臨床研究護理師專業角色與執業範疇之探討

Abstract

臨床研究護理師這個角色對護理人員來說，是一項新興的工作領域，有許多角色模糊不清的部分。本研究目的為探討台灣臨床研究護理師專業角色與執業範疇。此研究擬採二階段進行： 第一階段為運用系統性文獻查證方式，進行國內外以研究護理師專業角色與工作描述相關之全文，作為評核之文獻，而文獻的納入標準為：1).討論角色功能與工作範疇；2).測量群體為執行臨床試驗/研究之第一線收案人員(研究護理師/研究協調員等)；3).以中文、英文發表的全文研究文章。排除評讀的文獻標準為：1).討論護理研究者之文章：2).非討論臨床研究中研究護理師/研究協調員角色議題之文章；3).無全文或非以英文/中文書寫之文章，搜尋PubMed (1950s- 2011)、MEDLINE via Ovid online（1951-2011）、CINAHL(1983-2011)、華藝線上圖書館等索引資料庫，並依文獻內容將臨床試驗執行前期、中期、後期所扮演之臨床角色與需負責的業務，以及專業能力議題，分別條列於評核表中。接著進行二回合的前驅研究，完成問卷設計的表面效度與內容校度。 第二階段採用德菲研究法(Delphi)，擬進行二次專家修訂形成各界對於臨床研究護理師角色功能與執業範疇的共識，專家成員包括：計劃主持人、臨床研究護理師、臨床研究專員、臨床護理師等，共計23人。完成德菲研究法後，召開專家共識會議，將臨床研究護理師分為三個層級(Level 1~ Level 3)，並再邀請35位專家協助評核，以設立各層級應具備之專業能力與執業範疇。 未來可藉此擬訂台灣之臨床研究護理師(CRNs)之專業角色與執業範疇，同時可將本研究結果應用於臨床護理及學校教育，以作為醫院與護理學校設計臨床研究護理師執業規範與培訓依據。

Clinical Research Nurses (CRNs) is a new nursing role for nurses and there are many unclear job scopes. The purpose of my research is in order to setting up the professional role and job scope of Clinical Research Nurse in Taiwan. There were two steps in my study. First, I used the way of systematic review to find papers, which discussed about the professional role and job scope of CRNs, to appraisal it. Inclusion criteria of papers were 1) To discuss about the professional role and job scope of CRNs, 2) The research population were CRNs or Clinical Research Coordinators (CRCs), 3) Papers which published by Chinese or English with full text. Exclusion criteria of papers were 1) These papers were discussing nurse researchers, 2) The research population were not CRNs or CRCs, 3) Papers which did not publish in Chinese or English words or I could not got full text. I used PubMed (1950s- 2011), MEDLINE via Ovid online (1951-2011), CINAHL (1983-2011), and Airiti Library as my database. By using key words to search these databases, there were 61 related articles for me to appraisal it and I selected 58 articles for questionnaire. After extracting the clinical roles and job scopes for each period of clinical trials, I set up four parts on my questionnaire: before clinical trial start, during clinical trial, after clinical trial finish, professional role development issue of CRNs. Then, I invited three experts to make face validity and 23 experts to do the content validity for my questionnaire. Second, I used two rounds Modify Delphi Method to know the consensus of the professional role and job scope of CRNs. There were 23 experts in my study, including principle investigators, clinical research nurses, clinical research associates, registered nurses. After finishing the Modify Delphi Method, I convened the expert consensus meetings to check my questionnaire and they divided CRNs into three levels (Level 1~ Level 3) by their ability. Then, I invited 35 experts to review the questionnaire and assessed whether the three level classification were appropriate. In the future, we will use these results for setting up the professional role and job scope for CRNs. Base on the results, hospital and department of nursing will use it to development the training program for CRNs.