Skip to main content

Table 2 Problems in the ethical review process of clinical trials

From: Quality problems of clinical trials in China: evidence from quality related studies

Subject

Number

Item

Ethics committee configuration

1

Unreasonable number and composition of the ethics committee [11, 13, 20, 24, 26, 30]

2

Inadequate capacity of ethics committee members [7, 17, 26, 27, 29, 30]

Implementation

3

No review standards and norms [22, 26]

4

Incomplete review and nonstandard records [21]

5

Nonstandard documentation and qualification management [19]

6

Ignoring follow-up reviews and ethical acceptance check [22, 27]

7

No rigorous program review [25]

8

Inadequate consideration of ethical issues (such as subsidy for participants, wash-out time, procedures for reporting serious adverse events) [25]

9

Insufficient ethical consciousness of researchers [22]