Addendum to Opinion by Letter No 17 – Relevance of Mentioning Ethnic Origin in Clinical Trial Protocols

Can the collection of data on ethnic origin be justified in the context of clinical trials? The Advisory Committee on Bioethics of Belgium recently issued its opinion in Letter No. 17 dated 9 September 2024. It considers that this practice can be justified, provided that a strict ethical and scientific framework is respected.

On May 6, 2025, the Committee published an addendum to Opinion by Letter No 17 following additional questions from Barec.

Opinion by Letter No 19 concerning the communication of incidental findings during exploratory research aimed at developing a screening method​

Publication on December 18, 2024 of Opinion by Letter No 19 concerning the communication of incidental findings during exploratory research aimed at developing population screening

Opinion by Letter No 17 – Relevance of Mentioning Ethnic Origin in Clinical Trial Protocols

Opinion by Letter No 17 of 9 September 2024 concerning the relevance of mentioning race/ethnicity in clinical trial protocols involving healthy volunteers.

Opinion No 69 - Experiments and other scientific research involving inmates

Opinion No 69 of 13 February 2017 on experiments and other scientific research involving inmates.

Opinion No 62 - Ethical Implications of the “Statute” of the Pregnant Partner of a Male Participant in a Clinical Trial

Opinion No 62 of 12 October 2015 on the Ethical Implications of the “Statute” of the Pregnant Partner of a Male Participant in a Clinical Trial.

Opinion No 54 - Consent for the post mortem removal of human body material for human medical applications or for scientific research purposes

 Opinion No 54 of 10 December 2012 on consent for the post mortem removal of human body material for human medical applications or for scientific research purposes

Opinion No 51 -  Publication of the results of human experimentation

Opinion No 51 of 12 March 2012 on the publication of the results of human experimentation.

Opinion by Letter No 7 – Ethical Opinions Regarding Trials Examining Environmental Influences on the Health of Population Groups 

Opinion by Letter No 7 of 23 September 2011 concerning ethical opinions regarding trials examining environmental influences on the health of population groups.

Opinion by Letter No 5 – Relevance of Mentioning Ethnic Origin in Clinical Trial Protocols​

Opinion by Letter No 5 of 23 June 2009 concerning the relevance of mentioning race/ethnicity in clinical trial protocols involving healthy volunteers.

Opinion No 40 – The Scope of Application of the “Experiments” Law 

Opinion No. 40 of 12 February 2007 by the Advisory Committee on Bioethics of Belgium concerning the scope of application of the Law of 7 May 2004 relating to experiments on the human person.

Opinion by Letter No 3 – Deadlines for MRECs (Medical Research Ethics Committees)

Opinion by Letter No 3 of 24 May 2006 concerning the response deadlines imposed on local ethics committees (currently called medical ethics committees) by the Law of 7 May 2004 relating to experiments on the human person.

Opinion No 31 -  Experiments on pregnant and breastfeeding women

Opinion No 31 of 5 July 2004 regarding experiments on pregnant and breastfeeding women.  

Opinion No 26 – Pharmacogenetic Component in Experimental Protocols 

Here are the main recommendations of Opinion No 26 of 15 December 2003 concerning the introduction of a pharmacogenetic component in experimental protocols:​

1. Informed consent: Patients must give explicit consent for each stage of the pharmacogenetic study.
2. Confidentiality: Genetic data must be handled with the utmost confidentiality.
3. Independence of ethics committees: Committees must evaluate protocols independently, without pressure from sponsors.
4. Use of samples: Samples must be used only for the purposes defined in the initial protocol, unless additional consent is obtained from the patient.

Opinion No 14 - Persons suffering from dementia

Opinion No 14 of 10 December 2001 concerning “ the ethical rules with regard to persons suffering from dementia”

Opinion No 13 - Human experimentation

Opinion No 13 of 9 July 2001 on human experimentation

Opinion No 12 - Legal protection of biotechnological inventions

Opinion No 12 of 10 January 2000 on the legal protection of biotechnological inventions.

Opinion No 5 - Legal protection of biotechnological inventions

Opinion No 5 of 9 February 1998 on the legal protection of biotechnological inventions.