Clinician Scientists
Responsible Conduct of Research Course for Clinical Researchers
The RCR course helps clinical researchers learn how to address the ethical issues that inevitably arise in research. The course is comprised of video lectures, readings, case studies, and weekly real-time small group discussions via Zoom. It addresses requirements and regulations for human-subjects research, including IRB approval and consent.
Responsible Conduct of Research is a 7-week online course. Participants are expected to devote at least 4 hours per week to individual work and small group discussion. Receiving a passing grade in the course requires attending a one-hour discussion session by Zoom every week. There are no exceptions to this rule. Topics include:
- Clinical Research Regulations and IRB Review
- Informed Consent
- Conflicts of Interest
- Research Misconduct
- Big Data Ethics
- Authorship
- Research in Resource-Poor Countries
Online RCR Course Contacts
Sara Ackerman, PhD, MPH
Associate Professor, UCSF Bioethics Program
Associate Professor, Social and Behavioral Sciences
RCR Course Director
Winston Chiong, MD, PhD
Associate Professor, Neurology
Interim Director, UCSF Bioethics Program
Asha Robertson
RCR Course Manager
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 clinicians at the graduate student and postdoctoral level. 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, 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.
Subject Matter
The NIH lists several topics they strongly suggest RCR programs to cover, the majority of which are covered in the online hybrid course:
- 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.