See how this article has been cited at scite.ai
scite shows how a scientific paper has been cited by providing the context of the citation, a classification describing whether it supports, mentions, or contrasts the cited claim, and a label indicating in which section the citation was made.
Limits and challenges of the ICH GCP requirements
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Since the publication of the Good Clinical Practice (GCP) (1991) there has been a progressive movement away from the initial interest in the protection of the rights of the subject, towards the formal guarantee of the completeness of the data, wrongly confused with "credibility".
This causes conflicts and delays for ethical approval and appears to be due to the difference between the criteria used in drawing up the protocols in the pharmaceutical companies or the criteria with which some health authorities omit recommendations for performing clinical studies, and the criteria according to which the Ethics Committees should evaluate the protocol in order to guarantee real protection of the rights of the subject: conformity with the civil and penal law; compatibility with therapeutic practice and with medical ethics; appropriateness for the locally prevalent cultural, ethical, moral and religious conditions; respect for the principles of equal opportunities and justice for access to the study.
The GCP and other recommendations are considered only in this context. Neither the sponsor's internal criteria (Standard Operative Procedures o SOPs), nor any different criteria that can be applied elsewhere are considered. It is therefore suggested to sponsors and to the authorities to incorporate this considerations in the protocols and recommendations; to remember that clinical research is above all a therapeutic action; that a protocol does not necessarily have to be identical everywhere, as long as its integrity is respected.
The less important elements have to allow for adaptation according to the specific local characteristics. This suggests limiting the present practice of centralizing the procedures of drawing up and providing ethical approval of the protocols, leaving greater autonomy to the local operative reality.
How to Cite
PAGEPress has chosen to apply the Creative Commons Attribution NonCommercial 4.0 International License (CC BY-NC 4.0) to all manuscripts to be published.
An Open Access Publication is one that meets the following two conditions:
- the author(s) and copyright holder(s) grant(s) to all users a free, irrevocable, worldwide, perpetual right of access to, and a license to copy, use, distribute, transmit and display the work publicly and to make and distribute derivative works, in any digital medium for any responsible purpose, subject to proper attribution of authorship, as well as the right to make small numbers of printed copies for their personal use.
- a complete version of the work and all supplemental materials, including a copy of the permission as stated above, in a suitable standard electronic format is deposited immediately upon initial publication in at least one online repository that is supported by an academic institution, scholarly society, government agency, or other well-established organization that seeks to enable open access, unrestricted distribution, interoperability, and long-term archiving.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work.