Issues in Clinical Studies Leading to Medical Research Ethics Committee (MREC) Negative Decisions

Sigrid Heinsbroek, Vincent Bontrop, Rutger Chorus, Christian Michel Zwaan
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Abstract

The rationale behind a Medical Research Ethics Committee (MREC) negative decision is always shared directly with the applicants. However, insight into the review process and common reasons for a negative decision may also be valuable for other researchers, clinical research organizations and people with an interest in MREC processes. To our knowledge Medical Research Ethics Committees (MRECs) do generally not report on the negative decisions they issue and on the underlying rationale for such decisions. Here we give insight into the MREC review process by briefly describing procedures and discussing the negative decisions issued by MREC NedMec in the past five years.
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导致医学研究伦理委员会(MREC)做出否定决定的临床研究中的问题
医学研究伦理委员会 (MREC) 否决决定背后的理由总是直接与申请人分享。不过,深入了解审查过程和作出否定决定的常见原因,对于其他研究人员、临床研究机构和对 MREC 程序感兴趣的人来说也很有价值。据我们所知,医学研究伦理委员会(MREC)一般不会报告他们做出的否定决定以及做出这些决定的基本理由。在此,我们将简要介绍 MREC 的审查程序,并讨论奈德梅克 MREC 在过去五年中做出的负面决定,从而对 MREC 的审查过程有所了解。
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