Transcript 1.研究倫理審查實務經驗分享慈院林錦鴻總幹事

Difference in
Social and Medical Researches
An small Opinion from
Dr. 林錦鴻
花蓮慈濟醫院 研究倫理委員會
Should All Researches
be pass the IRB Regulation ?
Student Protocol ? (專題研究)
For the purpose of managerial
improvement? (院外專案)
Educational Intervention ? (教學研究)
Non-Published Protocol and Proposal?
Government regulation? (政府規範)
Exemption of IRB regulation ? (免審)
Expedited review (簡易審查)和Full Board
review (一般審查)
IRB Facing a Challenge
在人體研究法施行後，大量有關於社會科
學有關於人的研究，都需要送 IRB
而 IRB 在審查這些研究上是否已經準備好
了?
審查的標準是否和醫學研究是否要相同或
者要有差別?
文件表格和臨床研究是否可以一體適用?
原來的 SOP 是否可以適應整個社會科學的
硏究呢 ?
Protocol Quality Distribution
Statistics and IRB Regulation
Which Case Should be Dropped Out ?
Our Cutting-Off Line (心中的那條線在那裏)
Line Changes
– (Different Reviewers, members, IRB)
Protocol Quality Distribution
IRB Decision Making
True: Good Protocol
False: Bad Protocol
IRB Choices
Increase Type 1 Errors ?
Decrease Type 2 Errors ?
Increase Power ?
Positive Prediction Rate ?
Negative Prediction Rate ?
IRB should make its strategy for Social or
Medical Research
IRB Cutting-Off Line for
Decision Making
All the Research are Different
Different Categories have Their Own
Distribution
Not Only a Line is determined
There is rarely research for IRB running in
Social Science Researches
Single or Multiple Lines Regulation
IRB should be regulated with Government
Is it acceptable by other peers?
Need to negotiate and have more
compromise
However, I do not know now (走一步算一步)
Distributions
Petition for IRB
Any Thought after My Thought ?
Need to Evolve or Resolve ?
– ( 等待進化或進行革命）
Poison Tree or Venomous Snake ?