2. Preparation of research plans

Foto científica ellipse 602.1. Written projects subject to scrutiny by outside parties
Prior to their initiation, all research projects must be formulated in a written research plan. If the project directly involves humans, experimental animals, or human embryonic material, the text must have been independently assessed by an ethics committee on clinical research and/or animal experimentation.[7] The text of the research plan generally coincides with the written proposal necessary to obtain approval and funding.[8]

2.2. Unacceptability of secret research
Under no circumstances should a research plan, or any part of such plan, remain secret. This stipulation differs from temporarily restricted access to certain research plans or parts thereof for reasons of competition and confidentiality.

2.3. Extension or modification of the research plan
The development of an unexpected or additional research question may require preparation of a corresponding complementary written plan prior to initiating research in that direction. This is indispensable when the research directly involves human subjects, experimental animals, or human embryonic material, or in some cases where there is extension or alteration of the primary objectives of the research.[9] If the implications of the new research question so require, the revised research plan must follow established procedures for external authorisation and supervision.

2.4. Exceptionally urgent research
When situations relating to public health or safety require the immediate establishment and implementation of a research project, the start of research activities must nevertheless be supported by a research plan describing the procedures involved, albeit in a simplified form; this is especially applicable when that research involves human subjects or experimental animals. As far as possible, simplified research plans to be initiated urgently should nevertheless be externally reviewed and processed according to the normally required procedures for research plans.

2.5. Use of external equipment or facilities
In order to ensure appropriate use of resources, all research plans that involve the use of health service facilities or equipment designated for patient care, or of any research facilities or equipment not designated for the exclusive use of the research group, will require prior consent from the individual responsible for the facility or equipment that is to be used.

2.6. Collaborative research
When a planned research project involves the participation of several groups from the same or different centres, it is recommended that the limits and terms of the collaboration be formalized in writing before initiation of the definitive project.[10]

2.7 Registration of research involving human participants
All research projects involving human participants initiated after October 2013[11] should be registered in a publicly accessible database before recruitment of the first subject.

[7] See Section 8.

[8] A project proposal includes as a minimum requirement, the background to the project, specific objectives, proposed methods, a work plan including a predicted time scale, available and necessary resources, and the names of persons in the participating team. According to the type of study to be undertaken, the project proposal may also include ethical, legal and safety provisions, as well as a plan for the communication of the results of the study.

[9] This would be the case, for instance, when stored biological material that is associated with identifying information on the source individuals is used for purposes other than those predicted in the original project proposal.

[10] An appendix to the research project proposal might include the following: criteria defining the relationships between the different researchers involved and governing the exchange of information during the course of the project; the explicit distribution of responsibilities, rights, and obligations of the participating groups both in relation to the tasks to be undertaken and the results obtained; a plan for the presentation and communication of the results; procedures for the storage and distribution of data and samples; prediction of possible commercial implications; stipulations relating to funding and resolution of conflicts.

[11] World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013;310(20):2191-2194. doi:10.1001/jama.2013.281053


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