Bioequivalence and Bioavailability Forum

Dear Krish,

❝ Can any one let me know what are the rights of subjects participating in clinical trials.

There is no list of subjects rights in ICH GCP, at least nothing worded as such. But you can derive them from the obligations of other parties. For instance:

• you can interpret the whole section 4.8 as meaning that the subject has the right to receive fair, complete and understandable information, the right to ask questions and get fair and complete answers, and the right to have ample time before giving his consent and signing the consent form, of which he has the right to get a copy. He has the right to withdraw from the trial, and the right to do so without having to give an explanation;
  
• paragraph 2.11 can be interpreted as meaning that the subject has a right to have his records kept confidential and privacy rules respected.
  

If you really want to build a list, make sure to also take into consideration the Declaration of Helsinki and your national laws, regulations and recommendations. And don't forget to specify that the subjects rights "include, but are not limited to" items on your list.

Hi Krish,

I agree with Ohlbe’s remark about the WMA’s Declaration of Helsinki (JAMA 2013) and the Medical Ethics Manual. See also the UNESCO’s Universal Declaration on Bioethics and Human Rights. I would emphasize part of the DoH’s § 26:

The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal.

Some CROs and their PIs are infamous for their “interpretation” of this section. They follow the widespread – but false! – belief that dropouts/withdrawals have a substantial impact on power.* Hence, they have an entire arsenal of leading questions “Don’t you think that strong headaches happen once in a while? Are you a man or a sissy?” or even threats “If you leave this study you will never be accepted for any other. Think about it!”…

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• In most scenarios a dropout-rate of up to 15% reduces power by less than 5%.