Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators

Jones, Caleb; Hastings, Catherine; Wilson, Lynda

doi:10.1016/j.outlook.2015.02.002

Cited by 16 publications

(15 citation statements)

References 12 publications

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“…Currently, such staff may be paid less than the registered nurse's award to perform an equivalent research support role to nurses. There is also increasing attention being given to nonhealth professional research study coordinators who may be undertaking clinical roles not supported by scope of practice legislation and or expectations (Jones, Hastings, & Wilson, ). As a result, various organizations have articulated the scope of nonnurse roles in research studies (Nebraska Veteran Affairs Medical Center, ; University of Texas Health Science Center, ).…”

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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A proposed clinical research support career pathway for noninvestigators

Smith

Gullick

Ballard

et al. 2018

Int J of Nursing Practice

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A career pathway that guides education and outlines position descriptions and skill sets would enhance development of the research support workforce. This pathway could contribute to changing the patient outcomes through coordination and study completion of high-quality research. A wide consultative approach is required to determine a cost-effective and feasible approach to implementation and evaluation of the proposed pathway.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

A proposed clinical research support career pathway for noninvestigators

Smith

Gullick

Ballard

et al. 2018

Int J of Nursing Practice

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“…While there are increasing studies that explore nursing perceptions of scopes of practice and begin to address activities that are being shared by both nurses and nonnurses in the clinical research setting; 20,21 no study has directly compared study quality outcomes in the form of protocol deviation rates between nurse and non-nurse CRC counterparts. Olsen, et al addressed issues associated with nurse vs non-nurse staffing by evaluating delegation of duties using an external consultant, staff input and institutional and study site managers.…”

Section: Discussionmentioning

confidence: 99%

“…19 Survey research comparing RN-CRC perceptions of activities being performed by non-licensed CRCs confirm a broad overlap in roles despite RN-CRC concerns that assessment of safety and efficacy parameters may be jeopardized and that there is potential for unlicensed personnel to function outside their scope of practice. 20,21 Comparative research that demonstrates the RN-CRC contributions (e.g., quality indicators) to informed consenting, eligibility, safety, and endpoint assessment is lacking. 16 Moreover, as the complexity of patient populations, clinical research studies and assessments increase, the requirements for hiring RN-CRCs should be increasing, rather than decreasing.…”

Section: Introductionmentioning

confidence: 99%

A retrospective pilot study comparing data from monitoring reports to identify staffing influence on protocol deviation rates

et al. 2018

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Background: Clinical research sites are hiring more non-licensed personnel to coordinate clinical trials and to replace licensed nurse counterparts. Revised regulatory documents heavily emphasize research staff training and research activity delegation of authority. The Scope and Standards of Practice for Clinical Research Nursing, published by the American Nurses' Association and based on role delineation studies for nurses, is the guidance document for clinical research nurses participating in research activities. Policy making related to research activity delegation of authority would be informed by data that correlate protocol deviation rates with licensure and education of research staff. Protocol deviations can lead to invalid clinical trial results, adverse events, and ethical concerns related to participant risk exposure. Outcome data are lacking, which directly compare frequency of protocol deviations by licensed nurse study coordinators to deviation rates of non-licensed study coordinators. Methods: This pilot study reviewed 45 monitoring reports for 3 clinical research studies and associated research sites staffed with licensed RN study coordinators and research sites staffed with non-licensed, non-RN study coordinators to compare deviation rates related to informed consent, protocol endpoints, participant eligibility and adverse events. Results: We identified 101 deviations. Adverse event and endpoint deviations were the highest frequency. Differences were evident in overall deviation rates; however, specific deviation comparisons failed to show statistical significance due to low sample size. Conclusions: This study illustrates a useful method for planning future studies using monitoring reports for deviation tracking and comparison across staffing levels.

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“…However, this result suggests that CRCs need the ability to carry out basic responsibilities as medical personnel such as respecting patients, handling personal medical information, and understanding the contents of medical records. The lack of clear regulations and policies that guide delegation of clinical research activities creates risks to research participants and the quality of clinical research [13]. Further research is needed to clarify the scopes of practice of CRCs who do not have a medical license.…”

Section: Discussionmentioning

confidence: 99%