Note: The composition of a study team can vary across teams/departments. Use of the terms ‘research personnel’, ‘study team members’ and ‘staff’ below is meant to be inclusive of all individuals engaged in human subject research. This includes but is not limited to: Principal, Co- and Sub-Investigators, Study Coordinators, Project Managers, Research Assistants, Research Nurses, Lab Managers, Data Managers and Student Researchers.
Guideline for Training Research Personnel
In accordance with federal regulation and guidance, OHSP Policy 901: Investigator Responsibilities states that it is the responsibility of the Principal Investigator (PI) to oversee the conduct of all research activities, including the training and education of research staff.
Regulatory authorities and OHSP policy further recognize that PI’s may delegate training-related activities to other appropriately experienced and capable staff, based on department/division resources and infrastructure.
The purpose of this guideline is to assist PIs, study staff and other leadership in:
- Navigating training-related requirements and opportunities; and
- Identifying best practices for onboarding and training personnel engaged in human subject research.
Basic training requirements
All research personnel are required to complete basic Human Subject Protection (HSP) training prior to engaging in the conduct of human subject research.
This training is foundational; it provides an overview of major topic areas related to the protection of human subjects that are broadly applicable to all types of research (e.g., ethical obligations related to the conduct of human subject research, informed consent, vulnerable populations, and institutional review board review). The content of the training is not all encompassing or exhaustive, nor is it study/protocol-specific.
In addition to HSP training, further training such as Good Clinical Practice (GCP) and Conflict of Interest (COI) training may also be required based on the nature of the research (for a summary, reference the HRPP Training Requirements page). These types of training are also typically foundational.
Key point
Training beyond the basic HSP course is necessary for research personnel to meet their day-to-day responsibilities effectively. The nature of basic training requirements are just that—basic. Treat HSP training as a starting point only.
Best practices for training research personnel
Thoughtful planning for the training and onboarding of research personnel is a critical step for ensuring the success of the trainee, the study team and any given study protocol. Individuals can enter the research workforce from a wide array of roles, with varying responsibilities, and a range of prior research experience.
Failing to adequately consider prior experience (or lack thereof) when creating a training plan for incoming research personnel, can result in considerable ramifications for the Investigator, study team, and institution.
The inability to meet study aims (e.g., based on low enrollment, protocol non-adherence, and/or poor data quality) and jeopardizing subject safety are just two potential consequences of poor training. Inadequate preparation and onboarding can also result in job dissatisfaction, low productivity and turnover, which ultimately costs the study team in lost time, money and resources.
Historically, individuals overseeing human subject research (PIs or otherwise) have relied largely on ‘on-the-job’ training, in addition to the basic training requirements described above, as a mechanism for training new research personnel. ‘On-the-job’ training, however, is typically only as effective as the experiences a trainee encounters and the experience of the mentor providing job oversight, which may or may not be accurate, complete, and/or comprehensive. Moreover, as the nature of research continues to intensify in complexity, the shortcomings related to approaching training in this manner have become increasingly problematic.
In light of these challenges and the continued need to produce a highly skilled and qualified workforce, several professional organizations have published articles and white papers supporting a competency-based training approach among clinical research professionals. Briefly, competency-based training is learner-centric; which focuses on what trainees need to ‘know’ and ‘do’ to meet their job responsibilities. Additional characteristics of competency-based training include structuring training in a manner that allows trainees to move, at their own pace, through a sequential, hierarchy of training modules and assessing progress in settings that mimic real-world scenarios [1, 2]
In 2013, the Joint Task Force (JTF) for Clinical Trial Competency was convened to align and harmonize existing clinical research competency frameworks (e.g., from the Consortium of Academic Programs in Clinical Research, Academy of Physicians in Clinical Research, Association for Clinical Research Professionals, and Regulatory Affairs Professionals Society). One of the aims of the resulting harmonized competency framework is to support training initiatives and workforce development by identifying a comprehensive set of skills necessary for conducting safe, ethical and high-quality clinical research [8]. The JTF framework has since been updated and a ‘leveled’ version published to reflect increased competence through career advancement [7]. Additional competency statements, building off the JTF framework, have also been published through the Clinical and Translational Science Award (CTSA) Consortium’s Enhancing Clinical Research Professionals’ Training and Qualification project, including suggested edits to accommodate social-behavioral research [1].
From a training and onboarding standpoint, these publications can be utilized to identify competencies required for a given role. Once identified and prioritized, training and onboarding plans can be developed and structured in a way that supports staff in achieving the desired competencies. Training resources that are readily available to aid research personnel in meeting these competencies are identified below.
key point: Have a plan
Investigators have protocols in place to carry out their research systematically; training and onboarding should be approached in the same manner. Plans should be specific to the individual, based on their responsibilities and prior experience. Evidence further supports the utilization of a competency-based training curriculum for workforce development. Research-related competency standards can assist investigators in identifying what training may need to take place and how training should be structured.
