Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 3-002

Document information
Reference	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
Validity area	GBR
Scope(s)	HM
Document name	The Medicines for Human Use (Clinical Trials) Regulations 2004
Version / Revision	01-May-2004
Status	Current
Document type	Legal act
Language(s)	EN
Description	The Medicines for Human Use (Clinical Trials) Regulations 2004
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 3 — Unit 3.1.4
Scope	HM
Document part	Schedule 1 Part 3
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Incapacitated subject, Informed consent, Trial participant

Content

PART 3 CONDITIONS WHICH APPLY IN RELATION TO AN ADULT ABLE TO CONSENT OR WHO HAS GIVEN CONSENT PRIOR TO THE ONSET OF INCAPACITY 1. The subject has had an interview with the investigator, or another member of the investigating team, in which he has been given the opportunity to understand the objectives, risks and inconveniences of the trial and the conditions under which it is to be conducted.

2. The subject has been informed of his right to withdraw from the trial at any time.

3. The subject has given his informed consent to taking part in the trial.

4. The subject may, without being subject to any resulting detriment, withdraw from the clinical trial at any time by revoking his informed consent.

5. The subject has been provided with a contact point where he may obtain further information about the trial.