisition, management, sharing, and ownership
  • Research misconduct

 

Faculty Participation

Some institutes only require informal training by a faculty mentor, while others require actual formal instruction, preferably by faculty. If you participate in formal training, please include the names of the participating faculty members in your grant.

 

Duration of Instruction

NIH suggests RCR training should consist of at least 8 contact hours between participants and faculty instructors.  Applicants will also need to describe the plan and duration of instruction beyond the CTSI and/or CITI online training programs.

Reflection on RCR should recur throughout a scientist’s career: at the undergraduate, post-baccalaureate, pre-doctoral, postdoctoral, and faculty levels.  Institutional training programs and individual fellows/scholars are strongly encouraged to consider how to optimize instruction in RCR for the particular career stage(s) of the individual(s) involved.

Instruction must be undertaken at least once during each career stage, and at a frequency of no less than once every four years. It is highly encouraged that initial instruction during pre-doctoral training occurs as early as possible in graduate school. 

Individuals at the early career investigator level (including mentored K awardees and K12 scholars) must receive instruction in RCR at least once during this career stage. 

Senior fellows and career award recipients (including F33, K02, K05, and K24 awardees) may fulfill the requirement for instruction in RCR by participating as lecturers and discussion leaders.  

To meet the above requirements, instruction in RCR may take place, in appropriate circumstances, in a year when the trainee, fellow or career award recipient is not actually supported by an NIH grant.

Clinical and Translational Sciences Institute (CTSI) 
Online RCR Course Contacts


Marsha Michie
Assistant Professor, UCSF School of Nursing
CTSI RCR Course Director

Neha Kaul
CTSI RCR Course Co-director

Barbara Koenig
Professor, UCSF School of Nursing
CTSI RCR Senior Course Advisor

Asha Robertson
CTSI RCR Course Manage