As mentioned above, training should focus on both ‘knowing’ and ‘doing’ [1, 3]. Staff training is often centered on knowledge development, without a useful balance of applying that knowledge in meaningful settings to foster skill development.
A common methodology for skill development is the four-step process of LEARN, SEE, PRACTICE and DO, whereby a trainee learns about a specific skill or procedure by acquiring knowledge, sees the skill/procedure demonstrated, practices the skill/procedure with correction and reinforcement, and then performs the skill/procedure. More recently proposed skill development frameworks expand this process to include the additional steps of PROVE and MAINTAIN.
In this manner, once a trainee has practiced a skill, they undergo objective assessment to ensure a certain skill level has been obtained prior to performing the skill/procedure independently. The trainee is then further expected to maintain skill level through regular practice [4, 6]. As such, to the extent possible, building in opportunities for trainees to observe, practice and prove a trainee’s skill achievement, prior to independent performance of a given skill, will be of mutual benefit to both the trainee and supervisor/PI.
Key point: Knowing ≠ doing
Trainees are not typically able to successfully apply new information automatically. Skill development requires multiple opportunities for observation, practice and feedback.
Trainees are not capable of retaining all the information they are exposed to in one sitting. Deliberate re-exposure of information and continued opportunities for skill observation and practice through continued monitoring and training activities are necessary, at appropriately spaced intervals, in order to enhance retrieval of the information [5, 6]. Similarly, as research and the regulatory climate continue to evolve, it is essential for workforce members to remain up-to-date on developments and best practices.
To accommodate continued training, support and performance monitoring:
- Set specific, measurable onboarding and training goals based on the needs/role of the individual, e.g., set goals for each quarter of the trainee’s first year based on prioritized competency statements.
- Meet regularly with trainees to review progress, discuss milestones and provide feedback. As goals are reached, create new goals or consider how to advance original goals, accordingly.
- Incorporate quality checks and/or formal quality assurance processes to assess trainee performance and proactively. Performance errors that are not identified cannot be corrected, nor prevented. Incorporating a Quality Management Plan (QMP) into an onboarding and training plan (or by protocol), using the Plan-Do-Check-Act approach, will ensure the success of your team, as well as the research.
- Use ‘teachable moments’ to enforce requirements and/or best practices. Errors and ‘outlier’ or ‘one-off’ incidents (that aren’t necessarily performance-related) are going to happen over the course of research. Utilize such incidents to encourage trainees to reference/re-train on applicable regulations, policies and/or good practices.
- Monitor shifts in responsibilities or workload as research protocols progress through their lifecycle (i.e., start-up, implementation and closeout). Shifts in responsibility often require re-evaluation of staff training needs and time commitments. Time commitments, particularly when staff are engaged in multiple studies, with multiple PIs, can easily be overlooked and underestimated, especially as existing research protocols are completed and new ones are initiated. Overburdened staff are less likely to be able to dedicate an appropriate amount of time to continued training and are at risk for burnout and failures in performance, which can ultimately put the research, and the subjects enrolled, at risk.
- Set forth expectations for trainees to participate in continuing education opportunities and safeguard time for them to do so, e.g., set a goal for staff to participate in at least 8 hours of continuing education each performance cycle. Local continuing education opportunities, that are available at no-cost, are regularly offered through OHSP, the Clinical & Translational Science Institute, the Study Coordinators Organization for Research & Education and several external organizations (e.g., Advarra and WIRB-Copernicus Group [WCG]).
- Financially support trainee membership in research-related organizations (e.g., Association for Clinical Research Professionals [ACRP]; Society for Clinical Research Associates [SOCRA]) and attendance at local or national research-related conferences.
Key point: ‘good’ training takes time
Trainees need time to digest the information they are provided and repeated exposure to information to successfully retain and apply information. Phased (or spaced out) training, provided at an appropriate pace, will further aid retention and application.
OHSP training resources
training framework
The OHSP Division of Research Education & Training, in collaboration with other University Human Research Protection Program (HRPP) personnel, has developed free online training courses for all University employees and students. These courses provide a framework of tiered training for research personnel to utilize as needed, and can be used for onboarding, remedial training, and more. Components of these courses were designed to align with key JTF Core Competencies.
Explore the OHSP Training Framework
Study team member onboarding and training guide
This training guide was created to facilitate onboarding and training of study team members engaged in human subject research, and is meant to supplement the tools and resources provided by the Office of Human Resources (including the New Employee Orientation Checklist). It provides suggestions for general orientation tasks, research-related training, systems access and training, as well as protocol-specific onboarding activities.
The document is fully customizable. Contents should be modified per applicable institutional, departmental, and sponsor/funding agency requirements, as well as trainee roles/responsibilities and prior experience.
Sample tools, with contents tailored for generic biomedical and social-behavioral research support positions (e.g., study coordinator, research assistant) with limited experience are also available for reference.
