Re: Review of the Declaration of Helsinki
Dear Sir or Madam:
BIO appreciates the opportunity to comment on the World Medical Association’s (WMA’s) Declaration of Helsinki. The Biotechnology Industry Organization (BIO) represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations in 32 nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products.
1.1 General Comments
The integrity and safe conduct of clinical trials is of the utmost importance to BIO members developing biomedical products. BIO believes strongly in protecting the rights and welfare of human subjects involved in biomedical research. We recognize that well-accepted international standards for clinical research, including those published under the International Conference on Harmonization (ICH) and associated with Good Clinical Practice (GCP), draw on the important principles articulated in the Declaration of Helsinki.
Clinical trials involving the administration of a new drug to a human being should be conducted in accord with the ICH GCP guidelines, which are available at www.ich.org. These ICH guidelines provide an internationally accepted ethical and scientific quality standard for designing, conducting, recording and reporting trials. Compliance with this standard provides public assurance that the rights, safety, and well being of trial subjects are protected consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. The guidelines cover issues such as the selection and training of trial investigators, gaining informed consent from trial participants, trial monitoring and quality assurance.
In the United States (U.S.), the Food and Drug Administration (FDA) also provides GCP Guidances, and the GCP regulations for studies conducted in the U.S. can be found in the U.S. Code of Federal Regulations (21 CFR 50, 21 CFR 54, 21 CFR 56, 21 CFR 312). These guidances and regulations detail the responsibilities of sponsors, investigators, and institutional review boards (IRBs) and also outline monitoring practices to ensure regulatory and study design compliance and subject safety.
BIO opposes the current draft of the Declaration of Helsinki for the following reasons:
1) The nature of the Declaration changes from high level principles and becomes increasingly prescriptive, thereby duplicating the functions of legislation and regulation.
2) In some instances, the text that has been changed or added does not align with ICH GCP guidelines, the EU Clinical Trial Directive, United States law and FDA regulations, local laws/regulations, and other more comprehensive ethical guidance documents such as those published by the Council for International Organizations of Medical Sciences (CIOMS) and the World Health Organization (WHO). This lack of alignment creates confusion and a lack of regulatory clarity. We note that many of these other documents have been developed specifically to provide guidance or oversight for large multinational clinical research programs involving many diverse stakeholders.
Because the Declaration was and is written by treating physicians for treating physicians, its scope cannot easily be expanded to cover these types of programs appropriately, in a way that reflects current law/regulation and contains the detail necessary to be useful.
BIO considers the Declaration of Helsinki a significant document that exists to safeguard the safety and well being of trial participants and strongly advocates that the Declaration remain a high level document that provides important guiding principles for the ethical conduct of clinical research.
1.2 Specific Comments
BIO appreciates this opportunity to comment on WMA’s Declaration of Helsinki. We look forward to seeing the next draft, and would be pleased to work with WMA to provide further input or clarification of our comments, as needed.
Vice President, Science and Regulatory Affairs
Biotechnology Industry Organization