Preclinical & Clinical Trial Requirements
Preclinical and clinical trial requirements in Uruguay – a legal guide. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
2. How are clinical trials funded?
Clinical trials can be funded by a promoter (individual, company, institution or organization responsible for the start-up, management and/or financing of research) or by a Sponsor (individual or legal entity which supports the financing or finances research), as defined by Decree 379/008.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
Protocols must comply with the requirements of international regulations applicable to research on human beings and requirements set forth by Decree 379/008 and Ministerial Ordinance 827/016: description of the trial, risks and benefits, responsibilities of the Researcher, Institution, Promoter and Sponsor; financial plan, information on research participants, description of the characteristics of the population to be studied, submission of the research specific consent form, among others.
The preclinical and clinical trial protocols must be approved by the Institutional Ethics Committee of the Institution where research is conducted. Research on new drugs, vaccines, diagnostic tests, healthcare equipment and devices must be informed and –depending on their reach- approved by the National Commission of Ethics in Research, which shall send its assessment to the General Healthcare Directorate of the MSP. Depending on the reach of the project, other ministerial authorities may be involved in the process of approval.
4. What are the requirements for consent by participants in clinical trials?
The free and previous consent of participants is required. The consent for clinical trials should inform all participants of:
- justification, objectives and research proceedings;
- any discomfort, possible risks and expected benefits;
- existing alternative methods;
- follow-up and care, responsible persons;
- duration of participant’s involvement;
- the right of the person to refuse to participate or to withdraw his/her consent at any stage of the research, with no sanctions and regardless of the care that will be provided;
- method of reimbursing expenses incurred due to participation in the research;
- compensation vis-à-vis possible damages caused by the research;
- how to communicate with and access the researchers during the study.
In addition, for the free and informed consent to be valid, it shall meet the following requirements:
- be prepared by the responsible researcher;
- be approved by the Research Ethics Committee;
- be signed or identified by digital printing, by each and every research participant or legal representatives and by the responsible researcher;
- be issued in two counterparts: one to be given to the research participant or legal representatives and another one to be filed by the responsible researcher.
5. May participants in clinical trials be compensated?
There are no regulations as regards compensation for participants in clinical trials.
However, Decree 379/008 states that expenses incurred by research participants within the framework of the trial may be reimbursed as long as the amount of such expenses is not such that it may interfere with the decision-making autonomy of the participant or its legal representatives.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
Decree 379/008 states that participants in clinical trials who suffer damages of any nature (whether foreseen or not in the terms of the consent) resulting from their participation, in addition to the right to a comprehensive assistance, shall have the right to compensation. Under no circumstance may the research participant be required to waive the right to compensation for damages. The free and informed consent form must not include any term which reduces this liability or which implies that the research participants have waived their legal rights, including the right to compensation. Any term and condition in this sense will be void.