Shortening the time required to receive a permit
New treatments and medicines, and more advanced medical devices are always greeted with hope by patients. But research scientists have a long way to go before they appear. A necessary and crucial step during the process is biomedical research, which refers to the testing of hypotheses in biomedical sciences using scientific methods.
Biomedical trials must comply with bioethical requirements which have been set out in interrelated international, EU and national legislation.
An important requirement is to obtain a permit for any concrete biomedical research.
Who issues permits?
Permits are issued in Lithuania by the Lithuanian Bioethics Committee (LBEK) and the regional (Vilnius and Kaunas) bioethics committees (hereafter referred to as bioethics committees).
The territorial boundaries of these committees are determined by the Minister of Health. The bioethics committee to which documents must be submitted depends upon the area in which the study will be carried out.
For clinical medicinal products, medical device trials, and efficacy trials, you need to apply to the State Medicines Control Agency and the State Accreditation Service for Health Care Activities under the Ministry of Health.
In this article we will discuss only permits which relate to clinical biomedical trials (‘trials’).
Key principle
The guiding principle in these studies is that human interests come before scientific or societal interests. Therefore, requirements for the drafting of necessary documents are manifold. Drafting necessary documents in a way which is appropriate to ensure that the bioethics committee experts do not raise any objections or request supplemental information, thereby ensuring that the required permit is granted without hindrance, is a complex and painstaking task, one which requires legal expertise amongst other things.
Why is correctly-drafted documentation so important?
To be able to obtain a permit, documents which have been approved by order of the Minister of Health must be submitted. Certain forms which have been approved by order of the director of the LBEK have to be completed. It is important that the current version of the forms is submitted to the bioethics committees, otherwise the documents will be rejected. It is therefore advisable to take a good estimate of the actual time needed to obtain authorisation. Article 23 of the ‘Law on the Ethics of Biomedical Research’ stipulates that permission will be granted within forty-five days, but this time limit is calculated from the date upon which the required documents have been duly completed, which means that if the bioethics committee experts comment at least once, or if incomplete or incorrectly prepared documents are rejected, the time limit will be extended.
Considering the fact that the bioethics committees meet only once a month, and that any replies to expert comments also need to be submitted according to a set procedure, without any misrepresentation of versions, it is clear that the process of preparing the documents needs to be intelligently planned. Timelines are particularly important if the study is funded by international sponsors.
What are the main challenges in the preparation of documents?
The first step is to assess whether the research contains all those prerequisites which have been set out in the extact legal acts, whether the research is truly biomedical, and whether permission is strictly necessary.
Unfortunately, bioethics committees do not consult on this issue, and the answer will only be known once all of the documents have been submitted to the bioethics committee. It is important for researchers to decide whether vulnerable people will be involved in the study and to be able to justify the need for their participation.
There also exist challenges when it comes to obtaining informed consent to participate in the study (IASF). This specifically covers whether an IASF is needed, along with the procedure for obtaining it. The IASF is compulsory, but in certain cases the bioethics committee may waive the obligation to obtain it, provided that any request for a waiver is well-motivated and properly documented.
One situation in which mistakes can be made is the procedure for obtaining consent from a child who is to be included in the study. According to Lithuanian law, both of the child’s parents, or their legal guardian, must give written consent. Implementing this requirement to ensure the authorisation of both parents or the child’s legal guardian may be difficult if one of them does not agree with providing such consent, for whatever reason. However, the submission of an IASF which has been signed by only one of the parents would not lead to a permit being issued for the study and would present a challenge to the researchers when it comes to revising the documentation.
A common question for researchers is whether, if a person has already given their consent to a biobank, further consent is required to allow them to participate in a specific study. In answering this question, it is important to understand not only the difference in the formal legal regulation where it applies to these two forms of consent, but also the purpose of biobanks in general, and the content of the intended research.
We will discuss other challenges during the preparation of documents, including the specific details involved in completing the biomedical research protocol, responding to expert comments, the required contracts, researcher CVs, insurance, and so on in the following articles.
Perhaps you already have specific questions about completing the paperwork for a trials permit, or if you haven’t received a permit and want to appeal against the decision, please get in touch and we will be glad to provide you with individual advice.