ADHA Access March 2012 : Page 20
Table I. Research Teams Roles and Responsibilities Principle Investigator (PI) Execute the project as outlined in the funded proposal Carry out the project’s ¿ nancial plan as presented in the funded proposal Report project progress to the sponsor Maintain an accurate record of project related expenses Assembling the clinical team Communicate with the research team Comply with policies and procedures related to project manage-ment and personnel practices Comply will all applicable sponsor rules, regulations and/or terms and conditions of the funding Present scienti ¿ c papers to review the protocol with the option to request changes before the study can proceed. A means of organization and providing information to the dental team is with the use of a Manual of Procedures (MOP). The purpose of the MOP is to establish clear policies and procedures for a variety of critical decisions in the operation of the trial. 11 This document de-scribes the background, detailed logistics of the study and necessary tasks to complete each stage of the study. Speci ¿ c chapters within the MOP are included to assist in the day-to-day function and can include trial administration and organization of the study, training and monitoring of the team, quality assurance, documentation, recruit-ment and screening procedures, enrollment, study material packaging and dispensing, examination procedures, data collection, data entry and management, retention and adherence, and reporting of adverse events and study closure. Study Coordinator (SC) Protocol (MOP) construction/update Clinical trial preparation Development and evaluation of patient information Informed consent forms Using and developing clinical research forms Filing and archiving Patient recruitment Scheduling Regulatory and ethical submissions (IRB) Implement clinical trial from initiation through stages of develop-ment, documents, SOP, organization facilities and credentialing Screening and enrollment of patients Communication with sponsor and authorities Product accountability Time management Data collection and management Queries Trial closure The Role of the Dental Hygienist in Practice-Based Research Dental hygienists are well-suited for conducting research in a clinical setting. There are many roles the hygienist can ¿ ll in a clinical research study, including the role of study coordinator, examiner, re-corder or even the principal investigator. The education, training and experiences they possess make them uniquely capable of participat-ing in practice-based research. Since attention to detail is already an essential part of the dental hygienist’s responsibilities, the introduc-tion of clinical research into the dental hygienist’s daily schedule can be a relatively smooth transition. Research requires a heightened attention to detail because of the issues of privacy, protection of hu-man subjects, and adherence to the written protocol. Research also requires the dental hygienist to learn new skills, such as how to man-age research data, which is similar to managing patient medical re-cords, but also has its own management principles and requirements. To balance the daily schedule of providing oral health care to pa-tients and conducting research on human subjects, the dental hygien-ist and other members of the research team may need to adapt to new routines in their daily practice. The issues they face bring with it exciting opportunities and the chance to contribute to the knowledge base of the practice of dentistry. Examiner (E) Follow protocol for their speci ¿ c task Maintain a high level of competency in their role Comply with training and preparation for the task Maintain con ¿ dentiality with patients Attend on-going training/calibration sessions Participate in inter and intra-rater reliability measures Conclusion In 2004, the American Dental Association conducted a survey of its members asking speci ¿ c questions related to clinical research and how they believe it would affect the way they practice dentistry. Eighty percent of the members felt it was critical to follow treatment guidelines based on clinical research. The dental clinicians already involved in practice-based research felt their patients were bene ¿ ting from the integration of research in their private practice. 12 Once a dental team masters the research protocol and under-stands the framework of a clinical study (grant, protocol, consent, IRB, HIPAA, GCP, inclusion/exclusion, recruitment and retention), the subject matter will change with each study and with that change come new learning opportunities, new skills, new challenges, and possibly a new way in which to provide oral health care. The authors hope that this paper has provided an insight to those in a clinical en-vironment who may be considering or who are already in the process of integrating dental research into their profession. The integration of research can be a means for career growth and increased job satisfaction. Recorder (R) Follow protocol for their speci ¿ c task Familiarize themselves with documents of the study Follow protocol when recording study information Maintain con ¿ dentiality with patients and information gathering the procedures and process that make up the intervention detailed in the protocol. The private practice or institution where the study will take place (site) may require speci ¿ c and specialized GCP training for all staff prior to study start-up. This training helps to ensure that all study staff know how to provide the intervention and collect the data in the same manner across all sites. It is especially important to ensure that staff collecting the exams or primary outcome data is calibrated to ensure that collected data are standardized. In order to make sure the rights of research participants are protected, an Institutional Review Board (IRB) must review proj-ects funded through federal agencies prior to the start of a study. In general, most settings will require that all studies involving human subjects be reviewed and monitored. The study protocol and consent form must be submitted to an IRB before participants can be seen. An IRB is not only responsible for ensuring that participants will be protected, but also that the study is scienti ¿ cally sound and ethical. If a study protocol uses a product regulated by FDA, FDA may also need References 1. Pearce KA, Love MM, Barron MA et al. How and why to study the practice content of a practice-based research network. Ann Fam Med. 2004; 2: 425-8. 2. Fagnan LJ, Morris C, Shipman SA, et al. Characterizing a practice-based research network: Oregon rural practice-based research network (ORPRN) survey tools. J Am Board Fam Med. 2007; 20: 204-19. 20 MAR 2012 access
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