What training is required for a healthcare provider working in clinical research with pediatric populations?

Training Requirements for Healthcare Providers in Pediatric Clinical Research

Healthcare providers working in clinical research with pediatric populations require comprehensive core research training that includes at least 12 months of dedicated research time, with supervision by an experienced investigator, and must develop competencies in eight essential skill areas including biomedical ethics, informed consent, patient protection, and research methodology. 1

Core Research Training Components

All providers conducting pediatric clinical research must develop skills in the following areas under appropriate mentorship 1:

Essential Competency Areas

• Literature review and knowledge assessment - Providers must learn to ascertain the exact state of knowledge before undertaking new investigation 1

• Hypothesis formulation and study design - Training must include ensuring hypotheses are testable, goals are appropriate, and statistical power is achievable 1

• Research protocol development - This encompasses study design, subject recruitment, ethical considerations, informed consent and privacy protection, data collection modes, full description of procedures, and institutional approval of human investigation 1

• Data collection and management - Including preparation of data forms and handling of artifacts, missing data, outliers, and statistical inference 1

• Results presentation - Both oral and written presentation skills are required, with emphasis that no investigation is complete until reported in peer-reviewed journals 1

• Risk-benefit analysis - Providers must be trained to evaluate both patient (subject) risk and benefit as well as societal risk and benefit 1

• Health policy implications - Understanding how research findings translate to policy is essential 1

• Biomedical ethics and patient protection - Research must be carried out according to approved principles of biomedical ethics and institutional rules for patient protection, recognizing the complexity of achieving valid scientific conclusions while simultaneously protecting the interests of each pediatric patient 1, 2

Duration and Structure

Minimum Training Period

• For providers focused on education and patient care: A full 12 months of dedicated research time devoted to specific research projects is required in most cases 1

• For providers planning research-focused careers: An additional one to two years beyond core research training, working directly with an experienced funded mentor, is needed 1

Formal Educational Pathways

Core research training in the eight skill areas can be most easily obtained as part of a master's program in Clinical Investigation, Public Health, or some other structured program 1

Supervision and Mentorship Requirements

All pediatric clinical research training must be carried out under the supervision of an experienced investigator 1. The training institution must have:

• At least one full-time faculty member with demonstrated skill and research productivity as an investigator 1

• Staff and facilities for research, with opportunities available within clinical divisions and biomedical science programs 1

• Readily available expertise in epidemiology, outcome evaluation, biostatistics, population science, behavioral science, quality of care, outcomes research, and biomedical ethics 1

• An atmosphere of intellectual inquiry and support of the investigational process 1

Special Ethical Considerations for Pediatric Research

Unique Pediatric Requirements

Providers must receive specific training recognizing that pediatric research is particularly difficult because of 1:

• The complexity of achieving valid scientific conclusions while working with a diverse pediatric population 1

• The necessity of simultaneously protecting the interests of each child patient 1

• Children's status as a vulnerable population requiring special protections 2

Informed Consent and Assent

Training must address 2, 3:

• Obtaining appropriate parental permission for research participation 2

• Securing child assent when developmentally appropriate 2

• Understanding the special somatic, emotional, and mental needs of children at different developmental stages 3

• Respecting children's rights to be involved in consent or assent processes 4

Common Pitfalls to Avoid

Providers lacking expertise in these core areas may be unable to interpret critical reports bearing directly on their practice, may accept new data uncritically, or may recognize important advances tardily 1. Training programs should provide frequent opportunities for faculty and trainees to review and analyze small- and large-scale clinical and basic research reports in depth 1.

For multicenter clinical trials, participation in the full range of special activities outlined above is required 1. The training must ensure providers can balance the ethical demand to conduct clinical studies with the necessity to avoid doing harm to pediatric subjects 3.