Counting What Counts in Responsible Conduct of Research Training
Thinking about and acting responsibly in the conduct of research (RCR) underpins all aspects of day-to-day life as a scientist. To keep RCR content fresh and to show that scholars are consuming a well-rounded diet of RCR topics, our T and K leadership group sought to broaden how we gather information about annual RCR participation from scholars. In the process, we identified important trends.
In 2009 NIH mandated (with minor updates in 2022) that training grants ensure regular training in RCR. It was the right thing to do but the bar is set fairly low: each trainee needs eight hours total over the course of their time on the grant. In contrast, our local programs ask T and K scholars (and those on non-NIH CDAs) to aim for 8 to 12 hours per year.
While there is not a required curriculum, NIH guidance notes these topics are typical:
- Conflict of interest – personal, professional, and financial
- Human subjects policies and ethics
- Regulation and ethics of live vertebrate animal subjects in research
- Safe laboratory practices
- Mentor/mentee responsibilities and relationships
- Collaborative research including collaborations with industry
- Data acquisition and laboratory tools: management, sharing and ownership
- Research misconduct and policies for handling misconduct
- Responsible authorship and publication
- Peer review
- Scientists as members of society
- Contemporary ethical issues in biomedical research
- Environmental and societal impacts of scientific research
Because online courses like CITI modules cannot be the only modality, and because many of these topics can be as scintillating as watching grass grow when presented in straight seminar format, we aimed to describe and expand on the repertoire of more interactive forms of RCR experiences. We asked our CDA awardees to catalogue their exposure to RCR themes across four formats and to provide brief descriptions. We kept collecting information in this way because it allowed us to surface new topics for events like panel discussions and seminars and to better see what discussions and decisions about RCR dominate academic life.
Initial instructions for sharing individual hours of RCR exposure went something like this:
In order to best capture the range of RCR experiences you have participated in this year please complete the attached grid that indicates the number of hours of contact time you had for each of these formats. Please provide a one line description of the activity or the title of the seminar. If you are not sure what format to place an activity in or if it qualifies describe the participants in the group or the discussion and the interaction (while maintaining confidentiality of both) and we will help classify or exclude if not eligible.
- Online: Annual online human subjects and animal research re-certifications. Additional specialized online courses.
- Seminar/didactic: Each year Vanderbilt hosts more than 300 hours of centrally approved RCR content in this format. Related topics in the career development seminars in this grant year included: understanding effort reporting, negotiation skills, enhancing communication on teams, preparing letters of recommendation, and reproducible research and data integrity.
- Group discussions/case studies: Includes participatory workshops and discussion with content such as case studies on scientific misconduct and supervising of trainees; a department discussion about making effort more transparent; tenure and promotion challenges; panel discussions on study section function and foibles; and case studies on scientific integrity including leading activities for more junior trainees including clinical fellows, medical students and undergraduates.
- Individual and small discussion: Includes activities like: providing feedback to mentees (graduate students, fellows, and post-doctoral trainees) about importance of complete record keeping, professionalism and work ethic; and your conferring with more senior faculty to trouble-shoot concerns about potential conflicts of interest, disagreements among authors, and need to address behavior of collaborators and multi-site study teams.
The initial capture provided summary tallies like this table from a K12 program. Individual discussion and real-time “case studies” with small groups were common.
When we later asked more about content and leadership, we found scholars were as likely to be asking for individual discussion based on their concerns as leading the discussion for their teams or students who worked with them.
Examples of activities included:
- Discussing steps to be taken when a colleague at a prior institution misstates prior study methods in a new publication while referencing methods in a prior joint publication.
- Asking for a compliance review of how a division was codifying “protected time” in the context of an RVU-based performance system.
- Hosting a panel on cross-generational communication styles and the importance of mentors and mentees having blunt and proactive discussions about preferences.
- Developing a case study about consenting patients who could be perceived as “under duress” by using an example of an IRB application requesting to consent women in active labor.
- Formulating a plan to confront an individual who skirts the rules for using shared data and conducts analyses before seeking the permission of the senior investigators when group rules indicate the senior investigators’ team should receive concept proposals for analyses before even exploratory analyses are conducted.
- Identifying a need for pre-emptive discussion with students and staff in the lab about what activities and roles will lead to co-authorship via a group discussion of the ICJME authorship reporting form.
- Creating a manual for the scholar’s surgical division about the regulatory environment that surrounds use of operative specimens, tissue banking, and material transfer.
- Developing a referral infographic for safe university and community resources for reporting sexual harassment.
- Having a facilitated meeting of an entire lab team who had a member commit suicide in order to grieve together and talk about their desire to prevent future competition, isolation, and demoralization of peers in a pressured funding environment.
- Working with a mentor to draft a communication of an outside trainee who appeared to have plagiarized grant aims from a submitted but not yet funded K award.
- Hosting an event for postdocs about social media as a vehicle for science communication, science advocacy, and science policy.
- Planning materials for a Capitol Hill visit to legislators to emphasizing the return on investment in basic discovery research.
In almost every instance the scholar was central in identifying the topic and prompting the discussion. Fewer than half of discussions were mentor-prompted or solely led by a lab PI or mentor. Scholars were also likely to be the lead for preparing case studies, guiding related journal clubs or presentations, and teaching those more junior, in part because we had recently sponsored individualized training in creating case studies.
Not surprisingly, these summaries of the pervasiveness and breadth of topics in daily research life reinforced our belief that we can improve on content in more formal RCR training sessions like seminars when we stay plugged into challenges as they occur and provide confidential opportunities for scholars to describe concerning situations.
This form of tracking also provides a brief but clear documentation of RCR activities for individual trainees to use in their annual reporting. The sample below translates the K12 program level report into a summary for an individual K awardee. Supplemented with examples for each activity it provides a solid picture of a more well-rounded RCR experience than just listing seminar and IRB training hours.
This double win ─ compliance documentation and an acute sense of scholar involvement in hot topics ─ easily justifies continuing to collect data prospectively in this simple tool. The results keep us honest about the importance of setting aside time to seek best practices, have discussions on several scales, make decisions with trusted counsel, and emphasize that RCR topics are part of everyday life that deserve consistent and integrated attention.
Resources for Research Ethics Education is dedicated to providing resources and tools for teachers of research ethics with the goal of promoting best practices and evidence-based research ethics education.
NIH resources for Responsible Conduct of Research Training include an overview of required content as well as multiple additional resource links.
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