10 obligations of the sponsor of medical research in the law of clinical research

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The Clinical Research Law, known in the media as the Clinical Research Law, placed obligations on the sponsor of medical research, which the law defined as the person who undertakes the responsibility of initiating, managing, financing and supervising medical research, whether it is a natural person such as the main researcher, or a legal person such as a company, institution, or a local, regional or international organization. Provided that it is legally represented within the Arab Republic of Egypt

The commitments are as follows:

1- Obtaining all the required approvals according to the nature and type of medical research.

2- Supervising the implementation and financing of medical research from its inception until its completion.

3- Establishing mechanisms for monitoring performance and quality and ensuring that medical research results are extracted, documented and announced, all in accordance with the approved study protocol and in accordance with good medical practice.

4- Submit periodic reports to each of the competent institutional committee and the Supreme Council on how medical research is conducted and financed.

5- Editing the agreements that he concludes with all parties to the medical research, provided that he include them in the medical research file.

6- Maintaining with him and the database of medical research in the Supreme Council in the Arab Republic of Egypt, all main documents and private data related to medical research, after publishing their results.

7- Providing medical intervention to the respondents participating during and after the end of the medical research, according to each case and in whatever form it was, as well as transporting, preserving and storing it in appropriate safe ways.

8- Immediately reporting to the respondents participating in the medical research, and promptly, of any modifications made to it and of any results that may negatively affect the safety of the participating subjects, as well as the serious unexpected side effects of the medical research.

9 – Commitment to conclude an insurance contract for respondents participating in medical research with one of the approved insurance companies in the Arab Republic of Egypt, in order to face any damages that may result from participating in medical research, and the contract referred to in this clause must include the period of research The medical examination and the period of follow-up so that it is valid for a year after the completion of the medical research, and that the value of this insurance is approved by the Supreme Council.

10- Compensation and treatment required for respondents participating in the case of infection related to medical research.

11- Completion of treatment for those of the participating respondents who prove their need for this even after the end of the medical research.

All this is as determined by the executive regulations of this law

It is noteworthy that the parliament had approved the law at the end of the third session, then the president objected to it and did not ratify it and returned it to the council, and at the beginning of the fourth session the parliament formed a special committee to re-study the Clinical Research Law, in light of the 15 articles that the President objected to ) Matter.

The council approved the law in its last session at the fifth session to send it to the president pending ratification.

The Council approved a number of amendments to address the objections that came in the President’s message, whereby the institutional committees approved final approval of most medical research protocols submitted to them

The amendments dealt with the formation of the membership of the Supreme Council for Research, as it included a redistribution of the number of the 15 members of the Supreme Council, so that the Ministry of Higher Education and Scientific Research would have (5) members in exchange for (2) dawn, and the amendments included a reduction in penalties.



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