Table 5.
Common ethical misconduct by stage in clinical research in China
Research process | Misconduct |
---|---|
Research design | Research participants (e.g., graduate students) failing to receive proper scientific training; Failing to register the clinical trials in public databases before recruitment; |
Relaxing eligibility criteria to recruit participants (e.g., enrolling subjects who do not meet inclusion or exclusion standards to expedite project completion) | |
Recruitment | Recruitment materials misleading subjects (e.g., implying that the test drug is healthy, safe, and can cure diseases); Enticing subjects with reimbursement; Conducting clinical trials secretly without recruitment and failing to inform the patients before signing the informed consent. |
Informed consent | Failing to inform objectively (e.g., repeatedly emphasizing the free charge of drugs and subsidies while circumventing the key point); Going through informed consent as a formality with the only purpose to obtain the signature; Failing to obtain consent with signature. |
Clinical trial | Collecting additional specimens without informing participants with the intention of using them for other research; Simply ignoring minor adverse effects during clinical trials; Failure to document the trial process; Carrying out clinical research without ethical approval. |