More OHSP resources
- Recordings from the UR-HRPP Educational Forums
- Informed Consent Observation Tool : This worksheet can be used to assess study team member proficiency in facilitating informed consent discussions for the purposes of training, performance evaluation and professional development.
- A-Z Resource Index: The A-Z Resource Index provides a comprehensive index of OHSP resources, including OHSP policies, guidelines, FAQs and written reference materials on research-related topics.
- Click® IRB User Guides and Demo Videos
Non-OHSP training resources
Clinical and translational science institute (CTSI)
The University’s Clinical and Translational Science Institute (CTSI) offers multiple educational programs/opportunities for a wide range of staff/roles engaged in research. A complete listing of programs is available on the CTSI website. Of note:
- The Human Subject Research Coordinator Trainee Program is a 1-year, competency-based workforce development program aimed at preparing individuals with little to no research experience for roles in research coordination.
- The Study Coordinators Organization for Research & Education (SCORE) is a training, support and networking organization for research coordinators and staff.
library electronic textbooks
The following electronic textbooks are also available online through University of Rochester Libraries:
- Cavalieri, J. & Rupp, M. (2013). Clinical Research Manual: Practical Tools and Templates for Managing Clinical Research. Indianapolis, IN: Sigma Theta Tau International.
- Howes, L. M., White, S. A., & Bierer, B. E. (Eds.). (2019). Quality assurance and quality improvement handbook for human research. Baltimore, MD: Johns Hopkins University Press.
- Liu, M. & Davis, K. (2009). Clinical Trials Manual from the Duke Clinical Research Institution: Lessons from a Horse Named Jim. Hoboken, NJ: Wiley-Blackwell.
External resources
- ACRP Course Catalog (Note: Courses available through ACRP are fee-based. Their training opportunities are also searchable by competency domain.)
- Barnett International Training Courses (Note: Training opportunities available through Barnett International are fee-based.)
- Coursera.Org Courses (e.g., Design and Interpretation of Clinical Trials; Clinical Trials Operations Specialization; Faster Together, Enhancing the Recruitment of Minorities in Clinical Trials; Data Management for Clinical Research; Understanding Clinical Research: Behind the Statistics; Community Engagement in Research and Population Health)
- Department of Health and Human Service (HHS) Office of Research Integrity (ORI) ‘The Research Clinic’ Training
- Global Health Training Centre e-Learning Courses
- SOCRA In-Person & Online Courses (Note: Courses available through SOCRA are fee-based. Information regarding course alignment with competency domains are also available)
- Transcelerate Biopharma, Inc./Society for Clinical Research Site’s Informational Programs for Site Staff
- Calvin-Naylor, N., Jones, C., Wartak, M., Blackwell, K., Davis, J., Divecha, R., Ellerbeck, E., Kieburtz, K., Koziel, M., Luzuriaga, K., Maddox, J., Needler, N., Murphy, S., Pemberton, K., Radovich, C., Rubinstein, E., Selker, H., Tenaerts, P., Unsworth, K., Wilson, K., Wright, J., Barohn, R. & Shanley, T. (2017). Education and training of clinical and translational study investigators and research coordinators: A competency-based approach. Journal of Clinical and Translational Science. 1. 1-10. 10.1017/cts.2016.2.
- Institute of Medicine (US). Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing An Agenda for 2020: Workshop Summary. Washington (DC): National Academies Press (US); 2012. Available from: https://www.ncbi.nlm.nih.gov/books/NBK92275/ doi: 10.17226/13345
- Jones, C. & , Browning, S., Gladson, B., Hornung, C., Lubejko, B., Parmentier, J., Pidd, H., Silva, H. & Sonstein, S. (2012). Defining competencies in clinical research: Issues in clinical research education. Research Practitioner, 3, 99-107.
- Kovacs, G. (1997). Procedural skills in medicine: linking theory to practice. Journal of Emergency Medicine, 15: 387-391.
- Medina, J. (2014). Brain Rules: 12 Principles for Surviving and Thriving at Work, Home, and School Seattle, WA: Pear Press.
- Sawyer, T., White, M., Zaveri, P., Chang, T., Ades, A., French, H., Anderson, J., Auerbach, M., Johnston, L., Kessler, D. (2015, August). Learn, See, Practice, Do, Maintain: An Evidence-Based Pedagogical Framework for Procedural Skill Training in Medicine. Academic Medicine, 90: 1025-1033.
- Sonstein SA, Namenek Brower RJ, Gluck W, et al. Leveling the Joint Task Force Core Competencies for Clinical Research Professionals. Therapeutic Innovation & Regulatory Science. October 2018. doi:10.1177/2168479018799291
- Sonstein, S., Seltzer, J., Li, R., Silva, H., Jones, C., & Daeman, E. (2014). Moving from Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research Professional. Clinical Researcher, 28 (3), 17-23.